Optimize Audit and feedbaCk To Implement eVidence-based prAcTices in Primary Health carE (ACTIVATE)

Optimize Audit and feedbaCk To Implement eVidence-based prAcTices in Primary Health carE in Nepal, Mozambique, Tanzania and China: a Factorial Trial (ACTIVATE Trial)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Diabetes
• Intervention / Treatment: Behavioral: Feedback provided face to face; Behavioral: Feedback provided by researchers; Behavioral: Feedback provided with peer comparision; Behavioral: Feedback provided by authoritative bodies; Behavioral: Feedback provided without peer comparision; Behavioral: Feedback provided by electronic mail

Detailed Description

Researchers and experts will have a consultation meeting to generate the top 7 AnF intervention components, and a BWS survey will be employed to rank these components according to their importance and further select 3 potentially most effective and feasible components for effectiveness validation through the factorial trial in the next step. The BWS survey is a screening experiment, based on random utility theory, in which a trade-off mechanism is triggered by participants choosing the best and worst of a set of components or options, thereby quantifying the relative importance of each component and distinguishing the most salient among a set of important components. The BWS questionnaire will be developed and tested using a mixed-method approach based on the previous research results to obtain healthcare workers' prioritized acceptance of the different AnF components (relative importance) when deciding to improve the quality of care (completion rates of guideline entries), in order to further identify potentially the most important few components out of the range of components.

The Balanced Incomplete Block Design (BIBD) is an experimental design used in BWS for improving results by organizing items into blocks and balancing the number of presentations of items across participants, which allows researchers to efficiently compare a set of items with each other. BIBD ensures equal number of times of occurrence for items in blocks and pairs items equally, reducing bias and increasing statistical precision of ratings. BIBD is especially valuable with a larger number of ranked items. The investigators will use BIBD in BWS in a typical way, by dividing items randomly into subsets (i.e. blocks) and assigning a questionnaire with all blocks to each participant, ensuring robust preference rankings. The investigators will use the %MktBSize macro in SAS 9.4 software to realize BIBD for questionnaire development. In our study, for the 7 AnF intervention components (treatments), the investigators will have 7 different blocks, each containing 3 AnF components (treatments). the investigators will invite participants to reflect on which AnF component of these 7 different blocks is most effective and which AnF component is least effective. The investigators will be giving 1 point when a component is chosen as most effective, and -1 when a component is chosen as least effective. Then, based on the standardized score of each component, the investigators will be finalizing the 3 most effective components from the BWS survey.

In the optimization phase, a 2×2×2 factorial design (RCT) will be conducted, with three two-level components making up a total of 8 groups of AnF intervention. After obtaining consents from primary healthcare facilities and workers, all facilities will be randomly assigned to these 8 intervention groups. Then the investigators measure changes in healthcare quality from various audits and feedback in these facilities, and use statistical analysis to estimate main and interaction effects for AnF components on improving primary healthcare quality. The optimal AnF combination will be determined by considering effects and resource constraints in local implementation settings.

The investigators assume that the following 3 AnF components with 2 levels each are selected from the BWS survey.

1. Source of Feedback:

   Level 1: Researchers Level 2: Authoritative Bodies

2. Feedback with Peer Comparison:

   Level 1: Yes (Peer Comparison) Level 2: No (No Peer Comparison)

3. Delivery Method of Feedback:

Level 1: Face to face Level 2: Electronic Mail

After deciding the 8 AnF intervention groups, the investigators will invite primary healthcare workers, policymakers, and health system administrators to discuss feasible and operable details to conduct the 8 AnF interventions at primary healthcare facilities in the four different LMICs. The audited results of quality of care of the facility will be fed back to the healthcare workers of the facility, and then the outcome indicators reflecting effectiveness of AnF will be measured.

• Study Type: Interventional
• Enrollment (Estimated): 344
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huanyuan Luo; Phone Number: +8618215827985; Email: huanyuanluo33@gmail.com
• Study Contact Backup: Name: Dong Xu; Phone Number: +8613910988979; Email: romanxu@i.smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• In Mozambique, the inclusion criteria are nurses, technicians of general medicine and doctors in public primary healthcare facilities.
• In Zanzibar, Tanzania, the inclusion criteria are clinical officers, nurses and doctors in public primary healthcare facilities.
• In Nepal, the inclusion criteria are doctors, health assistants, and senior auxiliary health workers in public primary healthcare facilities.
• In China, the inclusion criteria are doctors practicing in public primary healthcare facilities.

Exclusion Criteria:

-The exclusion criteria are endocrinologists or diabetes specialists, interns, or students working during the time of visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Face to face by researchers with peer comparision; Feedback will be provided face-to-face by the researchers by visiting health facilities. The feedback report will include peer comparison data.	Behavioral: Feedback provided face to face; Feedback will be provided face-to-face.; Behavioral: Feedback provided by researchers; Feedback will be provided by researchers.; Behavioral: Feedback provided with peer comparision; Feedback will be provided with peer comparison.
Experimental: Face to face by authoritative bodies with peer comparision; Feedback will be provided face-to-face by the authoritative bodies by visiting health facilities. The feedback report will include peer comparison data.	Behavioral: Feedback provided face to face; Feedback will be provided face-to-face.; Behavioral: Feedback provided with peer comparision; Feedback will be provided with peer comparison.; Behavioral: Feedback provided by authoritative bodies; Feedback will be provided by authoritative bodies.
Experimental: Face to face by researchers without peer comparision; Feedback will be provided face-to-face by the researchers by visiting health facilities. The feedback report will not include peer comparison data.	Behavioral: Feedback provided face to face; Feedback will be provided face-to-face.; Behavioral: Feedback provided by researchers; Feedback will be provided by researchers.; Behavioral: Feedback provided without peer comparision; Feedback will be provided without peer comparision.
Experimental: Electronic mail by researchers with peer comparision; Feedback will be provided through electronic mail by the researchers. The feedback report will include peer comparison data.	Behavioral: Feedback provided by researchers; Feedback will be provided by researchers.; Behavioral: Feedback provided with peer comparision; Feedback will be provided with peer comparison.; Behavioral: Feedback provided by electronic mail; Feedback will be provided by electronic mail.
Experimental: Face to face by authoritative bodies without peer comparision; Feedback will be provided face-to-face by the authoritative bodies by visiting health facilities. The feedback report will not include peer comparison data.	Behavioral: Feedback provided face to face; Feedback will be provided face-to-face.; Behavioral: Feedback provided by authoritative bodies; Feedback will be provided by authoritative bodies.; Behavioral: Feedback provided without peer comparision; Feedback will be provided without peer comparision.
Experimental: Electronic mail by authoritative bodies with peer comparision; Feedback will be provided through electronic mail by the authoritative bodies. The feedback report will include peer comparison data.	Behavioral: Feedback provided with peer comparision; Feedback will be provided with peer comparison.; Behavioral: Feedback provided by authoritative bodies; Feedback will be provided by authoritative bodies.; Behavioral: Feedback provided by electronic mail; Feedback will be provided by electronic mail.
Experimental: Electronic mail by researchers without peer comparision; Feedback will be provided through electronic mail by the researchers. The feedback report will not include peer comparison data.	Behavioral: Feedback provided by researchers; Feedback will be provided by researchers.; Behavioral: Feedback provided without peer comparision; Feedback will be provided without peer comparision.; Behavioral: Feedback provided by electronic mail; Feedback will be provided by electronic mail.
Experimental: Electronic mail by authoritative bodies without peer comparision; Feedback will be provided through electronic mail by the authoritative bodies. The feedback report will not include peer comparison data.	Behavioral: Feedback provided by authoritative bodies; Feedback will be provided by authoritative bodies.; Behavioral: Feedback provided without peer comparision; Feedback will be provided without peer comparision.; Behavioral: Feedback provided by electronic mail; Feedback will be provided by electronic mail.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
Implementation outcome: Adoption of Audit and Feedback (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.	An average of 3 months
Implementation outcome: Costs to researchers of developing and implementing Audit and Feedback (AnF) intervention	It is a continuous variable and will be assessed using project final account of expenditure	An average of 3 months
Implementation outcome: Participants score of acceptability of AnF intervention	It will be self-reported by participants using Generic Theoretical Framework of Acceptability (TFA)-based questionnaire.	An average of 3 months
Correctness of diagnosis of hypertension cases and type II diabetes cases by PHC providers	This will be categorized into 2 categories: 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 2 categories: correct treatment, and incorrect treatment. It will be assessed by USPs.	An average of 1 month and 3 months

Collaborators and Investigators

• Sponsor: Southern Medical University, China
• Investigators: Study Director: Dong Xu, Southern Medical Univerity

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Primary health care; Audit and feedback; Quality of care
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: ACTIVATE (Immune Tolerance Network)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No