Dynamic waitlisted design for evaluating a randomized trial of evidence-based quality improvement of comprehensive women's health care implementation in low-performing VA facilities.

backgroundWomen's Health Services (WHS) in the Veterans Health Administration (VA) has long partnered with VA researchers to evaluate how VA care is organized for women veterans. This partnership has yielded substantial evidence of (1) variations in women veterans' access to comprehensive healthcare services that contribute to disparities in quality and patient experience and (2) the positive impacts of gender-specific care models for women veterans' quality and satisfaction. In an effort to provide support specifically to sites that were low-performing in women's health, WHS and the VA Quality Enhancement Research Initiative co-funded an effort to roll out and evaluate evidence-based quality improvement (EBQI), an implementation strategy with demonstrated effectiveness in a prior cluster randomized trial in women's health clinics.

methodsWe will identify 21 low-performing VA facilities through a combination of practice data, VA quality metrics (by gender), and other indicators. In partnership with WHS, an EBQI contractor will deliver the EBQI "package"-local consensus development and priority setting using stakeholder panels, multilevel stakeholder engagement, practice facilitation, local EBQI team training, and formative feedback-to participating sites. We propose a dynamic wait-listed design to evaluate the WHS plans for seven EBQI launches per year over 3 years. The goal is to evaluate (1) barriers and facilitators to achieving delivery of comprehensive women's health care in low-performing VA facilities; (2) effectiveness of EBQI in supporting low-performing VA facilities to achieve improved practice features (e.g., level of comprehensive services available, care coordination arrangements, Patient Aligned Care Team (PACT) features implemented, environment of care improvements), provider/staff attitudes (e.g., improved gender awareness, women's health knowledge and practice), quality of care, and patient experience; and (3) contextual factors, local implementation processes, and organizational changes over time. DISCUSSION: Access to comprehensive women's health care reduces fragmentation of care, improves patient satisfaction, and results in better patient outcomes. We hypothesize that EBQI implementation will result in changes in leadership awareness and buy-in, multilevel engagement in problem-solving, an enhanced culture of quality improvement, structural changes in care, improved provider/staff attitudes, and better quality and patient experience.

trial registrationClinicalTrials.gov, NCT03238417. Registered 3 August 2017. Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT03238417.