The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial

Abstract

BackgroundDiabetes 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.MethodsThe 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.DiscussionWe 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 registrationClinicalTrials.gov, ID: NCT02132676. Registered on 21 August 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1959-7) contains supplementary material, which is available to authorized users.

Enhancing Diabetes Self-Management Education and Psychological Services for Veterans With Comorbid Chronic Health and Mental Health Conditions

“…Of note, 4 veterans received other T2DM-specific self-management support within the same year of their participation with health psychology, such as attending a T2DM education class or T2DM shared medical appointment. 22 Reliability in the current sample for the DES-SF was high (Cronbach α = 0.90), PHQ-9 was good (Cronbach α = 0.81), and GAD-7 was very good (Cronbach α = 0.86).…”

Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial

“…The study protocol is described elsewhere. 19 Briefly, from May 2016 to May 2018, we identified from electronic health records (EHR) patients who had (1) two outpatient visits or one hospitalization with a diabetes-related ICD-10 code in the prior 12 months; or (2) at least one prescription for a glucose control medication; and (3) an A1c ≥ 7.5% if age < 70 or ≥ 8.0% if age 70+ years within 6 months prior to enrollment. We excluded patients with active substance abuse disorders, schizophrenia, severe dementia, or bipolar disorder.…”

Formative evaluation and adaptation of pre-and early implementation of diabetes shared medical appointments to maximize sustainability and adoption

“…This qualitative study is part of a larger implementation study, “The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study” [ 12 ]. The SHARES study is a multi-site cluster randomized trial of five geographically diverse Veterans Affairs (VA) health systems evaluating the effectiveness and implementation of diabetes Shared Medical Appointments (SMAs) with and without an additional reciprocal Peer-to-Peer (P2P) support program, when compared to usual care.…”