MedTrace Logo

Evaluating the Implementation Via Audit and Feedback

NCT07542587 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2026-04-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Optimised AnF intervention package

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.

Sponsors & Collaborators

  • Southern Medical University, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-08-31
Completion
2027-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542587 on ClinicalTrials.gov