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

Area of Science:

• Diabetes self-management research
• Health services research
• Clinical trial methodology

Background:

• Shared medical appointments (SMAs) and peer support programs show efficacy in improving diabetes self-management and short-term clinical outcomes.
• Translating evidence to system-level interventions requires large-scale, pragmatic trials across diverse settings.
• Evaluating the effectiveness, implementation, and costs of SMAs and peer support is crucial for widespread adoption.

Purpose of the Study:

• To evaluate the effectiveness and implementation of SMAs with and without reciprocal Peer-to-Peer (P2P) support.
• To compare outcomes of SMAs, SMAs plus P2P, and usual care in a multisite cluster randomized trial.
• To examine the long-term maintenance of clinical and patient-centered outcomes in diabetes self-management.

Main Methods:

• A multisite, cluster randomized trial (Shared Health Appointments and Reciprocal Enhanced Support - SHARES study) involving five Veterans Affairs (VA) health systems.
• Three treatment groups: SMAs, SMAs plus P2P support, and usual care.
• Primary outcome: relative change in hemoglobin A1c; secondary outcomes: systolic blood pressure, medication use, and insulin initiation. Mixed methods for process and cost evaluation.

Main Results:

• Hypothesized immediate improvements in patient outcomes following SMAs.
• Anticipated sustained gains over time with the addition of reciprocal peer support.
• First study to examine combined effects of SMAs and P2P in real-world clinical settings.

Conclusions:

• Results will inform system-level implementation of effective diabetes care models.
• Provides insights into contextual factors influencing successful program adoption.
• Contributes evidence on maintaining diabetes self-management gains through peer support.