Running head: DSME EFFECTS ON HGA1C Diabetes Self-Management Education Effects on Hemoglobin A1c Briana Smith, BSN, RN Judith Ochieng, PhD, DNP, MSN-ED, RN, FNP-BC Arizona State University 1 DSME EFFECTS ON A1C AND DSM 2 Abstract Diabetes, a common chronic condition, effects many individuals causing poor quality of life, expensive medical bills, and devasting medical complications. While health care providers try to manage diabetes during short office visits, many patients still struggle to control their diabetes at home. Lack of diabetes self-management (DSM) is a potential barrier for people with diabetes having to maintain healthy hemoglobin A1cs (HgA1c). In hopes of addressing this concern, an evidenced-based intervention; diabetic education and phone calls, using the chronic care model as its framework was implemented. The intervention targeted people with type II diabetes at a transitional care setting. Measured variables included HgA1c and DSM. Statistically significant improvements were seen in reported physical activity. Average improvements were seen in HgA1c and DSM after three months of diabetes self-management education (DSME). Attrition, cultural sensitivity, and increasing DSME hours should be further evaluated for future projects. Keywords: diabetes, diabetic patients, chronic care management, care management, hemoglobin A1c DSME EFFECTS ON A1C AND DSM 3 Diabetes Self-Management Education Effects on Hemoglobin A1c Chronic care management (CCM) is a significant part of caring for patients with diabetes as it contributes to better patient care and outcomes. Diabetes is a complex disease requiring referrals, continuous education, and frequent medication adjustments. All of which are included in CCM. With the health risks facing people with diabetes, it is important healthcare providers seek alternative methods to care for people with diabetes. There are approximately 422 million people living with diabetes worldwide, with a predicted increase to 642 million by 2040 (World Health Organization [WHO], 2019; Zou et al., 2018). About one in every five Americans aged 65 and older have been diagnosed with diabetes (Hasche, Ward, & Schluterman, 2017). In Arizona, approximately one-third of people are prediabetic and one in 10 are diabetic, representing 2.1 million and 720,000 people, respectively (Diabetes Action Plan and Report, 2019). With about 34,000 being newly diagnosed yearly (American Diabetes Association [ADA], 2014). Arizona spent an estimated $6.8 billion on diabetes care in 2019 (Diabetes Action Plan and Report, 2019). In 2016, the prevalence of diabetes in Yuma County, located in the southwest corner of Arizona, was 12.9% of the population aged 20 years and older (Centers for Disease Control and Prevention, n.d.). The county has seen diabetes rates double over the last decade (Yuma Regional Medical Center [YRMC], 2016). Transitional Care Services serves the Yuma Community providing patients with chronic conditions, such as congestive heart failure, chronic obstructive pulmonary disease, and acute myocardial infarctions, who need help transitioning home after a hospital discharge (YRMC, 2019). Their goal is to promote quality of life by enhancing knowledge and management of the patient’s chronic conditions (YRMC, 2019). About 90-95% of patients are referred by the only DSME EFFECTS ON A1C AND DSM 4 hospital in Yuma County, which had over 12,000 hospital and emergency room diabetes related discharges (Contreras & Sandoval-Rosario, 2018). Although Transitional Care Services cares for patients with complex chronic conditions, diabetes is not a disease they primarily focus on. This information led to the clinically relevant PICO question, in adult patients diagnosed with diabetes (P), how does CCM (I) compared to standard care (C) affect HgA1c (O)? Literature review of current evidence included 10 critically appraised articles chosen from CINHAL, PubMed, and Wiley (see Appendices A and B). Articles selected included five randomized controlled trials, two cohort studies, one quasi-experimental, one observational study with no control, and a case study. Level of evidence ranged from II-IV. All studies chosen had at least one dependent variable (DV) measuring HgA1c. Independent variables showing significant improvements in HgA1c were care coordination, telephone calls and education, especially related to diabetes self-management (DSM). It was determined the proposed evidence-based practice (EBP) project would use diabetes self-management education (DSME) and telephone calls to implement CCM to type II diabetic patients at Transitional Care Services. The measurable outcomes of the project were DSM and HgA1c. The EBP project was informed by the Chronic Care Model (CCMo) because evidence has shown it may improve diabetic outcomes, such as HgA1c (National Institute of Diabetes and Digestive and Kidney Diseases [NIDDK], n.d.; see Appendix C). By applying the elements of the CCMo, which are health systems, decision support, clinical information systems, patient self-management support, and community resources, and delivery systems, the project hoped to join informed, active patients and a prepared, proactive practice team to improve diabetic outcomes (Improving Chronic Illness Care, 2019). Rosswurm and Larabee’s (1999) model was chosen as the evidence-based model for this project to serve as guidance throughout DSME EFFECTS ON A1C AND DSM 5 the process changes (see Appendix D). The model assists in changes that are healthcare specific and strives for improved quality and outcomes. Methods Participants Adults, 18 years or older, were identified using the electronical health record (EHR) at Transitional Care Services with the target goal being 30 participants. Potential subjects of the project met the following inclusion criteria: ≥ 18 years old, previously documented type II diabetes diagnosis, previously documented HgA1c ≥ 6.5% in last month, English speaking, has access to telephone calls for the duration of project, and able to sign consent. Exclusion criteria includes: history of dementia, participating in other diabetic studies, and non-English speaking. Once identified, a flyer was handed to potential subjects to avoid coercion. If the subject wished to participate, consent was obtained. Ethical consideration for the project was processed and approved by Arizona State University’s Institutional Review Board and Yuma Regional Medical Center’s Innovation Council Advisory Board. Study Design All participants had a HgA1c collected from the EHR and completed a diabetes selfmanagement questionnaire (DSMQ) prior to intervention, which served as pretests. Diabetes education was then initiated during the same visit. All participants were given the same education by the same individual at individual times. Education included glucose management (GM), dietary control (DC), physical activity (PA), and healthcare use (HU). All participants were given a take home folder pertaining to the subject matter. Participants were given three monthly phone calls to serve as a reminder of the lesson content provided at the educational visit. After three months, participants had a new HgA1c collected from the EHR and complete a post- DSME EFFECTS ON A1C AND DSM 6 DSMQ. Participants who did not have a new HgA1c recorded in EHR after three months or did not complete a post-DSMQ were disqualified from the project. Measurable outcomes, HgA1c and DSM, were statistically analyzed using a paired sample t-test. Hemoglobin A1c HgA1c is a blood test reflecting average blood sugars over three months (ADA, 2019). The ADA (2019) recommends measuring HgA1c levels at least biannually if patients are meeting treatment goals or quarterly if therapy has changed or glycemic goals are not met. HgA1c was chosen as a measurable outcome because the ADA (2019) recognizes the blood test as a standard of care due to its strong predictability value for diabetic complications. Although is it recognized by the Centers for Disease Control and Prevention (2018) and the American College of Physicians (2018) as an appropriate diabetic test, there are some limitations. Conditions that affect red blood cell turnover might cause discrepancies in HgA1c (ADA, 2019). Additionally, HgA1c has shown to have low sensitivity but high specificity. Measuring against a single fasting glucose (≥126 mg per dL), the sensitivity and specificity of an HgA1c ≥6.5% for detection of diabetes was 47% and 98%, respectively (Selvin, Steffes, Gregg, Brancati, & Coresh, 2011). Three years later, repeated fasting glucose (≥126 mg/dL) showed sensitivity increased to 67% and specificity remained high at 97% (Selvin, Steffes, Gregg, Brancati, & Coresh, 2011). Diabetes Self-Management Questionnaire DSMQ has 16 questions pertaining to five subscales: GM, DC, PA, HU, and self-care summary (SS) (Schmitt et al. 2013). SS is an overall measurement of perceived self-care. During its evaluation, the DSMQ was found to be reliable with good factorial validity and a strong correlation to HgA1c in patients with type I and II diabetes. It also had good concurrent validity DSME EFFECTS ON A1C AND DSM 7 when compared to Summary of Diabetes Self-Care Activities Measure. Overall, internal reliability was good with a Cronbach’s α coefficient of 0.84. Its subscales were mostly acceptable (GM: 0.77; DC: 0.77; PA: 0.76; HU: 0.60). Statistical Analysis Statistical analysis began after data collection was finalized using Intellectus Statistics. A two-tailed paired samples t-test was conducted to examine whether the mean difference of DVs were significantly different from zero based on an alpha value of 0.05. Based on Shapiro-Wilk test and Levene’s test, all DVs’ normality assumptions and homogeneity of variances were met. Results Demographics In total, 29 participants were recruited. By final data collection, there were nine subjects who completed the intervention (see Appendix E). The most frequently observed age range was 65 years and older (n = 5, 56%). Most subjects were male (n = 8, 89%). Most subjects identified as Hispanic/Latino/Spanish (n = 8, 89%). Most subjects had been diagnosed with diabetes greater than 10 years ago (n = 5, 56%). The majority of subjects’ highest level of education was high school (n = 7, 78%). Hemoglobin A1c There were mean improvements in pre- and post-HgA1c for final subjects, 8.57% (SD = 1.92) and 8.29% (SD = 1.77), respectively. The result of the two-tailed paired samples t-test was not significant, t(8) = 0.57, p = .587. Diabetes Self-Management DSME EFFECTS ON A1C AND DSM 8 Each individual subscale of the DSMQ was statistically analyzed. Each subscale was first given a 10-point scale score. The scale score value was used to calculate the two-tailed paired samples t-test of each subscale. Glucose Management. There were mean improvements in pre-GM and post-GM, 6.30 (SD = 3.01) and 7.11 (SD = 2.37), respectively. The result of the two-tailed paired samples t-test was not significant, t(8) = -0.70, p = .507. Dietary Control. There were mean improvements in pre-DC and post-DC, 5.07 (SD = 2.34) and 7.12 (SD = 1.56), respectively. The result of the two-tailed paired samples t-test was not significant, t(8) = -0.71, p = .500. Physical Activity. There were mean improvements in pre-PA and post-PA, 6.30 (SD = 3.98) and 8.40 (SD = 2.02). The result of the two-tailed paired samples t-test was significant, t(8) = -2.56, p = .034. Healthcare Use. There were mean decreases in pre-HU and post-HU was 9.39 (SD = 0.94) and mean of post-HU was 10 (SD = 0). The result of the two-tailed paired samples t-test was not significant, t(8) = -1.89, p = .095. Self-Care Summary. The mean of pre-SS was 9.39 (SD = 3.53) and mean of post-SS was 10 (SD = 3.11). The result of the two-tailed paired samples t-test was not significant, t(8) = 0.61, p = .559. Project Impact By using the CCMo as the project’s conceptual framework, the project was able to combine aspects of the community, such as self-management support, and health systems, specifically the EHR, to produce proactive providers. The project encouraged providers to focus DSME EFFECTS ON A1C AND DSM 9 on diabetes. A chronic disease which was not a primary focus for providers at the clinic prior to the project. The framework supported informed, activated patients. Most results were not statistically significant. Yet, on average, subjects had lower Hg A1c levels and reported better GM, DC, PA, and HU. Furthermore, most subjects had been living with diabetes for 10 or more years and reported never receiving DSME prior to the project. Additional notable reports included: receiving their first diabetic eye exam after 10 or more years of diabetes diagnosis, increasing their daily physical activity, and keeping food and blood glucose logs. Project Sustainability Since phone calls were already apart of the clinic’s workflow and care management of patients, the project was perceived to have high sustainability moving forward. Nurses at the clinic conduct weekly phone calls with patients, which is more frequent than the project required. In addition, the initial DSME visit was approximately 20 minutes. Fortunately, the clinic’s patient volume and schedule flexibility allowed for this block of time. Seldomly providers were delayed seeing their patients. The sustainability of this project would require additional supplies for DSME folder packets, employee hourly pay, and time for education. This additional cost could be sustained by available reimbursement of DSME from entities, such as the Centers for Medicare and Medicaid Services and the CDC. Discussion The project did improve HgA1c levels and DSM with the use of DSME as CCM, but statistically significant improvements in HgA1c levels were not yielded. Statistically significant improvement was seen in reported PA. There was a worsening of reported SS. DSME EFFECTS ON A1C AND DSM 10 Findings were congruent to previous literature suggesting significant reduction in HgA1c levels are found in those offered greater than 10 hours of DSME services (Beck et al., 2017). Over the course of the intervention, the project provided about two hours of DSME per subject. Limitations The project sample size was small due to large attrition. Subjects were disqualified because they did not have a post-HgA1c value in the EHR to collect, they did not answer phone calls, or they did not perform a post-DSMQ. Social determinants could have played a factor in high rate of attrition. Evidence suggests Latino populations, especially men, struggle with shame of illness and lack of interest in health (Testerman & Chase, 2018). The project had a short interventional period. Furthermore, the three month period was over several holidays. Some subjects expressed they had overly indulged in culturally traditional foods over the holiday season. Recommendations Recommendations to retain subjects include incentivizing the completion of the project. Contacting subjects once a month may have lost the interest of subject’s participation without incentivization. Having scheduled phone calls could help retain subjects by avoiding missed phone calls. Increasing DSME hours to greater than 10 could help yield significant results. Increasing the hours of DSME could give opportunity to measure greater intervals of time, such as six-, nine-, and 12-months. This may give insight to sustainability of the project. Most subjects were Hispanic with the highest level of education being high school. Subjects could have benefited from culturally centered DSME. In addition, many patients at the DSME EFFECTS ON A1C AND DSM 11 clinic only spoke Spanish, which prevented them from being eligible participants. Further studies could target Spanish speakers. Conclusion CCM is a vital part of any chronic disease. In those with diabetes, CCM is an ongoing process that supports individuals with diabetes through the lifelong process of DSM. Tools that help individuals meet their HgA1c goals should be promoted to reduce diabetic complications. DSME, a component of CCM, has been shown to reduce Hg A1c levels. Additionally, DSME has been shown to have a positive impact on diabetes-related costs and complications. While the benefits of DSME have been demonstrated in the literature, low utilization of DSME remains. Efforts to improve DSME should be explored for improving CCM and lowering Hg A1c. This project showed DSME can be used to help improve HgA1c and DSM. Although statistical significant were not yielded in HgA1c and most subscales of DSM, average improvements were seen in mostly all DV. Attrition rates, cultural sensitivity, DSME hours provided, and length of project intervention should be further evaluated to produce significant results. DSME EFFECTS ON A1C AND DSM 12 Reference American Diabetes Association. (2014). The burden of diabetes in Arizona [PDF file]. Retrieved from http://main.diabetes.org/dorg/PDFs/Advocacy/burden-of-diabetes/arizona.pdf American Diabetes Association. (2019). Standards of medical care in diabetes – 2019 abridged for primary care providers. Clinical Diabetes, 37(1), 11-34. https://doi.org/10.2337/cd180105 American College of Physicians. (2018). ACP recommends moderate blood sugar control targets for most patients with type 2 diabetes. Retrieved from https://www.acponline.org/acpnewsroom/acp-recommends-moderate-blood-sugar-control-targets-for-most-patientswith-type-2-diabetes Beck, J., Greenwood, D. A., Blanton, L., Bollinger, S. T., Butcher, M. K., Condon, J. E…Wang, J. (2017). 2017 national standards for diabetes self-management education and support. The Diabetes EDUCATOR, 43(5). doi: 10.1177/0145721717722968 Centers for Disease Control and Prevention. (n.d). Diagnosed diabetes, total, adults aged 20+ years, age-adjusted percentage, Arizona, 2015. Retrieved from https://gis.cdc.gov/grasp/diabetes/DiabetesAtlas.html# Centers for Disease Control and Prevention. (2018). All about your A1c. Retrieved from https://www.cdc.gov/diabetes/managing/managing-blood-sugar/a1c.html Contreras, O. A. & Sandoval-Rosario, M. (2018). Diabetes in Arizona: The 2018 burden report [PDF file]. Retrieved from https://www.azdhs.gov/documents/prevention/tobaccochronic-disease/diabetes/reports-data/diabetes-burden-report-2018.pdf Diabetes Action Plan and Report 2019, 2258, 53rd AZ Legis. (2019). DSME EFFECTS ON A1C AND DSM 13 Improving Chronic Illness Care. (2019). The chronic care model. Retrieved from http://www.improvingchroniccare.org/index.php?p=The_Chronic_Care_Model&s=2 National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.) Chronic care model. Retrieved from https://www.niddk.nih.gov/health-information/communicationprograms/ndep/health-professionals/practice-transformation-physicians-health-careteams/team-based-care/chronic-care-model Rosswurm, M. A, & Larrabee, J. H. (1999). A model for change to evidence-based practice. Journal of Nursing Scholarship, 31(4), 317-322. https://doi.org/10.1111/j.15475069.1999.tb00510.x Schmitt, A., Gahr, A., Hermanns, N., Kulzer, B., Huber, J., & Haak, T. (2013). The Diabetes Self-Management Questionnaire (DSMQ): Development and evaluation of an instrument to assess diabetes self-care activities associated with glycemic control. Health Quality Life Outcomes, 11(138). https://doi.org/10.1186/1477-7525-11-138 Selvin, E., Steffes, M. W., Gregg, E., Brancati, F. L., & Coresh, J. (2011). Performance of A1C for the classification and prediction of diabetes. Diabetes Care, 34(1), 84-89. doi: 10.2337/dc10-1235 Testerman, J., & Chasse, D. (2018). Influences on diabetes self-management education participation in low-income, Spanish-speaking, Latino population. Diabetes Spectrum, 31(1), 47-57. https://doi.org/10.2337/ds16-0046 World Health Organization. (2019). Diabetes [Fact sheet]. Retrieved from https://www.who.int/news-room/fact-sheets/detail/diabetes DSME EFFECTS ON A1C AND DSM 14 Yuma Regional Medical Center. (2016). 2016 Yuma County Community health needs assessment [PDF file]. Retrieved from https://www.yumaregional.org/EmergeWebsite/media/YumaDocuments/Community-Health-Needs-Assessment_1.pdf Yuma Regional Medical Center. (2019). Transitional Care Services. Retrieved from https://www.yumaregional.org/Medical-Services/Transitional-Care-Services Zou, Q., Qu, K., Lou, Y., Yin, D., Ju, Y., & Tang, H. (2018). Predicting diabetes mellitus with machine learning techniques. Frontiers in Genetics, 9(515). doi: 10.3389/ fgene.2018.00515 DSME EFFECTS ON A1C AND DSM 15 Appendix A Table 1 Evaluation Table Citation Holtrop et al. (2017). Diabetic and obese patient clinical outcomes improve during a care management implementation in PC. Funding: NIDDK Bias: No conflicts recognized Country: USA Theory/Con ceptual Framework Design/Method/P urpose Sample/Setting CCMo Design: Pairmatched cluster randomized trial N – 1,392 IG – 696 CG – 696 Purpose: To understand how individual practices would implement care management, its successes and effects on those at risk of DM due to obesity. Demographics: M Age – 54.8 M/F – 50.4%/49.6% Setting: PC practices that are physician-owned medical group in southeast Michigan Inclusion: active pt at study practices during study period, 18 years or older, diagnosis of type 2 DM or obesity Major Variables Measurem Data Analysis ents/Instru mentation IV1 – care management which includes staffing improvements and new care management software and modifications to EMR As pts presented for care, clinical data and laboratory test were collected DV1 – A1C DV2 – weight Diabetics: DV1 – Baseline IG – M=8.4, SD = 0.4 CG – M=7.4, SD=0.4 12 months IG – M=7.5, SD=0.1 CG – 7.4, SD=0.5 Unadjusted CI - -0.8 (-1.4,-0.3) Adjusted CI - -0.5 (-1.0, -0.04) DV3 – BP DV 4 – LDL DV5 – BMI Exclusion: had less than 12 month life expectancy, non-English speaking, lived in nursing or group home, had substance Paired t test, McNemar’s chi-square test, StuartMaxwell symmetry test, linear mixed effects model, linear regression Findings/Results DV6 - AU DV2 – Baseline IG – M=234.1, SD = 8.3 CG – M=213.7, SD=6.9 12 months IG – M=230.4, SD=6.0 CG – M=209.8, SD=9.0 Level or Evidence/Decision for Use/Application to Practice LOE – Level I Strengths – RCT design Weakness – only 10 practices participated, which 5 received intervention, variability in baseline risks factors vs comparison pt, especially BMI and A1C for diabetics Conclusions – Findings add to the growing EB for the effectiveness of CM as an effective clinical practice with regard to improving DM and obesity related outcomes Feasibility/Applicability – findings consistent with literature, recommended for diabetic pts because of significant improvements in Key: A1C – hemoglobin A1C; ACE – angiotensin-converting enzyme inhibitor; ADA – American Diabetic Association; ARB – angiotensin-receptor blocker; AU – microalbumin; BMI – body mass index; BP – blood pressure; CCC – chronic care coordinator; CCMo – chronic care model; CHC – community health center; CHW – community health worker; CI – confidence interval; CM – care management; CMS – Centers for Medicare and Medicaid Services; Com. – community; Cr – serum creatinine; DM – diabetes; DOHMH – Department of Health and Mental Hygiene; DSME – diabetes self-management education; DSMS – diabetes self-management support; DV – dependent variable; Dx – diagnosis; EB – evidence based; EHR – electronic health record; EMR – electronic medical record; Endo – endocrinology; HTN – hypertension; IV – independent variable; KDIS – Key Drivers Implementation Scales; LDL – low-density lipoprotein; LOE – level of evidence; M – median; MCC – multiple chronic conditions; MEMS – medications event monitoring system; M/F – male/female; N – sample; n – subgroup of sample size; N/A – not applicable; NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases; Opht – ophthalmology; PCMH – patient centered medical home; PC – primary care; PCP – primary care provider; PHQ-9 – Patient Health Questionnaire; POCT – point of care testing; Pt – patient; QI – quality improvement; RCT – randomized controlled trial; SD – standard deviation; TP - telephone DSME EFFECTS ON A1C AND DSM Citation Theory/Con ceptual Framework Design/Method/P urpose Sample/Setting abuse, psychiatric illness, or cognitive impairment, had DM or impaired glucose tolerance due to chronic glucocorticoid use, polycystic ovary syndrome, pituitary lesion, or pancreatectomy. 16 Major Variables Measurem Data Analysis ents/Instru mentation Findings/Results Unadjusted CI – 0.2 (-9.1,9.5) Adjusted CI - -2.2 (-5.3,0.7) Level or Evidence/Decision for Use/Application to Practice A1C, but will require training and therefore, funding. DV3 – Baseline IG – M=127.0, SD = 2.0 CG – M=127.5, SD=0.7 12 months IG – M=127.0, SD=2.6 CG – M=125.8, SD=3.7 Unadjusted CI – 1.8 (-2.1,-5.7) Adjusted CI – 2.1 (-2.1, -6.2) DV6 – Baseline IG – M=26.6, SD = 4.0 CG – M=24.3, SD=8.7 12 months IG – M=21.1, SD=4.5 CG – 27.9, SD=11.7 Unadjusted CI - -9.1 (-26.3,8.1) Adjusted CI - -1.3 (-14.0, -11.4) Key: A1C – hemoglobin A1C; ACE – angiotensin-converting enzyme inhibitor; ADA – American Diabetic Association; ARB – angiotensin-receptor blocker; AU – microalbumin; BMI – body mass index; BP – blood pressure; CCC – chronic care coordinator; CCMo – chronic care model; CHC – community health center; CHW – community health worker; CI – confidence interval; CM – care management; CMS – Centers for Medicare and Medicaid Services; Com. – community; Cr – serum creatinine; DM – diabetes; DOHMH – Department of Health and Mental Hygiene; DSME – diabetes self-management education; DSMS – diabetes self-management support; DV – dependent variable; Dx – diagnosis; EB – evidence based; EHR – electronic health record; EMR – electronic medical record; Endo – endocrinology; HTN – hypertension; IV – independent variable; KDIS – Key Drivers Implementation Scales; LDL – low-density lipoprotein; LOE – level of evidence; M – median; MCC – multiple chronic conditions; MEMS – medications event monitoring system; M/F – male/female; N – sample; n – subgroup of sample size; N/A – not applicable; NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases; Opht – ophthalmology; PCMH – patient centered medical home; PC – primary care; PCP – primary care provider; PHQ-9 – Patient Health Questionnaire; POCT – point of care testing; Pt – patient; QI – quality improvement; RCT – randomized controlled trial; SD – standard deviation; TP - telephone DSME EFFECTS ON A1C AND DSM Citation Solorio et al. (2014). Impact of chronic care coordinator intervention on diabetes of care in a community health center Funding: University of Washington Royal Research Fund Bias: observational study based on retrospective study and may include bias due to confounding factors Country: USA Theory/Con ceptual Framework Design/Method/P urpose CCM Design: Retrospective cohort study design Purpose: to evaluate the impact of CCC intervention on quality of DM care within the CHC, predominantly low-income Hispanic and nonHispanic white pt Sample/Setting N – 1,483 IG – 664 CG – 819 Demographics: M Age – 50-59 M/F – 48.8%/ 51.2% 17 Major Variables Measurem Data Analysis ents/Instru mentation IV1 – at least 1 CCC visit, that includes case management, care coordination, and self-management Data collection through EMR Setting: Sea Mar CHC that provides PC services to predominantly lowincome Hispanics and non-Hispanic white pt in the Washington area DV1 – process of care, including A1C tested at least twice taken 3 months apart, LDL, AU, retinal eye exam, and foot exam Inclusion: established dx of DM type 2 in EMR in the past 12 months, current Sea Mar pt with clinic visit between 2/1/2009 and 9/30/2009, ages 18-69 years old, have at least 2 visits at the same clinic in last year, speak English or Spanish DV2 – intermediate outcomes of DM care, including A1C < 7.0 %, LDL < 100 mg/dL, BP < 130/80 mmHg Exclusion: older than 69 years old, DM type 1, pregnant, history of organ transplant, Cr 2.5 mg/dL, dementia, and terminal illness DV3 – health care utilization, including number of PC visits, at least once referral to opht, and at Propensity score analysis to reduce effect of selection bias, linear mixed effects model during 12 month preand postenrolleme nt , R statistical software, chisqaure test of homogeneity, two-sample ttest Findings/Results A1C – Baseline CG – M=8.0, SD= ±1.6 IG – M=8.4, SD= ±1.6 p<0.001 DV1 – A1C measurements: CI 2.63(1.88, 3.68), p < 0.001; AU screen: CI- 2.94 (2.07, 4.17), p < 0.001; Retinal exam: CI - 2.27 (1.59, 3.25), p < 0.001; Foot exam: CI - 5.22 (3.42, 7.98(, p < 0.001 DV2 – A1C < 7%: CI - 0.70 (0.39, 1.27), p = 0.242; A1C last value: CI - 0.06 (0.02, 0.13, p = 0.151; BP: CI - 0.99 (0.69, 1.42), p = 0.968; Level or Evidence/Decision for Use/Application to Practice LOE – Level IV Strengths – large sample Weakness – observational study prone to bias, no data on BMI, income, marital status, employment, education, alcohol use and time with DM, missing weight and height on some participants, data of duration of CCC visits is missing Conclusions – CCC is suggested and may benefit pt with DM type 2 by improving receipt of DM services Feasibility/Applicability – Due to significant findings in increases in DM services with CCC, diabetic pt may benefit from CCC. Therefore, making use for CCC. DV3 – PCP visit: CI -1.39 (1.28, 1.51), p < 0.001; Endo referral: CI - 0.88 (0.30 - 2.60), p = 0.818; Opht referral: CI - 1.59 (0.86, 2.94), p = 0.142 Key: A1C – hemoglobin A1C; ACE – angiotensin-converting enzyme inhibitor; ADA – American Diabetic Association; ARB – angiotensin-receptor blocker; AU – microalbumin; BMI – body mass index; BP – blood pressure; CCC – chronic care coordinator; CCMo – chronic care model; CHC – community health center; CHW – community health worker; CI – confidence interval; CM – care management; CMS – Centers for Medicare and Medicaid Services; Com. – community; Cr – serum creatinine; DM – diabetes; DOHMH – Department of Health and Mental Hygiene; DSME – diabetes self-management education; DSMS – diabetes self-management support; DV – dependent variable; Dx – diagnosis; EB – evidence based; EHR – electronic health record; EMR – electronic medical record; Endo – endocrinology; HTN – hypertension; IV – independent variable; KDIS – Key Drivers Implementation Scales; LDL – low-density lipoprotein; LOE – level of evidence; M – median; MCC – multiple chronic conditions; MEMS – medications event monitoring system; M/F – male/female; N – sample; n – subgroup of sample size; N/A – not applicable; NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases; Opht – ophthalmology; PCMH – patient centered medical home; PC – primary care; PCP – primary care provider; PHQ-9 – Patient Health Questionnaire; POCT – point of care testing; Pt – patient; QI – quality improvement; RCT – randomized controlled trial; SD – standard deviation; TP - telephone DSME EFFECTS ON A1C AND DSM Citation Swietek et al. (2018). Do medical homes improve quality of care for persons with multiple chronic conditions? Funding: Agency for Healthcare Research and Quality Bias: regression model used to reduce bias Country: USA Theory/Con ceptual Framework PCMH Design/Method/P urpose Design: quasiexperimental Purpose: examine the association between PCMH enrollment and receipt of diseasespecific quality measures for nonelderly Medicaid beneficiaries Sample/Setting N – 208,122 IG – 145,145 CG – 62,977 Demographics: M Age – 43.91 M/F – 32.4%/ 67.6% Setting: Com. Care of North Carolina, regional PC 18 Major Variables least 1 referral to endo IV1 – PCMH enrollment DV1 – A1C testing DV2 – attention for nephropathy DV3 – liver function tests Inclusion: ages 18-64 years old; at least 2 chronic conditions that included: DM, asthma, hyperlipidemia, hypertension, major depression and schizophrenia; pt with at least partial Medicaid eligibility; have at least 2 outpatient or emergency department visits or at least 1 inpatient visit for given condition DV4 – eye examinations Exclusion: Dual Medicare and Medicaid enrollees DV8 – any psychotherapy DV5 – Lipid profile DV6 – ACE or ARB DV7 – SABA overuse, which is 4+ canister equivalents in 3 months Measurem Data Analysis ents/Instru mentation Dataset that links Medicaid claims with other administrati ve data sources t-test, chisquare, linear probability model, fixedeffects model Findings/Results DV1 – CG – M=61.5 IG – M=82.1 p<0.001 DV2 – CG – M=30.3 IG – M=43.5 p<0.001 DV3 – CG – M=20.7 IG – M=25.4 p<0.001 DV4 – CG – M=30.0 IG – M=44.2 p<0.001 Level or Evidence/Decision for Use/Application to Practice LOE – Level III Strengths – large sample Weakness – Not generalized population, PCHM was only defined as any enrollment in a year which may not capture the effects of extended duration of PCMH Conclusions – PCMH model may improve quality of care for pt with MCC Feasibility/Applicability – Significant findings show PCMH could have benefits to pt with MCC, which shows feasibility. DV5 – CG – M=51.0 IG – M=70.72 p<0.001 DV6 – CG – M=53.3 IG – M=78.6 p<0.001 Key: A1C – hemoglobin A1C; ACE – angiotensin-converting enzyme inhibitor; ADA – American Diabetic Association; ARB – angiotensin-receptor blocker; AU – microalbumin; BMI – body mass index; BP – blood pressure; CCC – chronic care coordinator; CCMo – chronic care model; CHC – community health center; CHW – community health worker; CI – confidence interval; CM – care management; CMS – Centers for Medicare and Medicaid Services; Com. – community; Cr – serum creatinine; DM – diabetes; DOHMH – Department of Health and Mental Hygiene; DSME – diabetes self-management education; DSMS – diabetes self-management support; DV – dependent variable; Dx – diagnosis; EB – evidence based; EHR – electronic health record; EMR – electronic medical record; Endo – endocrinology; HTN – hypertension; IV – independent variable; KDIS – Key Drivers Implementation Scales; LDL – low-density lipoprotein; LOE – level of evidence; M – median; MCC – multiple chronic conditions; MEMS – medications event monitoring system; M/F – male/female; N – sample; n – subgroup of sample size; N/A – not applicable; NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases; Opht – ophthalmology; PCMH – patient centered medical home; PC – primary care; PCP – primary care provider; PHQ-9 – Patient Health Questionnaire; POCT – point of care testing; Pt – patient; QI – quality improvement; RCT – randomized controlled trial; SD – standard deviation; TP - telephone DSME EFFECTS ON A1C AND DSM Citation Theory/Con ceptual Framework Design/Method/P urpose Sample/Setting 19 Major Variables Measurem Data Analysis ents/Instru mentation DV9 – assertive community therapy Chamany et al. (2015). TP intervention to improve DM control: a randomized trial in New York City A1c registry. Funding: Albert Einstein College of Medicine Bias: None identified Country: USA CCM Design: RCT Purpose: 1) to evaluate the incremental effect of patientcentered TP intervention on the M A1C levels beyond that achieved with print materials mailed to pts and providers by the DOHMH registry intervention; 2) determine what patient demographic and psychosocial factors mediate the effect of the interventions; and 3) provide estimates of implementation costs of the TP N – 941 IG – 443 CG – 498 Demographics: M Age – 56.3, SD 11.7 M/F – 36.3%/ 63.7% IV1 – Telephonic: between 4-8 phone calls each year for health behavior counseling to improve A1C Setting: South Bronx Inclusion: pts with DM who speak English and/or Spanish and reside in the South Bronx; > 18 years, with DM, who become part of the NYC registry by virtue of having a reported A1C >7% to the DOHMH Exclusion: < 18 years; A1C < = 7 %; refuses informed consent and HIPAA consent; cognitive dysfunction as assessed by TP; does not read or speak CG – standard registry: letters from the DOHMH to promote improved A1C and give lists of Bronx resources for healthier food and activities DV1 – A1C DV2 – DM selfcare activities Findings/Results Level or Evidence/Decision for Use/Application to Practice DV7 – CG – M=7.8 IG – M=10.4 p<0.001 DOHMH Registry; self-report; Morisky Medication Adherence four-item scale; Summary of Diabetes Self-Care Activities ; PHQ-9; Well-Being scale of the WHO Two-tailed ztest; Mann– Whitney U te st; Sobel test; Stata, version 12.1 MP DV1 – Baseline IG – M=9.3, SD = 2.1, n=443 CG – M=9.1, SD=2.0, n=498 12 months IG – M=8.4, SD=1.9, n=334, CG – 8.6, SD=2.0, n=360 Statistically significant, p <0.05 LOE – Level II Strengths – randomized Weakness – missing primary outcome data for 26.3% of participants; not generalized and focuses on low-incomes, mostly Latinos with DM with TP access Conclusions – TP intervention delivered by health educators can be an effective tool to improve DM control in diverse populations, specifically for those with worse metabolic control identified using a registry. Feasibility/Applicability – The intervention is low cost and lowintensive, making it feasible and applicable. Key: A1C – hemoglobin A1C; ACE – angiotensin-converting enzyme inhibitor; ADA – American Diabetic Association; ARB – angiotensin-receptor blocker; AU – microalbumin; BMI – body mass index; BP – blood pressure; CCC – chronic care coordinator; CCMo – chronic care model; CHC – community health center; CHW – community health worker; CI – confidence interval; CM – care management; CMS – Centers for Medicare and Medicaid Services; Com. – community; Cr – serum creatinine; DM – diabetes; DOHMH – Department of Health and Mental Hygiene; DSME – diabetes self-management education; DSMS – diabetes self-management support; DV – dependent variable; Dx – diagnosis; EB – evidence based; EHR – electronic health record; EMR – electronic medical record; Endo – endocrinology; HTN – hypertension; IV – independent variable; KDIS – Key Drivers Implementation Scales; LDL – low-density lipoprotein; LOE – level of evidence; M – median; MCC – multiple chronic conditions; MEMS – medications event monitoring system; M/F – male/female; N – sample; n – subgroup of sample size; N/A – not applicable; NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases; Opht – ophthalmology; PCMH – patient centered medical home; PC – primary care; PCP – primary care provider; PHQ-9 – Patient Health Questionnaire; POCT – point of care testing; Pt – patient; QI – quality improvement; RCT – randomized controlled trial; SD – standard deviation; TP - telephone DSME EFFECTS ON A1C AND DSM Citation Edelman et al. (2015). Nurse-led behavioral management of DM and HTN in the com. practices: a randomized trial. Funding: NIDDK Bias: None identified Country: USA Theory/Con ceptual Framework CCM Design/Method/P urpose intervention for comparison with the print intervention. Design: RCT Purpose: To assess the effectiveness of nurse behavioral management of DM and HTN in com. practices among pts with both diseases. Sample/Setting 20 Major Variables Measurem Data Analysis ents/Instru mentation IV1 – 12 calls over 2 years: from a nurse experienced in DM and HTN management; calls were tailored to pts’s DM- and HTNbehavioral barriers Clinical data from visits and POCT Findings/Results Level or Evidence/Decision for Use/Application to Practice English or Spanish; no DM N – 377 IG – 193 CG – 184 Demographics: M Age – 59.6, SD – 10.7 M/F – 45.1%/ 54.9% Setting: Practice-based research network of com. PC practices Inclusion: adult pts with both DM 2 and HTN and receiving care at 1 of 9 com. fee-for-service practices; A1C ≥ 7.5% but could have wellcontrolled HTN and had to be taking medications for both CG – 12 calls not tailored or interactive: calls involved health issues unrelated to DM or HTN Exclusion: DM type 1; inability to receive a telephone intervention in English, participations in another diabetes or HTN DV2 – BP: taken at each visit, 2 measures 5 minutes apart and were averaged DV1 – A1C: measured by fingerstick Linear mixed model; covariance model; Wilcox ranksum test; generalized estimating equation model DV1 – Baseline IG – M=9.2, SD = 1.5, n=193 CG – M=9.0, SD=1.4, n=184 24 months IG – M=8.6, CG – 8.5 CI (-0.3%, 0.5%), p=0.50 – not significant LOE – Level II Strengths – blinded, randomized Weakness – intervention was ineffective Conclusions – telephonic nurse case management did not lead to improvement in A1c or SBP. Feasibility/Applicability – Small gains in clinical outcomes may add up to an important public health impact over a large population, the study of a modest intervention by traditional trial methods may not be feasible. Key: A1C – hemoglobin A1C; ACE – angiotensin-converting enzyme inhibitor; ADA – American Diabetic Association; ARB – angiotensin-receptor blocker; AU – microalbumin; BMI – body mass index; BP – blood pressure; CCC – chronic care coordinator; CCMo – chronic care model; CHC – community health center; CHW – community health worker; CI – confidence interval; CM – care management; CMS – Centers for Medicare and Medicaid Services; Com. – community; Cr – serum creatinine; DM – diabetes; DOHMH – Department of Health and Mental Hygiene; DSME – diabetes self-management education; DSMS – diabetes self-management support; DV – dependent variable; Dx – diagnosis; EB – evidence based; EHR – electronic health record; EMR – electronic medical record; Endo – endocrinology; HTN – hypertension; IV – independent variable; KDIS – Key Drivers Implementation Scales; LDL – low-density lipoprotein; LOE – level of evidence; M – median; MCC – multiple chronic conditions; MEMS – medications event monitoring system; M/F – male/female; N – sample; n – subgroup of sample size; N/A – not applicable; NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases; Opht – ophthalmology; PCMH – patient centered medical home; PC – primary care; PCP – primary care provider; PHQ-9 – Patient Health Questionnaire; POCT – point of care testing; Pt – patient; QI – quality improvement; RCT – randomized controlled trial; SD – standard deviation; TP - telephone DSME EFFECTS ON A1C AND DSM Citation Theory/Con ceptual Framework Design/Method/P urpose Sample/Setting 21 Major Variables Measurem Data Analysis ents/Instru mentation IV1 – DM knowledge/infor mation: 12 DM education modules over 12 week period based on guidelines from ADA EMR and clinical visits Findings/Results Level or Evidence/Decision for Use/Application to Practice study, or living in an assisted living facility. Egede. (2017) Telephonedelivered behavioral skills intervention for African American adults with type 2 DM: an RCT Funding: National Institute of Health/NIDDK Bias: None identified Country: USA Informationmotivation behavioral skills model Design: RCT Purpose: To assess the efficacy of a combined telephonedelivered education and behavioral skills intervention in reducing hemoglobin A1C levels in African Americans with type 2 DM N – 255 IG – knowledge: 63, skills: 65, combined: 63 CG – 64 Demographics: M Age – 50-64 M/F – 55.3%/44.7 % Setting: Medical University of South Carolina (general internal medicine, endo, family medicine, and com. PC clinics) and the Ralph H. Johnson Veterans Administration Medical Center, both located in Charleston, South Carolina. Inclusion: ≥18 years old; dx of type 2 DM and A1C ≥9% at screening visit; self-identified as Black or African American; taking at least 1 oral medication for DM, HTN, or hyperlipidemia and must be willing to use the IV2 – motivation/behavi oral: pt activation, pt empowerment, and behavioral skills training delivered via 30 minute phone call ever week for 12 weeks IV3 – combined: receives weekly telephonedelivered DM knowledge/infor mation, pt activation, pt empowerment, Chi-square; ANOVA; ANCOVA; longitudinal model DV1 – Baseline IG – Knowledge: M=9.3, SD = 1.5, n=63 Skills: M=9.2, SD = 2.1, n=65 Combination: M=9.2, SD = 1.9, n=63 CG – M=9.3, SD=2.1, n=64 12 months (Differences in levels of A1C) IG – Knowledge: CI – 0.49(-0.13, 1.11), p=0.123 – not significant; Skills: CI – 0.23(-0.38, 0.83), p=0.456 – not significant; Combination: CI – 0.48(0.10, 1.07), p=0.105 – not significant CG – reference group LOE – Level II Strengths – targets vulnerable population; no RCT in this populations; telephone calls are efficacious Weakness – eligibility between screening time and baseline visit varied causing drop in eligible pts; staff turnover was high during study, especially among health educators Conclusions – combined education and skills training did not achieve greater reductions in A1C at 12 months compared to CG, educations alone, or skills training alone. Feasibility/Applicability – Because telephone calls are low cost and nursing staff that are not mastered prepared are doing education makes this study feasible. Modifications must be made to show significant changes in A1C. Key: A1C – hemoglobin A1C; ACE – angiotensin-converting enzyme inhibitor; ADA – American Diabetic Association; ARB – angiotensin-receptor blocker; AU – microalbumin; BMI – body mass index; BP – blood pressure; CCC – chronic care coordinator; CCMo – chronic care model; CHC – community health center; CHW – community health worker; CI – confidence interval; CM – care management; CMS – Centers for Medicare and Medicaid Services; Com. – community; Cr – serum creatinine; DM – diabetes; DOHMH – Department of Health and Mental Hygiene; DSME – diabetes self-management education; DSMS – diabetes self-management support; DV – dependent variable; Dx – diagnosis; EB – evidence based; EHR – electronic health record; EMR – electronic medical record; Endo – endocrinology; HTN – hypertension; IV – independent variable; KDIS – Key Drivers Implementation Scales; LDL – low-density lipoprotein; LOE – level of evidence; M – median; MCC – multiple chronic conditions; MEMS – medications event monitoring system; M/F – male/female; N – sample; n – subgroup of sample size; N/A – not applicable; NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases; Opht – ophthalmology; PCMH – patient centered medical home; PC – primary care; PCP – primary care provider; PHQ-9 – Patient Health Questionnaire; POCT – point of care testing; Pt – patient; QI – quality improvement; RCT – randomized controlled trial; SD – standard deviation; TP - telephone DSME EFFECTS ON A1C AND DSM Citation Theory/Con ceptual Framework Design/Method/P urpose Sample/Setting MEMS cap and bottle for 1 year; speak English; access to a telephone for the 12 week period Exclusion: mental confusion; participations in other DM clinical trials, alcohol/drug abuse/dependence; active psychosis or acute mental disorder; life expectancy < 6 months. Halladay et al. (2014) More extensive implementation of the CCM is associated with better lipid control in DM. Funding: Agency of Healthcare Research and CCM Design: observational study N – 42 practices IG – N/A CG – N/A Purpose: This study examines whether higher KDIS scores are associated with improved diabetes outcomes. Setting: 42 PC practices in North Carolina Inclusion: participated with a practice coach for at least 13 months starting in February 2008 or later; submitted clinical data reports in months 22 Major Variables Measurem Data Analysis ents/Instru mentation Findings/Results Level or Evidence/Decision for Use/Application to Practice and behavioral skills CG – standard care with general health education DV1 – A1C at 12 months DV2 – costeffectiveness and change in physical activity, diet, medication adherence, and self-monitoring of blood glucose in 12 months IV1 – 4 key drivers: registries, planned care template, protocols, and self-management support CG – standard practice: without drivers Clinical data and KDIS data Logistic regression; odds ratio; extrabinomial variation in linear model DV1 – Baseline IG – 23 (37%), n=42 12 months IG – 4 – not significant LOE – Level IV Strengths – innovative approach for QI Weakness – Short length of data (2-3 years), was not significant Conclusions – Practices that implement key changes may achieve improved patient outcomes in LDL control among their pts with diabetes. Key: A1C – hemoglobin A1C; ACE – angiotensin-converting enzyme inhibitor; ADA – American Diabetic Association; ARB – angiotensin-receptor blocker; AU – microalbumin; BMI – body mass index; BP – blood pressure; CCC – chronic care coordinator; CCMo – chronic care model; CHC – community health center; CHW – community health worker; CI – confidence interval; CM – care management; CMS – Centers for Medicare and Medicaid Services; Com. – community; Cr – serum creatinine; DM – diabetes; DOHMH – Department of Health and Mental Hygiene; DSME – diabetes self-management education; DSMS – diabetes self-management support; DV – dependent variable; Dx – diagnosis; EB – evidence based; EHR – electronic health record; EMR – electronic medical record; Endo – endocrinology; HTN – hypertension; IV – independent variable; KDIS – Key Drivers Implementation Scales; LDL – low-density lipoprotein; LOE – level of evidence; M – median; MCC – multiple chronic conditions; MEMS – medications event monitoring system; M/F – male/female; N – sample; n – subgroup of sample size; N/A – not applicable; NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases; Opht – ophthalmology; PCMH – patient centered medical home; PC – primary care; PCP – primary care provider; PHQ-9 – Patient Health Questionnaire; POCT – point of care testing; Pt – patient; QI – quality improvement; RCT – randomized controlled trial; SD – standard deviation; TP - telephone DSME EFFECTS ON A1C AND DSM Citation Theory/Con ceptual Framework Design/Method/P urpose Quality/National Institutes of Health/National Institute of Environmental Health Sciences Country: USA Carrasquillo et al. (2017). Effect of a com. health worker intervention among Latinos with poorly controlled type 2 DM. Funding: National Heart, Blood, and Lung Institute, National Center for Advancing Translational Sciences and the National Institutes on Sample/Setting Major Variables 10,11,12, and submitted another clinical date report at some point during their second year of participation with their coach. DV1 – number of practices with pt at with A1C < 9% Exclusion: Not noted Bias: Lack of study design may lead to bias. 23 Measurem Data Analysis ents/Instru mentation Findings/Results Level or Evidence/Decision for Use/Application to Practice Feasibility/Applicability – Needs stronger study design to be feasible and applicable. DV2 – number of practices with pt with BP <130/80 DV3 – number of practices with pt with LDL <100 CCM Design: RCT Purpose: To compare a CHW intervention with enhanced usual care N – 300 IG – 150 CG – 150 Demographics: M Age – 55.2, SD – 7.0 M/F – 45%/ 55% IV1 – A 1-year CHW intervention consisted of home visits, telephone calls, and grouplevel activities. Setting: 2 public hospital outpatient clinics in Miami-Dade County, Florida CG – enhanced usual care Inclusion: A1C >8.0% DV2 – LDL Exclusion: dx with type 2 DM < 6 months previously, self-reported type 1 DM, dx with type 2 DV1 – SBP DV3 – A1C EMR, telephone calls 2-tailed t test, generalized estimating equation model, chisquared test DV3 – Baseline IG – M=9.3, SD = 2.1, n=150 CG – M=9.3 SD=1.9, n=150 12 months (Adjusted) IG – CI - -0.51% (-0.94, 0.09) - significant LOE – Level II Strengths – single-blinded RCT, correlates with previous evidence Weakness – does not provide evidence on which part of the intervention helped lower A1C Conclusions – Both groups showed a statistically significant reduction of HbA1c at 6 and 12 months following baseline. Feasibility/Applicability – Although CHW are not expensive compared to the average diabetic treatment, Key: A1C – hemoglobin A1C; ACE – angiotensin-converting enzyme inhibitor; ADA – American Diabetic Association; ARB – angiotensin-receptor blocker; AU – microalbumin; BMI – body mass index; BP – blood pressure; CCC – chronic care coordinator; CCMo – chronic care model; CHC – community health center; CHW – community health worker; CI – confidence interval; CM – care management; CMS – Centers for Medicare and Medicaid Services; Com. – community; Cr – serum creatinine; DM – diabetes; DOHMH – Department of Health and Mental Hygiene; DSME – diabetes self-management education; DSMS – diabetes self-management support; DV – dependent variable; Dx – diagnosis; EB – evidence based; EHR – electronic health record; EMR – electronic medical record; Endo – endocrinology; HTN – hypertension; IV – independent variable; KDIS – Key Drivers Implementation Scales; LDL – low-density lipoprotein; LOE – level of evidence; M – median; MCC – multiple chronic conditions; MEMS – medications event monitoring system; M/F – male/female; N – sample; n – subgroup of sample size; N/A – not applicable; NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases; Opht – ophthalmology; PCMH – patient centered medical home; PC – primary care; PCP – primary care provider; PHQ-9 – Patient Health Questionnaire; POCT – point of care testing; Pt – patient; QI – quality improvement; RCT – randomized controlled trial; SD – standard deviation; TP - telephone DSME EFFECTS ON A1C AND DSM Citation Theory/Con ceptual Framework Design/Method/P urpose Minority Health and Health Disparities Funding: National Coordinator for Health Information Technology, North Carolina Regional Extension Center Cooperative Agreement, The North Carolina Health and Wellness Trust Fund Major Variables Measurem Data Analysis ents/Instru mentation Findings/Results DM younger than 25 years old, were enrolled in intervention studies, planned to move from the county within the next year Bias: None noted Country: USA Cykert et al. (2016). Meaningful use in chronic care improved DM outcomes using PC extension center model Sample/Setting 24 Primary care extension center model/CCM Design: cohort study Purpose: to evaluate the effectiveness QI of EHR on diabetes N – 50 practices IG – 50 CG – N/A Demographics: N/A Setting: Inclusion: practices that signed up for Regional Extension Center for Health Information Technology services and agreed to implement a certified EHR system, perform QI through onsite practice facilitation using DM chronic care measures, and work toward achievement of CMS-defined meaningful use of their certified EHR. Level or Evidence/Decision for Use/Application to Practice insurance plans may not cover their services. IV1 – QI: provided to practices with a coach and practice team engagement at the site, or web-based communication DV1 – percentage of diabetic pts who achieved A1C< 7% DV2 – percentage who remained with HGB A1C > 9% for each practice site EMR, onsite practice facilitation Bivariate analysis, linear regression model, KDIS scores DV1 – Baseline IG – M=41.6, SD = 16.7, n=50 6 months (EHR + practice facilitation) IG – M = 51.3, SD = 16.0, n=45 6 moths (HER +practice facilitation + Meaningful Use IG – M = 60.0, SD = 11.6, n=29 DV2 – Baseline IG – M=21.6, SD = 11.8, n=50 6 months (EHR + practice facilitation) IG – M = 20.1, SD = 13.3, n=45 6 moths (EHR +practice facilitation + Meaningful Use LOE – Level IV Strengths – QI proven to be successful in DM management Weakness – No control Conclusions – Practice facilitation that provided EHR and QI coaching support showed important improvements in diabetes outcomes in practices that achieved meaningful use of their EHR systems. Feasibility/Applicability – if grant money can be rewarded this is feasible. Study is applicable since HER are highly used in practices. Key: A1C – hemoglobin A1C; ACE – angiotensin-converting enzyme inhibitor; ADA – American Diabetic Association; ARB – angiotensin-receptor blocker; AU – microalbumin; BMI – body mass index; BP – blood pressure; CCC – chronic care coordinator; CCMo – chronic care model; CHC – community health center; CHW – community health worker; CI – confidence interval; CM – care management; CMS – Centers for Medicare and Medicaid Services; Com. – community; Cr – serum creatinine; DM – diabetes; DOHMH – Department of Health and Mental Hygiene; DSME – diabetes self-management education; DSMS – diabetes self-management support; DV – dependent variable; Dx – diagnosis; EB – evidence based; EHR – electronic health record; EMR – electronic medical record; Endo – endocrinology; HTN – hypertension; IV – independent variable; KDIS – Key Drivers Implementation Scales; LDL – low-density lipoprotein; LOE – level of evidence; M – median; MCC – multiple chronic conditions; MEMS – medications event monitoring system; M/F – male/female; N – sample; n – subgroup of sample size; N/A – not applicable; NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases; Opht – ophthalmology; PCMH – patient centered medical home; PC – primary care; PCP – primary care provider; PHQ-9 – Patient Health Questionnaire; POCT – point of care testing; Pt – patient; QI – quality improvement; RCT – randomized controlled trial; SD – standard deviation; TP - telephone DSME EFFECTS ON A1C AND DSM Citation Theory/Con ceptual Framework Design/Method/P urpose Bias: None noted Funding: Bristol-Myers Squibb Foundation Major Variables Measurem Data Analysis ents/Instru mentation CCMo Design: empirical case study, retrospective N – 173 IG – 173 CG – N/A Purpose: to measure the implementation and effects of a multisite coordinated care approach that delivered DSME and DSMS for disadvantaged pts Demographics: N/A Setting: 4 PMCHs in Jacksonville, Florida, Athens County, Ohio, Oklahoma City, Oklahoma, and Nashville, Tennessee Bias: None identified Inclusion: PCMH had to be a part of Together on DM Country: USA Exclusion: Not noted Findings/Results Level or Evidence/Decision for Use/Application to Practice IG – M = 15.4, SD = 6.2, n=29 Exclusion: practices that had participated in QI programs Country: USA Sepers et al. (2015). Measuring the implementation and effects of a coordinated care model featuring DSME within 4 PCMH. Sample/Setting 25 IV1 – DSME and coordinated care: accredited DSME program with pttailored curricula, DSMS that targets unique needs of underserved populations, enhanced access and linkage to care services, and practice changes aimed at improving quality of DM clinical care CG – N/A DV1 – A1C SPSS Statistics for Windows, Pairedsample t test, Pearson productmoment correlation coefficient DV1 – Baseline IG – M=9.1, SD = 2.4 6 months IG – M=8.5, SD = 2.1 p = 0.01, significant LOE – Level IV Strengths – pt and staff satisfaction implementing intervention Weakness – no control group Conclusions – DSME and DSMS within coordinated care settings have the potential to improve PCMH practice and associated clinical health outcomes for populations experiencing health disparities. Feasibility/Applicability – pts and staff shared high satisfaction with DSME within the PCMH setting, making this intervention applicable. Testing of the intervention at multiple sites can be costly. DV2 – BMI DV3 – BP DV4 - LDL Key: A1C – hemoglobin A1C; ACE – angiotensin-converting enzyme inhibitor; ADA – American Diabetic Association; ARB – angiotensin-receptor blocker; AU – microalbumin; BMI – body mass index; BP – blood pressure; CCC – chronic care coordinator; CCMo – chronic care model; CHC – community health center; CHW – community health worker; CI – confidence interval; CM – care management; CMS – Centers for Medicare and Medicaid Services; Com. – community; Cr – serum creatinine; DM – diabetes; DOHMH – Department of Health and Mental Hygiene; DSME – diabetes self-management education; DSMS – diabetes self-management support; DV – dependent variable; Dx – diagnosis; EB – evidence based; EHR – electronic health record; EMR – electronic medical record; Endo – endocrinology; HTN – hypertension; IV – independent variable; KDIS – Key Drivers Implementation Scales; LDL – low-density lipoprotein; LOE – level of evidence; M – median; MCC – multiple chronic conditions; MEMS – medications event monitoring system; M/F – male/female; N – sample; n – subgroup of sample size; N/A – not applicable; NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases; Opht – ophthalmology; PCMH – patient centered medical home; PC – primary care; PCP – primary care provider; PHQ-9 – Patient Health Questionnaire; POCT – point of care testing; Pt – patient; QI – quality improvement; RCT – randomized controlled trial; SD – standard deviation; TP - telephone CHRONIC CARE MANAGEMENT AND A1C 26 Appendix B Table 2 Synthesis Table Author Holtrop Solorio Swietek Chamany Edelman Egede Year 2017 2014 2018 2015 2015 2016 LOE II IV III II II II Design RCT CS QE RCT RCT Sample Size 1,392 1,483 208,122 941 377 Age (Mean) 54.8 50-59 43.9 56.3 % Male 50.4 48.8 32.4 36.3 Improve A1C X X+ X+ X+ CCC X X X Staff ∆ X EMR ∆ X Demographics 59.6 45.1 Findings X Halladay Cykert Sepers 2014 Carrasquil lo 2017 2016 2015 IV II IV IV RCT OS RCT CS CC 255 42 300 50 173 50-64 N/A 55.2 N/A N/A 55.3 N/A 45 N/A N/A X X+ X+ Interventions DSME TP Call Education Registries X X X X X X X X X X X X X Home Visits X Group Activities CHW X X Key: A1C – hemoglobin A1C; CC – controlled case study; CCC – chronic care coordinator; CHW – community health worker; CS – Cohort study; DSME – diabetes self-management education; EMR – electronic medical record; LOE – level of evidence; N/A – not applicable; OS – observational study; QE – quasiexperimental; RCT – randomized controlled trial; TP – telephone; + - significantly improved; ∆ - modifications CHRONIC CARE MANAGEMENT AND A1C Appendix C Figure 1 Chronic Care Model 27 DSME EFFECTS ON A1C AND DSM 28 Appendix D Figure 2 Rosswurm and Larabee’s Model DSME EFFECTS ON A1C AND DSM 29 Appendix E Table 3 Demographics Variable RACE/ETHINICITY HISPANIC/LATINO/SPANISH WHITE Missing HISTORY OF DIABETES DIAGNOSIS >10 YEARS 1-5 YEARS 0-1 YEAR 5-10 YEARS Missing GENDER MALE FEMALE Missing AGE 45-54 >65 Missing EMPLOYMENT UNEMPLOYED RETIRED Missing EDUCATION HIGH SCHOOL NO FORMAL Missing Note. Due to rounding errors, percentages may not equal 100%. n % 8 1 0 88.89 11.11 0 5 1 2 1 0 55.56 11.11 22.22 11.11 0 8 1 0 88.89 11.11 0 4 5 0 44.44 55.56 0 2 7 0 22.22 77.78 0 7 2 0 77.78 22.22 0 DSME EFFECTS ON A1C AND DSM 30 Appendix F Budget Phase Preparation Activities Print copies of project overview for staff (qty 30) Print copies of consent, evaluation, and educational material for participants (qty 30) Educational session at clinic for staff for 30 min: site snacks time of presenter (project director) Delivery Site Evaluation Educational session (project director) Monthly phone calls by project director (30 min/call x 3 months) Front staff scheduling patient for visit(10 min/call x 30 patients) Review and analysis of results (10 hours plus software) Cost Subtotal $0.60 x 30 $18 $3 x 30 $90 Total $30 $0 $15 $15 $0 $0 $15 x 20 hours $15 x 30 hours $300 $12 x 5 hours $60 $20 x 10 hours + $60 $260 $450 $1,208 Budget Justification: Potential revenue and benefits of project exceeds costs. Decreasing A1c levels could decrease number of diabetes related visits to hospital and emergency room visits. Alongside, meeting quality measures set forth by Yuma Regional Medical Center. Possible funding: Transitional Care will fund part of the costs, such as site and front staff. Project director will volunteer time and provide funding for all other cost.