Randomised Field Trial of Community Health Centre Systems for Clinical Outcomes in Uganda: A Methodological Evaluation

{ "background": "Community health centres are pivotal for primary care delivery in sub-Saharan Africa, yet robust methodological frameworks for evaluating their systemic impact on clinical outcomes are lacking. Existing evaluations often rely on observational designs, limiting causal inference.", "purpose and objectives": "This study aimed to methodologically evaluate a novel cluster-randomised field trial design for assessing the impact of a streamlined patient management system on key clinical outcomes within Ugandan community health centres.", "methodology": "We conducted a parallel, two-arm, cluster-randomised controlled trial. Forty-eight health centres were randomised (1:1) to implement the new system or continue standard care. The primary outcome was the composite rate of treatment completion for malaria, pneumonia, and diarrhoea in children under five. Analysis used a generalised linear mixed model: logit(P(Yij=1)) = \β0 + \β1 Xij + uj + eij, where uⱼ is the cluster random effect, with robust standard errors.", "findings": "The intervention significantly increased the composite treatment completion rate (adjusted odds ratio 1.42, 95% CI 1.15 to 1.76). A key methodological finding was that outcome ascertainment required a hybrid of routine data and spot-audits to achieve >90% data completeness, a threshold below which effect estimates became unstable.", "conclusion": "The trial design proved feasible and generated precise effect estimates, demonstrating that rigorous experimental evaluation of health system interventions in low-resource settings is achievable. The new patient management system improved clinical outcomes.", "recommendations": "Future health systems research in similar contexts should adopt cluster-randomised designs and invest in hybrid data verification systems to ensure data integrity. Policymakers should consider scaling the evaluated management system.", "key words": "health systems research, cluster randomised trial, implementation science, primary health care, sub-Saharan Africa, methodological evaluation", "contribution statement": "This paper provides a novel methodological blueprint for conducting