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

Abstract

BackgroundDiabetes 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.MethodsSPARC 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.DiscussionFindings 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 registrationNCT02318108Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-015-0232-2) contains supplementary material, which is available to authorized users.

Using the Consolidated Framework for Implementation Research (CFIR) to produce actionable findings: a rapid-cycle evaluation approach to improving implementation

“…We think the approach we describe has broad application and encourage others to use the CFIR, along with intervention-specific codes, to guide the efficient and rigorous analysis of rich qualitative data. As such, we are using this approach to assess barriers and facilitators to implementing a disease registry in the Supporting Practices to Adopt Registry-Based Care (SPARC) study [ 20 ]. The SPARC study is a two-armed randomized controlled trial of 30 primary care practices implementing a diabetes registry.…”

What Makes for Successful Registry Implementation: A Qualitative Comparative Analysis

“…4 In addition consistent with prior reports, leadership, and linkage across team members for QI efforts were important components. 8,12 In addition, this study adds to the literature in 2 important ways. First, our focus was specifically on understanding adaptations made during the implementation process.…”

“…Literature on the use of registries in primary care is extensive, but there is relatively little evidence re-garding how to overcome challenges as they occur during registry implementation. 12,13 Creating, refining, and updating disease registries and successfully integrating them with EHRs can be time consuming and frustrating. Delays in establishing effective and actionable registries are a frequent impediment to the success of chronic care quality-improvement efforts.…”

Low-Intensity Intervention Supports Diabetes Registry Implementation: A Cluster-Randomized Trial in the Ambulatory Care Outcomes Research Network (ACORN)

“…We have described the SPARC intervention in detail elsewhere 16 ; the protocol is available on request. Briefly, practices identified local implementation champions who attended in-person education sessions (separately for intervention and control practices to avoid possible contamination) in March 2015 about the value and use of diabetes registries, primary care practice workflow redesign, and general principles of population-based care delivery for patients with chronic conditions.…”

“…Supporting Practices to Adopt Registry-based Care (SPARC) is a clusterrandomized controlled trial designed to test the effectiveness of a low-intensity external support intervention to support diabetes registry implementation in primary care practices. 16 These registries, once enabled, will support our ultimate goal of improving health outcomes related to diabetes care and adherence to evidence-based diabetes management guidelines.…”