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Trial record 71 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

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

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.


Condition or disease Intervention/treatment Phase
UTI - Urinary Tract Infection Behavioral: Externally-facilitated implementation Behavioral: Internally-driven implementation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Cluster Randomized Trial to Assess the Impact of Facilitated Implementation on Antibiotic Stewardship in Wisconsin Nursing Homes
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Internally-driven implementation 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.

Experimental: Externally-facilitated implementation 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.




Primary Outcome Measures :
  1. Urine culture orders per 1,000 resident-days [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]
  2. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. Percentage of antibiotic starts for UTI meeting appropriateness criteria [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]
  4. Percentage of urine cultures meeting appropriateness criteria [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]
  5. Percentage of urine cultures positive for resistant bacteria [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]
  6. Number of positive clostridium difficile tests [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]
  7. 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 ]
  8. Number of resident deaths per 1000 resident-days [ Time Frame: Up to 12 months pre-implementation and up to 12 months post-implementation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520010


Contacts
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Contact: Christopher J Crnich, MD, PhD (608)280-7055 cjc@medicine.wisc.edu
Contact: James Ford, PhD (608)262-4748 jhfordii@wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Christopher J Crnich, MD, PhD    608-280-7055    cjc@medicine.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Christopher J Crnich, MD, PhD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03520010     History of Changes
Other Study ID Numbers: 2018-0125
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents