Supporting Practices to Adopt Registry-Based Care (SPARC): protocol for a randomized controlled trial.

Background: Diabetes is predicted to increase in incidence by 42% from 1995 to 2025. Although most adults with diabetes seek care from primary care practices, adherence to treatment guidelines in these settings is not optimal. Many practices lack the infrastructure to monitor patient adherence to recommended treatment and are slow to implement changes critical for effective management of patients with chronic conditions. Supporting Practices to Adopt Registry-Based Care (SPARC) will evaluate effectiveness and sustainability of a low-cost intervention designed to support work process change in primary care practices and enhance focus on population-based care through implementation of a diabetes registry.

Methods: SPARC is a two-armed randomized controlled trial (RCT) of 30 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN). Participating practices (including control groups) will be introduced to population health concepts and tools for work process redesign and registry adoption at a meeting of practice-level implementation champions. Practices randomized to the intervention will be assigned study peer mentors, receive a list of specific milestones, and have access to a physician informaticist. Peer mentors are clinicians who successfully implemented registries in their practices and will help champions in the intervention practices throughout the implementation process. During the first year, peer mentors will contact intervention practices monthly and visit them quarterly. Control group practices will not receive support or guidance for registry implementation. We will use a mixed-methods explanatory sequential design to guide collection of medical record, participant observation, and semistructured interview data in control and intervention practices at baseline, 12 months, and 24 months. We will use grounded theory and a template-guided approach using the Consolidated Framework for Implementation Research to analyze qualitative data on contextual factors related to registry adoption. We will assess intervention effectiveness by comparing changes in patient-level hemoglobin A1c scores from baseline to year 1 between intervention and control practices.

Discussion: Findings will enhance our understanding of how to leverage existing practice resources to improve diabetes care in primary care practices by implementing and using a registry. SPARC has the potential to validate the effectiveness of low-cost implementation strategies that target practice change in primary care.

Trial Registration: NCT02318108.