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NCT Number: NCT07542587

Evaluating the Implementation Via Audit and Feedback

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

    Time frame: Through study completion, an average of 1 year

    This is a continuous score ranging from 0 to 100%

Secondary outcomes

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

    Time frame: Through study completion, an average of 1 year

    This will be categorized into 2 categories: correct and incorrect diagnosis

  2. Quality of care indicators: Correctness of treatment of hypertension and type II diabetes cases by PHC providers

    Time frame: Through study completion, an average of 1 year

    This will be categorized into 2 categories: correct and incorrect treatment

  3. 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

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

    Time frame: Through study completion, an average of 1 year

  5. Implementation outcome: Adoption of AnF intervention by study participants

    Time frame: Through study completion, an average of 1 year

    It is a dichotomous variable, consisting of two categories: adopted, not adopted. It will be self-reported by participants using team-developed questionnaire.

  6. Implementation outcome: Costs to researchers of developing and implementing AnF intervention

    Time frame: Through study completion, an average of 1 year

    It is a continuous variable and will be assessed using project final account of expenditure

  7. Implementation outcome: Participants score of acceptability of AnF intervention

    Time frame: Through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Southern Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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