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

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ClinicalTrials.gov Identifier: NCT03520010
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE April 26, 2018
First Posted Date  ICMJE May 9, 2018
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • Urine culture orders per 1,000 resident-days [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03520010 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • 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 ]
  • 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 ]
  • Percentage of antibiotic starts for UTI meeting appropriateness criteria [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]
  • Percentage of urine cultures meeting appropriateness criteria [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]
  • Percentage of urine cultures positive for resistant bacteria [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]
  • Number of positive clostridium difficile tests [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]
  • 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 ]
  • Number of resident deaths per 1000 resident-days [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Facilitated Implementation of Antibiotic Stewardship in Wisconsin Nursing Homes
Official Title  ICMJE A Cluster Randomized Trial to Assess the Impact of Facilitated Implementation on Antibiotic Stewardship in Wisconsin Nursing Homes
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE UTI - Urinary Tract Infection
Intervention  ICMJE
  • Behavioral: 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Active Comparator: Internally-driven implementation
    Intervention: Behavioral: Internally-driven implementation
  • Experimental: Externally-facilitated implementation
    Intervention: Behavioral: Externally-facilitated implementation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2018)
420
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Christopher J Crnich, MD, PhD (608)280-7055 cjc@medicine.wisc.edu
Contact: James Ford, PhD (608)262-4748 jhfordii@wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03520010
Other Study ID Numbers  ICMJE 2018-0125
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher J Crnich, MD, PhD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP