The PROCESS study: a protocol to evaluate the implementation, mechanisms of effect and context of an intervention to enhance public health centres in Tororo, UgandaReport as inadecuate




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Implementation Science

, 8:113

First Online: 30 September 2013Received: 29 July 2013Accepted: 17 September 2013DOI: 10.1186-1748-5908-8-113

Cite this article as: Chandler, C.I., DiLiberto, D., Nayiga, S. et al. Implementation Sci 2013 8: 113. doi:10.1186-1748-5908-8-113

Abstract

BackgroundDespite significant investments into health improvement programmes in Uganda, health indicators and access to healthcare remain poor across the country. The PRIME trial aims to evaluate the impact of a complex intervention delivered in public health centres on health outcomes of children and management of malaria in rural Uganda. The intervention consists of four components: Health Centre Management; Fever Case Management; Patient- Centered Services; and support for supplies of malaria diagnostics and antimalarial drugs.

MethodsThe PROCESS study will use mixed methods to evaluate the processes, mechanisms of change, and context of the PRIME intervention by addressing five objectives. First, to develop a comprehensive logic model of the intervention, articulating the project’s hypothesised pathways to trial outcomes. Second, to evaluate the implementation of the intervention, including health worker training, health centre management tools, and the supply of artemether-lumefantrine AL and rapid diagnostic tests RDTs for malaria. Third, to understand mechanisms of change of the intervention components, including testing hypotheses and interpreting realities of the intervention, including resistance, in context. Fourth, to develop a contextual record over time of factors that may have affected implementation of the intervention, mechanisms of change, and trial outcomes, including factors at population, health centre and district levels. Fifth, to capture broader expected and unexpected impacts of the intervention and trial activities among community members, health centre workers, and private providers. Methods will include intervention logic mapping, questionnaires, recorded consultations, in-depth interviews, focus group discussions, and contextual data documentation.

DiscussionThe findings of this PROCESS study will be interpreted alongside the PRIME trial results. This will enable a greater ability to generalise the findings of the main trial. The investigators will attempt to assess which methods are most informative in such evaluations of complex interventions in low-resource settings.

Trial registrationClinicaltrials.gov, NCT01024426

KeywordsProcess evaluation Theory-driven evaluation Pathways of change Complex interventions Cluster randomised trial AbbreviationsACTArtemisinin-based combination therapy

ADDATACT Drug Distribution Assessment Tool

ALArtemether-lumefantrine

FCMFever case management

HCHealth centre

HCMHealth centre management

HMISHealth management information systems

LSHTMLondon School of Hygiene and Tropical Medicine

PCSPatient-centered services

PHCPrimary healthcare

RDTRapid diagnostic test

SOMRECSchool of Medicine Research and Ethical Committee Makerere University

UNCSTUganda National Council of Science and Technology

WHOWorld Health Organization.

Electronic supplementary materialThe online version of this article doi:10.1186-1748-5908-8-113 contains supplementary material, which is available to authorized users.

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Author: Clare IR Chandler - Deborah DiLiberto - Susan Nayiga - Lilian Taaka - Christine Nabirye - Miriam Kayendeke - Eleanor Hutch

Source: https://link.springer.com/



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