UTI - Urinary Tract Infection Clinical Trial
— IMUNIFIOfficial title:
A Cluster Randomized Trial to Assess the Impact of Facilitated Implementation on Antibiotic Stewardship in Wisconsin Nursing Homes
| Verified date | December 2021 |
| Source | University of Wisconsin, Madison |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 338 |
| Est. completion date | November 24, 2021 |
| Est. primary completion date | November 24, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Wisconsin-Madison | Madison | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| University of Wisconsin, Madison |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Urine culture orders per 1,000 resident-days | Up to 12 months pre-implementation and up to 12 months post-implementation | ||
| Primary | Antibiotic starts for treatment of suspected UTI per 1,000 resident-days | Up to 12 months pre-implementation and up to 12 months post-implementation | ||
| Secondary | Days of therapy for treatment of suspected UTI per 1,000 resident-days | Up to 12 months pre-implementation and up to 12 months post-implementation | ||
| Secondary | Fluoroquinolone antibiotic starts and days of therapy per 1000 resident-days | Up to 12 months pre-implementation and up to 12 months post-implementation | ||
| Secondary | Percentage of antibiotic starts for UTI meeting appropriateness criteria | Up to 12 months pre-implementation and up to 12 months post-implementation | ||
| Secondary | Percentage of urine cultures meeting appropriateness criteria | Up to 12 months pre-implementation and up to 12 months post-implementation | ||
| Secondary | Percentage of urine cultures positive for resistant bacteria | Up to 12 months pre-implementation and up to 12 months post-implementation | ||
| Secondary | Number of positive clostridium difficile tests | Up to 12 months pre-implementation and up to 12 months post-implementation | ||
| Secondary | Number of transfers to hospitals or emergency departments per 1000 resident-days | Up to 12 months pre-implementation and up to 12 months post-implementation | ||
| Secondary | Number of resident deaths per 1000 resident-days | Up to 12 months pre-implementation and up to 12 months post-implementation |