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Facilitated Implementation of Antibiotic Stewardship in Wisconsin Nursing Homes (IMUNIFI)

Primary Purpose

UTI - Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Externally-facilitated implementation
Internally-driven implementation
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for UTI - Urinary Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Criteria for Nursing Homes (Sample size 20)

Inclusion Criteria:

  • Medicare and Medicaid (dually) certified nursing homes
  • 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

Exclusion Criteria:

  • Assisted living facility wards
  • Specialty care (ventilator or strict rehabilitation) wards

Criteria for Nursing Home staff (for interviews and observations, sample size 400)

Inclusion Criteria:

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:

For the interviews and observations, nursing home staff responsible for the care of at most 3 residents.

Sites / Locations

  • University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Internally-driven implementation

Externally-facilitated implementation

Arm Description

Outcomes

Primary Outcome Measures

Urine culture orders per 1,000 resident-days
Antibiotic starts for treatment of suspected UTI per 1,000 resident-days

Secondary Outcome Measures

Days of therapy for treatment of suspected UTI per 1,000 resident-days
Fluoroquinolone antibiotic starts and days of therapy per 1000 resident-days
Percentage of antibiotic starts for UTI meeting appropriateness criteria
Percentage of urine cultures meeting appropriateness criteria
Percentage of urine cultures positive for resistant bacteria
Number of positive clostridium difficile tests
Number of transfers to hospitals or emergency departments per 1000 resident-days
Number of resident deaths per 1000 resident-days

Full Information

First Posted
April 26, 2018
Last Updated
December 22, 2021
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03520010
Brief Title
Facilitated Implementation of Antibiotic Stewardship in Wisconsin Nursing Homes
Acronym
IMUNIFI
Official Title
A Cluster Randomized Trial to Assess the Impact of Facilitated Implementation on Antibiotic Stewardship in Wisconsin Nursing Homes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 24, 2021 (Actual)
Study Completion Date
November 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
UTI - Urinary Tract Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internally-driven implementation
Arm Type
Active Comparator
Arm Title
Externally-facilitated implementation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Externally-facilitated implementation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internally-driven implementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urine culture orders per 1,000 resident-days
Time Frame
Up to 12 months pre-implementation and up to 12 months post-implementation
Title
Antibiotic starts for treatment of suspected UTI per 1,000 resident-days
Time Frame
Up to 12 months pre-implementation and up to 12 months post-implementation
Secondary Outcome Measure Information:
Title
Days of therapy for treatment of suspected UTI per 1,000 resident-days
Time Frame
Up to 12 months pre-implementation and up to 12 months post-implementation
Title
Fluoroquinolone antibiotic starts and days of therapy per 1000 resident-days
Time Frame
Up to 12 months pre-implementation and up to 12 months post-implementation
Title
Percentage of antibiotic starts for UTI meeting appropriateness criteria
Time Frame
Up to 12 months pre-implementation and up to 12 months post-implementation
Title
Percentage of urine cultures meeting appropriateness criteria
Time Frame
Up to 12 months pre-implementation and up to 12 months post-implementation
Title
Percentage of urine cultures positive for resistant bacteria
Time Frame
Up to 12 months pre-implementation and up to 12 months post-implementation
Title
Number of positive clostridium difficile tests
Time Frame
Up to 12 months pre-implementation and up to 12 months post-implementation
Title
Number of transfers to hospitals or emergency departments per 1000 resident-days
Time Frame
Up to 12 months pre-implementation and up to 12 months post-implementation
Title
Number of resident deaths per 1000 resident-days
Time Frame
Up to 12 months pre-implementation and up to 12 months post-implementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Criteria for Nursing Homes (Sample size 20) Inclusion Criteria: Medicare and Medicaid (dually) certified nursing homes 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 Exclusion Criteria: Assisted living facility wards Specialty care (ventilator or strict rehabilitation) wards Criteria for Nursing Home staff (for interviews and observations, sample size 400) Inclusion Criteria: 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: For the interviews and observations, nursing home staff responsible for the care of at most 3 residents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Crnich, MD, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31509204
Citation
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.
Results Reference
derived

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Facilitated Implementation of Antibiotic Stewardship in Wisconsin Nursing Homes

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