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Background: 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. Methods/design: 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. Discussion: 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. [ABSTRACT FROM AUTHOR]

Background Health care in the United States is in the midst of a near perfect storm: strong cost pressures, dramatic redesign efforts like patient-centered medical homes and accountable care organizations, and a broad series of payment and eligibility reforms. To date, alternative models of care intended to reduce costs and improve outcomes have shown mixed effects in the U.S., in part due to the difficulty of performing rigorous evaluation studies that control for the broader transformation while avoiding other biases, such as organizational or clinic effect on individual patient outcomes. Our objective is to test whether clinics assigned to achieve high value elements (HVEs) of practice redesign are more likely than controls to achieve improvements in patient health and satisfaction with care and reduction in costs. Methods/Design To prepare, we interview stakeholders, align with health reform, and propose a pilot. Participants are primary care clinics engaged in reform. Study protocol requires that both arms receive monthly practice facilitation, IT-based milestone reporting, and small financial incentives based on self-determined quality improvement (QI) goals; intervention receives additional prompting to choose HVEs. Design is a cluster randomized controlled trial over 1 year with pre- and post-washout periods. Outcomes are unplanned utilization and costs, patient experience of care, quality, and team performance. Analysis is a multivariate difference-in-difference with adjustments for patient risk, intraclinic correlation, and other confounders. Discussion The TOPMED study is a cluster randomized controlled trial focused on learning how primary care practices can transform within health reform guidelines to achieve outcomes related to the Triple Aim. [ABSTRACT FROM AUTHOR]