Enhancing mental and physical health of women through engagement and retention (EMPOWER) 3.0 QUERI: study protocol for a cluster-randomized hybrid type 3 implementation-effectiveness trial.

backgroundWomen Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has challenged VA to ensure that appropriate services are available to meet women Veterans' needs, and that they are willing and able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans in midlife. Enhancing Mental and Physical Health of Women through Engagement and Retention (EMPOWER) 3.0 builds on prior work to optimize women Veterans' access to and quality and experience of care. It offers trauma-informed, evidence-based interventions that meet high-priority health needs in midlife, with the objective to increase women Veterans' trust, well-being, and engagement in VA care.

methodsEMPOWER 3.0 will evaluate two implementation strategies, an Evidence-Based Quality Improvement booster (EBQI/B) and EBQI/B plus external facilitation (EBQI/B+EF). These strategies are designed to support implementation of three evidence-based practices (EBPs) for women Veterans: Trauma-Informed Care, a VA-mandated set of activities and approaches that support trust and safety in primary care interactions; Cognitive Behavioral Therapy for Symptoms of Menopause, which provides group-based therapy, education, and personalized referrals for women across the menopausal transition; and Women's MOVE!, which provides tailored lifestyle and weight management support to enhance women's health and well-being. Year 1 activities will include iterative co-production to tailor each intervention to meet the needs of women Veterans and diverse VA sites. We will conduct a mixed methods implementation evaluation using a cluster-randomized hybrid type 3 effectiveness-implementation trial design to compare the effectiveness of EBQI/B and EBQI/B+EF in terms of: (a) access to trauma-informed care tailored for women Veterans; (b) implementation strategy fidelity, speed of implementation, and sustainment; (c) recipient perspectives on and experiences of EBP implementation; and (d) costs of implementation and business case analysis to support sustained EBP use. DISCUSSION: Grounded in the Health Equity Implementation Framework, EMPOWER 3.0 provides an innovative model for conducting partnered and collaborative mixed methods implementation in a hybrid type 3 effectiveness-implementation project; the evaluation will comprise a comprehensive set of measures including performance metrics, implementation progress, stakeholder experience, and cost and return on investment across a complex organizational setting.