From feedback to action: a process evaluation of implementation strategies for sepsis bundles in emergency departments.

Background: Sepsis is a burdensome and costly condition and a leading cause of death in acute care centers. Guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) Framework, the Assessment of Implementation Methods in Sepsis (AIMS) study is an ongoing hybrid type 2 effectiveness-implementation study. One co-primary aim is to compare two multi-component sepsis "bundles"-one accomplished within 3-h and one within 1-h-and their effects on mortality and related health outcomes. The other co-primary aim is to assess implementation strategies that support bundle implementation within emergency departments. Implementation strategies include learning collaboratives, provision of educational materials, audit and feedback reports, capturing and sharing local knowledge, and technical assistance. The goal of this implementation-focused process evaluation was to identify barriers and facilitators to the implementation process and to develop subsequent adaptations to enhance implementation. Methods: A multi-method data collection and analysis was undertaken in the Implementation stage. The two champions (one nurse and one physician) from each of the 18 AIMS study sites were invited to participate in semi-structured interviews. Learning collaborative attendees completed quantitative satisfaction surveys. After analysis, potentially impactful and feasible modifications to the implementation process were identified, documented using the FRAME-IS, and enacted. Results: Synthesis of 24 interviews and 19 surveys indicated that the implementation strategies were generally executed as planned and respondents were satisfied with the implementation process. Monthly learning collaboratives included helpful topics and facilitated inter-site networking and learning. Educational materials were valuable resources for onboarding and ongoing reference, and monthly audit and feedback reports helped to quantify progress and benchmark with other AIMS sites. Barriers and related adaptations were focused on simplifying and streamlining touchpoints and materials, further supporting inter-site networking and learning, and increasing knowledge of and access to resources. Fifteen adaptations (content = 7; context = 4; evaluation = 2; training = 1; and multi-purpose = 1) were made to increase the acceptability, appropriateness, or feasibility of the implementation effort ( Conclusion: The implementation strategies were well-received and site-specific feedback led to modifications. The summative evaluation will provide insight into if and how modifications enhanced implementation efforts. Trial registration: ClinicalTrails.gov, Identifier NCT05491941.