Strengthening Primary Care with a Minimal Digital Ecosystem in Burkina Faso: Protocol for a Pragmatic Mixed-Methods Implementation Study (Preprint)

BACKGROUND In Burkina Faso, the Minimal Digital Ecosystem (MDE)—a suite of nine integrated digital tools—was introduced to support key health system functions, including care delivery, financial management, medication oversight, governance, and data use. However, evidence regarding the maturity of its real-world implementation and the determinants influencing its adoption remains scarce. OBJECTIVE This pragmatic mixed-methods study aims to: (1) measure MDE implementation maturity across four dimensions (adoption, fidelity, penetration, sustainability); (2) identify multilevel determinants using the Consolidated Framework for Implementation Research (CFIR 2.0) and Normalization Process Theory (NPT); and (3) examine associations between implementation degree and primary health care (CSPS) performance METHODS We employ a sequential explanatory design (QUAN→qual) in four districts covering 72 CSPS. Phase 1: Cross-sectional survey of all eligible health workers, facility managers, and community health workers (estimated n=612 respondents nested within facilities) using CFIR-and NPT-informed questionnaires. Following psychometric validation (exploratory/confirmatory factor analysis; reliability assessment via Cronbach's α and McDonald's ω), we will fit multilevel models with CSPS random intercepts and district fixed effects to: (a) quantify between-facility implementation variance; (b) test associations with CFIR/NPT determinants; and (c) examine relationships with CSPS performance indicators. Phase 2: Purposive sampling of facilities with varying implementation profiles for interviews, focus groups, and observations, analyzed using reflexive thematic analysis to explain quantitative patterns RESULTS Ethics approval was obtained from Burkina Faso's National Ethics Committee (No. 2023-06-136). Quantitative data collection was completed in September 2025, and qualitative fieldwork is ongoing as of October 2025. Psychometric analyses are underway. CONCLUSIONS By addressing key evidence and measurement gaps in digital health implementation, this protocol will (i) generate context-specific guidance on implementing and institutionalizing a complex digital health ecosystem and (ii) provide validated, ready-to-use instruments to quantify implementation at the CSPS level. Together, these outputs will help policymakers and program managers define and track “implementation success,” informing—and accelerating—the scale-up and optimization of the MDE in resource-constrained settings.