Running head: TECHNOLOGY AND THE INFLUENZA VACCINE Utilizing Technology to Affect Influenza Vaccine Coverage Among Children with Chronic Respiratory Conditions Sarah L. Bay Arizona State University 1 TECHNOLOGY AND THE INFLUENZA VACCINE 2 Abstract Purpose: To integrate text messaging into a multi-component reminder system to improve influenza vaccination rates among children with chronic respiratory conditions. Background: Influenza presents burdens for children with chronic respiratory conditions including increased mortality, morbidity, hospitalizations, and decreased quality of life for children and caregivers. Influenza vaccinations may reduce these complications yet approximately half of children remain unprotected annually. Synthesized evidence supports integration of text messaging into a multi-component strategy to increase the influenza vaccination rate in many populations of interest. Methods: The intervention was a single text message and electronic mail message sent to all families in a private pediatric pulmonology practice who enabled text and/or electronic mail messages in the patient portal. A follow-up survey assessed various aspects of message receipt. Surveys were completed without collection of demographic information. Results: Electronic mail messages were sent to 3140 addresses available in the patient portal. The number of text messages sent out via the patient portal was 75 with 66 (88%) delivered successfully. Follow-up surveys were initiated by 107 recipients. Frequency analysis showed that participants preferred text and electronic mail messages over other forms of communication. A statistically significant positive relationship was found utilizing Chi Square between those who received a message and those whose child received an influenza vaccination (p= .027). Conclusions: Text and electronic mail messaging are cost-effective and well-received forms of communication that can be easily integrated into existing systems. These delivery routes are translatable to many populations and can convey various types of messages. Keywords: asthma, pediatrics, influenza vaccination, prevention, text messaging TECHNOLOGY AND THE INFLUENZA VACCINE 3 Utilizing Technology to Affect Influenza Vaccine Coverage Among Children with Chronic Respiratory Conditions Chapter 1 Introduction Children with chronic respiratory conditions have compromised systems that greatly increase their risk of complications and mortality from influenza illnesses. Children with asthma and other respiratory conditions are infected with influenza at the same rate as other children but experience additional complications such as pneumonia and are more likely to require hospitalization (Morbidity & Mortality Weekly Report [MMWR], 2013). These children have higher utilization of health care resources with increased financial expense. The annual cost of treating children with asthma and influenza is approximately $3.2 billion dollars (Jones Cooper & Walton-Moss, 2013). Asthma exacerbations result in reduced quality of life, missed days of school, and lost work days for parents (Ong, Forester, & Fallot, 2009). Annual influenza vaccines have been shown to be beneficial in reducing complication and hospitalization rates for kids with asthma and other chronic respiratory conditions (Murphy, 2014; Patria, Tagliabue, Longhi, & Esposito, 2013). Background and Significance In 1964, the Advisory Committee on Immunization Practices first issued a recommendation that everyone over the age of six months receive an annual influenza vaccine (Murphy, 2014). Since then the committee has designated children with asthma as one of five high risk groups which should be specifically targeted for an increase in annual vaccine coverage (Dombkowski et al., 2014). For more than fifty years, annual influenza vaccinations have been a TECHNOLOGY AND THE INFLUENZA VACCINE 4 standard of care for all children yet compliance is low with approximately half of children remaining unprotected (MMWR, 2013). Providers and healthcare systems have taken various approaches to improving the vaccination rate. Reminder and recall systems have been used for many years in pediatric offices but the exact process used varies widely among providers (Jones Cooper & Walton-Moss, 2013). Offices with a reminder/recall system do have higher influenza vaccination rates than those without any recall system but rates remain below recommended levels (Dombkowski, Davis, Cohn, & Clark, 2006). For these high risk children to benefit from influenza vaccine coverage an innovative and effective approach utilizing technology has shown promise. The use of text messaging via smart or SMS enabled cellular phones is an appropriate use of modern technology that has shown increased efficacy in reminding parents about general immunizations and scheduled appointments (Stockwell, Kharbanda, Martinez, Lara, et al., 2012; Jordan, Bushar, Ingersoll, & Goodman, 2014). It is estimated that at least 92% of the U.S. population has a cellular phone (Stockwell, Kharbanda, Martinez, Vargas, et al., 2012). More than 70% of the population reports using text messages on a daily basis and cell phones are more common in low income urban populations than in other populations (Stockwell & Fiks, 2013; Stockwell, Westhoff, et al., 2014). The permeation of cell phone technology into all socioeconomic populations makes it a useful tool for health care providers. Few authors have conducted research utilizing text messaging specifically for the pediatric respiratory condition population and influenza vaccine. Data from these studies is promising and the demonstrated efficacy in other similar populations should be easily translated. Data from one study reports that preschool age children whose caregivers received a text message about influenza vaccination received the flu shot 16 days earlier, on average, than the TECHNOLOGY AND THE INFLUENZA VACCINE 5 children of caregivers receiving a mailed letter (Coleman, 2014). Other particularly effective studies utilizing text messaging to increase compliance and attendance are the Text4baby and the TEXT 4 HEALTH programs (Jordan et al., 2014; Stockwell, Kharbanda, Martinez, Lara, et al., 2012). Additional studies examined the perception and acceptance of text messaging in the health care sector. Parents report high interest in receiving text messaged immunization reminders and appointment confirmations (Ahlers-Schmidt et al., 2012; Hofstetter, Vargas, Kennedy, Kitayama & Stockwell, 2013). Parents, providers, and staff were all supportive of the use of text messaging and parents report preferring personalized, interactive messages (Hofstetter et al., 2013). The major concern of all stakeholders in this study was incorrect cell phone numbers (Hofstetter et al, 2013). Other concerns that arise when using technology in health care include patient privacy and compliance with the Health Insurance Portability and Accountability Act (HIPPA), as well as staff unfamiliarity with technology (Pereira et al., 2012). These concerns can be mitigated with careful planning and appropriate design of text messaging protocols. In the Phoenix metropolitan area, key stakeholders in an accountable care organization (ACO) report low vaccination rates in the community pediatric population, particularly those with asthma. Anecdotal responses indicate that the local rate for influenza vaccine coverage of the pediatric asthma population is at or below the national average and well below recommended levels. Problem Statement and PICO Influenza vaccination rates average less than 50% in both the general population and children with chronic respiratory disease (MMWR, 2013). Children with respiratory conditions have a higher risk of developing pneumonia, respiratory distress, and requiring hospitalization TECHNOLOGY AND THE INFLUENZA VACCINE 6 when infected with influenza. Influenza vaccination has been shown to reduce complications, decrease hospitalizations, and in some studies reduce the need for oral steroids (Murphy, 2014; Patria, Tagliabue, Longhi, & Esposito, 2013). The Center for Disease Control and Prevention initiative, Healthy People 2020, has set the goal of annual influenza vaccine coverage at 70% (United States Department of Health and Human Services, 2011). The prevalence of asthma in the pediatric population of the United States (U.S.) is approximately 8% making asthma the most common chronic condition of childhood (Murphy, 2014). About one-third of all patients hospitalized with the flu have asthma (Murphy, 2014). In fact, the risk of hospitalization for asthmatic children is two to four times higher than that of children without the disease (Neuzil, Mitchel, & Griffin, 2000). Cystic fibrosis is a fatal genetic condition that affects secretions and airway clearance. About 30,000 people in the U.S. are living with cystic fibrosis and 1,000 new cases are diagnosed each year. More than half of cases are diagnosed before the first birthday (March & Schub, 2013). This inquiry has led to the clinically relevant PICO question: In children with chronic respiratory conditions (P), how does a multi-component strategy consisting of a text-based reminder message and/or electronic mail message (I) compared to no reminder (C) affect influenza vaccine coverage (O)? Search Strategy Evidence pertaining to the research question presented above was obtained by performing an exhaustive search of the following databases: Cumulative Index to Nursing and Allied Health Literature (CINAHL), ProQuest Medline, PubMed, and Cochrane (Appendix A). In addition, grey literature was searched and hand ancestry searching was utilized to uncover additional relevant resources. Articles were considered relevant if at least one aspect of the PICO question TECHNOLOGY AND THE INFLUENZA VACCINE 7 was addressed. Retained articles focused either on improvement in vaccination compliance or the use of text messaging to transmit healthcare information. Index terms used for search in CINAHL database included text messaging, immunization, reminder, asthma, pediatric, and children, the same terms were used as keywords for the ProQuest Medline database and as MeSH terms in the PubMed database. A total of 410 relevant articles were obtained. Further refinement occurred when search terms were combined. Limits were placed on published date between January 2010 and March 2015 and English language (Appendix A). Cochrane Database of Systematic Reviews was searched utilizing the keywords immunizations and reminders and children resulting in retrieval of 3 articles. These articles were all excluded, one was published more than five years ago, the second focused on immunizations in other countries, and the third examined medicine safety and efficacy. Manual review was conducted of the results from all articles retrieved from the three databases. Articles were excluded if no elements of the PICOT question were addressed. A total of 16 articles were selected for critical appraisal (Appendix A). Clinical practice guidelines and editorials were excluded with only level I, II, and III evidence retained (Appendix B). Level of evidence was assigned per the Rating System for the Hierarchy of Evidence for Intervention/Treatment Questions as discussed by Melnyk and Overholt (2015) on page 11. The final 10 studies are comprised of six randomized control trials, two systematic reviews, one randomized community intervention trial, and one cluster randomized trial. All studies are English language, published after January 2010, and support at least one element of the PICOT question. TECHNOLOGY AND THE INFLUENZA VACCINE 8 Evidence Synthesis Text messaging is a technology that is currently being examined for an emerging application in healthcare. Research gathered to support the use of text messaging yields high levels of evidence in the form of systematic reviews and randomized control trials. Validity and reliability of the studies are overall very high (Appendix B). Sample demographics are similar across studies with the majority focusing on children or children with high risk conditions (Appendix B). Additional studies target adult populations which supports the proposed intervention as the adults are tasked with making medical decisions for dependents (Appendix B). Outcomes measured homogenously include the receipt of a vaccination, influenza or otherwise, or the uptake of general healthcare related information. Supporting evidence shows that measurement of outcomes is best achieved through EMR review or review of local or state immunization databases when available (Appendix C). The potential for bias was addressed in one study where a contributor disclosed involvement with a pharmaceutical company who manufactures immunizations (Stockwell, Kharbanda, Martinez, Vargas, et al., 2012). Most studies were conducted in healthcare settings affiliated with academic institutions or in public health centers. All studies showed an increase in outcomes measured though not all were statistically significant (Appendix C). Several conceptual frameworks were repeated throughout studies with the most common being Trans-theoretical Model, Health Belief Model, and Social Cognitive Theory (Appendix C). Evidence shows that increasing influenza vaccination rates among children with chronic respiratory conditions is a cost-effective and relatively simple way to reduce additional disease burden. Adding text messaging alerts to a practice that currently has the technological infrastructure available is an efficient way to provide timely information to a large number of TECHNOLOGY AND THE INFLUENZA VACCINE 9 patients. Expected results from this intervention are a higher rate of vaccination among patients of the practice, less emergency department/urgent care visits, and reduced hospitalizations. Some evidence shows that increased vaccination rates could also reduce the need for oral corticosteroids and this may be seen anecdotally in the practice (Murphy, 2014; Patria, Tagliabue, Longhi, & Esposito, 2013). Additional results that should be seen are less school days missed and overall higher quality of life for parents and children (Ong, Forester, & Fallot, 2009). Purpose Statement The purpose of the project is to reach caregivers with a multi-component strategy to encourage the uptake of influenza vaccinations among children with chronic respiratory conditions. Key stakeholders will be the providers at the office and will also include the patients and their families. The providers will gain additional insight into communication delivery preferences of the patients serviced. The greatest benefit, according to synthesis of evidence, will occur when vaccination rates are improved and patients experience reduced corticosteroid use, decreased hospitalizations, and improved quality of life (Murphy, 2014; Patria, Tagliabue, Longhi, & Esposito, 2013). Study Questions • Among children with chronic respiratory conditions, do reminder messages influence influenza vaccination rates? • How do patient caregivers’ wish to be contacted in this era of increasing reliance on technology? TECHNOLOGY AND THE INFLUENZA VACCINE 10 Chapter 2 This section will detail the methods used during the practice improvement project as well as the results of the intervention. Methods will include the theoretical frameworks, models, data collection and analysis tools. Ethical considerations, protection of human subjects, and practice setting will also be described. Models Theoretical Frameworks and Evidence-Based Practice Theoretical frameworks and evidence-based practice (EBP) models lend guidance to practice changes. The Health Belief Model (HBM), as discussed by Polit and Beck (2012), focuses on health-seeking behaviors. The HBM theorizes that in order for a person to seek out preventive care they must understand the risks and benefits associated with the intervention. Increasing the caregiver’s knowledge about the benefits of the influenza vaccination in children with asthma, according to the HBM, should increase the motivation to seek out this preventive intervention. This theory serves as a precursor to the models that will facilitate practice change. Asthma is the most common chronic condition of childhood and improvements in quality of care for such conditions are the foundation of Wagner’s Chronic Care Model (CCM). The CCM encourages the examination of health care systems to provide the best outcomes for the chronically ill. The CCM focuses on several elements including the community, the health system, self-management support, system design, decision support and information technology (Silver et al., 2011). The goal of the CCM design is to create a relationship between a wellinformed patient and expert providers in which the patient takes an active role in their own care. The Ottawa Model of Research Use (Ottawa Model) helps to guide the implementation of an innovation (National Collaborating Centre for Methods and Tools, 2010). The Ottawa Model TECHNOLOGY AND THE INFLUENZA VACCINE 11 lends itself to this implementation as it offers a streamlined process for evaluating not only the intervention but the practice environment and barriers. This evidence-based practice model (EBP) provides points for assessing barriers and supports, monitoring the intervention and degree of use, as well as evaluating outcomes (Appendix D). The combination of the HBM, the CCM and the Ottawa Model are appropriate to guide an intervention in which a clinical improvement team seeks to improve standard of care for pediatric pulmonology patients. The application of both models provide a solid framework for the proposed intervention of utilizing text messaging to increase influenza vaccination rates among children with chronic respiratory conditions. Logic Model The logic model chosen for this intervention is a simple one that delineates the necessary inputs, outputs, outcomes, and impacts of the project (Appendix F). The overall design calls for inputs of staffing and technology. Outputs, or the activities required for the intervention, include assessing preferred delivery methods, delivering the message according to those preferences, and an analyzing the delivery status of messages. After delivery of the messages, a survey will be sent out via the same delivery routes to assess for additional outcomes. These outcomes will be analyzed to identify additional measurements that may be impacted by the intervention. These include whether patients received an influenza vaccination, intention to receive, and other factors in the decision making process. Metrics indicating approval and acceptance of the message delivery method will also be included. Expected outcomes of the intervention include increased parental receipt of reminders, caregivers seeking out additional resources, increased vaccination receipt and therefore a decreased incidence of influenza among patients. Short term impacts may TECHNOLOGY AND THE INFLUENZA VACCINE 12 include reduced asthma exacerbations for patients, less use of corticosteroid use, and reduction in hospitalizations. Project Methods Ethics Protection of human subjects was ensured through appropriate training of investigators through Collaborative Institutional Training Initiative (CITI). There was no collection of identifying patient information during the intervention or the follow up survey. The survey was completed anonymously and only aggregate data was reported. A separate recruitment protocol was not necessary to complete the intervention as routine office procedure dictates that all patients are requested to enable the patient portal and set up delivery preferences. Consent to receive messages from the practice is obtained when participants enroll in the patient portal. A statement was added to the survey that explained to participants that completion of the survey implies consent to use the results in summary form. Permission to implement the intervention was obtained from the practice site (Appendix G). Approval for the project was received from the Arizona State University (ASU) Institutional Review Board on August 8, 2015 (Appendix H). Setting and Organizational Culture Crazy About Kids Pulmonary Services is a private pediatric pulmonology practice located in Gilbert, Arizona. The practice is owned by a Family Nurse Practitioner (FNP) and employs a pediatric pulmonologist. Athenahealth is the practice electronic medical record system which offers an integrated patient portal. The patient portal utilized by this practice has both text messaging and electronic mail capabilities. TECHNOLOGY AND THE INFLUENZA VACCINE 13 Participants and Intervention All patients of Crazy About Kids Pulmonary Services will receive the intervention. There will be no exclusion criteria for age. Inclusion criteria will capture all children within the practice. Approximately 75% of the children in the practice have asthma the remaining 25% are afflicted with a variety of chronic respiratory conditions such as cystic fibrosis. Intervention design will focus on the use of text messaging and electronic mail messaging initiated by the EMR through the patient portal. The content of the intervention messages is an alert that their provider encourages patients and their families to receive the influenza vaccination. Embedded links in the intervention messages offer county and national resources for education and locations to receive the vaccination. These resources will be important for patients who do not have a primary care provider (PCP) or chose to go elsewhere for vaccinations. The messages were sent to all patients within the practice with active text or electronic mail message preferences in the patient portal. One month later a survey was sent out to the same patients through both delivery routes. Outcome Measurements Summary data will be collected include the total number of successfully delivered messages compared to attempted messages. The total percent of patients who received a reminder during the intervention compared to last year. This intervention will be guided by Donabedian’s S-P-O Model, as discussed by Hickey and Brosnan (2012), which is a conceptual model that serves as a pathway to evaluating quality of care. The model uses three major concepts: structure, process, and outcome (Appendix E). The structure will consist of reaching pediatric pulmonology patients and their caregivers or legal guardians. The guardians have set up their communication delivery method preferences through the patient portal as part of routine TECHNOLOGY AND THE INFLUENZA VACCINE 14 practice policy. The process will be an intervention message sent via text and/or electronic mail and will include all caregivers that have preferences enabled in the patient portal. The main outcome will be that more caregivers receive reminders about vaccinations than in previous years. A second measurement component is a follow-up Internet-based survey to be distributed in December 2015 that measures key indicators via caregiver response. The survey consists of seven questions that address aspects such as recipient recall of the intervention, whether a vaccination was received, caregiver opinion of influenza vaccinations, as well as communication delivery preferences. Drop down boxes, multiple choice, and Likert-type scales will be utilized within the survey. The data from this survey will be input into IBM SPSS Statistics (SPSS) for further data analysis. The nature of the data will allow for descriptive statistics as well as chi square for determining relationships between variables. While follow-up surveys have a low return rate, some data does show that electronic surveys have more favorable rates than those that are mailed (Hart, A., Brennan, Sym, & Larson, 2009). The advantage of utilizing an Internet-based survey in this case lies in that Internet access and use can be assumed of all recipients who are enrolled and active in the patient portal. Project Budget The Crazy About Kids practice site uses a fully integrated electronic medical record which offers text and electronic mail messaging and not incur any additional costs for this intervention. The amount of time that will be required to complete the intervention and run a report is estimated at less than one hour. Other fully integrated vendors that currently offer this function are: eClinicalWorks, NextGen, GE Centricity, and Epic among others. TECHNOLOGY AND THE INFLUENZA VACCINE 15 For practice sites that do not have these capabilities but wish to pursue text messaging several options exist. Stockwell and et al. (2012) placed the cost of a standalone text messaging system at approximately $2700, with much of the cost stemming from over 400 hours of programming time. This high financial and time cost may make a third party or add-on system more attractive. Practice Unite is one such add-on system that offers text messaging. There are also a few third-party software companies that offer message media campaigns without cost but HIPAA compliance cannot be assured, these include SMS Marketing 360, Frontline SMS, and Magpi (Arya & et al., 2014). For most third-party managed text messaging campaigns the monthly fees are from $50 to $1,000. The wide range of cost depends entirely on the needs of the practice and includes factors such as the vendor chosen, staff time, equipment, length of project, number of messages to be sent, one-way or two-way capabilities, and web platform (Northwest Center for Public Health Practice, University of Washington, 2015). Information and guidance from the United States Department of Health and Human Services is available online for private practices or public health offices interested in integrating text messaging into their practices. Project Results The initial results for the intervention phase of the project were collected in a report generated through the EMR. Electronic mail messages were received by 3140 unique addresses. Total number of text messages sent was 75, of these 66 (88%) were delivered successfully while 9 (12%) were not deliverable. It is likely that some caregivers received both a text message and an email message. The practice site did not send out influenza vaccination reminders last year and this influenza season 3206 reminders were successfully delivered. TECHNOLOGY AND THE INFLUENZA VACCINE 16 The follow-up survey was sent out approximately 60 days after the initial intervention message (Appendix I). The survey was sent via text and email message to all available numbers in the patient portal. A total of 107 participants initiated the survey (Appendix J, Table 1). The initial question assessed whether the individual received the intervention message. Participants were also polled on whether their child had received a vaccination this influenza season. A statistically significant relationship between receiving the message and the child receiving an influenza vaccination was found utilizing chi square analysis (p=.032) and Fischer’s Exact showed this to be a positive relationship (p= .027) (Appendix J, Table 2). The participants were asked to rate how much their decision to vaccinate or not vaccinate was influenced by the intervention message. Those who received the vaccination were more likely to indicate that they were somewhat or very much influenced than those who had not. However, those who received the influenza vaccination also indicated that they were influenced not at all by the intervention message at a higher rate than those who did not. There was no statistically significant difference in the influence decision variables (Appendix J, Table 3). The participants who stated that they had not obtained vaccinations for their child and did not plan to or were unsure were asked why they chose not to vaccinate. Over half (53.33%) of those responding indicated that they believed that flu shots are not beneficial (Appendix J, Table 1). The final survey question assessed the participants preferred method of communication from their healthcare providers. This question allowed for the participant to choose multiple routes of delivery, 102 people completed this question (Appendix J, Table 4). The highest rated forms of communication were email (86), text messaging (64). The ranking of email and text messaging as preferred is congruent with evidence synthesis undertaken prior to implementation. TECHNOLOGY AND THE INFLUENZA VACCINE 17 Chapter 3 This section will detail the organizational impacts and sustainability issues of the practice improvement project. Barriers and supports for this type of practice change will be discussed as well as gaps identified during implementation. Recommendations for further research and changes to implementation process will be identified. Organizational/Health Policy Impact & Sustainability Implications The ability of practices and health systems to utilize text and email specifically will vary depending on the resources available. The use of technology for communication between provider and patient or caregivers is so highly individual that it does not lend itself easily to the formation of a single set of guidelines. However, the intervention is a tool that can be used to ensure compliance with standard guidelines for treating children with chronic respiratory conditions such as the National Heart Lung and Blood Institute’s widely accepted Third Expert Panel on the Diagnosis and Management of Asthma (National Asthma Education and Prevention Program, 2007). The results of the project were overwhelmingly positive. The project was well-received by the practice site as well as the intervention population. The practice site has indicated that it will continue to employ these delivery methods for influenza campaigns as well as various other messages. The intervention implemented at this practice site did not incur additional costs as the EMR employed at the facility had all necessary capabilities integrated. Impacts Implementation of new communication routes between providers and patients can only be beneficial overall. These communication routes increase the ability of providers to engage TECHNOLOGY AND THE INFLUENZA VACCINE 18 patients with education, reminders, and health promotion information. As a new nurse practitioner it is important to embrace technology and become familiar with the capabilities of the EMR systems available. Utilizing all communication methods available to their fullest potential increases the provider’s ability to educate, encourage, and remind our patients in the ways that they prefer. Limitations that were encountered mainly centered on the lack of the capability to collect data on actual receipt of influenza vaccinations. Replication of this intervention in a practice that offers the vaccination onsite would offer the opportunity to observe a change in vaccination rates from previous years. Had this data been available it would allow for a more thorough comparison of outcomes to evidence. This project was most successful in that it adds to the body of evidence supporting the wide acceptance and versatility of text and electronic mail messaging. The results of the survey were congruent with evidence synthesis for this variable. Sustainability The practice site found that the delivery of messages to patients through text and email to be efficient and require little allocation of resources. The practice owner has indicated that she plans to utilize these delivery methods to communicate various messages to their patients including new provider introductions, changes in practice hours, as well as to continue to use them for influenza campaigns. The intervention implemented at this practice site did not incur additional costs as the EMR employed at the facility had all necessary capabilities integrated. The most important facilitators of this practice change were having strong support from the practice owner and a robust EMR system with high patient engagement in the portal. As comprehensive EMR systems become commonplace in practices, these types of delivery options will become ubiquitous and create more opportunities to implement multi-component reminder TECHNOLOGY AND THE INFLUENZA VACCINE 19 campaigns. The Affordable Care Act should have little to no impact on implementing this type of intervention however, current mobile healthcare and HIPPA regulations should be evaluated carefully prior to implementation. Future research endeavors that employ text and email messaging may encompass a vast array of topics. Structured programs that offer interval messages with education and resources have shown promise in chronic illness management and general health promotion. One time campaigns such as this project can be easily adapted to suit any message that a practice may find important for their patients. Studies assessing the use of technology should focus on learning about how patients and caregivers chose to receive information so that providers can tailor methods to individual needs and maximize patient engagement. Conclusion Text and electronic mail messaging are cost-effective and appropriate ways to communicate with many populations. Evidence exists to support the use of technology in various populations and for a myriad of variables including general health information and immunizations. This practice improvement project has demonstrated that caregivers of children with chronic respiratory conditions support the use of technology as a route of communication from providers. Practices who are able to integrate technology into their daily workflow will communicate with more patients and their caregivers in a more effective way. Uptake of information and education is improved with the use of technology as well as recall rates. 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Journal Of Community Health, 36(2), 180-190. doi:10.1007/s10900-010-9296-8 Stockwell, M. S., & Fiks, A. G. (2013). Utilizing health information technology to improve vaccine communication and coverage. Human Vaccines & Immunotherapeutics, 9(8), 1802–1811. doi:10.4161/hv.25031 Stockwell, M., Kharbanda, E., Martinez, R., Vargas, C., Vawdrey, D., & Camargo, S. (2012). Effect of a text messaging intervention on influenza vaccination in an urban, low-income pediatric and adolescent population: a randomized controlled trial. JAMA: Journal Of The American Medical Association, 307(16), 1702-1708. Stockwell, M. S., Kharbanda, E. O., Martinez, R. A., Lara, M., Vawdrey, D., Natarajan, K., & Rickert, V. I. (2012). Text4Health: Impact of Text Message Reminder-Recalls for Pediatric and Adolescent Immunizations. American Journal Of Public Health, 102(2), e15-21. doi:10.2105/AJPH.2011.30033 TECHNOLOGY AND THE INFLUENZA VACCINE 24 Stockwell, M. S., Westhoff, C., Olshen Kharbanda, E., Vargas, C. Y., Camargo, S., Vawdrey, D. K., & Castano, P. M. (2014). Influenza Vaccine Text Message Reminders for Urban, Low-Income Pregnant Women: A Randomized Controlled Trial. American Journal Of Public Health, 104(S1), e7-e12. doi:10.2105/AJPH.2013.301620 United States Department of Health and Human Services, Healthy People 2020. (2011). Immunizations and Infections. Retrieved March 9, 2015 from http://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectiousdiseases/objectives Vaccination coverage among persons with asthma - United States, 2010-2011 influenza season. (2013). MMWR: Morbidity & Mortality Weekly Report, 62(48), 973-978. TECHNOLOGY AND THE INFLUENZA VACCINE Appendix A Search Strategy Flow Chart 25 RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix B Table 1 Evaluation Table Citation/Article Title/ Funding/ConflictsBias/Country Ahlers-Schmidt, (2012) Feasibility of a randomized control trial to evaluate Text Reminders for Immunization Compliance in Kids (TRICKs) Country: United Sates Funding: Wichita Center for Graduate Medical Education and Kansas Bioscience Authority Level III Grant Bias: None reported Conceptual Framework Design/Method Sample/Setting Major Variables & Definitions Measurement Data Analysis Findings Decision for Use in Practice/Application to Practice HBM RCT N= 90 CG = 40 IG= 50 IV: Text messages 7 days prior to anticipated immunization date plus standard reminder Kansas Immunization Registry data Chi Square = categorical data IG = increase in receipt of 2 month immunizations, increase in on time immunizations at 2and 4 months Level of Evidence: II Purpose: To pilot test the Text Reminders for Immunization Compliance in Kids (TRICKs) program to evaluate the feasibility and potential to increase immunization coverage. ES 83% SS 17% Mean Age (P) 26 Public insurance 59% Education: High School Diploma or less 66% DV 1: Receipt of immunizations at 2/4/6 months DV2: Timeliness of immunizations at 2/4/6 months Setting: Academic Exclusion criteria: Parent under 18 years of age, did not own mobile phone, personal or religious beliefs against vaccination All participants received $20 gift card at enrollment, IG received additional $20 gift card for completion of follow up interview Received = any time in child’s first 7 months of life Timeliness = within thirty days of due date t-test = independent samples 40% IG lost to follow-up 18 of IG available for final follow up 83% found TM helpful Strengths: • High level of evidence • Study quality Weaknesses: • Pilot study • Small sample size • High attrition rate • Low follow up (40% lost cell phone service during study) Conclusions: Showed increase in overall immunization rates but not SS, if duplicated on a larger scale may show SS Feasibility: Likely very high without incentive component, no potential for harm (C) – child, CDC – Center for Disease Control and Prevention, CG-control group, DV – dependent variable, EHR – electronic health record, ES – English speaking HBM – Health Belief Model, HRC – high risk condition(s), IG – intervention group, IV – independent variable, MCS – multi-component strategy, N – sample size, Non-RCT – Non-randomized control trial, (P) – parent, PCP – primary care provider, RCT – randomized control trial, SCT – Social Cognitive Theory, SR – systematic review, SS – Spanish speaking, TM – text message, TTM – Trans-theoretical Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Citation/Article Title/ Funding/ConflictsBias/Country Aigbogun, (2014) Interventions to increase influenza vaccinate rates in children with highrisk conditions – a systematic review Country: United Kingdom Conceptual Framework Design/Method Sample/Setting Major Variables & Definitions Measurement Data Analysis Findings Decision for Use in Practice/Application to Practice HBM SR N= 18 RCT = 7 Non- R, CT = 1 Other = 10 IV1: MCS IV2: Letters IV3: Telephone recall IV4: Letter + telephone IV5: Asthma education tool IV6: Year round scheduling Self-report Logistic Regression (1) MCS: Small increase Level of Evidence: I Military database Review Pre/Post Intervention Comparison (10) Letter: 6-26% increase State or local immunization database review Control Year vs. Study Year Comparison (7) DV: Receipt of vaccination Billing records Purpose: To conduct a systematic review of studies that have examined interventions aimed at improving influenza vaccination in children with HRC. Age range (C) 6 months – 19 years Settings: Public, Private, Academic, Military Funding: Health Protection Agency and Public Health England Bias: None reported Exclusion Criteria: Not focused on influenza vaccine, children with HRC. EHR Review Telephone recall 15-25% Strengths: • High level of evidence • Data retrieved from across setting types Asthma education tool: increase Weaknesses: • Studies retrieved from only 2 databases • Wide variation in IV • Various methods of measurement used • Did not report data analysis methods for some studies Conclusion: Supports need for intervention in high risk groups, does not address TM Feasibility: No potential for harm, supports need for intervention but does not address TM (C) – child, CDC – Center for Disease Control and Prevention, CG-control group, DV – dependent variable, EHR – electronic health record, ES – English speaking HBM – Health Belief Model, HRC – high risk condition(s), IG – intervention group, IV – independent variable, MCS – multi-component strategy, N – sample size, Non-RCT – Non-randomized control trial, (P) – parent, PCP – primary care provider, RCT – randomized control trial, SCT – Social Cognitive Theory, SR – systematic review, SS – Spanish speaking, TM – text message, TTM – Trans-theoretical Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Citation/Article Title/ Funding/ConflictsBias/Country Dombkowski, (2012) Seasonal influenza vaccination reminders for children with highrisk conditions: Country: United States Funding: CDC Cooperative Agreement Bias: None reported Conceptual Framework Design/Method Sample/Setting Major Variables & Definitions Measurement Data Analysis Findings Decision for Use in Practice/Application to Practice SCT Randomized Community Intervention Trial N= 2730 IG = 1374 CG = 1356 IV: Mailed reminder Michigan State Immunization Records Bivarate regression 30.8% of children with valid addresses received flu vaccination Level of Evidence: II Purpose: To assess the feasibility and effectiveness of using a statewide immunization information system reminder from local health department targeting children with HRC. Age range (C) 24-60 months Setting: Public Exclusion Criteria: Children without a chronic condition, no address on file DV: Receipt of vaccination 24.3% of children in CG Strengths: • Well designed • Large sample size Weaknesses: • High number of invalid addresses 26.7% Conclusion: Conclusion: Supports need for intervention in high risk groups, does not address TM Feasibility: No potential for harm, supports need for intervention but does not address TM (C) – child, CDC – Center for Disease Control and Prevention, CG-control group, DV – dependent variable, EHR – electronic health record, ES – English speaking HBM – Health Belief Model, HRC – high risk condition(s), IG – intervention group, IV – independent variable, MCS – multi-component strategy, N – sample size, Non-RCT – Non-randomized control trial, (P) – parent, PCP – primary care provider, RCT – randomized control trial, SCT – Social Cognitive Theory, SR – systematic review, SS – Spanish speaking, TM – text message, TTM – Trans-theoretical Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Citation/Article Title/ Funding/ConflictsBias/Country Evans (2012) Pilot evaluation of the text4baby mobile health program Country: United States Funding: George Washington University Healthy Mothers Healthy Babies Coalition Bias: None reported Conceptual Framework Design/Method Sample/Setting Major Variables & Definitions Measurement Data Analysis Findings Decision for Use in Practice/Application to Practice HBM SCT TTM Pilot RCT N= 86 IG = 48 CG = 38 IV: TM Pre/Post interview Logistic generalized estimating equation model Increase in positive pregnancy health beliefs Level of Evidence: II Purpose: To test the feasibility and effectiveness of the text4 baby program in a local population. All pregnant females, ages 20-35 79% Hispanic DV: Changes in specific pregnancy related beliefs 73% retention rate Strengths: • Study design • Quality of data Setting: Public Exclusion: No mobile phone Weaknesses: • Small sample size • 27% lost during study • Interview style measurement Conclusion: Supports use of TM, does not address target IV, retention rate not ideal Feasibility: Highly translatable to target population and IV, no potential for harm. (C) – child, CDC – Center for Disease Control and Prevention, CG-control group, DV – dependent variable, EHR – electronic health record, ES – English speaking HBM – Health Belief Model, HRC – high risk condition(s), IG – intervention group, IV – independent variable, MCS – multi-component strategy, N – sample size, Non-RCT – Non-randomized control trial, (P) – parent, PCP – primary care provider, RCT – randomized control trial, SCT – Social Cognitive Theory, SR – systematic review, SS – Spanish speaking, TM – text message, TTM – Trans-theoretical Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Citation/Article Title/ Funding/ConflictsBias/Country Fiks (2010) Impact of electronic health record-based alerts on influenza vaccination for children with asthma. Country: United States Funding: Children’s Hospital of Philadelphia Bias: None reported Conceptual Framework Design/Method Sample/Setting Major Variables & Definitions Measurement Data Analysis Findings Decision for Use in Practice/Application to Practice TTM Cluster Randomized Trial N= 11,919 IG= 6110 CG = 5809 IV: EHR clinical alerts during visit DV: Receipt of flu vaccine EHR review Logistic Regression IG: increase 4% CG: increase 4% Level of Evidence: III Purpose: To assess the impact of influenza vaccine clinical alerts on missed opportunities for vaccination and on overall influenza immunization rates for children and adolescents with asthma. Age range (C) 5 -19 years with a diagnosis of asthma Setting: Private and academic Exclusion Criteria: Already received for the season, no asthma diagnosis Strengths: • Study design • Large N Weaknesses: • Clustered vs. control • Findings not SS • Did not capture why vaccination not given after alert acknowledged Conclusion: Conclusion: Supports need for intervention, does not address TM or HRC. Feasibility: No potential for harm, supports need for intervention but does not address TM (C) – child, CDC – Center for Disease Control and Prevention, CG-control group, DV – dependent variable, EHR – electronic health record, ES – English speaking HBM – Health Belief Model, HRC – high risk condition(s), IG – intervention group, IV – independent variable, MCS – multi-component strategy, N – sample size, Non-RCT – Non-randomized control trial, (P) – parent, PCP – primary care provider, RCT – randomized control trial, SCT – Social Cognitive Theory, SR – systematic review, SS – Spanish speaking, TM – text message, TTM – Trans-theoretical Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Citation/Article Title/ Funding/ConflictsBias/Country Jones Cooper, (2013) Using Reminder/Recall systems to improve influenza immunization rates in children with asthma Country: United States Funding: None reported Bias: None reported Conceptual Framework Design/Method Sample/Setting Major Variables & Definitions Measurement Data Analysis TTM SCT SR N= 11 studies RCT = 6 Quasi-Experimental= 5 IV1: Mailed letter IV2: Telephone IV3: EHR alert IV4: Letter + phone call IV5: Asthma action plan IV6: Letter + verbal IV7: Flu clinic IV8: Letter + interview IV9: Letter + flu clinic EHR review State and Local databases • Purpose: A literature review to examine effectiveness of reminder/recall systems in improving influenza immunization rates among children with asthma. Sample size range 114-6000+ (C) Ages 6months – 19 years Asthma or at least 1 high risk condition Settings: Public, private, and academic Excluded: Children without chronic conditions DV: Receipt of flu vaccine • • • • 3 studies >30% 2 studies >50% Mailed letters (5) Telephone (2) Scheduled flu clinics (2) Findings Decision for Use in Practice/Application to Practice IV effect on DV Level of Evidence: I IV1: Increase 52% IV2: Increase 55% IV3: Increase 8% IV4 (1): Increase 27% IV4: (2) 50% increase over 2 years IV5: 36% increase over 3 years IV6: Increase 14% IV7: 6% increase over 1 year IV8: Increase 23% IV9: 3% over 1 year Strengths: • Level of evidence • Number of databases searched Weaknesses: • Includes quasiexperimental • Various IVs • Disparate findings Conclusion: Supports overall use of IVs for increasing vaccination compliance, does not address TM Feasibility: No potential for harm, supports need for intervention but does not address TM (C) – child, CDC – Center for Disease Control and Prevention, CG-control group, DV – dependent variable, EHR – electronic health record, ES – English speaking HBM – Health Belief Model, HRC – high risk condition(s), IG – intervention group, IV – independent variable, MCS – multi-component strategy, N – sample size, Non-RCT – Non-randomized control trial, (P) – parent, PCP – primary care provider, RCT – randomized control trial, SCT – Social Cognitive Theory, SR – systematic review, SS – Spanish speaking, TM – text message, TTM – Trans-theoretical Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Citation/Article Title/ Funding/ConflictsBias/Country Moniz (2013) Improving influenza vaccination Rates in pregnancy through text messaging: a randomized controlled trial Country: United States Funding: Grant from Amy Roberts Health Promotion Foundation Conceptual Framework Design/Method Sample/Setting Major Variables & Definitions Measurement Data Analysis Findings Decision for Use in Practice/Application to Practice HBM RCT – blinded N =204 pregnant women <28 weeks gestation IV: 12 weekly TM including influenza related content EHR review (per-protocol analysis) No difference between groups 32% rate of receipt Level of Evidence: II CG: 31% IG: 34% Strengths: • Study design • well received by participants • adequately powered CG = 100 IG = 104 Education: High school diploma or less 90% Public or no insurance 88% Setting: Academic Bias: None reported Exclusions: No mobile phone, vaccine already received, egg allergy or previous immunization reaction DV: Receipt of influenza vaccine >67% liked the TM >64% thought the TM was helpful Weaknesses: • Sample demographics may reduce generalizability of findings • Single urban facility Conclusion: No significant difference between groups but IG increase, evidence for parental support Feasibility: High, no potential for harm, easily translatable (C) – child, CDC – Center for Disease Control and Prevention, CG-control group, DV – dependent variable, EHR – electronic health record, ES – English speaking HBM – Health Belief Model, HRC – high risk condition(s), IG – intervention group, IV – independent variable, MCS – multi-component strategy, N – sample size, Non-RCT – Non-randomized control trial, (P) – parent, PCP – primary care provider, RCT – randomized control trial, SCT – Social Cognitive Theory, SR – systematic review, SS – Spanish speaking, TM – text message, TTM – Trans-theoretical Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Citation/Article Title/ Funding/ConflictsBias/Country Stockwell, M., Kharbanda, E., Martinez, R., Vargas, C., Vawdrey, D., & Camargo, S. (2012) Text4Health:Impact of Text Message Reminder–Recalls for Pediatric and Adolescent Immunization Country: United States Funding: Maternal and Child Health Bureau, Health Resources and Services Administration, United States Department of Health and Human Services Conceptual Framework Design/Method Sample/Setting HBM SCT 2 Independent RCTs conducted as complementary studies. Study 1: (C) Ages 11-18 years needed either meningococcal or Tdap Purpose: Study 1: Evaluate TM efficacy in adolescents needing vaccination Study 2: Evaluate TM efficacy in children less than 22 months old needed Hib immunization. N= 361 CG = 166 IG = 195 Setting: Academic Excluded: No mobile phone, already received vaccination Study 2: (C) Aged 722 months old lacking at least one Hib immunization N= 174 CG = 87 IG = 87 Setting: Academic Bias: One author is on the advising board of Merck Pharmaceuticals. Excluded: No mobile phone, already received vaccination Major Variables & Definitions IV: TM reminder DV: Receipt of required vaccination Measurement Data Analysis Review of New York Presbyterian EzVAC registry Study 1: ANOVA Study 2: Fischers Exact Findings Decision for Use in Practice/Application to Practice Level of Evidence: II Vaccination receipt rates: 4 weeks IG = 15.4% CG = 4.2 % 12 week: IG = 26.7% CG = 13.9% 24 weeks IG = 36.4% CG = 18.1% 2.6% declined further messages after enrolling Strengths: • Study design • Adequately powered • Low opt out rate Weaknesses: • Results and outcomes of studies reported separately. Conclusion: TM does improve vaccination compliance. Feasibility: Recommended with no potential for harm, easily translate to influenza vaccination (C) – child, CDC – Center for Disease Control and Prevention, CG-control group, DV – dependent variable, EHR – electronic health record, ES – English speaking HBM – Health Belief Model, HRC – high risk condition(s), IG – intervention group, IV – independent variable, MCS – multi-component strategy, N – sample size, Non-RCT – Non-randomized control trial, (P) – parent, PCP – primary care provider, RCT – randomized control trial, SCT – Social Cognitive Theory, SR – systematic review, SS – Spanish speaking, TM – text message, TTM – Trans-theoretical Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Citation/Article Title/ Funding/ConflictsBias/Country Stockwell, M. S., Westhoff, C., Olshen Kharbanda, E., Vargas, C. Y., Camargo, S., Vawdrey, D. K., & Castano, P. M. (2014) Effect of a text messaging intervention on influenza vaccination in an urban, low-income pediatric and adolescent population randomized control trial. United States Funding: None reported Bias: None reported Conceptual Framework Design/Method Sample/Setting Major Variables & Definitions Measurement Data Analysis Findings Decision for Use in Practice/Application to Practice HBM RCT N= 3162 IG = 1653 CG - 1509 IV: TM DV: Flu vaccination receipt EHR review Chi Square IG: 43.6% CG: 39.9 % Level of Evidence: II Purpose: Among low income urban families, do targeted text message reminders to parents increase the receipt of influenza vaccinations among their children? Setting: Public Age range (C) 6-18 years 98% minority 88% public insurance 58% SS Excluded: No mobile phone, already received vaccination Strengths: • Large N • Adequate power • Achieved statistical significance Weaknesses: • Mostly minority population Conclusion: TM reminders did cause a 4% increase in flu vaccination receipt. Feasibility: Cost effective, no potential for harm (C) – child, CDC – Center for Disease Control and Prevention, CG-control group, DV – dependent variable, EHR – electronic health record, ES – English speaking HBM – Health Belief Model, HRC – high risk condition(s), IG – intervention group, IV – independent variable, MCS – multi-component strategy, N – sample size, Non-RCT – Non-randomized control trial, (P) – parent, PCP – primary care provider, RCT – randomized control trial, SCT – Social Cognitive Theory, SR – systematic review, SS – Spanish speaking, TM – text message, TTM – Trans-theoretical Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Citation/Article Title/ Funding/ConflictsBias/Country Stockwell, M. S., Kharbanda, E. O., Martinez, R. A., Lara, M., Vawdrey, D., Natarajan, K., & Rickert, V. I. (2012) Influenza Vaccine Text Message Reminders for Urban, LowIncome Pregnant Women: A Randomized Controlled Trial Country: United States Funding: Maternal and Child Health Bureau, Health Resources and Services Administration, United States Department of Health and Human Services Conceptual Framework Design/Method Sample/Setting Major Variables & Definitions Measurement Data Analysis Findings Decision for Use in Practice/Application to Practice SCT HBM RCT N= 1153 IG = 576 CG = 577 IV: TM DV: Receipt of Influenza Vaccination EHR review Chi Square Multivariable logistic regression analysis Overall 30% increase in receipt, highest effect in third trimester Level of Evidence: II Setting: Academic All pregnant females age range 20-40 67% public insurance 60% SS Excluded: No mobile phone, by request, previously received influenza vaccine for season 83% of participants who replied to final TM supported use of TM Strengths: • Study design • Adequate power • Included detailed cost analysis Weaknesses: • Mostly minority participants • 12.5% replied to final TM Conclusion: Overall TM did increase receipt of flu vaccination Feasibility: High, cost effective, with no potential for harm Bias: None reported (C) – child, CDC – Center for Disease Control and Prevention, CG-control group, DV – dependent variable, EHR – electronic health record, ES – English speaking HBM – Health Belief Model, HRC – high risk condition(s), IG – intervention group, IV – independent variable, MCS – multi-component strategy, N – sample size, Non-RCT – Non-randomized control trial, (P) – parent, PCP – primary care provider, RCT – randomized control trial, SCT – Social Cognitive Theory, SR – systematic review, SS – Spanish speaking, TM – text message, TTM – Trans-theoretical Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix C Table 2 Synthesis Table Study Year Level of Evidence Design Theoretical Framework Children 2-6 months AhlersSchmidt 2012 2014 2012 2012 2010 JonesCooper 2013 2013 Stockwell Lara 2012 II I II II III I II II II II RCT SR RCIT RCT C-RCT SR RCT RCT RCT RCT SCT HBM, SCT, TTM TTM SCT, TTM HBM SCT, TTM HBM, SCT HBM HBM Aigbogun Dombkowski Evans Fiks HBM Moniz Stockwell Vargas 2012 Stockwell Westhoff 2014 X Children 7-22 months X Children 6-18 years Target Population X Children 11-18 years X Children HRC 24-60 months X Children HRC 6 months – 19 years X X Children HRC 5 years – 19 years X Pregnant females >18 years old TM Intervention X X MCS X X Letter Results X X X X X X X X X X X X X X X Health Care Information Increase X X Influenza Vaccination Vaccination other than influenza X X EMR provider alert Outcomes Measured X X X X X X X X X X Decrease No Change Key: C-RCT – Cluster Randomized Trial, EMR – Electronic Medical Record, HBM – Health Belief Model, HRC – High Risk Condition, MCS – Multicomponent Strategy, RCIT – Randomized Community Intervention Trial, RCT – Randomized Control Trial, SCT – Social Cognitive Theory, TM – Text Message, TTM – Trans-theoretical Model X RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix D Theoretical Framework: Ottawa Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix E Conceptual Model: Donabedian’s S-P-O Model Approach Criterion Standard Structure Patient caregivers Enable communication delivery preferences Pediatric Pulmonology Patients Process Intervention message sent via text or electronic mail All caregivers with valid electronic mail addresses or cell phone numbers will receive reminder Outcome Reminders will be received successfully Increase in caregivers who receive a reminder to obtain influenza vaccinations for patient RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix F Logic Model RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix G Practice Site Permission Letter RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix H IRB Approval Letter APPROVAL: EXPEDITED REVIEW Daniel Crawford CONHI - DNP Daniel.J.Crawford@asu.edu Dear Daniel Crawford: On 8/7/2015 the ASU IRB reviewed the following protocol: Type of Review: Title: Initial Study Integrating text messaging into a multi-component reminder strategy to improve influenza vaccination rates among children with chronic respiratory conditions. Investigator: IRB ID: Category of Daniel Crawford STUDY00003001 (5) Data, documents, records, or specimens, (7)(a) review: Behavioral research Funding: None Grant Title: None Grant ID: None Documents • BayS_CKP Terms and Conditions.pdf, Category: RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Reviewed: Consent Form; • HRP - 503 a - Protocol, Category: IRB Protocol; • CITI Certificate, Category: Other (to reflect anything not captured above); • HRP - 502C - Cover Letter for Survey Consent, Category: Consent Form; • Message Content, Category: Measures (Survey questions/Interview questions /interview guides/focus group questions); • Site Agreement Letter, Category: Off-site authorizations (school permission, other IRB approvals, Tribal permission etc); • BayS_Privacy Practice Statement.pdf, Category: Consent Form; • Survey Questions with Consent Cover Letter Page 1, Category: Measures (Survey questions/Interview questions /interview guides/focus group questions); The IRB approved the protocol from 8/7/2015 to 8/6/2016 inclusive. Three weeks before 8/6/2016 you are to submit a completed Continuing Review application and required attachments to request continuing approval or closure. RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE If continuing review approval is not granted before the expiration date of 8/6/2016 approval of this protocol expires on that date. When consent is appropriate, you must use final, watermarked versions available under the “Documents” tab in ERA-IRB. In conducting this protocol you are required to follow the requirements listed in the INVESTIGATOR MANUAL (HRP-103). Sincerely, IRB Administrator cc: Sarah Bay Daniel Crawford Sarah Bay RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix I Survey RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix J Table 1: Survey Results Survey Question Received message How much message influenced vaccination decision Followed Link for Resources Child Received Influenza Vaccination If No, Do You Intend to Vaccinate Reasons Given For Not Vaccination Preferred Delivery Methods for Communication from Healthcare Providers (Choose All That Apply) N % Yes 66 61.68% No 41 38.32% Very Much 13 19.69% Somewhat 10 15.15% Neutral 13 19.7% Very Little 6 9.09% Not At All 23 34.85% No Answer 1 1.52% Yes 7 10.6% No 54 81.82% Not Sure 4 6.06% No Answer 1 1.52% Yes 66 61.68% No 39 36.45% No Answer 2 1.87% Yes 10 24.39% No 21 51.22% Not Sure 9 21.95% No Answer 1 2.44% Not beneficial 16 5.33% May harm my child 1 3.33% Religious or personal 1 3.33% Not eligible 2 6.67% Inadequate resources 1 3.33% Prefer not to say 5 16.67% No Answer 4 13.33% Telephone 45 42.06% Email 86 80.37% Text 64 59.81% Postal 18 16.82% Other 1 .09% No Answer 5 4.67% RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix J Table 2: Chi Square Tests- Received Message/Received Vaccination Received Message Yes Received Influenza Vaccination Yes No 46 (70.8%) 19 (29.3%) No 20 (50%) 20 (50%) Value df Asymptotic Sig. 2 – sided Pearson Chi-Square 4.575 1 .032 Continuity Correction 3.729 1 .053 Likelihood Ratio 4.541 1 .033 Fisher’s Exact Linear-by-Linear Association 4.531 N of Valid Cases 105 1 .033 Exact Sig. (2sided) Exact Sig. (1sided) .039 .027 RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix J Table 3: Chi Square Tests – Influence Decision/Received Vaccination Received Influenza Vaccination Yes No Influence Decision Very Much 11 (16.9%) 2(3.1%) Somewhat 8 (12.3%) 2(3.1%) Neutral 7 (10.8%) 6 (9.2%) Very Little 6 (9.2%) 0 (0%) Not At All 14 (21.5%) 9 (13.8) Value df Asymptotic Sig. 2 – sided Pearson Chi-Square 6.984 4 .137 Likelihood Ratio 8.642 4 .071 Linear-by-Linear Association 1.636 1 .201 N of Valid Cases 65 RUNNING HEAD: PEDIATRIC ASTHMA AND INFLUENZA VACCINE Appendix J Table 4: Frequency Distribution – Preferred Delivery Methods Methods Telephone Text Message Email Postal Other No Answer a Responses N 45 65 86 18 1 5 Percent a 42.06% 60.75% 80.37% 16.82% .01% .05% Percent out of 107 potential responses, total is higher than 100% due to participants choosing multiple methods