Evaluating the Implementation Via Audit and Feedback

Evaluating the Implementation of Clinical Competency for Hypertension and Diabetes in Primary Care Via Audit and Feedback: a Multicentre, Randomized Implementation Trial Across Four Nations

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 Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Diabetes
• Intervention / Treatment: Behavioral: Optimised AnF intervention package

• Study Type: Interventional
• Enrollment (Estimated): 324
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• In Mozambique, the inclusion criteria are nurses, general medicine technicians, and physicians in PHC facilities.
• In Zanzibar, Tanzania, the inclusion criteria are clinical officers, nurses, and other healthcare providers involved in consultation, examination, diagnosis, and treatment in PHC facilities.
• In Nepal, the inclusion criteria are medical officers, health assistants, and senior auxiliary health workers in PHC facilities.
• In China, the inclusion criteria of PHC facilities are primary and secondary hospitals, community health centers (stations) and clinics, as well as township health centers and village health clinics; and the inclusion criteria of research participants are practicing (assistant) physicians and rural physicians working in healthcare facilities that meet the above criteria, with a scope of practice only including general practice and internal medicine.

Exclusion Criteria:

• In Mozambique, the exclusion criteria are healthcare providers from other departments, such as tuberculosis, malaria, human immunodeficiency virus/acquired immune deficiency syndrome, or emergency services, as well as students currently on internship.
• In Nepal, the exclusion criteria are interns or students present during the visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Optimised AnF intervention package	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	It is a dichotomous variable, consisting of two categories: adopted, not adopted. It will be self-reported by participants using team-developed questionnaire.	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	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.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 11, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus
• Other Study ID Numbers: 72404118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No