Background: Healthcare systems face the challenge of delivering care of the highest possible quality while simultaneously ensuring broad access to services and prudent use of resources. Without thoughtfully designed implementation strategies, the impact of evidence-based practices (EBPs) cannot be fully realized because it is difficult to spread the EBP beyond early adopting facilities. The Spreading Healthcare Access, Activities, Research and Knowledge (SHAARK) QUERI will compare implementation strategies for EBPs in two areas of high relevance to VA: addressing the needs of veterans suffering from moral pain (e.g., guilt, shame, betrayal) as a result of actions taken or not taken during their service (aka, moral injury) and veterans who face the substantial health risks of persistently poor diabetes control. While these groups are important in-and-of themselves, the synergy that comes from studying implementation of distinct EBPs aimed at different complex health conditions will lead to a greater understanding of how to address the overarching implementation challenge of moving clinical EBPs across health systems. Significance/Impact: In alignment with VA facility and VISN Director Performance Plan metrics to identify and spread innovations, the SHAARK QUERI will provide evidence for how VA and other healthcare systems can use strategies for spreading complex clinical EBPs beyond successful earlier adopters across the healthcare system. This evidence will be obtained by conducting clinical trials of an implementation strategy aligning with the Exploration, Preparation, Implementation, Sustainment (EPIS) implementation framework, while specifically seeking to improve care for moral injury and persistently uncontrolled diabetes. Specific Aims: Using two EBPs, Advanced Comprehensive Diabetes Care (ACDC) and Moral Injury Groups, we will conduct two hybrid type 3 implementation trials that align with the EPIS framework for the establishment of strategies to implement EBPs. The specific aims are as follows: Aim 1a: Measure difference in the percentage of patients receiving appropriate dose/adherence to group attendance (attending ≥ 80% of group sessions) as an indication of fidelity; Aim 1b: Measure differences in the percentage of core components implemented and number of adaptations to EBP processes; Aim 1c: Examine differences in the number and intensity of quality improvement efforts/plan-do-study-act cycles undertaken by sites; Aim 2: Examine differences in change in PTSD symptoms, suicidal behavior, & perceived life significance (for Moral Injury Groups trial) and difference in change in hemoglobin A1c (for ACDC trial); Aim 3: Conduct evaluation of implementation process; and Aim 4: Build a business case including budget impact (for both EBP trials). Methods: We will test the implementation strategy, Dynamic Diffusion Network (DDN), for operationalizing EPIS (1 separate DDN per trial) for later adopters of EBPs. The DDN will be compared to technical assistance. For each trial, 10 VA facilities will be randomized to implement the EBP using either the Dynamic Diffusion Network EPIS implementation strategy (5 sites) or technical assistance (5 sites). Primary outcomes will be focused on successful implementation of the EBPs, use of EBP components, and rapid improvement processes, as well as secondary clinical outcomes of the practice. Program materials previously used for both EBPs will be refined into an initial change package/implementation toolkit to be shared with each interested site. The toolkits will be assessed by two frontline staff members who have had previous experience implementing the EBPs. We will also conduct a formative evaluation of both EBPs to explore factors potentially influencing outcomes at each EPIS stage based on the Consolidated Framework for Implementation Research (CFIR). The evaluation will use a mixed methods approach consisting of semi-structured, qualitative interviews, surveys and other complementary methods with participating VA sites. A business case will be developed based on a balanced scorecard approach, accounting for outcomes, cost, and implementation.

Implementation science has frequently focused on organizations that are early adopters of evidence-based practices (EBPs). This work has been important in understanding implementation facilitators and barriers, examining reasons for differing effects of innovations, and establishing the effectiveness of implementation strategies. However, there is a need to further investigate practical strategies that can be utilized among later adopters of innovations that may face less than ideal implementation conditions. The SHAARK QUERI’s impact goal is to provide evidence for how VA and other healthcare systems can successfully spread complex clinical EBPs beyond early adopters to reach underserved late adopter sites. This evidence will be obtained by conducting two randomized trials of an implementation strategy that aligns with the Exploration, Preparation, Implementation, Sustainment (EPIS) implementation framework. These trials will specifically address two pressing clinical areas: moral injury and persistently uncontrolled diabetes.