Running head: LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE

An Innovative Literacy-Supportive Education Pilot for Wound Self-Care
Erin M. Tharalson
Arizona State University

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Abstract
As the incidence of acute and chronic wound conditions rises and wound dressing protocols
become more complex, uninsured patients lacking access to specialty wound care are challenged
to manage their own wounds. Understanding multistep dressing change protocols may be
inhibited by low health literacy. Low health literacy is associated with reduced disease
knowledge and self-care. Little evidence of health literacy effects on wound patients is available
nor are literacy-sensitive educational interventions that address wound knowledge and self-care.
Improved outcomes occur in all health literacy levels in other diseases with the use of literacysensitive educational interventions that incorporate more than one literacy strategy over multiple
sessions. To examine the effectiveness of a literacy-sensitive wound education intervention on
wound knowledge and self-care, an evidence-based pilot project was conducted in an urban
wound clinic. A convenience sample of 21 patients received a literacy-sensitive wound
education intervention consisting of spoken and written communication over several sessions.
Instruments measured health literacy level, wound knowledge, dressing performance, and wound
healing status. There was a significant increase in wound knowledge scores in all literacy groups
from baseline to visit two (p < .01) and four (p < .01). Dressing performance scores remained
consistently high through visit four in all literacy levels. All participant’s wounds progressed
toward wound healing significantly from baseline to visit two (p < .01) and four (p < .01).
Incorporation of a literacy-sensitive education intervention with supportive literacy aids over
several sessions supports improved wound knowledge and dressing self-care and can affect
healing in patients of all health literacy levels.
Keywords: health literacy, wounds, dressings, self-care, knowledge

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
An Innovative Literacy-Supportive Education Pilot for Wound Self-Care
The incidence of acute and chronic wound conditions is growing rapidly in the United
States. Advances in wound care add complexity to wound care protocols, including dressing
changes. Uninsured patients who require wound care services typically perform multistep
dressing changes by themselves at home. If they are performed improperly the patient is at risk
for negative outcomes. Medical personnel are tasked with teaching dressing changes to patients
in a manner that factors in the health literacy needs of the patient. Evidence is limited in the
effect of health literacy on self-wound care, but research in other chronic diseases with similar
multi-step treatment regimens report improvement in disease knowledge and self-care in all
health literacy levels with literacy-sensitive educational interventions that incorporate mixed
strategies over multiple sessions. The purpose of this manuscript is to review the results of an
evidence-based pilot project aimed at improving wound knowledge and self-care with the
implementation of a literacy-supportive educational intervention in clients with wounds treated
in an outpatient clinic.
Background and Significance
The incidence of acute and chronic wound conditions is growing rapidly. This is due to
an increasing incidence of predisposing factors: diabetes, obesity, and an aging population (Sen
at al., 2009). According to the Centers for Disease Control and Prevention (CDC) (2014), 21
million people in the United States have been diagnosed with diabetes, and an estimated 8.1
million have not yet been diagnosed. An estimated 25% of people with diabetes will develop a
diabetic foot ulcer, and 66% of these will recur (Singh, Armstrong, & Lipsky, 2005). Chronic
wounds or wounds that fail to improve in a timely and orderly process affect 6.5 million people
in the United States and cost over 25 billion dollars annually to treat (Sen et al., 2009). Acute

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wounds arise from a variety of sources including surgical wounds, trauma, abrasions, bites, and
burns (Sen at al., 2009). The National Center for Health Statistics reported 48 million inpatient
surgical procedures were performed in 2009, up 8 million from 2000 (CDC, 2009). As the
number of surgical procedures continues to rise, so will the number of resultant wounds.
With this increase, the wound care product market is one of the world’s largest and fastest
growing, costing 15.3 billion dollars in 2010 (Sen et al.). This has led to availability and
variability of wound products. Currently, there are over 4,000 wound products on the market
(Hettrick, 2014). Dressing application protocols vary based on product type and usually require
multiple steps to apply and remove.
Patients with health insurance typically receive wound care and dressing changes in
specialty clinics or through home health care. On the other hand, most uninsured patients
manage their wounds at home themselves or with help from family members. Compared with
insured patients, uninsured patients experience poorer health outcomes, reduced quality of life,
and increased mortality (Institute of Medicine, 2009). They also generally lack access to regular
screening and prevention services (Institute of Medicine, 2009). In 2015, 28.4 million
Americans were reportedly uninsured (National Center for Health Statistics, 2016). Patients
without insurance find it harder to obtain care than those with insurance (Pieper, 2005).
Uninsured patients with a wound face challenges in seeking assistance due to costly specialty
care and dressings, and a limited number of wound clinics providing charity services (Pieper,
2005). Also, uninsured patients with chronic wounds require long-term attention and frequent
follow-up (Pieper, 2005). This lack of access to wound services makes chronic wound healing
difficult to achieve.

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Limited access to wound care is concerning in major metropolitan cities such as Phoenix,
Arizona. There, the rate of uninsured patients is as high as 22.2%, compared with the national
average of 10.5% (United States Census Bureau, 2015). Uninsured rates are reported to be even
greater in minorities. Phoenix has a large Hispanic population (40.8%) compared to the entire
United States (16.3%) (United States Census Bureau, 2010). Over 30% of Hispanics in Phoenix
lack health insurance according to the 2012 Pew Hispanic Report (Motel & Patten, 2012).
Phoenix also has the highest Hispanic poverty rate in the United States and the lowest median
household income (Motel & Patten, 2012). Based on these demographics, Hispanic patients with
chronic wounds are especially challenged to receive wound care services.
Internal Evidence
Several clinics in Phoenix provide primary care to uninsured populations at little to no
cost. Few offer specialty care. Currently, one clinic provides charity wound care. This clinic
conducted an internal review of its uninsured patient population. The detailed results are shown
in Table 1. The majority of patients reported their country of origin as Mexico and their primary
language as Spanish (Lee, 2016). Of those who answered, 54% reported their education as high
school or GED, and 33% reported less than an eighth-grade education (Lee, 2016). These
findings suggest educational and language barriers that may impact health literacy levels.
In the charity wound clinic, an adult nurse practitioner who is a certified wound specialist
sees a full range of wound patients from acute post-op surgical wounds to chronic venous stasis
ulcers. The wound clinic offers most available wound care products and follows current
evidence-based wound care protocols. Presently, wound care and dressing instructions are given
orally and then demonstrated. Wound instructions are communicated through a certified medical
interpreter for patients who speak Spanish. Though some patients do well, others are

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inconsistent or fail to carry out dressing instructions. Specific problems include improper
dressing changes, skipping dressing changes, and using mixed methods of wound care.
Complications of suboptimal wound care in the clinic include infections, delayed healing,
increased clinic dressing costs, patient inconvenience, and hospitalizations. Underlying causes
of unsuccessful dressing changes reported by patients include lack of understanding of
instructions, language barriers, reliance on family members not present at the clinic visit to
change the dressings, and challenges with the complexity of the dressing change protocol. These
factors indicate that current educational practices are not meeting the needs of the population.
No formal health literacy assessment has been conducted in this clinic’s population, and with the
noted variables of language, education, and dressing complexity, the current dressing education
process may not be appropriate for all patients.
Health Literacy
Health literacy is the capacity to process, understand, and obtain basic health information
and services and act on them (Agency for Healthcare Research and Quality, 2015). Limited
health literacy affects people of all incomes, races, ages, and education levels, but it
disproportionately affects those with a lower socioeconomic status and minority groups (Baur,
2010). In 2006, The United States Department of Education published its findings on the first
national assessment of health literacy of English-speaking adults (Kutner, Greenberg, Jin, &
Paulsen, 2006). The study noted that over one-third of participants had basic to below basic
health literacy (Kutner et al., 2006). Hispanic adults had lower health literacy than any other
group. Of the adults who did not complete high school, 49% scored in the below basic health
literacy category (Kutner et al., 2006).

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Literacy and health literacy are similar, but health literacy requires additional skills in
understanding health contexts such as knowledge and language of the body, healthy behaviors,
and workings of the healthcare system (Baur, 2010). Patients with low to moderate health
literacy skills struggle with self-management, require more visits to their healthcare provider,
lack necessary skills to seek services, and incur higher healthcare costs due to treatment errors
and delays (Egbert & Nanna, 2009). Health literacy has been noted to be an important factor in
cancer screening utilization, patient compliance, and chronic disease outcomes (Shaw, Huebner,
Armin, Orzech, & Vivian, 2009). The associations among health literacy status, chronic disease
outcomes, and self-care behaviors have been well studied. In a large systemic review conducted
by DeWalt, Berkman, Sheridan, Lohr, and Pignone (2004), patients with low health literacy were
three times more likely to experience a poor health outcome. Schillinger et al. (2002) noted
worse glycemic control and higher rates of retinopathy in type two diabetics with inadequate
health literacy. Similarly, Al Sayah et al. (2013) and Macabasco-O’Connell et al. (2011) noted
that lower health literacy was associated with lower heart failure knowledge, self-efficacy, and
self-care behaviors.
Health literacy research pertaining to wound outcomes is limited. A single prospective
cohort study on a subset of enrollees from a cross-sectional study noted that patients with lower
health literacy scores had larger and older wounds compared to patients with higher health
literacy (Margolis, Hampton, Hoffstad, Malay, & Thom, 2015). The initial cross-sectional study
reported that those with lower health literacy were less likely to enroll in an investigational study,
raising concern for decreased study recruitment in this population (Margolis et al., 2015).
Although this study included a small sample size and had limited generalization, its findings
indicate that health literacy and wound outcomes (size, duration) may be correlated.

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Health literacy initiatives. Since health literacy has a significant effect on public health,
several government agencies have sought to address health literacy by providing education,
assessments, research, and intervention strategies. The United States Department of Health and
Human Services through the Office of Disease Prevention and Health Promotion included health
literacy in its national initiative Healthy People 2020 (Office of Disease Prevention and Health
Promotion, 2014). Included is the National Action Plan to Improve Health Literacy, which
contains seven goals for improving health literacy with associated strategies (Baur, 2010). The
strategy document assists organizations and individuals with program planning and action steps
for multisector efforts to improve health literacy (Office of Disease Prevention and Health
Promotion, 2010). It is based on the principle that services should be delivered in ways that are
beneficial and understandable to enhance longevity, health, and quality of life (Office of Disease
Prevention and Health Promotion, 2010). The Affordable Care Act and the Joint Commission on
Accreditation of Healthcare Organizations include several health literacy provisions for insurers,
clinicians, and organizations. Health literacy is a national health care priority, and these agencies
call for action in medical communities to address limited health literacy.
Problem Statement
Uninsured wound patients face several challenges managing their condition, including
cost and access to dressing supplies, follow-up care with a health care professional, and proper
performance of the multistep wound dressing regimens. Teaching these multistep regimens is a
challenge for clinicians as barriers to effectively communicate may inhibit understanding (Pieper,
2009). One of those barriers is health literacy (Pieper, 2009). Health literacy includes the
functional, interactive, critical, and numeracy skills needed to function well in healthcare
environments (Al Sayah, Majumdar, Williams, Robertson, & Johnson, 2013). Low health

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literacy is a barrier to improving clinical outcomes (Al Sayah et al., 2013). Understanding the
health literacy of a patient and directing education accordingly should allow for more effective
teaching and better outcomes.
Due to the limited health literacy research in wound populations, investigating other
diseases that have comparable self-care practices is warranted. Three such conditions are
diabetes mellitus, chronic obstructive pulmonary disease, and congestive heart failure. The
results of health literacy research in these conditions may be transferrable to interventions for
wound populations. This leads to the clinically relevant PICOT question: in patients with
chronic diseases, how does a health literacy assessment, compared to no health literacy
assessment, impact health outcomes?
Sources and Search Process
An exhaustive literature search was conducted to identify published articles relevant to
the PICOT question. The six databases systematically searched included: Cumulative Index to
Nursing and Allied Health Literature (CINAHL), Cochrane Library, Education Resources
Information Center (ERIC), National Guideline Clearinghouse, PsycINFO, and PubMed. The
following keywords were used: health literacy, assessment, assessments, outcome, and outcomes.
The additional use of the Boolean operators “AND” and “OR” were applied in appropriate
databases to focus and narrow the search. The search was limited to English-language studies
published in scholarly journals between 2007 and 2017. After completion of this initial search,
all articles identified underwent manual review by title and abstract for the inclusion of chronic
diseases. No exclusion criteria were applied.
In the CINAHL database search, all keywords, Boolean operators and the initial inclusion
criteria were applied. This search yielded 173 articles (Appendix A). After additional review,

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seven articles were chosen for critical appraisal. The Cochrane Library was searched using the
keyword health literacy resulting in 11 articles (Appendix B). No inclusion criteria were applied
to maximize results. All articles underwent manual review, and none were selected for critical
appraisal due to lack of direct PICOT relevance. The ERIC database search included the use of
Boolean operators with all keywords and the initial inclusion criteria. This search yielded 26
articles (Appendix C). After further review, two articles were chosen for critical appraisal. The
National Guideline Clearinghouse database was searched using the keyword health literacy.
This database has a set date range from 2011 to 2016; therefore, the inclusion criteria date range
was not performed in this database. As noted in Appendix D, this yielded 21 articles. After
manual review, no articles relevant to the PICOT were found. Appendix E details the PsycINFO
database search which included the use of all keywords, Boolean operators and the addition of
the inclusion criteria resulting in 171 articles. After further evaluation, seven articles were
selected for critical appraisal. The PubMed database was searched using all keywords, the
Boolean operators, and the field limit of “Title/Abstract.” This initial search yielded 242 articles
(Appendix F), and after setting the initial inclusion criteria, 147 articles were identified. After
manual review, four articles related to the PICOT underwent critical appraisal. To conclude the
search, a hand ancestry search of the 20 articles undergoing critical appraisal resulted in three
PICOT relevant articles that were not present in the initial search process due to publication
before 2006. All three articles underwent further critical appraisal.
The search process of six databases plus an ancestry search led to an initial yield of 552
articles that met the inclusion criteria and a final yield of 23 studies directly related to the PICOT
that underwent further critical appraisal. Ten final studies were chosen from these 23 based on
level of evidence, PICOT, and clinical relevance and are detailed in Appendix G.

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Critical Appraisal and Synthesis of Evidence
The ten final studies chosen for critical appraisal were quantitative in design. The
majority were in the top two levels of Melnyk and Fineout-Overholt’s (2015) hierarchy of
evidence rating system. Appendix G details four level I studies (meta-analysis and systemic
reviews) that included comprehensive database searches and valid appraisal methods to
determine the strength of evidence. Although the systemic reviews exhibited heterogeneity in
the number and types of included studies, they reported consistent results in their evaluation of
low health literacy effects and intervention outcomes, indicating acceptable quality and validity
(Appendix H). The five level II studies (randomized controlled trials) used the independent
variable of health literacy level and performed multivariate regression analysis among subgroups
of the dependent variables (Appendix G). The dependent variables were numerous and were
measured with valid and reliable instruments (Appendix G). The studies were conducted with
high quality as evidenced by scripted interventions with appropriate controls and statistically
significant results (Appendix G). The level IV prospective cohort study consisted of urban
wound patients and employed valid and reliable health literacy and self-efficacy instruments
(Appendix G). This fair quality though underpowered (n = 22) study, had statistically significant
results and yielded relevant findings in wound patients with low health literacy (Appendix G).
Overall, the ten studies exhibited a large degree of heterogeneity in the number of
subjects (31-23,889), sample demographics, instrumentation, and statistical analysis methods
(Appendix G). The mean age of subjects ranged from 11.5 to 76 years (Appendix H). The
majority of studies consisted of at least 48% females (Appendix H). Four studies reported fewer
subjects with low health literacy (30.8-37.2 %) than adequate or high health literacy (Appendix
H). The majority of studies were conducted in outpatient clinics and focused on three chronic

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diseases: diabetes mellitus, pulmonary disease, and cardiovascular disease (Appendix H). Bias
was minimal with one study reporting information bias in chart review processes and another
reporting measurement bias due to the use of a tool the researcher owned (Appendix G). All
studies used valid and reliable health literacy assessment tools (Appendix G). Data analyses for
the studies were conducted based on design and included t-tests, Fischer’s exact test, multivariate
models, and random effects models (Appendix G). Most studies reported confidence intervals,
means, standard deviations, and significant findings (Appendix G).
Some studies evaluated the effect of health literacy level on outcomes, while others
evaluated the impact of health literacy-sensitive interventions (Appendix H). Some looked at
both (Appendix H). Patients with low health literacy exhibited significantly reduced adherence,
self-care behaviors, health status, and disease knowledge (Appendix H). The studies of literacysensitive interventions included single and multiple education sessions and mixed-strategies
encompassing four domains (Appendix H). Although intervention designs were variable, all
reported statistically significant improvements in all health literacy levels with a greater effect on
lower health literacy patients (Appendix G and H).
Evidence Conclusion
The evidence indicates the presence of reduced disease knowledge, self-care, and
adherence in low health literacy patients. All patients benefit from literacy-sensitive
interventions regardless of baseline health literacy. Similar to other low health literacy patients
with chronic diseases, wound patients with low health literacy enroll less often in studies and
have worse disease status. Most literacy-sensitive interventions include spoken and written
communication, but alternative methods also improve outcomes. The body of evidence supports
educational intervention efficacy for all literacy levels, but those with lower levels benefit from

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more intense interventions (mixed strategies, multiple sessions). The tools available to measure
health literacy are valid and reliable for assessing health literacy to allow for assessment of
intervention efficacy and outcomes across groups.
Purpose Statement
A practice change in the form of an evidence-based pilot project was implemented with
the purpose of improving wound knowledge and self-care with a literacy-supportive wound
educational intervention that incorporated mixed strategies and multiple sessions in an uninsured
wound population.
Theory Contribution to Utility of Evidence
The Health Literacy Skills Conceptual Framework (Squiers, Peinado, Berkman,
Boudewyns, & McCormack, 2012) was chosen for development and design of this pilot project
and is detailed in Appendix I. It systematically illustrates the pathway and relationships of the
development and moderators of health literacy skills, their applications, and resultant outcomes
(Squiers et al., 2012). The framework is built upon existing health literacy models and focuses at
the level of the individual (Squiers et al., 2012).
This framework initially evaluates factors that influence the development and use of
health literacy skills. Consistent with the framework, the pilot project assessed each participant’s
demographics, capabilities, and prior knowledge. This was conducted with a patient
questionnaire, a wound knowledge pre-test, and a three-question Brief Health Literacy Screen
(Chew, Bradley, & Boyko, 2004). Next, a health-related stimulus in the form of a wound
educational intervention reviewing general wound knowledge, dressing change steps and
schedule placed a health-literacy demand on the participant, and they used their health literacy
skills to comprehend the stimulus. Next, an assessment of comprehension of the stimulus was

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conducted with a Wound Knowledge Post-test and a Wound Dressing Steps Performance
Checklist. To address mediators, an immediate reteach of concepts missed on the post-test and
performance checklist were addressed with participants. In congruence with the framework, the
health-related behavior of wound self-care and the outcome of wound knowledge and healing
was assessed through valid measures.
Evidence-Based Practice Model
Larrabee’s (2009) Model for Evidence-Based Practice Change systematically guides the
implementation of research into practice and was utilized to guide pilot project implementation.
Appendix J presents the model’s six-step process that includes a practice needs assessment,
identification of evidence, critical analysis of high-level evidence, designing practice change,
change implementation, and integration and maintenance of the change (Larrabee, 2009). This
model was chosen due to its extensive use in nurse-led evidence-based practice projects and its
application by nursing and non-nursing disciplines in diverse settings (Larrabee, 2009). In the
application of the model to the pilot project, step one identified the problem of limited wound
knowledge and understanding of multi-step dressing application processes in uninsured wound
patients in an outpatient clinic. In step two, a comprehensive source and search process
produced ten applicable studies that led to step three, critical analysis of the evidence. This
analysis suggested an effective approach would be to design literacy-sensitive education
materials that incorporated mixed strategies and were conducted over multiple sessions. Step
four consisted of designing the practice change through the creation of a literacy-sensitive
educational intervention focused on wound knowledge and dressing change instructions utilizing
evidence-based health literacy strategies. In step five, the implementation of the practice change
was conducted, and outcome evaluations and project conclusions were determined. The final

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step of implementation included ongoing communication and use of the materials with patients,
integration and use of the education program by the clinic’s wound nurses, and monitoring of the
practice change to ensure congruency with practice and project sustainability.
Project Methods
A correlational design was used to answer the following pilot project questions: In
uninsured adult wound patients with adequate and inadequate health literacy, does wound
knowledge improve after a literacy-sensitive educational intervention and remain improved over
time? Does wound self-care improve after a literacy-sensitive educational intervention and
remain improved over time? Do patients exhibit an improved wound status over time after a
literacy-sensitive educational intervention that focuses on wound knowledge and self-care?
Ethics
Proper standards of conduct were instituted to ensure education material design, project
recruitment and conduct, and instrument handling followed the highest ethical standards. All
wound educational material content were obtained from valid and reliable wound education
sources. To ensure congruency with clinical practice, all materials underwent additional
validation by three wound experts. Cultural congruency of the education materials was
evaluated before pilot implementation with a random sample of the clinic’s patients that were
ethnically diverse and included English and Spanish speakers. The education materials detailed
in Appendix K were designed as literacy-supportive, and measures were taken to ensure support
for low literacy populations. All educational materials, project instruments, consents, and the
project recruitment script were graded for literacy based on two valid and reliable readability
formulas (Flesch Reading Ease and Flesch-Kincaid Grade) with the goal of a fifth-grade reading
level or less (Badarudeen & Sabharwal, 2010; Eckman et al., 2012). All materials met this goal.

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The poster and pamphlet also included other literacy-supportive design elements including
simple pictorials, limited words, and a layout design consist with current education materials that
the clinic’s population is familiar with (Badarudeen & Sabharwal, 2010).
All written materials were offered in English and Spanish and include the consent, project
educational materials, the demographic questionnaire, wound knowledge test, and the
recruitment script. All materials were initially written in English and confirmed literacysupportive and congruent with a fifth-grade reading level or less. The Arizona State University
Institutional Review Board (IRB) approved the English versions of all materials. Next, a
certified Spanish medical interpreter translated the materials from English to Spanish. Then
another certified Spanish medical interpreter back-translated the materials from Spanish to
English. A final evaluation was conducted by a Spanish linguistics professor from Arizona State
University who identified and clarified any discrepancies between the two translations and also
ensured literacy-supportive readability in low-literacy Spanish language populations. Upon
finalization of the Spanish materials, they were submitted along with a Translation Certification
Form to the IRB and underwent approval for use.
Approvals. Site approval, detailed in Appendix L, was received from the medical
director at the outpatient medical clinic where the wound clinic is operated. The site did not
require an internal IRB process. Appendix M details the approval of this pilot project by the
Arizona State University IRB including all project materials, methods, and data collection
procedures. Appendix N contains the measurement tool approvals from Mary Chew for the use
of the Brief Health Literacy Screen and Barbara Bates-Jensen for the use of the Bates-Jensen
Wound Assessment Tool.

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Project risks and benefits. No foreseeable risk was identified with the pilot project.
Direct participant benefits included improved knowledge and skills in the ability to take care of
their wound in the home, leading to appropriate wound self-care by cleaning and performing the
dressing changes properly and observing for early infection or other wound concerns. No
compensation or credit was provided to participants.
Recruitment and consent. Potential participants presenting for wound care at an urban
charity outpatient medical clinic were invited orally to participate using a recruitment script
(Appendix O). For Spanish speakers, a certified Spanish medical interpreter read the Spanish
recruitment script (Appendix O). Participants who verbalized interest underwent verbal consent.
Since participants included English and Spanish speakers, this author, an English speaker,
obtained verbal consent from all English-speaking participants and utilized a certified medical
interpreter for the Spanish-speaking participants. Appendix P details the English and Spanish
verbal consents utilized in pilot project implementation.
Privacy and confidentiality. Verbal consent was conducted in the participant’s exam
room to ensure privacy and confidentiality. Project data was obtained, accessed, and stored
solely by this author. All written materials were kept in a folder that was not in plain view when
in use and when not in use was locked in a secure location. Information placed on the computer
was password protected. Participant IDs were linked via an anonymous reproducible ID in
which participants were instructed to pick the first three letters of their mother’s name and the
last three digits of their telephone number. This anonymous ID was used to collect and analyze
the data. No participant identifying data was collected. All written data was promptly shredded
at the conclusion of the project.
Setting and Organizational Culture

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The setting for the pilot project took place at a wound clinic that operates within an urban
charity outpatient medical clinic in South Phoenix. The medical clinic operates within a large
501(c)(3) nonprofit charity that not only provides free medical care to the uninsured and working
poor in South Phoenix but also has additional departments that support the mission of the
organization to provide aid in the form of food, shelter, clothing, healthcare, and financial
support. The mission of the clinic is to “sustainably increase the health and well-being of the
community, by empowering those who have the greatest need, yet the least resources” (SVDP,
n.d.). The clinic leadership and staff are devoted to this mission. As a result, they expressed
interest and enthusiasm about the pilot project, since project outcomes could improve health
education and empower the population they serve to improve self-care. Support provided by the
clinic included space, materials, Spanish medical interpreters, and adjustments to the wound
schedule appointments to allow time for project recruitment and implementation.
Innovation Leadership and Collaboration
Applying an innovation leadership mindset to pilot projects supports the translation of
research evidence into novel solutions, encourages diverse approaches and knowledge
development, and guides integration of pilot projects into organizational systems. Evidence
suggested that complex multi-step regimens can be effectively taught and designed to improve
outcomes. Translating this evidence to wound care dressing regimens required innovation.
Innovation was called for in this project due to the lack of available wound education materials
that addressed the complexity of wound care regimens that varied with each patient. In the
search for an answer, the discovery of a small sticker with a heart on an illiterate patient’s
medication bottle led to its adaption, alteration, and application to the pilot. This sticker concept

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was applied to the educational materials and met the needs of each patient’s unique wound
dressing regimen and provided literacy support for low-literacy and illiterate participants.
Team and interprofessional collaboration helped drive pilot project design through the
sharing of diverse approaches and knowledge development. Throughout project development,
the author brought together a diverse team to encourage sharing of wound education concepts,
patient needs, and consultation on material design. The team consisted of point-of-service
workers, knowledge workers, wound nurses, and clinic leadership, all stakeholders in this pilot
project. The author encouraged idea-sharing and open communication. As a result, a diverse
range of ideas, approaches, and new knowledge was created. In future collaborations,
emergence occurred when the collaborative team prioritized their ideas on wound education and
material design through consensus and sharing and co-created materials and an education process
that were cohesive with the needs of the clinic and its patients. The author also collaborated
interprofessionally to enhance the educational materials, validate the study instruments and
materials, and appropriately translate all pilot materials. Collaboration was conducted with
graphic designers, a photographer, several medical interpreters, patients, wound experts, and a
Doctor of Nursing Practice project mentor. Through these diverse collaborations, the author was
exposed to divergent methods for project design and recommendations that were culturally
congruent with the population. As a result, project materials were successfully literacysupportive and were reported by participants as having high usability and understanding.
Innovation leadership guided the pilot projects implementation into the clinic. Through a
systems-based approach, the author focused on the medical assistants, who were at the point of
interaction of multiple factors critical to the project: recruitment of patients, wound clinic flow,
medical interpreting, and patient scheduling. These key point-of-service workers were integral

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in supporting pilot project implementation. The author worked collaboratively with them to
understand current wound clinic flows and co-created an integrated process that was cohesive
with current workflows, provided time for pilot project institution, and the dedication of
resources to support pilot institution. As a result, pilot project implementation was effectively
integrated and resulted in the ongoing presence of medical interpreters, patient participation, and
an appropriate allotment of time during clinic hours to conduct the pilot.
Participants
Adults with acute or chronic wounds were recruited for this pilot project. Inclusion
criteria were: adults, age 18 years or older, Spanish or English speaking, and able to provide
consent. Exclusion criteria included wounds that required Negative Pressure Wound Therapy or
Profore Multi-layer Compression Banding system since both of these treatments do not require
patients to perform a wound dressing change.
Procedures
A literacy-sensitive educational intervention focusing on wound knowledge and dressing
change instructions was conducted with the use of the health literacy strategies supported by the
evidence (spoken and written communication, teach-back method) over several sessions (Kim &
Lee, 2016). A poster was designed in English and Spanish focusing on wound knowledge and
included the stages of healing, signs of infection, and pictures of items that are “good” and “bad”
for wounds (Appendix K). A corresponding pamphlet included the information from the poster,
a wound dressing change schedule, and a ten-step dressing change process (Appendix K). These
same steps were converted to stickers and placed on the wound products allowing for patients to
match steps to the products (Appendix K).

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After participants underwent verbal consent, and chose the English or Spanish pilot
materials, their unique identifier was placed in the upper left-hand corner of the pilot materials.
During visit one, the participant filled out the Wound Education Participant Questionnaire
(Appendix Q) that included basic demographic questions and a three-question Brief Health
Literacy Screen (Chew, Bradley, & Boyko, 2004). The participant then took the Wound
Knowledge Pre-test (Appendix R). The author, a wound care nurse practitioner, recorded wound
healing status using the Bates-Jensen Wound Assessment Tool (Appendix S) (Bates-Jensen,
Vredevoe, & Brecht, 1992). Usual care for the wound visit was then performed. Next, an
educational intervention was orally presented using the teach-back methodology with visual aids
(poster and brochure (Appendix K)) that detailed basic wound knowledge, self-care, dressing
change steps, and dressing change schedule. Since each patient received a unique dressing
treatment and dressing cover based on wound diagnosis, a sticker with a picture of the prescribed
treatment and dressing cover was placed on step six and seven of the wound dressing brochure
(Appendix K) and the corresponding wound dressing material packages. The participant then
took the Wound Knowledge Post-test (Visit 1) (Appendix T) and performed the dressing change
steps on a wound model. While the participant performed the steps, the author observed each
step and filled out the Wound Dressing Steps Performance Checklist (Visit 1) (Appendix U). For
any missed questions or steps, education by the teach-back methodology was conducted utilizing
the same visual aids (poster and brochure). At wound care visits two and four, the author
assessed and recorded the wound healing status using the Bates-Jensen Wound Assessment Tool
(Appendix S). Participants took the Wound Knowledge Post-test (Visit 2, 4) (Appendix T), and
performed the dressing change steps on a wound model. The author observed each performance
step and filled out the Wound Dressing Steps Performance Checklist (Visit 2, 4) (Appendix U).

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For any missed questions or steps, education by the teach-back methodology was conducted
utilizing the same visual aids as at visit 1 (poster and brochure) (Appendix K). The study
activities took 15 minutes per visit for each of the three visits. Visit two was scheduled one to
two weeks from visit one, and visit four was scheduled four to six weeks from visit one.
Outcome Measures
The outcomes measured in this pilot project included wound knowledge and self-care in
adequate and inadequate health literacy participants. Health literacy was measured using Chew,
Bradley, and Boyko’s (2004) Brief Health Literacy Screen. The three-question screen detailed in
Appendix V, asks about confidence in forms, reading hospital materials, and learning about
medical conditions (Chew et al., 2004). Answers are assigned a number from one to five to
create a summative scale with a possible score range of three to fifteen. A score of nine or higher
is correlated with inadequate health literacy and scores eight or lower with adequate health
literacy (Sarkar, Schillinger, Lopez, & Sudore, 2010). The screen has adequate validity when
compared to two established health literacy screens (AUROC=0.87, p<.05, 95% CI [0.78-0.96],
p<.05) and high internal consistency reliability ( = .80) among clinic and hospital patients
(Chew et al., 2004; Wallston et al., 2014).
The wound knowledge outcome was chosen due to internal evidence from the charity
clinic reporting that the low health literacy demographic had limited understanding in these
areas. Additionally, high-level evidence showed literacy-sensitive educational interventions
focused on disease knowledge resulted in statistically significant improvement in knowledge and
disease outcomes for all health literacy levels (Al Sayah et al., 2013; Hahn et al., 2015; Kim &
Lee, 2016). The wound knowledge outcome was measured with a wound knowledge test created
by the author from the intervention’s educational materials (poster, brochure). The wound

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educational materials were obtained from valid sources including clinical guidelines published
by the Association for the Advancement of Wound Care (n.d.) and the publication Chronic
Wound Care: The Essentials (Krasner, 2014). The test content included basic wound self-care
activities and signs and symptoms of infection. The ten-item test, detailed in Appendix R and T,
was constructed and scored based on the Diabetes Knowledge Questionnaire (DKQ) by Garcia,
Villagomez, Brown, Kouzekanani, and Hanis (2001) due to its established use in health literacy
studies, validity in Spanish-speaking patients, and adequate reliability ( = .78). Similar to the
DKQ, questions in the wound knowledge test were written in the form of “my” statements with
the answer options “Yes,” “No,” or “Don’t know.” Three wound experts reviewed the test
contents, and they were edited based on feedback. All were in agreement on the sufficiency of
the test’s final form, lending adequate face validity to the test. The test did not undergo
reliability testing.
The second outcome measured in the pilot project was wound self-care. This outcome
was chosen due to internal evidence noting self-care impairments such as improper dressing
change performance in the home and studies such as that of Kiser et al. (2012) reporting
statistically significant improvement in self-care in all health literacy levels after a literacysensitive educational intervention that included a multi-step inhaler technique, similar to dressing
changes in that it was a multi-step process. The areas of study for wound self-care included the
performance of dressing steps, reporting of the dressing schedule, and measurement of wound
healing. The performance of the dressing steps and reporting of the dressing schedule were
measured with a Wound Dressing Steps Performance Checklist created by the author. Appendix
U details the eleven-item checklist and includes the educational brochure steps and schedule.
The dressing steps are based on clinical guidelines published by the Wound Healing Society

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(n.d.). Checklist development and scoring were modeled from a literacy-sensitive educational
intervention for patients using metered-dose inhalers, a process that requires a similar step-wise
approach (Kiser et al., 2011). Face validity was deemed adequate by three wound experts who
reviewed the checklist contents and provided no further feedback. The checklist did not undergo
reliability testing. Wound healing status was measured with the Bates-Jensen Wound Assessment
Tool (Bates-Jensen, Vredevoe, & Brecht, 1992). A wound professional conducted the assessment
in which 13 items were scored (Bates-Jensen et al., 1992). The items, detailed in Appendix S,
include parameters such as measurement and wound condition (Bates-Jensen et al., 1992). A
total score is calculated with lower scores indicating wound improvement and higher scores
indicating wound degeneration (Bates-Jensen et al., 1992). The tool was content validated by
nine expert wound nurses (content validity index value=.91, p=.05) and the tool was deemed to
have adequate reliability ( = 0.91) in the assessment of wound status (Bates-Jensen, 1997).
Data Collection and Analysis Plan
Data were collected solely by the author and for each participant included demographic
information (age, sex, language preference, race/ethnicity, visit type), a three-question Brief
Health Literacy Screen (Chew et al., 2004), four Wound Knowledge Tests, three Wound
Dressing Steps Performance Checklists, and three assessments of wound healing using the BatesJensen Wound Assessment Tool (Bates-Jensen et al., 1992). Data analysis began with the
evaluation of missing data on the instruments. No missing answers or items were noted.
Participants recorded all answers on paper. All variables were taken from paper and directly
entered into SPSS 23 statistical software, followed by three checks for input accuracy.
Descriptive statistics were used to analyze participant demographic characteristics, health
literacy, wound knowledge, dressing performance, and wound healing. The independent-

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samples t test was conducted to compare the means of each health literacy group (adequate
versus inadequate) of the study variables (health literacy, wound knowledge, performance,
healing). Wound knowledge, performance, and healing were evaluated using the paired-samples
t test to compare means from visit one, visit two, and visit four. These underwent further
subgroup analysis by health literacy status (adequate versus inadequate). A value of p<.05 was
used to establish statistical significance.
Budget
The budget for the pilot project (Appendix W) including materials and resources for pilot
development and implementation totaled $319.10. Many of the project costs were one-time
incurrences related to educational material development. The education brochures and
corresponding stickers were purchased in bulk and were expected to last an additional year.
Project Results
Demographic Data
A convenience sample of 21 participants completed the pilot project. Table 2 details the
characteristics of the participants. The mean age of the participants was 46.5 (SD = 14.8) years
with a wide range of ages reported (20 to 85 years). Roughly half were male (57%), the majority
spoke Spanish (67%), and identified their race as Hispanic (81%). Other races participating
included White, non-Hispanics (5%), Black or African Americans (10%), and one participant
identified as Asian. Nearly half of the participants were new patients of the wound clinic (43%).
Health Literacy
The participant sample self-reported both adequate (n=12) and inadequate (n=9) literacy
levels based on scores from the Brief Health Literacy Screen (Chew et al., 2004). Further
subgroup analysis of the adequate versus inadequate health literacy groups demonstrated that

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they were well matched demographically (Table 2). Both subgroups contained the same number
of Spanish speaking participants. Although the age range for the participants was wide, there
was no statistically significant difference in mean age (t(19) = -2.03, p = .057) between the
subgroups. One notable difference was the low number of female participants reporting
inadequate health literacy (n=2). An independent-samples t test comparing the mean health
literacy scores of the inadequate and adequate health literacy groups found a significant
difference (t(19) = -5.08, p < .001). The mean score of the adequate health literacy group was
significantly lower (M = 5.92, SD = 2.07) than the mean score of the inadequate health literacy
group (M = 9.78, SD = 1.093). This was an expected finding and allows for the comparison of
educational intervention effects in both literacy groups.
Wound Knowledge
Baseline wound knowledge in participants was adequate with more than half of the
questions answered correctly (M = 7.71, SD = 1.52) on the Wound Knowledge Pre-test (Table 3).
There was no significant difference in baseline wound knowledge between those with adequate
health literacy (M = 7.58, SD = 1.62) and those with inadequate health literacy (M = 7.89, SD =
1.45), t(19) = .45, p = .66. This trend continued in all three post-tests in which no significant
difference in mean knowledge scores was appreciated between the adequate and inadequate
health literacy participants. After the educational intervention wound knowledge scores
increased on the post-test at visit one in all participants (M = 9.57, SD = .87) and remained
increased at visits two and four (Table 3). A paired-samples t test was calculated to compare the
mean Wound Knowledge Pre-test scores to the mean of all three post-tests (Table 4). A
statistically significant increase in mean wound knowledge scores was found comparing the pretest to the post-test at visit one (t(20) = -5.15, p < .01) suggesting an immediate positive

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educational intervention effect on wound knowledge in the participants. This effect continued in
future wound visits with statistically significant sustained increases in wound knowledge scores
at visit two (t(20) = -5.42, p < .01) and visit four (t(20) = -5.13, p < .01) compared to pre-test
scores.
Paired-samples t test calculations of the health literacy subgroup were calculated
comparing the mean Wound Knowledge pre-test scores to the mean of all three post-tests. Both
the adequate and inadequate health literacy participants showed similarly increased and sustained
wound knowledge with statistically significant improvements in mean wound knowledge scores
at visit one, two, and four (Table 4) suggesting a positive educational intervention effect on all
literacy levels through the pilot.
Consistently missed questions included number five “letting my wound dry out helps
wound healing” (32% missed) and number two “keeping my wound uncovered helps my wound
heal” (18% missed). These findings were not surprising and were consistent with clinical
practice in which patients reported frequent wound drying and uncovering practices prior to the
pilot. Despite the educational intervention addressing recommendations to avoid drying and
uncovering, participants did continue to miss these questions on the post-tests.
These pilot findings suggest improved would knowledge after the literacy-supportive
wound education intervention that remained improved over time in all health literacy levels.
Wound Self-care
Participants scored consistently well on the Wound Dressing Steps Performance
Checklist across all visits (Table 5). As predicted, immediately after the initial educational
intervention at visit one, participants scored high (M = 10.38, SD = 1.12) on the Wound Dressing
Steps Performance Checklist. Wound dressing performance and schedule reporting scores

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remained high and increased slightly from visit one to visit two (M = 10.71, SD = .56). This
same trend continued at visit four with high wound dressing performance scores and an
additional increase in the mean (M = 10.86, SD = .36). These increases were not found to be
statistically significant with paired-samples t testing comparing the mean of visit one to visit two
(t(20) = -1.23, p = .232) and visit four (t(20) = -2.02, p = .056). This was not unexpected since
participants performed well initially, had supportive wound dressing educational materials, and
continually repeated the dressing performance in the home. The small jumps in mean scores
after each visit suggest increased and consistent proficiency in wound dressing changes over
time. This is congruent with the author’s observations during the pilot. By visit four, the
participants had memorized the steps, performed them with confidence, and were eager to
demonstrate their skills.
Subgroup analysis of those with adequate and inadequate health literacy showed
improvement in the Wound Dressing Steps Performance Checklist scores with each progressive
visit but participants with inadequate health literacy improved and then peaked at visit two.
Those with adequate health literacy continued to improve through visit four (Table 5). At visit
one, the adequate health literacy participants had slightly higher scores (M = 10.58, SD = 1.17)
than those with inadequate health literacy (M = 10.11, SD = 1.05). At visit two, both groups
continued to show small improvements in the dressing performance score (Table 5) but the
inadequate health literacy groups remained at its visit two score mean through visit four (M =
10.78, SD = .44) unlike the adequate group, whose highest wound dressing performance scores
were at visit four (M = 10.92, SD = .29). Comparison of subgroup findings on the independentsamples t test of mean scores at each visit and paired-samples t testing comparing the mean

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subgroup’s scores of visit one to visit two and visit four were as expected not statistically
significant due to little variance.
The most frequently missed wound dressing performance steps included number five
“applied skin protectant to periwound” (14% missed) and number two “put gloves on” (6%
missed). The missed periwound skin protectant step was not surprising since applying protection
to the periwound is a relatively new concept for patients. Participants recalled accurately their
dressing schedule almost all of the time (97%).
These pilot findings suggest that self-care improved after a literacy-supportive
educational intervention and remained improved over time in all health literacy groups.
Wound Healing
Initial wound healing measurements with the Bates-Jensen Wound Assessment Tool
(Bates-Jensen et al., 1992) (Appendix S) were on average midway on the tool’s wound status
continuum between “healed” and “wound degeneration” (M = 31.48, SD = 4.90). Table 6 details
score progression from visit one through visit four. Wound status progressed towards wound
regeneration (healing) at visit two (M = 27.05, SD = 6.17) and more so by visit four (M = 19.14,
SD = 8.30). Paired-samples t tests confirmed statistically significant improvements in mean
wound healing scores from visit one to two (t(20) = 4.86, p < .01) and from visit one to four
(t(20) = 9.60, p < .01) suggesting healing effect in all participants.
The adequate and inadequate health literacy participants were well matched regarding
wound healing status which was surprising due to the wide variety of wound types and variable
chronicity of the wounds enrolled in the pilot. Mean healing status scores were similar between
the adequate and inadequate health literacy groups at visit one, two, and four with a consistent
trend towards healing noted in all groups by visit four (Table 6). An independent-samples t test

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was calculated comparing the mean score of adequate health literacy participants to the mean
score of the inadequate health literacy participants at visit one, two and four. No significant
differences between the means were found between the groups at visit one (t(19) = .59, p = .559),
visit two (t(19) = .75, p = .464), and visit four (t(19) = .40, p = .693). Paired-samples t testing
showed statistically significant improvements in mean wound healing scores from visit one to
two for adequate health literacy participants (t(11) = 3.80, p = .003) and inadequate health
literacy participants (t(8) = 2.87, p = .021). This healing effect continued in the comparison of
means for visit one and four for adequate health literacy participants (t(11) = 6.60, p < .01) and
inadequate health literacy participants (t(8) = 6.91, p < .01).
These pilot findings suggest that participants, regardless of health literacy level, exhibited
improved wound status (healing) over time after a literacy-supportive educational intervention
that focused on wound knowledge and self-care.
Discussion
In this pilot project, uninsured wound patients with various wound types and duration
underwent a literacy-sensitive educational intervention that focused on general wound
knowledge and self-care. Initial demographic data from the medical clinic suggested a low
health literacy population, and when the author investigated studies on wounds and health
literacy, a single cohort study reported patients with low health literacy had larger and older
wounds compared with those of higher health literacy (Margolis et al., 2015). Internal evidence
of the medical clinic suggested a need for wound knowledge support and dressing assistance.
Evidence verified these clinical findings noting the association of reduced knowledge and selfcare in low health literacy populations (Al Sayah et al., 2013; Egbert & Nanna, 2009). As a
result of this information, pilot design focused on addressing wound knowledge and self-care,

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with attention to all health literacy levels. High-level evidence suggested designing the
educational intervention with the use of mixed literacy strategies over several sessions in order to
improve knowledge and self-care outcomes (Berkman, Sheridan, Donahue, Halpern, & Crotty,
2011; Dewalt et al., 2012; Eckman et al., 2012; Kim & Lee, 2016). Based on this research, the
author utilized oral and written communications over three clinic visits. Each patient’s unique
wound dressing treatment was innovatively addressed through the use of stickers and applying
them not only to the multi-step wound brochure, but to product bags to facilitate matching
products to the steps in the process. Several literacy-supportive strategies were employed to
enhance learning. All written communications (materials) were designed according to current
recommendations for literacy-sensitivity, which included the use of readability formulas, simple
pictorials, and limited words (Badarudeen & Sabharwal, 2010). Also, the author utilized several
medical interpreters to ensure readability in low literacy Spanish populations. Oral
communications included simplified language and the teach-back methodology. Additionally,
the use of wound models allowed participants to practice the wound dressing steps repeatedly
and comfortably. The pilot results indicated the efficacy of the above. Increasing wound
knowledge and dressing performance led to improved healing for all health literacy levels.
The pilot’s demographic diversity supports applicability to wider wound populations.
The pilot’s demographics were representative of the wider medical clinic’s population and
consisted mostly of Spanish-speaking participants of Hispanic origin. Other ethnicities were
represented. Both English and Spanish materials were utilized. The age range was wide. Both
new and follow-up patients were represented. There was a large variety of wound types,
including acute surgical wounds, venous ulcers, and chronic diabetic foot wounds. The pilot
consisted of two health literacy groups (adequate, inadequate) that were well matched

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demographically, thereby allowing for the comparison of education intervention efficacy
between these groups. Similar to Kiser et al. (2011) in their trial of a literacy-sensitive
intervention teaching a multi-step inhaler technique, health literacy levels were determined to
provide an understanding of intervention benefits and determine if adjustments were needed.
These demographics represent typical patients who present to outpatient wound clinics and
therefore enhance project generalizability to other wound clinic populations.
In this pilot, wound knowledge improved in all participants. Wound knowledge
significantly improved from baseline immediately after the literacy-sensitive education
intervention and at visits two and four, reflecting immediate understanding and continued
retention of the knowledge four to six weeks later. These same findings were present in both the
adequate and inadequate health literacy groups suggesting efficacy at all literacy levels. These
findings were expected, and were consistent with the results of Eckman et al. (2012) and Kim
and Lee (2016), in which disease-specific knowledge increased for all literacy levels with an
educational intervention that used mixed educational strategies. One aspect of the educational
intervention was the immediate reteach of missed questions to address knowledge gaps right
away. This likely assisted with continued knowledge proficiency. Surprisingly, no significant
differences were present between the pre-test and post-test knowledge scores across all visits for
both health literacy groups. Reasons for this finding may be that the literacy-sensitive design of
the test, which measured low on the readability formulas, allowed improved understanding of the
questions in both literacy groups. Other factors may have included knowledge test design, lack
of power, and previous wound knowledge acquisition.
Certain areas of wound knowledge tied to cultural practices were difficult to change for
some. Participants consistently scored incorrectly on wound care’s biggest myths: letting

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wounds dry out and leaving them uncovered is beneficial. This misconception goes back
centuries and is considered an outdated practice. Despite repeated education on this missed
question, four participants answered it incorrectly on the final post-test. This reflects the
challenge of educating patients on stopping outdated practices, and is an important area to
provide continued education at future wound visits.
Wound self-care improved after a literacy-sensitive educational intervention and
remained improved over time. This was reflected in the dressing performance scores which
remained consistently high throughout all visits, reflecting an understanding of the dressing steps
and ongoing correct application. Nonsignificant small increases in mean dressing performance
scores were noted from visit one to four suggesting that re-teaching missed steps at each visit
may have contributed to future performance. Both literacy groups had similar mean performance
scores with no significant difference between them throughout the study. This was likely due to
the comprehensive educational program that used the teach-back methodology, practice on a
wound model, and ongoing practice with visual aids. These findings were consistent with those
of Kiser et. al. (2012) in which the teach-back method, a visual aid, and oral communications
were used in teaching multi-step inhaler techniques with noted improvements for all literacy
levels. Similar to this pilot, their mean inhaler technique scores non-significantly improved in all
literacy levels and both groups (low and higher literacy) had similar baseline and follow-up
scores (Kiser et al., 2012).
Determination of consistently missed steps or technique direct future education design
and teaching emphasis. Kiser et al. (2012) noted a consistently missed step in inhaler technique,
breathing out completely before inhalation. This finding was similar to the literature and served
as an area of consideration for education technique adjustment. The most frequently missed

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wound dressing steps by patients has not been reported in the literature. In this pilot, patients
primarily missed applying skin protectant to the periwound. This was not surprising since most
were not familiar with periwound protection and the concept of protecting the intact skin around
the wound. One solution could be to eliminate this step for low-exudating wounds. Perhaps a
better approach would be to reteach the process in a different manner or at a different step to
allow for improved comprehension. Checking in with patients on this step at future visits is
critical since it is a new concept and likely to be missed.
Participants overall performed well reporting their wound dressing schedule accurately,
an important step to prevent infection and prolonged contact of the wound with soiled dressings.
Participants significantly demonstrated an improved wound status (healing) with each
visit, suggesting a healing effect after the intervention. These were surprising findings,
considering the variety of wounds represented, and the multitude of factors that affect healing
(e.g., diabetes). Unlike the study of Margolis et al. (2015), which noted larger and more
prolonged wounds in low health literacy patients, this pilot showed no baseline differences in
wound scores between those with adequate and inadequate health literacy. This trend continued
through visit four, suggesting similar healing effects in both groups. These findings suggest that
proper and consistent wound care performance by patients impacts healing and emphasizes the
importance of effective literacy-supportive education of uninsured wound patients on specific
knowledge and self-care dressing practices.
Impacts
Patient. The results of this pilot project and the innovative educational aids utilized have
a direct patient impact. As a result of this literacy-sensitive education intervention, participants
of all literacy levels gained wound knowledge, consistently demonstrated performance of their

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wound dressing, and, as a result, continued to progress towards healing. Most notable was the
confidence developed by visit four. Most, if not all, participants reported their dressing schedule
and demonstrated their dressing change correctly. They learned the language of wound care,
asked more informed questions, and were quick to identify early signs of infection. Since the
materials were developed with patient input, patients easily understood the educational aids. The
participant’s knowledge retention is likely to have an impact on future wounding and the ability
to note wound concerns and provide proper self-care early.
Most importantly, this pilot addressed the wound educational needs of the Hispanic and
Spanish-speaking participants. This understudied group is the largest ethnic minority in the
United States (United States Census Bureau, 2010). Due to lower health insurance rates, they are
likely to perform their own wound care. This pilot addresses their educational needs.
Provider. This pilot enhances patient-provider communication. Due to the literacysupportive design, participants of all health literacy levels gained an understanding of their
wounds and the dressing process, and as a result, had improved dialogue and sharing with the
author. The easily used educational intervention was integrated into the visit after the history and
physical was performed, and after informing the patient of their wound diagnosis. Also, the
innovative use of stickers addressed the complexity of unique dressing regimens in an easy and
simplified form. Lastly, just about any medical personnel can perform the educational
intervention including nurses, medical assistants, residents, and students.
System. The pilot project had direct system impacts on the urban wound clinic. Due to
the design of the educational aids, the products were organized into bags containing seven days
of supplies. Matching product stickers were placed on the bags. This allowed for an appropriate
distribution of the products based on the patient’s wound schedule and less waste. As a result of

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less unused product being distributed, the clinic needed to order fewer supplies and saved money.
With this new organizational system, the wound nurses were able to efficiently grab the needed
materials. No longer were they spending time searching for materials in the clinic’s wound
supply closet. As participants progressed towards healing, fewer supplies and visits were
needed. This allowed increased availability of products and clinic appointments for new
patients.
Policy. Few clinics offer charity wound care for the uninsured. This pilot project lends
feasibility to support policy for wound care for the uninsured. The pilot supports the use of an
educational intervention that develops the needed wound knowledge and dressing application
skills for this population, so they are able to perform proper self-care. Due to the organization of
the materials, wound products can be distributed appropriately with reduced waste.
This project also supports health insurance policy changes that effect coverage of home
health or wound specialty care. With reductions in covered services such as home health and
wound specialty care, patients will be required to perform their own dressing changes. This
education program addresses the needed teaching, and this teaching can be conducted in a
variety of settings, including primary care.
Sustainability
Currently, the pilot’s educational intervention and aids continue to be utilized by the
wound clinic nurses, provider, and patients. Due to educational aid congruency with the needs of
the clinic and patients, use in a variety of wounds, and the literacy-sensitive design, their use is
likely to continue. The educational aids can be adjusted for changes in products. When the
patient has a wound product change, a new brochure with the appropriate product sticker is
placed. They also can be adjusted for future wound products, by taking pictures of the new

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products and ordering the corresponding stickers online. The educational intervention is easily
integrated into the clinic visit after the wound diagnosis is given and the education can be done
quickly since the educational materials are already organized. Wound nurses and medical
assistants can be trained in teaching the wound education and use of the teach-back
methodology. Providers can work collaboratively with their wound care team, and each teaches
a section of the education. Utilizing this team approach ensures education is covered from visit
one and through future visits as well.
Project Strengths
This pilot project has several strengths. The project’s educational methodology and aids
were well developed and well translated to meet the educational needs of all health literacy
levels. They can be utilized and distributed in all settings where wound care occurs at little cost,
since the only purchases required are the poster, brochures, and stickers. The project met the
needs of the urban wound clinic by providing an educational program to teach complex wound
self-care in a simplified manner. As an added bonus, there was less material use and improved
efficiency. Most notably, Spanish-speaking participants were provided literacy-sensitive
education that met their needs. The pilot results supports the assertion that a wound educational
intervention on general knowledge and self-care over several visits can increase wound
knowledge, dressing application proficiency and dressing schedule reporting, and effect healing
in all literacy levels of English and Spanish-speaking patients.
Project Limitations
There are notable limitations to this pilot project. A control group would have
strengthened conclusions about the educational intervention effects, especially in the area of
wound healing. Also, the sample size was too low to allow for valid Pearson’s correlation

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calculations. Also, the Wound Knowledge Test and Wound Dressing Steps Performance
Checklist were only content validated. Efforts to determine further reliability and validity were
not conducted. Finally, the pilot did not evaluate or control for comorbid conditions that can
influence wound healing, therefore limiting the generalizability of the healing effects noted by
the educational intervention.
Conclusion
Uninsured wound populations tasked with completing their own dressing changes require
education on general wound information such as signs and symptoms of infection and instruction
and skill development on how and when to apply their wound dressings. Low health literacy
contributes to reduced disease knowledge and self-care ability. When coupled with dressing
complexity, impairments in wound healing and other wound complications can occur. Findings
from this pilot suggest that a literacy-sensitive educational intervention that utilizes mixed
literacy strategies with repeated education for missed areas at future visits increases wound
knowledge and self-care, and positively impacts wound healing. This project led to the
development of innovative educational aids that simplified the dressing steps and matched steps
with wound products. Also, the educational intervention streamlined an urban wound clinic’s
wound education into an organized process that could be conducted by all healthcare personnel,
addressed the education needs of English as well as Spanish-speakers, and led to reduced wound
product waste and cost. Findings from the pilot were congruent with previous research
conducted in other chronic diseases with multi-step processes in that literacy-sensitive education
improved outcomes for all health literacy levels. This pilot supports current health literacy
initiatives calling for the delivery of healthcare services that are understandable over the full
range of literacy levels. Although generalization to larger wound populations is limited, the pilot

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE

39

supports efforts to develop and employ literacy-sensitive wound education in uninsured English
and Spanish speaking populations.

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE

40

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LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Table 1
Wound Clinic Demographics
Characteristic
Gender
Male
Female
Country of Origin
Mexico
United States of America
Other
Language
English
Spanish
Other
Education
Less than 8th grade
High school or GED
2-year college
4-year college
Post graduate education
Race
Black
Hispanic
Other
Native American/Asian
White

%
48
52
73
18
9
28
72
1
33
54
5
6
1
4
79
2
2
13

Note. Adapted from Patient demographics last six months [Data File], by M. Lee, retrieved
November 11, 2016 from https://athenanet.athenahealth.com

47

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Table 2
Characteristics of the Participants
Characteristic

All
Participants
(n = 21)
46.5 (14.8)
20-85

Adequate
Health
Literacy
(n = 12)
41.2 (12.2)
20-67

Inadequate
Health
Literacy
(n = 9)
53.6 (15.7)
39-85

Age in years, M (SD)
Age range in years
Gender, N (%)
Male
Female
Language Preference, N (%)
English
Spanish
Race/Ethnicity, N (%)
White, non-Hispanic
Hispanic
Black or African American
Asian
Visit Type, N (%)
First visit
Follow-up visit

12 (57.1)
9 (42.9)

5 (41.7)
9 (58.3)

7 (77.8)
2 (22.2)

7 (33.3)
14 (66.7)

5 (41.7)
7 (58.3)

2 (22.2)
7 (77.8)

1 (4.8)
17 (80.9)
2 (9.5)
1 (4.8)

9 (75)
2 (16.7)
1 (8.3)

1 (11.1)
8 (88.9)
-

9 (42.9)
12 (57.1)

6 (50)
6 (50)

3 (33.3)
6 (66.7)

Health Literacy Score, M (SD)
Score range

7.57 (2.58)
3-12

5.92 (2.07)
3-8

9.78 (1.09)
9-12

48

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE

49

Table 3
Wound Knowledge Test Scores
M

SD

Range

Pre-test
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

7.71
7.58
7.89

1.52
1.62
1.45

4-10
4-9
6-10

Post-test (Visit 1)
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

9.57
9.92
9.11

.87
.29
1.17

7-10
9-10
7-10

Post-test (Visit 2)
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

9.24
9.17
9.33

1
.94
1.12

7-10
7-10
7-10

Post-test (Visit 4)
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

9.62
9.58
9.67

.81
.67
1

7-10
8-10
7-10

Tests

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Table 4
Comparison of Wound Knowledge Test Scores Over Time
Test Comparison

Pairedsamples t test,
t

p value

Pre-test vs. Post-test (Visit 1)
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

-5.15
-4.84
-2.48

< .001*
.001*
.038*

Pre-test vs. Post-test (Visit 2)
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

-5.42
-4.42
-3.04

< .001*
.001*
.016*

Pre-test vs. Post-test (Visit 4)
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

-5.13
-4.06
-2.98

< .001*
.002*
.017*

* statistically significant (p < .05)

50

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE

51

Table 5
Wound Dressing Steps Performance Checklist Scores
M

SD

Range

Visit 1
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

10.38
10.58
10.11

1.12
1.17
1.05

7-11
7-11
8-11

Visit 2
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

10.71
10.67
10.78

.56
.65
.44

9-11
9-11
10-11

Visit 4
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

10.86
10.92
10.78

.36
.29
.44

10-11
10-11
10-11

Visit Checklist

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52

Table 6
Bates-Jensen Wound Assessment Tool Scores
M

SD

Range

Visit 1
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

31.48
30.92
32.22

4.90
3.18
16.70

25-45
28-38
25-45

Visit 2
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

27.05
26.17
28.22

6.17
4.95
7.66

14-42
18-33
14-42

Visit 4
All participants (n = 21)
Adequate health literacy (n = 12)
Inadequate health literacy (n = 9)

19.14
18.50
20

8.30
7.38
9.79

9-35
9-28
9-35

Tests

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Appendix A
Search Strategy 1
CINAHL

53

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Appendix B
Search Strategy 2
Cochrane Library

54

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Appendix C
Search Strategy 3
ERIC

55

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Appendix D
Search Strategy 4
National Guideline Clearinghouse

56

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Appendix E
Search Strategy 5
PsycINFO

57

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Appendix F
Search Strategy 6
PubMed

58

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59

Appendix G
Table 1
Evaluation Table
Citation
Aboumatar et
al. (2013)
The impact of
health literacy
on desire for
participation in
healthcare,
medical visit
communication,
and patient
reported
outcomes.
Country: USA
Funding:
National Heart,
Lung, and
Blood Institute
Conflict/Bias:
Conflict of
interest and
measurement
bias-Author is
copyright
holder of the
RIAS coding
software and is

Theory/Conceptual
Framework
Communication
accommodation
theory
Pre-visit coaching
model

Design/
Purpose
Design:
Quantitative,
RCT, crosssectionally
analyzed
Purpose: To
determine how
HL influences
patients’
healthcare
participation,
visit
communication,
and selfreported
outcomes.

Sample/
Setting
N=329
n=279 patients
Groups:
Minimal
patient/minimal
physician (control)=55
Intense
patient/minimal
physician=57
Minimal
patient/intensive
physician=84
Intensive
patient/intensive
physician=83
n=50 physicians
ATT: 4%
Patients=1.4% (LTF,
illness, withdrew)
Physicians=18%
(illness, withdrew)
Demographics:
Patients:
M age=61.2
Females=181 (65.8)
CR=101 (36.7)
HS degree=189 (69)
HI=249 (90.2)
LHL: n=86

Variables &
Definitions
IV: HL status
(LHL: score
less than or
equal to 60,
AHL: score
greater than 60)
DV1: Patients’
desire for
involvement in
medical
decision
making
DV2: PPC
behaviors
DV3: Patient
care ratings
(post-visit
physician PDM
style, physician
trust, visit
satisfaction)
DV4: Blood
pressure

Measurement/
Instrumentation
IV: REALM
(=.80-.91)
DV1: Single item
question with 4
options. Answer
#3 or #4, positive
desire for
involvement in
care (CVR NR)
DV2: RIAS
(=.82)
DV3: 3-item
PDM scale (0100) (CVR NR)
DV4:
Sphygmomanometer

Data Analysis
SAS (versions
9.22 and 9.3)
Fischer’s exact
test: to compare
categorical data
JonckheereTerpstra test: to
compare ordinal
responses
Two samples ttest: to compare
the distributions
of the outcome
measures
Generalized
linear models
regression
analysis with
generalized
estimating
equations: to
assess the effect
of literacy status
on outcomes

Findings/
Results
DV1: LHL: n=73 (71.6)
AHL: n=119 (68.8)
p=.32
DV2: Medical question
asking:
LHL: M=4.46
95% CI [3.37, 5.89]
AHL: M=6.82
95% CI [5.90, 7.89]
p=.02
All other RIAS measures
ns between LHL and AHL
Intensive patient/intensive
physician:
LHL: M=3.85
95% CI [2.84, 5.22]
AHL: M=6.42
95% CI [5.15, 8.0]
p=.002
All other groups ns
DV3: ns between LHL and
AHL groups
Intensive patient/minimal
physician:
LHL: M=58.3
95% CI [45, 71.6]
AHL: M=73.6
95% CI [67.6, 79.6]

Level/Quality
Application
Level II
Strengths:
Appropriate
control, multiple
settings, 12month study,
narrow CI,
measurement
tools CVR,
theoretical
framework
discussed.
Weaknesses:
Participants
awareness of
being audiotaped,
small n of LHL in
each group, lack
of masking.
Conclusions:
LHL and AHL
similar desire to
participate in
care. LHL less
medical question
asking.
LHL lower PDM
scores than AHL
most significant
in intensive

Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Citation

Theory/Conceptual
Framework

Design/
Purpose

the co-owner of
the company
that provided
the RIAS
coding service.

Sample/
Setting
AHL: n=147
Physicians:
M age=43
Female=22 (53.6)
CR=18 (43.9)
IM=33 (80.5)
M PE=11.9 years

Variables &
Definitions

60
Measurement/
Instrumentation

Data Analysis

Findings/
Results
p=.04
All other groups ns
DV4: LHL n=40 (39.6%)
AHL n=92 (54.1%)
p=.02 (AHL higher BP
control)

Setting: 14 PC clinics
Time: 12-month study
IC: Patients:
gecontact
information
Physicians: 20 hours
per week direct patient
care

Al Sayah et al.
(2013)
Health literacy
and health
outcomes in
diabetes: A
systemic
review.
Country:
Canada

Not directly stated,
cited model noted:
Nutbeam’s Health
Literacy Model
(2000)

Design:
Quantitative,
SR, AHRQ
evidence-based
practice center
method

EC: Patients: Acutely
ill, disoriented,
unresponsive to
assessment, MC that
limit participation.
Physicians: Planning
to leave practice  one
year.
Databases=6
Citations=723
Met IC=34 articles (24
studies)
CSS=29
Longitudinal=5

Purpose: To
systematically
review research
evidence on the
relationships
between HL or
numeracy and

Demographics:
RG=31-17,795
participants per study
M age RG=45.8-67.2
Females RG=42.779.4%
CR RG=2-65%

IV1: HL level
(low, high)
DV1: CO
(Glycemic
control,
hypoglycemia,
BP, DM
complications,
LDL)
DV2:
Behavioral
indicators (DK,

IV1: REALM,
REALM-R,
TOFHLA,
STOFHLA
(=.73-.98)
DV1: HbA1C,
self-reported
hypoglycemia,
sphygmomanometer, selfreported
retinopathy,
nephropathy,

Cohen’s Kappa:
used to assess
inter-rater
reliability in
rating the
strength of
evidence
between the two
reviewers
Fixed and
random effects
models: to
perform meta-

Eligible articles:
Inter-rater agreement=88%
Cohen’s kappa=.70
95% CI [.59, .84]
Quality rating:
Inter-rater agreement=97%
Cohen’s kappa=.91
95% CI [.76, .98]
I2=80-90% (large
heterogeneity) Data
reported qualitatively
DV1: Glycemic control,
DM complications:

Level/Quality
Application
patient/minimal
physician
intervention
group. Worse BP
control in LHL.
Feasibility: For
physician
communication
interventions,
LHL may be less
responsive and
beneficial.
Consider in LHL
patients their
reduced question
asking and
perception of
PDM in
determining
interventions.

Level I
Strengths:
Appropriate
search methods
and number of
studies, SOE
rating method
CVR, IV and DV
appropriate and
included CVR
HL
measurements.
Weaknesses:
Heterogeneity

Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Citation

Theory/Conceptual
Framework

Design/
Purpose
health
outcomes in
patients with
diabetes.

Sample/
Setting
HS degree=variable
reporting

Variables &
Definitions
SE, SC,
SMBG)
DV3: Patientprovider
interaction
indicators
(PPC, patient
trust,
information
exchange and
involvement in
decisionmaking, use of
computers and
internet, other)

61
Measurement/
Instrumentation
CAD, stroke,
amputation), LDL
level
DV2: DK
questionnaire,
Summary of
diabetes SC
activities,
Morisky score,
DM SE scale,
Diabetes Care
Profile, Other
(CVR NR)
DV3: Wake
Forest Physicians
Trust Scale,
Facilitation of
Patient
Involvement,
Healthcare
Relationship
Trust Scale, Other
(CVR NR)

Data Analysis

Findings/
Results
INSUFF Hypoglycemia,
BP: low SOE
LDL: no association

Level/Quality
Application
analysis to
across studies,
Funding:
Alliance for
quantitatively
studies lacked
Canadian
summarize the
power,
Health
Setting: PC clinic,
evidence for
methodological
Outcomes
GM clinic, MCO,
outcomes
DV2: DK: high SOE, high
issues, no
Research in
hospital, DM clinic
HL better DK
interventions
Diabetes,
SE: INSUFF
described,
Canadian
IC: Studies assessing
SC: moderate SOE, no
majority CSS.
Institute for
HL or numeracy and
association
Conclusions:
Health
HO in DM patients,
SMBG: low SOE
Moderate to High
Research,
valid HL or numeracy
SOE for HL level
Institute of
measure, at least 1
DV3: PPC: low SOE
and DK (direct
Nutrition,
HO, written in
Trust, Information:
relationship) and
Metabolism and
English.
INSUFF
no difference
Diabetes
Computers, Other: low
between HL and
EC: Review and
SOE
SC behaviors.
conceptual articles,
Studies in HL and
Conflict/Bias:
None reported
lack of outcomes of
clinical outcomes
or appreciated.
interest reported,
weak with low
studies not including
SOE.
diabetes, studies
Feasibility: High
including gestational
SOE between
diabetes, studies of
LHL and poorer
HL in caregivers of
knowledge. The
individuals with DM.
link to outcomes
is INSUFF
therefore HL
screening to
improve
outcomes may be
premature.
Berkman et al.
Integrative theory
Databases=5
IV1: HL level
IV1: REALM,
Studies rated on
DV1: All moderate SOE,
Design:
Level I
(2011)
from an integrated
Quantitative,
Citations=3,911
(low, high)
REALM-R,
quality (internal
Emergency/hospitalization
Strengths:
model of behavioral
SR, PRISMA,
Met IC=111 articles
TOFHLA,
validity and risk
s: increased use in LHL
Appropriate
Low health
theory
AHRQ
(86 studies)
STOFHLA
of bias) using
Preventative services:
search methods,
DV1:
literacy and
evidence-based
CSS=91
Outcomes
predefined
decreased use in LHL
large number of
(=.73-.98)
health
practice center
Other=10
(emergency
criteria from four
studies, SOE
outcomes: An
method
care and
established
DV2: Taking medications
rating CVR, IV
DV1: Total
updated
hospitalization,
sources
appropriately: Moderate
and DV
Demographics:
emergency room
systemic
Purpose: To
HL:
preventative
SOE, reduced in LHL
appropriate and
and
review.
update a 2004
89 articles
services)
Interpreting labels and
included CVR
Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
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Country: USA
Funding:
Agency for
Healthcare
Research and
Quality, U.S.
Department of
Health and
Human
Services
Conflict/Bias:
None reported
or appreciated.

Theory/Conceptual
Framework

Design/
Purpose
SR and
determine if
low HL is
associated with
poorer use of
healthcare,
outcomes, cost,
and disparities
in health
outcomes in
people of all
ages.

Sample/
Setting
RG=50-23,889
participants per study
M age RG=11.5-76
Females RG=0-91%
CR RG=0-97.4%
HS degree=variable
reporting
Numeracy:
22 articles
RG=62-1,436
participants per study
M age RG=37-68
Females RG=2-100%
CR RG=4.8-96%
HS degree=variable
reporting
Setting: PC clinic,
GM clinic,
endocrinology clinics,
MCO, hospitals,
academic medical
centers, medical
schools, schools, HIV
clinics, DM clinics,
residents in U.S.
cities.

Variables &
Definitions
DV2: Health
care-related
skills (taking
medications,
interpreting
labels and
messages)
DV3: Disease
prevalence and
severity (MH
outcomes, HIV
infection)
DV4: Global
health status of
elderly
DV5: Death
DV6:
Interventions
(singlestrategies,
mixed
strategies)

62
Measurement/
Instrumentation
hospitalization
visits, frequency
of mammography
screening and
influenza
immunization
DV2: Direct
medication
observations, selfreports,
measurement of
medication blood
test (CVR NR)
DV3: CES-D
scale, HIV viral
load, HIV
symptom
reporting (CVR
NR)
DV4: Self-report
of overall health
status, 12- and 36
Item Short Form
Health Survey
(All CVR)
DV5: Evaluation
of Prudential
Medicare sample
DV6: AHRQ
method (SOE)

Data Analysis
Due to
heterogeneity
across studies in
approaches to
measuring health
literacy,
numeracy,
interventions and
outcomes metaanalysis not
possible and
findings
qualitatively
presented

Findings/
Results
messages: Moderate SOE,
reduced in SOE
DV3: MH outcomes: Low
SOE
HIV severity and
symptoms: INSUFF
DV4: Global health status
of elderly: Moderate SOE,
poor health status in LHL
DV5: Death: High SOE,
higher mortality with LHL
DV6: Single strategy: all
rated low SOE or INSUFF
Mixed strategy: Moderate
SOE mixed strategies for
adherence and SC
Moderate SOE for disease
management interventions.
Moderate SOE studies
included simple language,
simple organization,
pictures, teach back and
repetition

Level/Quality
Application
HL
measurements,
appropriate IC
and EC.
Weaknesses:
Heterogeneity,
measurements
and
instrumentation
used for DV with
limited
descriptions and
reporting of
validity and
reliability.
Conclusions:
High to Moderate
SOE in LHL
associated with
several outcomes.
Interventions
with mixed
strategies
moderate SOE
focusing on
adherence, selfmanagement, and
disease
management.
Feasibility:
Supports LHL
association with
health outcomes
and interventions
focusing on selfmanagement with
simple
techniques.

IC: HL articles 20032/22/2011, numeracy
articles 1966-2/22/11,
English language, all
ages, HL of patients or
caregivers directly
measured.
Comparison to
outcomes, health care
access, HO, and costs
of care. For numeracy
studies includes
knowledge.
Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
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DeWalt et al.
(2012)

Theory/Conceptual
Framework

Social cognitive
theory

Design/
Purpose

Design:
Quantitative,
RCT

Sample/
Setting
EC: Self-reported HL,
outcomes concerning
attitudes, social
norms, or patientprovider relationships.
N=605
n=302 (single session)
n=303 (multisession)
ATT: 27.8%
Single session=30.8%
(died, missed 6 and
12-month interview)
Multisession=28.1%
(died, withdrew,
missed 6 and 12month interview)

Variables &
Definitions

IV1: HL
intervention
(single session)
IV2: HL
intervention
(multisession)
IV3: HL level
(LHL: 0-22
answers correct
HHL: 23-36
answers
correct)

63
Measurement/
Instrumentation

IV3: STOFHLA
(=.90)

Data Analysis

Findings/
Results

Negative
binomial
regression: to
compare
differences in the
incidence rates
between the two
study groups
Wald test on the
coefficient of the
interaction term
was used to test
health literacy
effectiveness
between the two
groups

DV1:
Unadjusted IRR=1.01,
95% CI [0.83, 1.22], no
difference between
intervention groups
LHL: Unadjusted
IRR=0.75 95% CI [0.45,
1.25], favoring the
multisession group (lower
incidence)
HHL: Unadjusted
IRR=1.22 95% CI [0.99,
1.50], favoring the singlesession group (lower
incidence)
Interaction P=.048 for
multisession literacy level
differences

Level/Quality
Application

Level II
Strengths: Large
N, low risk
Multisite
intervention,
DV1: admission
Randomized
Purpose: To
multi-site, 12and discharge
Trial of a
compare the
month study,
summary review,
single-session
effects of two
CVR HL
medical-record
versus
different
measurement
confirmed events,
multisession
amounts of HF
tool, significant
national death
literacyself-care
findings with
index
sensitive selftraining on the
narrow CI.
DV2: admission
care
incidence of
Weaknesses:
and discharge
intervention for
all-cause
Lack of
Demographics:
summary review
patients with
hospitalization
concurrent
Single session:
DV1:
DV3: Emergency
heart failure.
or death and
M age=60.3
Hospitalization
control group not
department visit
HF-related
Females=146 (48)
or death (allexposed to the
record review
Country: USA
hospitalization
CR=122 (40)
cause)
intervention,
DV4: Improving
and quality of
HS degree=86 (28)
DV2: HFGeneralized
lower number of
Chronic Illness
life.
HI=260 (86)
related
estimating
LHL participants.
Funding:
Care Evaluation
National Heart,
hospitalizations
equations: to
DV2: (95% CI)
Multisession:
Conclusions:
Heart Failure
Lung, and
M age=61.1
determine the
Unadjusted IRR=0.92,
Intensive
DV3:
Symptom Scale
Blood Institute
Females=145 (48)
Emergency
change in
95% CI [0.77, 1.11],
multisession
(=.88)
CR=111 (37)
department
HFQOL
favoring the multisession
interventions did
HS degree=91 (30)
visits
associated with
group
not change
Conflict/Bias:
No reported
HI=266 (87.8)
DV4: HFQOL
the intervention
LHL: Unadjusted
clinical outcomes
conflicts.
IRR=0.53 95% CI [0.25,
compared to the
Information
Setting: General IM
1.12], favoring the
single-session but
bias risk in
and cardiology clinics
multisession group (lower
differed by
medical record
from 4 sites.
incidence)
literacy group.
review process.
Time: 12-month study
HHL: Unadjusted
LHL participants
IRR=1.32 95% CI [0.92,
in multisession
IC: Age 20 or older,
1.88]
intervention
diagnosis of HF,
Adjusted IRR=1.34 95%
group benefitted
NYHA class II-IV
CI [0.87, 2.07], favoring
more clinically.
symptoms in past 6
the single-session group
Feasibility:
months, current use of
(lower incidence)
Multisession
Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
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Theory/Conceptual
Framework

Design/
Purpose

Sample/
Setting
loop diuretic, absence
of cognitive
impairment, working
phone, speaks English
or Spanish.

Variables &
Definitions

64
Measurement/
Instrumentation

Data Analysis

DV3: Unadjusted
IRR=0.82, 95% CI [0.42,
1.64]
Adjusted IRR=0.79 95%
CI [0.47, 1.31] no
difference between groups,
interaction probability
value ns

EC: Inadequate
vision, on dialysis,
severe vascular
disease, using oxygen
for COPD, life
expectancy <1 year,
unable to pass mini
cog screener, lives in a
nursing facility or
other place without
medication control.

Eckman et al.
(2012)

Not directly stated,
cited model noted:
Schillinger
Functional Health
Literacy Model
(2001)

Design:
Quantitative,
RCT

N=187
n=83 (VHS/DVD plus
booklet)
n=87 (booklet
(control))
ATT: 9% (deaths,
withdraws)

Findings/
Results
Interaction P=.005 for
multisession literacy level
differences

IV1: Preintervention
CAD
knowledge
assessment
IV2: HL level
(LHL: score
less than or
equal to 60,
HHL: score
greater than 60)
IV3: Clinical
co-morbidities

IV1: CAD
knowledge
assessment (12item test made by
researchers, pilot
tested prior, no
CVR).
IV2: REALM
(=.91)
IV3: Checklist of
other diagnosis
(NR)

Descriptive
statistics of
baseline
assessments

DV4: HFQOL
improvement: (Favoring
multisession)
1-month p<0.001
6-month p=0.003
12-month p=0.08 (ns)
Intervention effects on
HFQOL did not differ by
literacy
DV1: LHL: Before
intervention: M=7.66,
SD=2.20
Final follow-up: M=9.34,
SD=1.17
p<.001
HHL: Before intervention:
M=8.46, SD=1.68
Final follow-up: M=9.71,
SD=0.93
p<.001
LHL: coefficient -0.03
(.01), p=0.03 (larger
improvement in CAD
scores from baseline)

Level/Quality
Application
interventions
benefits LHL
participants and
improves clinical
outcomes and is a
design
consideration for
HL interventions.

Level II
Strengths: Low
risk intervention,
Impact of
multi-site, 6health literacy
Purpose: To
month study,
on outcomes
study the
Fisher’s Exact
CVR HL
and
impact of HL
test: to compare
measurement
effectiveness of
on an
the patient
tool, significant
an educational
educational
characteristics by
results, all steps
Demographics:
intervention in
intervention for
M age=59.9 (34-85)
intervention
of interventions
patients with
patients with
Females= 104 (61.2)
group
scripted.
chronic
coronary artery
CR=61 (35.9)
Weaknesses:
diseases.
disease.
HS degree=100 (58.8)
t-test: to compare
Lower number of
HI=170 (100)
means of the
LHL participants,
DV1: CAD
Country: USA
LHL: n=68
DV1: CAD
continuous
a priori power
knowledge
HHL: n=101
knowledge
variables
analysis
assessment (12DV2: Health
DV2: MEDFICTS: LHL:
supported 100 per
Funding:
item test made by
Foundation for
Setting: 3 IM
behaviors
Paired t-test: to
Before intervention:
group, n below
researchers, pilot
Informed
practices
(smoking
compare baseline M=47.71, SD=25.17
this, lack of
Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Citation

Theory/Conceptual
Framework

Design/
Purpose

Medical
Decision
Making

IC: Age 21, speak
and understand
English, CAD.

Conflict/Bias:
None reported
or appreciated

Hahn et al.
(2015)

Sample/
Setting
Time: 6-month study

Variables &
Definitions
status, selfreported
exercise and
dietary habits),
HO (weight,
BP)

Measurement/
Instrumentation
tested prior, no
CVR).
DV2:
MEDFICTS
scale, 12-item
Physical Scale for
the Elderly,
(>.70)
DV3: Scale,
Sphygmomanometer

IV1: HL score
IV2: SE
IV3: Health
beliefs
IV4: Clinical
characteristics

IV1: Health LiTT
(14-items)
(=70-.78)
IV2: DM SE (8items) (=84-.85)
IV3: Health
beliefs (20-items)
(=67-.94)
Diabetes
Knowledge (24items) (=85-.87)
IV4: self-reported
medication use,

EC: Cognitive
dysfunction, visual
problems.

Behavioral model
for vulnerable
populations

Design:
Quantitative,
RCT, crosssectionally
analyzed

N=308
n=146 (English)
n=149 (Spanish)
ATT: English=5.2%
Spanish=3.9%
(LTF, illness,
withdrew)

65
Data Analysis
and postintervention
assessments
Multivariate
models: to
predict change in
knowledge
scores, health
behaviors, and
clinical
outcomes

SAS (version
9.3) and Mplus
(version 6.11)

Findings/
Results
Final follow-up: M=40.50,
SD=22.75
p<.001
HHL: Before intervention:
M=49.38, SD=23.27
Final follow-up: M=41.16,
SD=19.10
p<.001
Physical scale for Elderly:
LHL ns
HHL p=.01
Cigarette smoking: ns all
literacy groups
Average number of
cigarettes: LHL: p<.001,
HHL p=.01
LHL: intervention
predicting weight change:
coefficient -0.47 (.24),
p=0.05 (greater impact on
weight loss)
Subgroups analysis run for
each DV between HHL
and LHL and results ns
DV4: Weight, BP ns all
literacy groups
Health LiTT:
English T score
M=52.1, SD=10.6
Spanish T score
M=47.8, SD=8.9
p=.001

Level/Quality
Application
concurrent
control group not
exposed to
intervention.
Conclusions:
CAD knowledge
scores and health
behaviors
improved all
groups, dual
intervention
group showed
significant
improvement.
Feasibility:
Mixed
intervention
strategies to
improve chronic
disease
knowledge and
behaviors benefit
both LHL and
HHL patients and
improve
outcomes.
Level II
Strengths:
Measurement
tools CVR,
theoretical
framework
discussed,
adequate N, low
risk, appropriate
IC and EC.
Weaknesses:
Single setting,
demographical
differences,

Health literacy
and patientt-test, Chi-square
reported
test, Fisher’s
outcomes: A
Purpose: To
exact test: to
cross-sectional
examine the
DV1: DM SC
compare the
DM SE
study of
association
DV2: Health
characteristics
English: M=75.7, SD=19.4
Demographics:
underserved
between patient
English:
status
between English
Spanish: M=82.4,
English- and
characteristics,
M age=54.8
and Spanish –
SD=18.3
DV3:
Spanishhealth
Females= 68 (46)
Satisfaction
speaking
p=.01
speaking
behaviors, and
CR=31 (21)
with
participants
patients with
health
HS degree=46 (32)
communication
Health beliefs
type 2 diabetes.
outcomes and
HI=59 (40)
Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Citation

Country: USA
Funding:
Agency for
Healthcare
Research and
Quality
Conflict/Bias:
None reported
or appreciated.

Theory/Conceptual
Framework

Design/
Purpose
explore the role
of HL as a
mediator of
outcomes.

Sample/
Setting
Spanish:
M age=54.5
Females= 91 (61)
CR=0
HS degree=17 (11)
HI=28 (19)
Setting: General
medical clinic
IC: Age 18, males or
nonpregnant females,
speak English or
Spanish, DMII on oral
medication or insulin,
sufficient cognitive
function and manual
dexterity.
EC: Pregnant women.

Variables &
Definitions

66
Measurement/
Instrumentation
body mass index,
HbA1C
DV1: DM SCpast 7 days (8items) (CVR NR)
DV2: Health
status (10-items)
(=.70-.80)
DV3:
Satisfaction with
communication
(7-items)
(=.85-.91)
Decision-making
preference
(Single item
question with 4
options to choose
from (CVR NR)

Data Analysis
Multivariate
regression
analyses: to
determine the
statistical
interaction of
language with
health behavior
and outcome

Findings/
Results
Diet and medication
barriers, Social support for
diet: p<.001 (English
lower score=less barriers
and support)
DK: English: M=15,
SD=4.1
Spanish: M=13, SD=3.9
p<.001
Information sources:
Pamphlets (p<.001),
internet (p=.009),
healthcare professionals
(p=.005), (English- higher
use of sources)
DV1: DM SC ns between
groups
DV2: Physical health
English: T score M=41.6,
SD=7.8
Spanish: T score M=39.5,
SD=8.9
p=.03 (English better
physical health) Mental
health T score ns

Level/Quality
Application
cross-sectional
design.
Conclusions:
Spanish speakers
had lower HL and
worse physical,
mental and
overall health
then English
speakers. LHL
associated with
low DK, barriers
and limitations in
communication.
Feasibility:
Multimedia
assessments
feasible in all HL
levels and
speakers. Study
includes similar
population to
wound clinic.
Supports LHL in
Spanish-speakers
and limitations in
knowledge and
communication.

DV3: English: M=14.9,
SD=3.8
Spanish: M=13.4, SD=4.2
p=.001 (English more
satisfaction with
communication)
Kim & Lee
Framework of
Databases=3
IV1: HL level
IV1: STOFHLA,
Comprehensive
DV 1, 2: Mixed Methods
Design:
Level I
(2016)
health literacy and
Quantitative,
Citations=490
(low, high)
REALM,
Meta-Analysis
Appraisal Tool Quality
Strengths:
its associations with
SR and MA,
Met IC=13
IV2: HL
software (version rating 100%:
Appropriate
(=.90-.91)
Health-literacydiabetes
PRISMA,
All but 1 USA studies
interventions
2.2)
Study 1: Cultural
search methods,
sensitive
mechanisms and
RCT w/ control=6
(written
competency training,
SOE rating
Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Citation

Theory/Conceptual
Framework
outcomes (Bailey et
al., 2014)

Design/
Purpose
Mixed Methods
Appraisal Tool

Sample/
Setting
RCT 2 intervention
groups=3
RCT 1 group
pre/posttest=4

Variables &
Definitions
communication,
spoken
communication,
empowerment,
tailoring
communication
to patients’
language or
cultural
practices and
beliefs)

67
Measurement/
Instrumentation
IV2: Two authors
reviewed
separately and
categorized into
previously
developed
inclusive list of
HL intervention
types (CVR NR)
Mixed Methods
Appraisal Tool
Quality score
(CVR)

Data Analysis

Findings/
Results
communication tailored to
population, motivational
interviewing=Significant
difference in medication
adherence
Study 2: Simplified
internet
program=significant
differences in DK at end of
sessions at 2, 3, 4 weeks.
(All p NR)

Level/Quality
Application
diabetes selfRandom effects
method CVR,
management
model: to
CVR HL
interventions: A
calculate effects
measurements,
systemic review
Purpose: To
sizes and
appropriate IC
and metareview healthstandardized
and EC.
analysis.
literacymean differences
Theoretical
Demographics:
sensitive
N=2,543
in HbA1C
framework
diabetes
RG=46-339
between groups
discussed. All
Country:
Korea
management
participants per study
RCT.
interventions
M age RG=NR
Weaknesses:
focusing on
Females RG=NR
Heterogeneity,
Funding:
National
strategies for
CR RG=NR
limited statistical
Research
accommodating
AA RG=20.6-100%
DV1: Cognitive
Mixed Methods Appraisal
analysis,
Foundation of
patients with
HS degree=NR
or
Tool Quality rating 75%:
measurements
Korea
low HL and to
psychological
DV1: NR
Study 1: Communication
and
examine the
Setting: NR
outcomes
DV2: NR
training, easy-to-read
instrumentation
efficacy of the
(knowledge,
DV3: HbA1C
materials=significant
used for DV NR,
Conflict/Bias:
None reported
interventions to
IC: January 2000self-efficacy,
difference in SE at 6
limited
or appreciated.
improve health
January 2015,
activation,
months
demographics.
outcomes.
described intervention
perceived
Study 2: Easy-to-read
Conclusions:
adapted for patients
susceptibility)
materials with pictorial
Multiple LHL
with low HL, patient
DV2: SC
images, teach-back method interventions in
with DMII, measured
outcomes (SC
with clear
DM led to
HL levels,
behavior, diet,
communication=significan
positive health
experimental design
exercise,
t differences in DK,
outcomes, most
used, peer-reviewed,
medication,
adherence to diet and
included a spoken
published in English,
problem
medication in both groups
communication
measured outcomes.
solving,
versus control
domain which
glucose testing,
Study 3: Provider
was found to be
EC: Studies aimed to
foot care)
communication training,
an important
develop or validate
DV3: HO
teach-back,
factor in DM selfinstruments.
(HbA1C)
communication tailored to
management. HLculture, conversation
sensitive
maps=significant
interventions
improvement in HbA1C,
produced a
DK, SE, SC, foot care,
moderate effect
exercise, both HHL and
on HbA1c in
LHL DK improvement.
LHL patients.
Study 4: Telephone
Feasibility:
follow-up, easy-to-read
Several
education materials,
interventions
Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Citation

Theory/Conceptual
Framework

Design/
Purpose

Sample/
Setting

Variables &
Definitions

68
Measurement/
Instrumentation

Data Analysis

Findings/
Results
counseling focusing on
action plans=significant
improvements in
participants’ activation,
SE, diabetes-related stress,
behaviors, DK at 3
months, similar
improvements with HHL
and LHL
(All p NR)

Level/Quality
Application
discussed and
their associated
communication
domains can be
applied to the
wound clinic
population
depending on the
outcome goal.

DV3: Intervention effects
on HbA1C overall:
ES=-0.18, 95% CI [-0.36, 0.004] (small effect)
p=.04
Intervention effects on
HbA1C for LHL:
ES=-0.51, 95% CI [-0.97, 0.04] (moderate effect)
p=.03

Kiser et al.
(2012)

Not directly stated,
cited model noted:
Baker’s Health
Literacy Conceptual
Model (2006)

Design:
Quantitative,
RCT

N=99
n=67 (education
intervention)
n=32 (usual care
(control))
ATT:
Intervention=20.9%
Usual care=25%
(LTF)

IV: HL level
(LHL: score 22, AHL: score
23-36)

IV: STOFHLA
(=.90)

t-test: to compare
mean change in
scores between
groups

Intervention effects on
HbA1C for HHL:
ES=-0.13, 95% CI [-0.80,
0.54] (small effects)
p=.70 (ns)
MDI overall:
Control:
Baseline Score: M=5.6
Follow-up score: M=5.2
Intervention:
Baseline Score: M=5.2
Follow-up score: M=6.7
M change= 2.1 95% CI
[1.1, 3.0], p<.001 (mean
2.1 point improvement
from control)

Level II
Strengths:
Appropriate
A randomized
control group,
DV: Researcher
controlled trial
Purpose: To
low risk
designed eightof a literacyexamine the
DV: Inhaler
intervention with
item inhaler
sensitive selfimpact of a
technique
appropriate
technique
management
literacyassessment
follow-up
checklist (CRV)
intervention for
sensitive
measurement,
chronic
intervention on
CVR HL
obstructive
inhaler
measurement
Demographics:
pulmonary
technique and
Intervention:
tool, several
determine if
M age=63 (43-84)
LHL:
findings
Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Citation

Theory/Conceptual
Framework

disease
patients.

Design/
Purpose
effects differ by
literacy in
COPD patients.

Country: USA
Funding: not
reported
Conflict/Bias:
None reported
or appreciated.

Sample/
Setting
Females= 64%
CR=67%
HS degree=30%
HI=91%
Low HL: 37%
Usual Care:
M age=63 (44-83)
Females=66%
CR=72%
HS degree=28%
HI=97%
Low HL: 33%

Variables &
Definitions

69
Measurement/
Instrumentation

Data Analysis

Control:
Baseline Score: M=5.2
Follow-up score: M=4.0
Intervention:
Baseline Score: M=4.8
Follow-up score: M=6.3
M change=2.8 95% CI
[0.6, 4.9], p=.015 (mean
2.8 point improvement
from control)
HHL:
Control:
Baseline Score: M=5.8
Follow-up score: M=5.5
Intervention:
Baseline Score: M=5.4
Follow-up score: M=6.9
M change=1.8 95% CI
[0.7, 2.9], p=.001 (mean
1.8 point improvement
from control)

Setting: General IM
clinic
Time: 8-week study
IC: Active
prescription for an
inhaled medication,
order for inhaled
medication on the
inpatient service,
age18, English
speaking, diagnosis of
COPD, chronic
bronchitis, or
emphysema.

7 or greater score on MDI
technique:
Control: baseline= 29.6%
Follow-up=23.5%
Intervention: baseline=
21.4%, Follow-up=66.7%
p=.002

EC: NR

Margolis et al.
(2015)
Health literacy
and diabetic
foot ulcer
healing.

Not directly stated,
cited model noted:
Health literacy
causal conceptual
model (PaascheOrlow & Wolf,
2007)

Design:
Quantitative,
Prospective
cohort study
taken from a
subset enrolled
in a CSS

N=41 CSS
n=22 subjects for
Cohort study (enrolled
from CSS)
AR: 0%

Findings/
Results

IV1: HL score
IV2: DM HL
and numeracy
IV3:DM SE

IV1: STOFHLA
(=.90)
IV2: Diabetes
literacy and
numeracy (=.95)
IV3: Perceived
Diabetes Self-

Stata (version
13.1)
Descriptive
statistics of all
variables

STOFHLA:
Enrolled:
M= 33.8, SD=2.3
Not enrolled:
M= 27.3, SD= 9.6
p=.009

Level/Quality
Application
significant,
intervention
scripted and
consistent.
Weaknesses:
Single site,
unmatched
number in both
groups, lower
number of LHL
participants, no
masking.
Conclusions:
Intervention
group had greater
improvement in
technique and
score. Both LHL
and HHL showed
improvements.
Feasibility:
Multi-strategy
intervention
(spoken
communication
and literacysensitive written
communication)
benefitted both
literacy levels
with
improvement in
SC.
Level IV
Strengths: CVR
HL measurement
tool and log
healing rate CVR,
12-week study
appropriate.

DV: Wound
outcomes (size,
Demographics:
Cohort study:
DM numeracy:
Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Citation
Country: USA
Funding:
National
Institutes of
Health
Conflict/Bias:
None reported
or appreciated

Theory/Conceptual
Framework

Design/
Purpose
Purpose: To
understand how
a patient’s HL
affects
management
decisions of
their foot
ulcers.

Sample/
Setting
M age=53.5 (47-61.5)
Females=37%
CR=NR
AA=75%
HS degree=NR
HI=NR
STOFHLA CSS: 31.1
STOFHLA Cohort:
33.8
STOFHLA Not
enrolled in cohort:
27.3 (low)

Variables &
Definitions
duration of
wound)

70
Measurement/
Instrumentation
Management
Scale (=.83)
DV: Wound ruler

Data Analysis
Chi-square, ttest, linear
regression: to
compare literacy
assessments
between groups

Findings/
Results
Enrolled:
M= 0.71, SD= 0.26
Not enrolled:
M= 0.55, SD=0.32
p=.02
DM SE and DM HL mean
scores ns between groups

Level/Quality
Application
Weaknesses:
Study design, low
N and n, single
site, IC and EC
NR, lower
number of LHL
participants than
AHL in cohort.
Conclusions:
LHL less likely to
enroll in study
and had larger
and older
wounds.
Feasibility:
Consider
challenges of
study recruitment
and LHL wound
patient
presentation with
larger and longer
wounds.

DV: Enrolled:
M wound=4.5cm2 SD=7.1
Mdn=2.3 cm2
Range= 0.48-3.8 cm2
M duration (months)=13.2,
Setting: Urban wound
SD=14.1
care setting
Mdn (months)=7
Time: 12 weeks
Range (months)= 3-24
Week 4: 59.1% (n=13)
IC: NR
increased in size, log
EC: NR
healing rate =0.09
cm2/week, SD=0.29
Week 12: 27.3% (n=6)
healed.
LHL had larger (p=.04)
and older (p=.125)
wounds.
Miller (2016)
Not directly stated,
Databases=2
IV1: HL level
IV1: TOFHLA,
SPSS (version
DV1: Unweighted mean
Design:
Level I
cited model noted:
Quantitative,
Citations=8,463
(low, high)
REALM, Other
12.0)
r=0.14, 95% CI [0.08,
Strengths:
Health literacy
Framework of
MA, PRISMA
Met IC=220
IV2: HL
0.19], p<.001 (14% higher
Appropriate
(=.73-.91)
and adherence
health literacy and
CSS=48
interventions
t-test: to compare risk of nonadherence
search methods,
IV2: HL
to medical
health action (von
Purpose: To
Experimental
moderators in
among LHL than of HHL
MA method
interventions
treatment in
Wagner, Steptoe,
assess effect
studies=172
correlational and
patients.
CVR, CVR HL
DV1:
(details NR)
chronic and
Wolf, & Wardle,
sizes in studies
Treatment
experimental
SRR= 1.33 95% CI [1.17,
measurements,
acute illness: A
2009)
of (a) the
Demographics: NR
adherence
studies
1.47]
appropriate IC
DV1, DV3: Selfmeta-analysis.
correlation
SOR= 1.76 95% CI [1.38,
and EC, multiple
DV2:
reports, patient
between HL
HL and adherence= 48 Improving HL
Random effects
2.16]
sites, large
diaries, pill
Country: USA
and medication
studies
level
model: to
Moderator Variable:
amount of
counts, physical
and nonHL interventions on
DV3: Patient
compute and
Treatment regimen: t
included studies.
examination,
medication
improving HL= 71
adherence
combine effect
(46)=-2.443, p=.018,
Funding:
Weaknesses:
electronic
Robert Wood
adherence, and
studies
size statistics and r=.34
Theoretical
assessments,
Johnson
(b) the effects
allow for
Patient illness: t
framework not
Medication Event
Investigator
of HL
generalization
(46)=2.564, p=.014, r=.35
discussed,
Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Citation
Award in
Health Policy,
National
Institutes of
Health
Conflict/Bias:
None reported
or appreciated.

Theory/Conceptual
Framework

Design/
Purpose
interventions on
improvement of
HL and
adherence.

Sample/
Setting
HL interventions on
improving
adherence=101 studies
Setting: 3 HMO’s, 4
VA hospitals, 41
UMC’s, 6 private
practices, 39 clinics,
49 hospitals, 6 patient
homes, 99 other
settings, 24 in
multiple categories.
IC: 1948-2012, peerreviewed, English, HL
and adherence
measurement.
EC: Not an empirical
study, qualitative
reviews, mental illness
articles, no HL
intervention aimed at
improving adherence,
no quantitative data to
calculate an r effect
size.

Variables &
Definitions

71
Measurement/
Instrumentation
Monitoring
System,
pharmacy refill
assessments,
appointment logs,
other (CVR NR)
DV2: NR

Data Analysis

Findings/
Results

Fixed effects
model: to
calculate
weighted mean
analysis and test
for heterogeneity

DV2: Unweighted mean
r=0.22, 95% CI [0.18,
0.25], p<.001
SRR= 1.56 95% CI [1.44,
1.67]
SOR= 2.45 95% CI [2.07,
2.78]
Moderator Variable:
HL assessment: t
(69)=3.992, p<.001, r=.43
Context of Care: t (69)=2.17, p=.033, r=.25
Patient income: t (69)=2.345, p=.022, r=.27

Binominal effect
size display: to
estimate the
effect size in
changes in
success rates that
are attributable
to a specific
treatment and
calculate the
standardized
odds ratio and
standardized
relative risk

DV3: Unweighted mean
r=0.16, 95% CI [0.14,
0.19], p<.001
SRR= 1.38 95% CI [1.32,
1.47]
SOR= 1.91 95% CI [1.76,
2.16]
Moderator Variable:
Adherence: t (99)=4.578,
p<.001, r=.42
Ethnicity: t (99)=-2.06,
p=.043, r=.2

Level/Quality
Application
measurements
and
instrumentation
used for DV
limited reporting
and CVR NR.
Demographics
NR.
Conclusions: HL
positively related
to adherence and
was higher in
non-medication
regimens. HL
interventions had
a greater effect on
low income and
minority patients.
Feasibility:
Supports
effectiveness of
HL interventions
for nonmedication
regimens in
adherence and
support in
vulnerable
populations.

Key:  - Cronbach’s alpha, AA – African-American, AHL – adequate health literacy, AHRQ – Agency for Healthcare Research and Quality, ATT – attrition rate, BP – blood pressure, CAD –
coronary artery disease, CES-D – Center for Epidemiologic Studies Depression Scale, CI – confidence interval, CR – Caucasian race, CSS – cross-sectional study, CO – clinical outcomes, COPD –
chronic obstructive pulmonary disease, CVR – confirmed valid and reliable, DK – diabetes knowledge, DM – diabetes mellitus, DV – dependent variable, EC – exclusion criteria, GM – general
medical, HbA1C – hemoglobin A1c, HF – heart failure, HFQOL – heart failure quality of life, HHL – high health literacy, HI – health insurance, HIV – Human immunodeficiency virus, HL – health
literacy, HMO – Health Maintenance Organization, HO – health outcomes, HRQOL – health-related quality of life, HS – high school, HTN – hypertensions, IC – inclusion criteria, IM – internal
medicine, INSUFF – insufficient evidence, IRR – incidence rate ratio, IV – independent variable, LDL – low-density lipoprotein, LHL – low health literacy, LTF – loss to follow-up, M – mean, MA –
meta-analysis, MC – medical condition, MCO – managed care organization, MDI – metered dose inhaler, Mdn – median, MEDFICTS – meat, eggs, dairy, fried foods, fat in baked goods, convenience
foods, fats added at the table, and snacks MH – mental health, N – number of participants, n – number of subgroup, NR – not reported, ns – not significant, NYHA – New York Heart Association, OS –
observational study, PC – primary care, PDM – participatory decision-making, PE – practice experience, PPC – patient-provider communication, PRISMA – Preferred Reporting Items for Systematic
Reviews and Meta-Analyses, RCT – randomized controlled trial, REALM – Rapid Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, RIAS –
Roter Interaction Analysis System, RG – range, SAS – Statistical Analysis Software, SC – self-care, SD – standard deviation, SDC – sociodemographic characteristics, SE – self-efficacy, SMBG – selfmonitoring of blood glucose, SOE – strength of evidence, SOR – standardized odds ratio, SPSS – Statistical Package for Social Sciences, SR – systemic review, SRR – standardized relative risk,
STOFHLA – Short Test of Functional Health Literacy, TOFHLA – Test of Functional Health Literacy in Adults; UMC – University Medical Center, VA – Veteran’s Affairs

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE

72

Appendix H
Table 1
Synthesis Table
Studies
Year
Design
LOE
Number of Subjects
Demographics
Mean age
% Females
% Low HL
% High/adequate HL
Chronic Disease
DM
Pulmonary
Cardiac
Wound
Other
Setting
PC/GM/IM Clinic
Specialty Clinic
Other
HL Instruments
REALM/REALM-r
TOFHLA/STOFHLA
Other
PRE Intervention LHL Effects
Adherence
Self-care/self-management
Self-efficacy
Interpreting print materials
Blood pressure control
Emergency/Hospitalization use
HbA1C control
Preventative services
Health status
Patient-Physician Communication
Disease knowledge

Aboumatar
2013
CSS of RCT
II
329

Al Sayah
2013
SR
I
31-17,795

Berkman
2011
SR
I
50-23,889

DeWalt
2012
RCT
II
605

Eckman
2012
RCT
II
187

Hahn
2015
CSS of RCT
II
308

61.2
65.8
30.8
69.2

45.8-67.2
42.7-79.4

11.5-76
0-100

60.7
48
37.2
62.8

59.5
61.2
36
54

54.7
51.6

X

X
X
X

X

X

Kim
2016
SR and MA
I
46-339

Kiser
2012
RCT
II
99

Margolis
2015
CS
IV
41

63
65
36
64

53.5
37

X

X
X
X

X
X

Miller
2016
MA
I

X
X

X
X

X

X
X
X

X
X
X

X
X

X
X
X



X
X

X

X

X

X

X
X

X

X

X

X
X
X

X

X
X
X

X







X





















Key:  – significant improvement,  – significant reduction,  – no change, CS – cohort study, CSS – cross-sectional study, DM – diabetes mellitus, GM – general medical, HbA1C – hemoglobin
A1c, HL – health literacy, IM – internal medicine, LHL – low health literacy, LOE – level of evidence, MA – meta-analysis, PC – primary care, RCT – randomized controlled trial, REALM – Rapid
Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, SR – systemic review, STOFHLA – Short Test of Functional Health Literacy, TOFHLA
– Test of Functional Health Literacy

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Studies
HL Intervention Strategy
Single session
Multiple sessions
Provider Communication
Spoken Communication
Written Communication
Video/DVD/Computer
HL Intervention Outcomes
Behavioral:
Adherence
Disease management
Self-care/self-management
Self-efficacy
Clinical:
Blood pressure

Aboumatar

X
X
X
X
X

Al Sayah

73

Berkman

DeWalt

Eckman

X
X
X
X
X
X

X
X

X

X
X






X
X

Kim

Kiser

X
X
X
X
X
X

X








Margolis

Miller

X
X









Weight



HbA1C



Quality of Life
Communication:
Participatory decision making
Medical question asking
Knowledge:
Disease knowledge

Hahn











Key:  – significant improvement,  – significant reduction,  – no change, CS – cohort study, CSS – cross-sectional study, DM – diabetes mellitus, GM – general medical, HbA1C – hemoglobin
A1c, HL – health literacy, IM – internal medicine, LHL – low health literacy, LOE – level of evidence, MA – meta-analysis, PC – primary care, RCT – randomized controlled trial, REALM – Rapid
Estimate of Adult Literacy in Medicine, REALM-r – Rapid Estimate of Adult Literacy in Medicine revised, SR – systemic review, STOFHLA – Short Test of Functional Health Literacy, TOFHLA
– Test of Functional Health Literacy

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Appendix I
Theoretical Framework
Health Literacy Skills Conceptual Framework (Squiers et al., 2012)

74

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Appendix J
Evidence Based Practice Model
Model for Evidence-Based Practice Change (Larrabee, 2009)

75

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Appendix K
Education Materials
Wound Poster

76

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Wound Brochure English

77

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Wound Brochure Spanish

78

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Wound Stickers

79

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Appendix L
Site Approval

80

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Appendix M
Institutional Review Board Approvals
Modification approval

81

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82

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Initial approval

83

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84

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Appendix N
Measurement Tool Approval
Brief Health Literacy Screen

Bates-Jensen Wound Assessment Tool

85

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Appendix O
Recruitment Script
English

RECRUITMENT SCRIPT
I am a graduate student under the direction of Dr. Lynda Root from
the College of Nursing and Health Innovation at Arizona State University.
I am conducting a study to evaluate a wound educational program that
may improve your wound knowledge and ability to care for your wound.
I am recruiting individuals who would like to learn more about their
wound and dressing changes. Participants will answer 10 questions
before and after a brief 10-minute education session and perform their
dressing change on a wound model. The total time each visit is
approximately 15 minutes and will occur at your next three clinic visits.
In order to participate, you must be 18 years or older, able to speak
English or Spanish, and your wound must not require a wound vac or
multi-layer compression. Your participation in this study is voluntary. If
you choose not to participate in this study or withdraw at any time it will
not impact your care or treatment at the clinic.

86

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87

Spanish

RECRUITMENT SCRIPT-Spanish
Soy una estudiante de postgrado bajo la dirección de la Dr. Lynda Root de la
escuela de enfermería y innovación de salud en la Universidad Estatal de Arizona. Estoy
llevando a cabo un estudio para evaluar un programa educativo sobre heridas, el cual
puede mejorar su conocimiento y cuidado sobre su herida.
Estoy reclutando a personas que deseen aprender más sobre su herida y cambio de
vendaje. Los participantes responderán 10 preguntas antes y después de una sesión
educativa breve de 10 minutos y realizarán su cambio de vendaje en un modelo de herida.
El tiempo total de cada visita es de aproximadamente 15 minutos y ocurrirá en sus tres
próximas visitas en la clínica.
Para participar, usted debe tener más de18 años, hablar inglés o español, y la
herida no debe requerir un terapia de presión negativa o múltiples capas de compresión.
Su participación en este estudio es voluntaria. Su atención o tratamiento en la clínica no
se verá afectado en caso de que usted decida no participar o retirarse de este estudio.

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Appendix P
Informed Consent
Informed consent in English

88

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89

LITERACY-SUPPORTIVE EDUCATION FOR WOUND SELF-CARE
Informed consent in Spanish

90

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91

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Appendix Q
Wound Education Participant Questionnaire
English

92

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Spanish

93

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Appendix R
Wound Knowledge Pre-test
English

94

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Spanish

95

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Appendix S
Wound Healing Status
Bates-Jensen Wound Assessment Tool (Bates-Jensen et al., 1992)

96

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Appendix T
Wound Knowledge
English
Post-test (Visit 1)

98

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Post-test (Visit 2)

99

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Post-test (Visit 4)

100

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Spanish
Post-test (Visit 1)

101

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Post-test (Visit 2)

102

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Post-test (Visit 4)

103

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Appendix U
Wound Dressing Steps
Performance Checklist (Visit 1)

104

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Performance Checklist (Visit 2)

105

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Performance Checklist (Visit 4)

106

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Appendix V
Health Literacy Tool
Brief Health Literacy Screen (Chew et al., 2004)

107

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Appendix W
Budget

GOODS & SERVICES
Graphic designer

COST
$100.00

Photography copyrights

$29.99

English Brochures

$38.50

Spanish Brochures

$38.50

Stickers

$78.90

Study instrument photocopying

$8.72

Plastic bags for products

$11.70

Posters

$12.79

DONATED SERVICES
Interpreter Services

$0.00

Wound Model

$0.00

Photographer

$0.00

Illustrator

$0.00

TOTAL

$319.10

108