Abstract
BACKGROUND: Modifications to interventions can jeopardize intervention outcomes. Pre-existing perceived barriers and facilitators to the intervention arising in the implementation preparation phase may help explain why modifications to the intervention may occur during the implementation phase. This two-site comparative case study describes modifications made to a complex organizational-level intervention and examines how known implementation science factors may have enabled such changes to occur. METHODS: Northwestern Medicine's(TM) Hispanic Kidney Transplant Program (HKTP) is a culturally competent transplant center-based intervention designed to reduce disparities in living donor kidney transplantation among Hispanics. In-depth qualitative interviews and discussions were longitudinally conducted with transplant stakeholders (i.e., physicians, administrators, clinicians) at two kidney transplant programs with large Hispanic populations during implementation preparation and implementation phases. The Consolidated Framework for Implementation Research (CFIR) guided interview design and qualitative analysis, and Stirman's Framework for Reporting Adaptations and Modifications-Expanded (FRAME) guided modification classification. RESULTS: Across sites, 57 stakeholders participated in an interview, group discussion, and/or learning collaborative discussion. Site-B made more modifications than Site-A (n = 29 versus n = 18). Sites differed in the proportions of delaying/skipping (Site-A 50% versus Site-B 28%) and adding (Site-A 11% versus Site-B 28%) but had comparable substituting (Site-A 17% versus Site-B 17%) and tweaking (Site-A 17% versus Site-B 14%) modification types. Across sites, the transplant team consistently initiated the most modifications (Site-A 66%; Site-B 62%). While individuals initiated slightly more modifications at Site-B (21% versus Site-A 17%), institutions instigated proportionately slightly more modifications at Site-A (17% versus Site-B 10%). CFIR inner setting factors (i.e., structural characteristics, culture, available resources, implementation climate) that prominently emerged during the implementation preparation phase explained similarities and differences in sites' modification numbers, types, and agents in the implementation phase. CONCLUSION: Organizations implementing a culturally competent care intervention made modifications. CFIR inner setting factors emerging in the implementation preparation phase largely explained similarities and differences in study sites' modifications. Identifying factors contributing to modifications may help institutions become better prepared to implement an intervention by addressing known factors in advance, which may foster greater fidelity leading to desired outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03276390 . We registered the study retrospectively on 9-7-17.