Optimizing Audit and feedbaCk To Implement eVidence-based prAcTices in primary health carE in Nepal, Mozambique, Tanzania and China (ACTIVATE trial): rationale and design of a factorial randomized trial

BackgroundThe ability of primary health workers (PHWs) to practice in accordance with evidence-based guidelines and norms is a critical component of improving the quality of primary healthcare. Implementation science seeks to promote the routine use of evidence-based practices in healthcare by identifying barriers and facilitators to their implementation, and by developing strategies such as audit and feedback (AnF) to overcome these barriers. However, the effects of AnF show significant heterogeneity across studies, so this research focuses on the validity of AnF components and the optimal combinations of these components through head-to-head comparisons. MethodsDuring the preparation phase, we will conduct a preliminary exploration to optimize AnF intervention aimed at improving the quality of primary healthcare. This will involve identifying key candidate components and levels of the AnF intervention, understanding the mechanisms of action, and assessing the resource constraints associated with implementing AnF in primary healthcare (PHC) facilities. This will be achieved through expert consultation and a Best-Worst Scaling (BWS) questionnaire survey. In the optimization phase, we will use the gold standard method of Unannounced Standardized Patients (USP) to assess the quality of primary healthcare for diabetes and hypertension, focusing on the accuracy and standardization of consultation, examination, diagnosis, and treatment procedures in comparison to evidence-based practices, across Nepal, Mozambique, Tanzania, and China. A factorial design randomized controlled trial will be conducted to determine how feedback on care quality can be delivered to PHWs in order to optimize its impact on healthcare quality improvement. To achieve this, the factorial trial will incorporate four key AnF components, each at two levels, resulting in a total of sixteen intervention groups. PHWs will be randomly assigned to these groups. DiscussionThis study will provide an empirical foundation for using AnF to improve the quality of primary healthcare in developing countries, while also enhancing and complementing the existing AnF theory. This study focuses on the optimization of the important implementation strategy of AnF in implementation science, contributing a universal research paradigm to the field. Trial registrationClinicalTrials.gov, NCT06480487. Registered 27 December 2024, https://clinicaltrials.gov/study/NCT06480487.