Ignite Creation Date:
2024-05-06 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03520010
Status:
COMPLETED
Last Update Posted:
2021-12-23
First Post:
2018-04-26
Brief Title:
Facilitated Implementation of Antibiotic Stewardship in Wisconsin Nursing Homes
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
A Cluster Randomized Trial to Assess the Impact of Facilitated Implementation on Antibiotic Stewardship in Wisconsin Nursing Homes
Status:
COMPLETED
Status Verified Date:
2021-12
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:
IMUNIFI
Brief Summary:
The Wisconsin Healthcare-Associated Infections in Long-Term Care Coalition has developed a toolkit of evidence-based best practices to improve the management of urinary tract infection UTI in Wisconsin nursing homes NHs The theory and evidence supporting the individual improvement strategies promoted in the Wisconsin UTI Improvement Toolkit are strong but their combined impact on antibiotic prescribing in Wisconsin NHs is not known Moreover many Wisconsin NHs lack the internal resources and expertise to successfully implement and sustain the change interventions recommended in the toolkit Consequently there is a critical need to identify effective strategies to support implementation of best practices in this setting The investigators hypothesize that an externally-facilitated implementation based on coaching and peer-to-peer learning will result in superior toolkit adoption and reduced rates of antibiotic utilization compared to a standard implementation
To test these two hypotheses the investigators are proposing a hybrid type 2 effectiveness-implementation randomized clinical trial in 20 Wisconsin NHs Facilities randomized to the standard implementation approach will participate in a kickoff meeting and have access to a variety of online implementation resources Facilities randomized to the enhanced implementation approach will have access to the same resources but will also be assigned a clinical coach and be invited to participate in ongoing collaborative learning sessions The clinical coach will meet regularly with NH staff to guide the facility through implementation of the toolkit including assembling a change team performing an assessment to identify baseline barriers and facilitators of change and ongoing integration of the toolkit practices into existing workflows The learning collaborative will bring NH participants together to share change and improvement strategies with each other UTI prescriptions per 1000 resident-days in the study arms will be compared using generalized linear mixed models A mixed methods evaluation structured around the REAIM framework Reach Effectiveness Adoption Implementation and Maintenance will be employed to assess differences in toolkit implementation among facilities in both arms of the study
To test these two hypotheses the investigators are proposing a hybrid type 2 effectiveness-implementation randomized clinical trial in 20 Wisconsin NHs Facilities randomized to the standard implementation approach will participate in a kickoff meeting and have access to a variety of online implementation resources Facilities randomized to the enhanced implementation approach will have access to the same resources but will also be assigned a clinical coach and be invited to participate in ongoing collaborative learning sessions The clinical coach will meet regularly with NH staff to guide the facility through implementation of the toolkit including assembling a change team performing an assessment to identify baseline barriers and facilitators of change and ongoing integration of the toolkit practices into existing workflows The learning collaborative will bring NH participants together to share change and improvement strategies with each other UTI prescriptions per 1000 resident-days in the study arms will be compared using generalized linear mixed models A mixed methods evaluation structured around the REAIM framework Reach Effectiveness Adoption Implementation and Maintenance will be employed to assess differences in toolkit implementation among facilities in both arms of the study
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A534265 | OTHER | None | None |
| SMPHMEDICINEMEDICINEI | OTHER | None | None |
| Protocol Version 6162020 | OTHER | UW Madison | None |