Optimize Audit and feedbaCk To Implement eVidence-based prAcTices in Primary Health carE
ACTIVATE
1 other identifier
interventional
344
0 countries
N/A
Brief Summary
The investigators will use two phases of Multiphase Optimization Strategy (MOST) - preparation and optimization phases. In the preparation phase, Audit and Feedback (AnF) intervention will be prepared. First, the investigators will use scoping review to develop conceptual frameworks for AnF components. The outcome indicators and resource constraints for intervention will be identified based on the literature reviews. Second, an expert consultation meeting will be conducted to develop a set of candidate components for the AnF intervention. Around 10 relevant scholars and primary healthcare workers will be invited to rank the components that researchers conclude from the literature. The top 7 ranked components will be assessed by Best-Worst Scaling (BWS) questionnaires to finally identify 3 key components for AnF intervention. In the optimization phase, the investigators will identify AnF intervention that will lead to the best desired results within key resource constraints in terms of effectiveness , efficiency, economy and scalability. First, the investigators will realistically and comprehensively assess the quality of care provided by primary healthcare facilities of the four Low and Middle Income countries (LMICs) using USP. Second, a 2×2×2 factorial design (RCT) will be conducted to determine how the results of quality of care can be fed back to primary healthcare workers in the four LMICs in order to optimize the impact of improving healthcare quality. To achieve this goal, the factorial trial will involve the 3 identified key AnF components at 2 levels each, for a total of 8 intervention groups (i.e. 8 different ways to conduct audit and feedback). By randomly assigning healthcare facilities to one of these 8 different ways to conduct audit and feedback, the investigators can obtain the change in the quality of care after implementing audit and feedback interventions in these facilities. Then, through statistical analysis, the investigators can estimate main and interaction effects for AnF components on improving the quality of primary health care. After that, the optimal combination of AnF components will be determined by trade off of the effects of AnF components and resource constraints in local primary healthcare implementation settings. Study details are as follows.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started May 2025
Shorter than P25 for not_applicable hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
June 28, 2024
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedApril 27, 2025
April 1, 2025
5 months
June 17, 2024
April 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of completed guideline-recommended quality checklist items for consultation of hypertension cases and Type II diabetes cases of the primary healthcare (PHC) providers among all of the items
The primary outcome is a continuous score ranging from 0 to 100%. It will be assessed by Unannounced Standardized Patients (USPs).
An average of 1 month and 3 months
Secondary Outcomes (8)
The proportion of completed guideline-recommended quality checklist items for physical and laboratory exams of hypertension cases and Type II diabetes cases of the PHC providers among all of the items
An average of 1 month and 3 months
Correctness of diagnosis of hypertension cases and type II diabetes cases by PHC providers
An average of 1 month and 3 months
Correctness of treatment of hypertension cases and type II diabetes cases by PHC providers
An average of 1 month and 3 months
Timeliness of hypertension and type II diabetes services in primary healthcare settings.
An average of 1 month and 3 months
Patient-centered quality of healthcare in primary healthcare settings.
An average of 1 month and 3 months
- +3 more secondary outcomes
Study Arms (8)
Face to face by researchers with peer comparision
EXPERIMENTALFeedback will be provided face-to-face by the researchers by visiting health facilities. The feedback report will include peer comparison data.
Face to face by authoritative bodies with peer comparision
EXPERIMENTALFeedback will be provided face-to-face by the authoritative bodies by visiting health facilities. The feedback report will include peer comparison data.
Face to face by researchers without peer comparision
EXPERIMENTALFeedback will be provided face-to-face by the researchers by visiting health facilities. The feedback report will not include peer comparison data.
Electronic mail by researchers with peer comparision
EXPERIMENTALFeedback will be provided through electronic mail by the researchers. The feedback report will include peer comparison data.
Face to face by authoritative bodies without peer comparision
EXPERIMENTALFeedback will be provided face-to-face by the authoritative bodies by visiting health facilities. The feedback report will not include peer comparison data.
Electronic mail by authoritative bodies with peer comparision
EXPERIMENTALFeedback will be provided through electronic mail by the authoritative bodies. The feedback report will include peer comparison data.
Electronic mail by researchers without peer comparision
EXPERIMENTALFeedback will be provided through electronic mail by the researchers. The feedback report will not include peer comparison data.
Electronic mail by authoritative bodies without peer comparision
EXPERIMENTALFeedback will be provided through electronic mail by the authoritative bodies. The feedback report will not include peer comparison data.
Interventions
Feedback will be provided face-to-face.
Feedback will be provided by electronic mail.
Feedback will be provided by researchers.
Feedback will be provided by authoritative bodies.
Feedback will be provided with peer comparison.
Feedback will be provided without peer comparision.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dong Xu
Southern Medical Univerity
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The data analysis will be done by a team and those team members will be masked on the intervention provided.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Post Doctoral Researcher
Study Record Dates
First Submitted
June 17, 2024
First Posted
June 28, 2024
Study Start
May 1, 2025
Primary Completion
September 30, 2025
Study Completion
October 31, 2025
Last Updated
April 27, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share