A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices

Background: Advanced primary care models emphasize patient-centered care, including self-management support (SMS), but the effective use of SMS for patients with type 2 diabetes (T2DM) remains a challenge. Interactive behavior-change technology (IBCT) can facilitate the adoption of SMS interventions. To meet the need for effective SMS intervention, we have developed Connection to Health (CTH), a comprehensive, evidence-based SMS program that enhances interactions between primary care clinicians and patients to resolve self-management problems and improve outcomes. Uptake and maintenance of programs such as CTH in primary care have been limited by the inability of practices to adapt and implement program components into their culture, patient flow, and work processes. Practice facilitation has been shown to be effective in helping practices make the changes required for optimal program implementation. The proposed research is designed to promote the translation of SMS into primary care practices for patients with T2DM by combining two promising lines of research, specifically, (a) testing the effectiveness of CTH in diverse primary-care practices, and (b) evaluating the impact of practice facilitation to enhance implementation of the intervention.

Methods: A three-arm, cluster-randomized trial will evaluate three discrete strategies for implementing SMS for patients with T2DM in diverse primary care practices. Practices will be randomly assigned to receive and implement the CTH program, the CTH program plus practice facilitation, or a SMS academic detailing educational intervention. Through this design, we will compare the effectiveness, adoption and implementation of these three SMS practice implementation strategies. Primary effectiveness outcomes including lab values and evidence of SMS will be abstracted from medical records covering baseline through 18 months post-baseline. Data from CTH assessments and action plans completed by patients enrolled in CTH will be used to evaluate practice implementation of CTH and the impact of CTH participation. Qualitative data including field notes from encounters with the practices and interviews of practice personnel will be analyzed to assess practice implementation of SMS.

Discussion: This study will provide important information on the implementation of SMS in primary care, the effectiveness of an IBCT tool such as CTH, and the use of practice facilitation to assist implementation.

Trial registration: Registered with ClinicalTrials.gov - ClinicalTrials.gov ID: NCT01945918 , date 08/27/2013. Modifications have been updated.