Strengthening implementation of integrated care for small and nutritionally at-risk infants under six months: pre-trial feasibility study

Abstract

An integrated care pathway to manage small and nutritionally at-risk infants under 6 months (u6m) and their mothers (MAMI Care Pathway) is consistent with 2023 WHO malnutrition guidelines and is being tested in a randomised controlled trial (RCT) in Ethiopia. To optimize trial implementation, we investigated contextual fit with key local stakeholders. We used scenario-based interviews with 17 health workers and four district managers to explore perceived feasibility. Eighteen policymakers were also surveyed to explore policy coherence, demand, acceptability, evidence needs, opportunities and risks. The Bowen feasibility framework and an access to healthcare framework were adapted and applied. Health workers perceived the MAMI Care Pathway as feasible to implement with support to access services and provide care. The approach is acceptable, given consistency with national policies, local protocols and potential to improve routine care quality. Demand for more comprehensive, preventive and person-centred outpatient care was driven by concerns about unmet, hidden and costly care burden for health services and families. Inpatient care for all severe wasting treatment is inaccessible and unacceptable. Support for routine and expanded components, especially maternal mental health, is needed for successful implementation. Wider contextual factors may affect implementation fidelity and strength. Policymakers cautiously welcomed the approach, which resonates with national commitments, policies and plans but need evidence on how it can work within varied, complex contexts without further system overstretch. A responsive, pragmatic RCT will generate the most useful evidence for policymakers. Findings have informed trial preparation and implementation, including a realist evaluation to contextualise outcomes.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study was funded by the Eleanor Crook Foundation (MAMI RISE project). The authors or their institutions at any time did not recieve payment or services from a third party for any aspect of the submitted work.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study secured ethical approval of Jimma University Institutional Review Board (IRB), Ethiopia and London School of Hyigene and Tropical Medicine (LSHTM) Research Ethics Committee, UK.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors.

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