The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.
ABSTRACT: BACKGROUND:Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes. METHODS:This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability. DISCUSSION:Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.
Project description:BACKGROUND:Diabetes shared medical appointments (SMAs) and reciprocal peer support programs have been found in efficacy trials to help adults with diabetes improve their self-management and achieve short-term gains in clinical and patient-centered outcomes. In order to translate this evidence to system-level interventions, there is a need for large-scale, pragmatic trials that examine the effectiveness, implementation, and costs of SMAs and reciprocal peer support across diverse settings. METHODS:The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study is a multisite, cluster randomized trial that is evaluating the effectiveness and implementation of SMAs with and without an additional reciprocal Peer-to-Peer (P2P) support program, when compared to usual care. The P2P program comprises periodic peer support group sessions and telephone contact between SMA participant pairs to promote more effective diabetes self-management. We will examine outcomes across three different treatment groups: (1) SMAs, (2) SMAs plus P2P, and (3) usual care. We will collect and analyze data over a 2.5-year implementation period at five geographically diverse Veterans Affairs (VA) health systems. The primary outcome is the relative change in hemoglobin A1c over time. Secondary outcomes are changes in systolic blood pressure, antihypertensive medication use, statin use, and insulin initiation over the study period. The unit of analysis is the individual, adjusted by the individual's SMA group (the cluster). We will use mixed methods to rigorously evaluate processes and costs of implementing these programs in each of the clinic settings. DISCUSSION:We hypothesize that patients will experience improved outcomes immediately following participation in SMAs and that augmenting SMAs with reciprocal peer support will help to maintain these gains over time. The results of this study will be among the first to examine the effects of diabetes SMAs alone and in conjunction with P2P in a range of real-life clinical settings. In addition, the study will provide important information on contextual factors associated with successful program implementation. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02132676 . Registered on 21 August 2013.
Project description:BACKGROUND Successful diabetes care requires patient engagement and health self-management. Diabetes shared medical appointments (SMAs) are an evidence-based approach that enables peer support, diabetes group education, and medication management to improve outcomes. The purpose of this study is to learn how diabetes SMAs are being delivered in North Carolina, including the characteristics of diabetes SMAs across the state.METHOD Twelve health systems in the state of North Carolina were contacted to explore clinical workflow and intervention characteristics with a member of the SMA care delivery team. Surveys were used to assess intervention characteristics and delivery.RESULTS Diabetes SMAs were offered in 10 clinics in 5 of the 12 health systems contacted with considerable heterogeneity across sites. The majority of SMAs were open cohorts (80%), offered monthly (60%) for 1.5 hours (60%). SMAs included a mean of 7.5 ± 3.4 patients with a maximum of 11.2 ± 2.7 patients. Survey data revealed barriers (cost-sharing and provider buy-in) to, and facilitators (leadership support and clinical champions) of, clinical adoption and sustained implementation.LIMITATIONS External validity is limited due to the small sample size and geographic clustering.CONCLUSION There is significant heterogeneity in the delivery and characteristics of diabetes SMAs in North Carolina with only modest uptake across the health systems. Further research to determine best practices and effectiveness in diverse, real-world clinical settings is required to inform implementation and dissemination efforts.
Project description:Shared medical appointments (SMAs) are an increasingly used system-redesign strategy for improving access to and quality of chronic illness care. We conducted a systematic review of the existing literature on SMA interventions for patients with diabetes in order to understand their impact on outcomes.MEDLINE, EMBASE, CINAHL, PsycINFO, and Web of Science from January 1996 through April 2012. PubMed search updated June 2013.English-language peer-reviewed publications of randomized controlled trials (RCTs), nonrandomized cluster controlled trials, controlled before-and-after studies, or interrupted time-series designs conducted among adult patients with diabetes. Two independent reviewers used prespecified criteria to screen titles and abstracts for full text review.Two different reviewers abstracted data and rated study quality and strength of evidence. When possible, we used random-effects models to synthesize the effects quantitatively, reporting by a weighted difference of the means when the same scale was used across studies, and a standardized mean difference when the scales differed. We measured heterogeneity in study effects using Forest Plots, Cochran's Q, and I(2), and explored heterogeneity by using subgroup analyses for categorical variables and meta-regression analyses for continuous or discrete variables. Outcomes not suitable to meta-analysis were summarized qualitatively.Twenty-five articles representing 17 unique studies compared SMA interventions with usual care. Among patients with diabetes, SMAs improved hemoglobin A1c (? = -0.55 percentage points [95 % CI, -0.11 to -0.99]); improved systolic blood pressure (? = -5.2 mmHg [95 % CI, -3.0 to -7.4]); and did not improve LDL cholesterol (? = -6.6 mg/dl [95 % CI, 2.8 to -16.1]). Nonbiophysical outcomes, including economic outcomes, were reported too infrequently to meta-analyze, or to draw conclusions from. The A1c result had significant heterogeneity among studies, likely secondary to the heterogeneity among included SMA interventions.Heterogeneity among the components of diabetes SMAs leads to uncertainty about what makes a particular SMA successful.SMA interventions improve biophysical outcomes among patients with diabetes. There was inadequate literature to determine SMA effects on patient experience, utilization, and costs.
Project description:BACKGROUND:Insulin initiation and/or titration for type 2 diabetes (T2DM) is often delayed as it is a resource-intensive process, often requiring frequent exchange of information between a patient and their diabetes healthcare professional, such as a credentialed diabetes educator (CDE) for insulin dose adjustment (IDA). Existing models of IDA are unlikely to meet the increasing service demand unless efficiencies are increased. Mobile health (mHealth), a subset of Ehealth, has been shown to improve glycaemic control through enhanced self-management and feedback leading to improved patient satisfaction and could simultaneously reduce costs. Considering the potential benefits of mHealth, we have developed an innovative mHealth-based care model to support patients and clinicians in diabetes specialist community outreach and telehealth clinics, that is, REthinking Model of Outpatient Diabetes care utilizing EheaLth - Insulin Dose Adjustment (REMODEL-IDA). This model primarily aims to improve the glycaemic management of patients with T2DM on insulin, with the secondary aims of improving healthcare service delivery efficiency and the patients' experience. METHODS/DESIGN:A two-arm pilot randomized controlled trial (RCT) will be conducted for 3 months with 44 participants, randomized at a 1:1 ratio to receive either the mHealth-based model of care (intervention) or routine care (control), in diabetes specialist community outreach and telehealth clinics. The intervention arm will exchange information related to blood glucose levels via the Mobile Diabetes Management System developed for outpatients with T2DM. They will receive advice on insulin titration from the CDE via the mobile-app and receive automated text-message prompts for better self-management based on their blood glucose levels and frequency of blood glucose testing. The routine care arm will be followed up via telephone calls by the CDE as per usual practice. The primary outcome is change in glycated haemoglobin, a marker of glycaemic management, at 3 months. Patient and healthcare provider satisfaction, and time required to perform IDA by healthcare providers in both arms will be collected. This pilot study will guide the conduct of a large-scale pragmatic RCT in regional Australia.
Project description:Diabetes educators provide self-management education for people living with diabetes to promote optimal health and wellbeing. Their national association is the Australian Diabetes Educators Association (ADEA), established in 1981. In Australia the diabetes educator workforce is a diverse, interdisciplinary entity, with nurses, podiatrists, dietitians and several other health professional groups recognised by ADEA as providers of diabetes education. Historically nurses have filled the diabetes educator role and anecdotally, nurses are perceived to have wider scope of practice when undertaking the diabetes educator role than the other professions eligible to practise diabetes education. The nature of the interprofessional role boundaries and differing scopes of practice of diabetes educators of various primary disciplines are poorly understood. Informed by a documentary analysis, this historical review explores the interprofessional evolution of the diabetes educator workforce in Australia and describes the major drivers shaping the role boundaries of diabetes educators from 1981 until 2017.This documentary analysis was undertaken in the form of a literature review. STARLITE framework guided the searches for grey and peer reviewed literature. A timeline featuring the key events and changes in the diabetes educator workforce was developed. The timeline was analysed and emerging themes were identified as the major drivers of change within this faction of the health workforce.This historical review illustrates that there have been drivers at the macro, meso and micro levels which reflect and are reflected by the interprofessional role boundaries in the diabetes educator workforce. The most influential drivers of the interprofessional evolution of the diabetes educator workforce occurred at the macro level and can be broadly categorised according to three major influences: the advent of non-medical prescribing; the expansion of the Medicare Benefits Schedule to include rebates for allied health services; and the competency movement.This analysis illustrates the gradual movement of the diabetes educator workforce from a nursing dominant entity, with an emphasis on interprofessional role boundaries, to an interdisciplinary body, in which role flexibility is encouraged. There is however, recent evidence of role boundary delineation at the meso and micro levels.
Project description:Surface modifying additives (SMAs), which may be readily blended into silicones to improve anti-fouling behavior, must have excellent surface migration potential and must not leach into the aqueous environment. In this work, we evaluated the efficacy of a series of poly(ethylene oxide) (PEO)-based SMA amphiphiles which varied in terms of crosslinkability, siloxane tether length (m) and diblock versus triblock architectures. Specifically, crosslinkable, diblock PEO-silane amphiphiles with two oligodimethylsiloxane (ODMS) tether lengths [(EtO)3Si-(CH2)3-ODMS m -PEO8, m = 13 and 30] were compared to analogous non-crosslinkable, diblock (H-Si-ODMS m -PEO8) and triblock (PEO8-ODMS m -PEO8) SMAs. Prior to water conditioning, while all modified silicone coatings exhibited a high degree of water-driven surface restructuring, that prepared with the non-crosslinkable diblock SMA (m = 13) was the most hydrophilic. After conditioning, all modified silicone coatings were similarly hydrophilic and remained highly protein resistant, with the exception of PEO8-ODMS 30 -PEO8. Notably, despite twice the PEO content, triblock SMAs were not superior to diblock SMAs. For diblock SMAs, it was shown that water uptake and leaching were also similar whether or not the SMA was crosslinkable.
Project description:BACKGROUND:Rates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management. METHODS:Jump Starting Shared Medical Appointments for Diabetes with Weight Management (Jump Start) is a randomized, controlled trial that is allocating overweight Veterans (body mass index?27kg/m2) with type 2 diabetes into two arms: 1) a traditional SMA group focusing on medication management and self-management counseling; or 2) an SMA group that combines low-carbohydrate diet-focused weight management (WM/SMA) with medication management. Hemoglobin A1c reduction at 48weeks is the primary outcome. Secondary outcomes include hypoglycemic events, diabetes medication use, weight, medication adherence, diabetes-related quality of life, and cost-effectiveness. We hypothesize that WM/SMA will be non-inferior to standard SMA for glycemic control, and will reduce hypoglycemia, diabetes medication use, and weight relative to standard SMA, while also improving quality of life and costs. CONCLUSIONS:Jump Start targets two common problems that are closely related but infrequently managed together: diabetes and obesity. By focusing on diet and weight loss as the primary means to control diabetes, this intervention may improve several meaningful patient-centered outcomes related to diabetes.
Project description:Limited evidence exists on the effectiveness of external diabetes support provided by diabetes specialists and community retail pharmacists to facilitate insulin-prescribing in family practice.A stratified, parallel group, randomized control study was conducted in 15 sites across Canada. Family physicians received insulin initiation/titration education, a physician-specific 'report card' on the characteristics of their type 2 diabetes (T2DM) population, and a registry of insulin-eligible patients at a workshop. Intervention physicians in addition received: (1) diabetes specialist/educator consultation support (active diabetes specialist/educator consultation support for 2 months [the educator initiated contact every 2 weeks] and passive consultation support for 10 months [family physician initiated as needed]); and (2) community retail pharmacist support (option to refer patients to the pharmacist(s) for a 1-hour insulin-initiation session). The primary outcome was the insulin prescribing rate (IPR) per physician defined as the number of insulin starts of insulin-eligible patients during the 12-month strategy.Consenting, eligible physicians (n = 151) participated with 15 specialist sites and 107 community pharmacists providing the intervention. Most physicians were male (74%), and had an average of 81 patients with T2DM. Few (9%) routinely initiated patients on insulin. Physicians were randomly allocated to usual care (n = 78) or the intervention (n = 73). Intervention physicians had a mean (SE) IPR of 2.28 (0.27) compared to 2.29 (0.25) for control physicians, with an estimated adjusted RR (95% CI) of 0.99 (0.80 to 1.24), p = 0.96.An insulin support program utilizing diabetes experts and community retail pharmacists to enhance insulin prescribing in family practice was not successful. Too few physicians are appropriately intensifying diabetes management through insulin initiation, and aggressive therapeutic treatment is lacking.
Project description:BACKGROUND:Recommendations for good clinical practice have been reported to be difficult to apply in real life by primary care clinicians. This could be because the clinical trials at the origin of the guidelines are based on explanatory trials, conducted under ideal conditions not reflecting the reality of primary care, rather than pragmatic trials conducted under real-life conditions. The objective of this study was to evaluate how pragmatic are the clinical trials used to build the French High Authority of Health's recommendations on the management of type II diabetes. METHODS:Trials from the 2013 Cochrane meta-analysis that led to the 2013 French High Authority of Health's recommendations on the management of type II diabetes were selected. Each trial was analysed by applying the PRECIS-2 tool to evaluate whether the trial was pragmatic or explanatory, according to the nine domains of PRECIS-2. Each domain was scored between 1 (very explanatory) and 5 (very pragmatic) by two blinded researchers, and consensus was reached with a third researcher in case of discrepancy. Median scores were calculated for each of the nine domains. RESULTS:Twenty-three articles were analysed. Eight out of nine domains - namely eligibility, recruitment, setting, organisation, flexibility of delivery, flexibility of adherence, follow-up, and primary outcome - had a median score of less than 3, indicating a more explanatory design. Only the primary analysis domain had a score indicating a more pragmatic approach (median score of 4). In more than 25% of the articles, data to score the domains of recruitment, flexibility of delivery, flexibility of adherence, and primary analysis were missing. CONCLUSIONS:Trials used to build French recommendations for good clinical practice for the management of type 2 diabetes in primary care were more explanatory than pragmatic. Policy-makers should encourage the funding of pragmatic trials to evaluate the different strategies proposed for managing the patient's treatment according to HbA1C levels and give clinicians feasible recommendations.
Project description:BACKGROUND:Substantial evidence supports the effectiveness of peer educator programs for diabetes management in low- and middle-income countries. However, little is known about peer educators' impact relative to other treatment components such as medication and physician consultation. In Cambodia, the non-governmental organization MoPoTsyo organizes four services for people with diabetes: self-management training through peer educator visits, lab tests, physician consultations, and low-cost medicines. Our aims were to 1) quantify MoPoTsyo participant utilization of each program service and 2) define the relationship between each program service and glycemic control. METHODS:We conducted a retrospective cohort study among 4,210 MoPoTsyo participants, using data collected by MoPoTsyo from 2006-2016. Independent variables assessed were medication adherence, number of peer educator visits, number of physician consultations, and number of lab tests. A multiple logistic regression model was used to evaluate the association between these disease management services and glycemic control-fasting plasma glucose ?130 mg/dl or post-prandial glucose ?180 mg/dl-based on most recent glucose level. The model was adjusted for baseline demographic and disease characteristics. FINDINGS:Participants with 12 or more peer educator visits per year had a 35% higher odds of glycemic control relative to participants with 4 or fewer visits (odds ratio 1.35, 95% CI: 1.08-1.69; p = 0.009), after adjustment for utilization of other treatment components (medication adherence, number of physician visits, number of lab tests), follow-up time, and demographic and disease characteristics. Better adherence to medications and a greater number of lab tests per year were also associated with a higher odds of glycemic control after adjustment. Number of physician consultations was not associated with glycemic control after adjustment. CONCLUSIONS:This study demonstrates a positive association between peer educator utilization and glycemic control incremental to other elements of diabetes management. These results suggest that peer educators may be a valuable addition to comprehensive diabetes management programs in low- and middle-income countries even when other health care services are accessible. The associations identified in this research warrant further prospective studies to explore the causal impact of peer educators on glycemic control relative to other disease management components.