Evaluating the Implementation Via Audit and Feedback

NCT07542587 | Not Yet Recruiting

• 1 other identifier: 72404118
• Study Type: interventional
• Target: 324
• Locations: 0 countries
• Sites: N/A

Brief 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

Hypertension; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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%

  Through study completion, an average of 1 year

Secondary Outcomes (7)

• Quality of care indicators: Correctness of diagnosis of hypertension and type II diabetes cases by PHC providers

  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

  Through study completion, an average of 1 year

• Quality of care indicators: Timeliness of hypertension and type II diabetes services in PHC settings

  Through study completion, an average of 1 year

• Quality of care indicators: Patient-centered quality of healthcare in PHC settings

  Through study completion, an average of 1 year

• Implementation outcome: Adoption of AnF intervention by study participants

  Through study completion, an average of 1 year

Study Arms (2)

Control group

NO INTERVENTION

Optimised AnF intervention package

EXPERIMENTAL

Behavioral: Optimised AnF intervention package

Interventions

Optimised AnF intervention package BEHAVIORAL

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.

Optimised AnF intervention package

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Southern Medical University, China: lead

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research fellow

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04