Background Despite significant reductions in mortality, preventable and treatable conditions remain the leading causes of death in children under five within South Africa. The WHO’s Integrated Management of Childhood Illness (IMCI) programme has been widely implemented to address the most common causes of mortality in children under five. Although effective, limitations in IMCI scope and adherence have emerged. The Practical Approach to Care Kit (PACK) Child guide has been developed to expand on IMCI and address these limitations. It is intended as a clinical decision support tool for health workers with additional systems strengthening components, including active implementation and training strategy to address contextual and organisational factors hindering quality of care for children. Implementation is complex, requiring comprehensive pilot and process evaluation. The PACK Child pilot and feasibility study will sample 10 primary care facilities in the Western Cape Province. Staff will be trained to integrate the PACK Child guide into routine practice. The process evaluation will investigate implementation and health systems components to establish how to optimise delivery, strengthen IMCI principles and factors required to support effective and sustained uptake into everyday practice.
Methods Mixed method process evaluation. Qualitative data include interviews with managers, staff, caregivers and policymakers; observations of training, consultations and clinic flow. Quantitative data include training logs and staff questionnaires. Quantitative and qualitative analysis will be integrated to describe study sites and develop explanations for implementation variation.
Discussion The process evaluation will provide the opportunity to document implementation and refine the programme prior to a larger pragmatic trial or scale-up.
- child health
- health systems evaluation
- prevention strategies
- other study design
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Handling editor Seye Abimbola
Contributors All authors contributed to the conceptualisation of the research and contributed to writing the manuscript. LF, EB, RVC, MB, JM, RC and TD designed the process evaluation protocol. MLS and SCP led the development of the PACK Child training intervention. RVC led the development of the content of the PACK Child guide. JM drafted the manuscript and all coauthors edited and commented on revised drafts. All authors approved the final draft for submission. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding This research is funded by the Joint Health Systems Research Initiative (Department For International Development, Economic and Social Research Council, UK Medical Research Council and Wellcome Trust). The Children’s Hospital Trust, South Africa provided funding to support the development of the PACK Child guide. Grant ref: MR/R004080/1
Competing interests LF, EB, RC, MLS and SCP are employees of the KTU. TD is an employee of the South African Medical Research Council. EB reports personal fees from ICON, Novartis, Cipla, Vectura, Cipla, Menarini, ALK, ICON, Sanofi Regeneron, Boehringer Ingelheim and AstraZeneca and grants for clinical trials from Novartis, Boehringer Ingelheim, Merck, Takeda, GlaxoSmithKline, Hoffmann le Roche, Actelion, Chiesi, Sanofi-Aventis, Cephalon, TEVA and AstraZeneca. All of EB’s fees and clinical trials are for work outside the submitted work. EB is also a Member of Global Initiative for Asthma Board and Science Committee. Since August 2015, the KTU and BMJ have been engaged in a non-profit partnership to provide continuous evidence updates for PACK, expand PACK related supported services to countries and organisations as requested and where appropriate license PACK content. The KTU and BMJ cofund core positions, including a PACK Global Development Director, and receive no profits from the partnership. PACK receives no funding from the pharmaceutical industry. This paper forms part of a Collection on PACK sponsored by the BMJ to profile the contribution of PACK across several countries towards the realisation of comprehensive primary healthcare as envisaged in the Declaration of Alma Ata, during its 40th anniversary.
Patient consent Not required.
Ethics approval University of Cape Town Human Research Ethics Committee (HREC), City of Cape Town Research Ethics Committee and the Western Cape Provincial Health Research Committee.
Provenance and peer review Not commissioned; internally peer reviewed.
Data sharing statement No additional data are available.
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