The ability of primary healthcare (PHC) providers 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 by identifying barriers to their implementation and developing strategies, such as audit and feedback (AnF), to overcome them. However, because the effects of AnF show significant heterogeneity across studies, this research focuses on systematically developing an optimized AnF strategy and rigorously evaluating its effectiveness in improving clinical practice compared to no intervention. The development of an optimized AnF strategy involves a preparation phase, which utilizes expert consultation and a Best-Worst Scaling (BWS) survey to identify key candidate components and assess resource constraints, followed by an optimization phase utilizing a 2×2×2×2 factorial design randomized controlled trial (RCT) to determine the most effective combination of AnF components. Subsequently, in the evaluation phase, a two-arm, multicentre RCT will be conducted across four nations (Nepal, Mozambique, Tanzania, and China). Primary healthcare providers (PHPs) will be 1:1 randomly assigned to either the optimized AnF intervention group or a no intervention control group based on randomly permuted blocks (sizes 2, 4, and 6), stratified by country. Care quality will be assessed using the gold standard method of Unannounced Standardized Patients (USPs). The primary outcome is the proportion of completed guideline-recommended quality checklist items for the consultation of hypertension and Type II diabetes cases among all items. This outcome will be expressed as a continuous score ranging from 0% to 100%. Furthermore, a mixed-methods research strategy will be employed to extract Context-Mechanism-Outcome (CMO) elements and construct a Causal Pathway Diagram (CPD). This study will provide a robust empirical foundation for using an optimized AnF strategy to improve the quality of primary healthcare in developing countries. By deconstructing "why, for whom, and under what circumstances" the intervention works through the CMO framework and CPD, this study will provide vital mechanistic evidence for the future scale-up of this model, contributing a comprehensive and universal research paradigm to the field of implementation science.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
324
The intervention is audit and feedback (AnF). An audit involves assessing professional performance against clinical guidelines. The results of this assessment are then systematically communicated back to the professionals in a structured manner.
Quality of care indicators: The proportion of completed guideline-recommended quality checklist items for physical and laboratory exams of hypertension and type II diabetes cases of the PHC providers among all of the items
This is a continuous score ranging from 0 to 100%
Time frame: Through study completion, an average of 1 year
Quality of care indicators: Correctness of diagnosis of hypertension and type II diabetes cases by PHC providers
This will be categorized into 2 categories: correct and incorrect diagnosis
Time frame: Through study completion, an average of 1 year
Quality of care indicators: Correctness of treatment of hypertension and type II diabetes cases by PHC providers
This will be categorized into 2 categories: correct and incorrect treatment
Time frame: Through study completion, an average of 1 year
Quality of care indicators: Timeliness of hypertension and type II diabetes services in PHC settings
Time frame: Through study completion, an average of 1 year
Quality of care indicators: Patient-centered quality of healthcare in PHC settings
Time frame: Through study completion, an average of 1 year
Implementation outcome: Adoption of AnF intervention by study participants
It is a dichotomous variable, consisting of two categories: adopted, not adopted. It will be self-reported by participants using team-developed questionnaire.
Time frame: Through study completion, an average of 1 year
Implementation outcome: Costs to researchers of developing and implementing AnF intervention
It is a continuous variable and will be assessed using project final account of expenditure
Time frame: Through study completion, an average of 1 year
Implementation outcome: Participants score of acceptability of AnF intervention
It will be self-reported by participants using Generic Theoretical Framework of Acceptability-based questionnaire, with items rated on a 0-5 scale and will be summarized as a mean acceptability score. The higher scores mean a better outcome.
Time frame: Through study completion, an average of 1 year
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