Optimize Audit and feedbaCk To Implement eVidence-based prAcTices in Primary Health carE
NCT Number: NCT06480487
Acronym: ACTIVATE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension|Diabetes
Interventions: BEHAVIORAL: Feedback provided face to face|BEHAVIORAL: Feedback provided by electronic mail|BEHAVIORAL: Feedback provided by researchers|BEHAVIORAL: Feedback provided by authoritative bodies|BEHAVIORAL: Feedback provided with peer comparision|BEHAVIORAL: Feedback provided without peer comparision
Sponsor: Southern Medical University, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 344
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-09
Completion Date: 2025-03-31

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.

Primary Outcome Measures: 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 Outcome Measures: 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, This is a continuous score ranging from 0 to 100%. It will be assessed by USPs., An average of 1 month and 3 months|Correctness of diagnosis of hypertension cases and type II diabetes cases by PHC providers, This will be categorized into 3 categories: correct diagnosis, partially correct diagnosis, and incorrect diagnosis. It will be assessed by USPs., An average of 1 month and 3 months|Correctness of treatment of hypertension cases and type II diabetes cases by PHC providers, This will be categorized into 3 categories: correct treatment, partially correct treatment, and incorrect treatment. It will be assessed by USPs., An average of 1 month and 3 months|Timeliness of hypertension and type II diabetes services in primary healthcare settings., Timeliness of hypertension and type II diabetes will be assessed by USPs by using Quality of care assessment tools. Timeliness will be judged on the basis of opening hours, waiting time, and consultation time of the service., An average of 1 month and 3 months|Patient-centered quality of healthcare in primary healthcare settings., Patient-centered quality of healthcare will be assessed by USPs using Patient Perception of Patient-Centeredness (PPPC-R) questionnaire., An average of 1 month and 3 months|Acceptability of Audit and Feedback (AnF) intervention, Acceptability of AnF intervention will be judged on the basis of satisfaction with various aspects of AnF intervention. This includes content, complexity, comfort, delivery, and credibility. It will be assessed among the study stakeholders which are study participants, implementation science experts, and government officials who are health policymakers and health program implementers., An average of 3 months|Appropriateness of Audit and Feedback (AnF) intervention, It will be judged on the basis of organizational experience of appropriateness of implementing AnF intervention. It will be assessed among the study stakeholders which are study participants, implementation science experts and government officials who are health policy makers and health program implementers., An average of 3 months|Feasibility of implementing AnF intervention at primary healthcare level, Feasibility means the extent to which AnF intervention can be successfully carried out within the primary health facilities. It will be assessed among the study stakeholders which are study participants, implementation science experts, and government officials who are health policymakers and health program implementers., An average of 3 months|Cost of implementing an AnF intervention, This outcome measures the cost of implementing an AnF intervention in primary health facilities. It will be assessed by calculating the expenditure, time, and human resources utilized., An average of 3 months