Evaluating the Implementation Via Audit and Feedback
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Optimised AnF intervention package.
- Who it may be relevant to
- Registry conditions: Hypertension, Diabetes. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
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.
Primary outcome measures
- 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]
Secondary outcome measures (7)
- 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]
- 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]
- 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 [Time frame: Through study completion, an average of 1 year]
- Implementation outcome: Costs to researchers of developing and implementing AnF intervention [Time frame: Through study completion, an average of 1 year]
- Implementation outcome: Participants score of acceptability of AnF intervention [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07542587 · 72404118