Tailoring site-specific implementation strategy selection for a multi-site cesarean risk calculator trial: a mixed-methods approach

Our prior single-site study demonstrated that patient and clinician awareness of individualized patient cesarean risk, facilitated by a novel calculator, was associated with reductions in maternal morbidity and cesarean rates. To prepare for a 14-site stepped-wedge type I hybrid effectiveness-implementation trial of this calculator, we developed a reproducible, multi-phase mixed-methods approach to create context-specific implementation guides that center the opinions of front-line clinicians. Guided by Consolidated Framework for Implementation Research 2.0 and the Implementation Research Logic Model, our embedded sequential mixed-methods study (QUAN-> QUAL; 8/2023-9/2024) systematically identified implementation determinants at 14 diverse U.S.-based labor and delivery sites to inform selection of Expert Recommendations for Implementing Change strategies most likely to achieve successful local implementation. Strategies were categorized as “set” (required across sites), “optional” (potentially beneficial based on preliminary qualitative data), or “emergent” (responsive to newly identified site-specific barriers). First, we established site-based leadership teams (3–15 physicians, midwives, nurses, doulas, and patient/community partners). Next, pre-implementation clinician surveys (QUAN) across sites assessed perceived benefit/feasibility of four “optional” strategies: (1) preparing patients as active consumers (outpatient calculator discussion), (2) enhancing patient uptake (outpatient preliminary risk score), (3) electronic health record integration, and (4) visual aids for counseling and barriers/facilitators to implementation. Survey (QUAN) data was presented to site-based leadership teams to generate preliminary plans. These plans were refined, including the selection of emergent strategies, and finalized through clinician focus groups (QUAL) at each site. Frontline clinicians participated meaningfully across the survey (QUAN, n = 324) and focus groups (QUAL, 21 groups, n = 92). Cross-cutting barriers reported by clinicians included time constraints, buy-in, and competing priorities. Site-specific barriers also emerged, e.g., minimal physician/midwife presence on nurse-driven labor units for risk counseling. Perceived benefit/feasibility ratings of the “optional” strategies varied across sites. Leadership teams’ preliminary plans combined these ratings with personal judgement. Focus groups were crucial for finalizing plans and identifying “emergent” strategies, such as development of a direct-to-patient educational video for use at nurse-driven sites. This methodology allowed systematic development of 14 context-specific implementation guides, detailing selected implementation strategies, that center frontline perspectives prior to a national trial. Ongoing work will evaluate how these tailored plans impact calculator penetration and outcomes after trial completion, offering a feasible and scalable model for future multi-site implementation research.