Study protocol for “Healthy Hearts Northwest”: a 2 × 2 randomized factorial trial to build quality improvement capacity in primary care

Michael L. Parchman, Lyle J. Fagnan, David A. Dorr, Peggy Evans, Andrea J. Cook, Robert B. Penfold, Clarissa Hsu, Allen Cheadle, Laura-Mae Baldwin, Leah Tuzzio

Little attention has been paid to quality improvement (QI) capacity within smaller primary care practices which comprise nearly half of all primary care settings. Strategies for external support to build such capacity include practice facilitation (PF), shared learning opportunities, and educational outreach. Although PF has proven effectiveness, little is known about the comparative effectiveness of combining these strategies. Here, we describe the protocol of the "Healthy Hearts Northwest" (H2N) study, a randomized trial designed to address these questions while improving risk factors for cardiovascular disease. The targeted enrollment is 250 smaller primary care practices across Washington, Oregon, and Idaho. The study is utilizing a two-by-two factorial design to assess four different combinations of practice support: PF alone, PF with educational outreach, PF with shared learning opportunities, or PF with both. A mixed methods approach is being used for evaluation and will include data from (1) baseline and follow-up practice and staff surveys; (2) baseline and quarterly clinical performance measurement from each practice on four cardiovascular risk factors: appropriate aspirin use, blood pressure control, lipid management and smoking cessation support; and (3) a quality improvement capacity assessment (QICA) survey used by external practice facilitators to guide improvement efforts. Results from this study will inform future large-scale practice improvement initiatives by providing comparisons of promising external practice support strategies and advance our understanding of how to build QI capacity in primary care. ClinicalTrials.gov, NCT02839382.