Integration and scale-up of a primary healthcare-based chronic wound care package for persons affected by skin-NTDs and other conditions in Ethiopia: a protocol for an implementation research study

Abstract

ABSTRACT Introduction: The profound impact of wounds on the quality of life of those affected is often underestimated. Chronic wounds impose substantial burdens on individuals and communities in terms of disability, mental distress, stigma, and economic productivity losses. To effectively address these challenges, an integrated and comprehensive approach to primary healthcare-based chronic wound care prevention and management is essential. This implementation research study aims to assess the integration and scale-up of a comprehensive package of primary healthcare-based wound care and psycho-social support for persons affected by chronic wounds caused by neglected tropical diseases (NTDs) and other conditions in selected districts in Ethiopia. Methods: The study will be implemented in Central Ethiopia in three stages, utilizing a mixed-methods approach to co-develop a comprehensive care package and progressively implement the care package building on learnings from successive stages of implementation. Stage 1 will encompass the co-development of a holistic wound care package and strategies for its integration into routine health services. Stage 2 will involve a pilot study in one sub-district, to establish the care package adoption, feasibility, acceptability, fidelity, potential effectiveness, readiness for scale-up, and costs. Stage 3 will involve the scale-up of the wound care package and its evaluation in several districts. Ethics and dissemination: Ethics approval was obtained for the study from the relevant authorities in both the UK (Ref no: ER-BSMS9D79-6) and Ethiopia [Reference no. 013/23/CDT]. The results of the study will be disseminated through a variety of channels, including publications in scientific journals, conference presentations, policy briefs, and workshops. This will ensure that the findings are disseminated widely to the scientific community, policymakers, and the public. Key words: Chronic wound care, Primary healthcare, Neglected Tropical Diseases, Integrated Care, Low-income countries, Ethiopia

Competing Interest Statement

The authors have declared no competing interest.

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Funding Statement

This research was funded by the National Institute for Health and Care Research (NIHR) Global Health Research Unit on NTDs at the Brighton & Sussex Medical School

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:

Addis Ababa University,College of health sciences, Institutional Research Ethics Review Committee and Brighton and Sussex Medical School Research Governance Ethics Committee gave ethical approval for this work

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 this study will be available upon reasonable request to the authors.

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