Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480487
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-17
Brief Title:
Optimize Audit and feedbaCk To Implement eVidence-based prAcTices in Primary Health carE
Sponsor:
Southern Medical University China
Organization:
Southern Medical University China
Study Overview
Official Title:
Optimize Audit and feedbaCk To Implement eVidence-based prAcTices in Primary Health carE in Nepal Mozambique Tanzania and China a Factorial Trial ACTIVATE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTIVATE
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 222 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 ie 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
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 222 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 ie 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
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 ie blocks and assigning a questionnaire with all blocks to each participant ensuring robust preference rankings The investigators will use the MktBSize macro in SAS 94 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 222 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
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 ie blocks and assigning a questionnaire with all blocks to each participant ensuring robust preference rankings The investigators will use the MktBSize macro in SAS 94 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 222 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None