Facilitated Implementation of Antibiotic Stewardship in Wisconsin Nursing Homes
NCT ID: NCT03520010
Last Updated: 2021-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
338 participants
INTERVENTIONAL
2018-06-01
2021-11-24
Brief Summary
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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 1,000 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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Internally-driven implementation
Internally-driven implementation
Study NHs randomized to the control arm will participate in kickoff meetings introducing the different UTI toolkit components. The meeting will also cover topics on how to assemble a change team, how to use the different tools in the UTI toolkit, and how to track process and outcome measures to monitor progress. NHs assigned to the control arm will have access to a web-based data tracking tool that will allow them to trend a number of study outcomes (e.g., number of monthly urine cultures and UTI treatment events) in their facility over time. Instructions and educational tools will be made available as an online resource but otherwise NHs in the control arm will be expected to implement the Wisconsin UTI Improvement Toolkit using existing internal resources.
Externally-facilitated implementation
Externally-facilitated implementation
NHs randomized to the externally-facilitated arm will attend the same kickoff meetings and have access to the same online resources as the control arm but will also be assigned a clinical coach and will have the opportunity to participate in a series of hosted peer-to-peer learning opportunities. The clinical coach will meet regularly with NH staff to guide the facility through implementation of the Wisconsin UTI Improvement Toolkit.
Interventions
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Externally-facilitated implementation
NHs randomized to the externally-facilitated arm will attend the same kickoff meetings and have access to the same online resources as the control arm but will also be assigned a clinical coach and will have the opportunity to participate in a series of hosted peer-to-peer learning opportunities. The clinical coach will meet regularly with NH staff to guide the facility through implementation of the Wisconsin UTI Improvement Toolkit.
Internally-driven implementation
Study NHs randomized to the control arm will participate in kickoff meetings introducing the different UTI toolkit components. The meeting will also cover topics on how to assemble a change team, how to use the different tools in the UTI toolkit, and how to track process and outcome measures to monitor progress. NHs assigned to the control arm will have access to a web-based data tracking tool that will allow them to trend a number of study outcomes (e.g., number of monthly urine cultures and UTI treatment events) in their facility over time. Instructions and educational tools will be made available as an online resource but otherwise NHs in the control arm will be expected to implement the Wisconsin UTI Improvement Toolkit using existing internal resources.
Eligibility Criteria
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Inclusion Criteria
* Long-term care and skilled nursing beds \> 50 beds
* The management of the facility agrees to random allocation to control or intervention group
* The facility is able to submit 3 sequential months of data on facility urine culture and antibiotic treatment rates via the study web portal
For the interviews and observations, all facility-employed and per diem nursing staff (certified nursing assistants \[CNA\], licensed practical nurses \[LPN\] and registered nurses \[RN\]) who are responsible for the care of \>3 residents will be included in the study. For the questionnaires, all nursing home clinical care staff will be invited to participate.
Exclusion Criteria
* Specialty care (ventilator or strict rehabilitation) wards
Criteria for Nursing Home staff (for interviews and observations, sample size 400)
For the interviews and observations, nursing home staff responsible for the care of at most 3 residents.
18 Years
ALL
Yes
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Christopher J Crnich, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin-Madison
Madison, Wisconsin, United States
Countries
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References
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Ford JH 2nd, Nora AT, Crnich CJ. Moving behavioral interventions in nursing homes from planning to action: a work system evaluation of a urinary tract infection toolkit implementation. Implement Sci Commun. 2023 Dec 12;4(1):156. doi: 10.1186/s43058-023-00535-y.
Ford JH 2nd, Vranas L, Coughlin D, Selle KM, Nordman-Oliveira S, Ryther B, Ewers T, Griffin VL, Eslinger A, Boero J, Hardgrove P, Crnich CJ. Effect of a Standard vs Enhanced Implementation Strategy to Improve Antibiotic Prescribing in Nursing Homes: A Trial Protocol of the Improving Management of Urinary Tract Infections in Nursing Institutions Through Facilitated Implementation (IMUNIFI) Study. JAMA Netw Open. 2019 Sep 4;2(9):e199526. doi: 10.1001/jamanetworkopen.2019.9526.
Other Identifiers
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A534265
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/MEDICINE/MEDICINE*I
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 6/16/2020
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0125
Identifier Type: -
Identifier Source: org_study_id