Factors influencing implementation of an integrated care pathway for at risk infants under 6 months and their mothers in Ethiopia

Background : Globally, one in five infants under 6 months is at risk of death, illness and poor development. They may be identified as being malnourished, growing poorly, or underweight and may have been born too early or too small. The MAMI Care Pathway Package is an integrated care pathway approach, with a package of adaptable resources to guide inter-disciplinary continuity of care for these at-risk infants under 6 months and their mothers within health systems. This approach supports implementation of WHO health and nutrition guidelines that recommend outpatient care. However, the MAMI Care Pathway approach has not been robustly tested within national health systems that has impeded national policy transtion from inpatient-only care for this age-group. To address this evidence gap, the MAMI RISE (Research, Innovate, Scale, Establish) Research Project was developed to test the MAMI Care Pathway in a randomised controlled trial (RCT) in outpatient clinics in Ethiopia. This five-year project (2019-2025) was delivered in a co-creative partnership between LSHTM, Emergency Nutrition Network, Jimma University and GOAL Ethiopia funded by the Eleanor Crook Foundation. Within this research project, I investigated what factors influence implementation of an integrated care pathway in outpatient clinics in Ethiopia through three studies. Methods: I undertook a scoping review of global policies to appraise global policy guidance relevant to the care of at-risk infants under 6 months and their mothers in Ethiopia (Study 1); a pre-trial feasibility study to identify factors that may influence implementation of the MAMI Care Pathway in outpatient health facilities (Study 2); and a realist-informed process evaluation to evaluate how the MAMI Care Pathway worked, for whom and under what circumstances during the RCT (Study 3). The scoping review of global policies involved a literature search of publicly available data according to PRISMA-ScR guidance. The feasibility study involved interviews with health workers and senior policymakers in Ethiopia to explore both health service and policy fit. The process evaluation involved interviews with mothers, fathers, health and research staff in intervention and control sites, and secondary RCT data from research team meetings and incident logs. Results: The scoping review of global policies found rich but fragmented policy guidance that mask interdiscipline policy synergies and important guidance gaps. Evidenced growth markers of infant mortality risk are largely absent from WHO health-oriented guidance. Continuity of care for mothers and infants lacked depth and detail. Using the MAMI Care Pathway to support WHO recommendation uptake is constrained by institutional procedures that limit consideration of nonUN guidance. Transitioning to a living guideline system is necessary and urgent. Applying the WHOINTEGRATE framework to handle complexity within guidance could improve policy fit for implementation of integrated care. The feasibility study found the intervention was perceived by staff as feasible to implement in outpatient services with additional structural support and likely acceptable to mothers. High staff acceptability was influenced by perceived demand, need, implementation realities and integration potential with Integrated Management of Childhood Illness (IMCI) protocols. Identified service constraints included low availability of maternal nutrition and health services and limited breastfeeding and mental health counselling competencies. Policymakers identified good coherence of the MAMI Care Pathway with national policy provisions and intent but emphasised their need for implementation evidence to appraise policy implications of RCT findings. Overall, the process evaluation found the MAMI Care Pathway approach was acceptable, feasible, valued and impactful during a pragmatic, responsive RCT in outpatient services. Positive and varied RCT outcomes were explainable, given case complexities, setting differences, and implementation conditions. Synergism between intervention components, people and health-research systems maximised what was possible. Shared vision gave purpose and drove impact. Adaptive changes meant implementation varied between clinics, settings and over time. Both mothers and health workers had improved access to resources and experienced motivational outcomes that empowered them to cooperatively act. The study also identified that routine service gaps have negative consequences for infants, mothers and families. It is likely that greater scope and intensity of intervention is needed for some cases. Embedded staff generated rich transferable knowledge that strengthens integration potential. Evidencing approaches should transition to locally led implementation research embedded in health services. In summary, the scoping review of global policies identified strong potential but important limitations with global policy content and processes that risk limiting implementation of integrated care. The feasibility study confirmed consistency of the MAMI Care Pathway approach with national policy guidance and IMCI based outpatient protocols. The process evaluation confirmed intervention fit with outpatient services in Ethiopia and strong integration potential. Implications: This body of research provides contextualised evidence for the interpretation of an RCT of the MAMI Care Pathway approach in Ethiopia. Findings have informed national policy development on malnutrition management in Ethiopia. This research provides transferable learning on evidencing and implementing integrated, equitable and just systems of health for localised, scalable, and sustainable care. Co-creative research partnerships that plan for scale maximise national policy fit and system readiness. Implementation research should accompany trials of complex health interventions. The generative knowledge of local stakeholders is essential to evidencing how to deliver effective sustainable care. Programming approaches for at risk infants and mothers must extend beyond nutrition interventions, health interventions must embed action on infant growth and maternal wellbeing. Integrated care is feasible with structural and professional support for staff. Multi-level research, programming and policy action and interaction is necessary for synergistic effects. Inter-disciplinary and inter-system brokerage and stronger global accountability mechanisms to secure better international policy order are needed to achieve this. My findings demonstrate how implementation of integrated care requires policies and programmes that empower local stakeholders to develop, adapt and deliver interventions for at risk infants under 6 months and their mothers. This approach will require a re-focus of international support on catalytic long-term investments in systems of person-centred care, and the pursuit of sustainable scale through contextually grounded, locally led implementation research and learning exchange.