Clinical trial NCT03520010: Facilitated Implementation of Antibiotic Stewardship in Wisconsin Nursing Homes
Official title: A Cluster Randomized Trial to Assess the Impact of Facilitated Implementation on Antibiotic Stewardship in Wisconsin Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: UTI - Urinary Tract Infection
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Urine culture orders per 1,000 resident-days
timeFrame: Up to 12 months pre-implementation and up to 12 months post-implementation
measure: Antibiotic starts for treatment of suspected UTI per 1,000 resident-days
timeFrame: Up to 12 months pre-implementation and up to 12 months post-implementation
Secondary outcomes:
measure: Days of therapy for treatment of suspected UTI per 1,000 resident-days
timeFrame: Up to 12 months pre-implementation and up to 12 months post-implementation
measure: Fluoroquinolone antibiotic starts and days of therapy per 1000 resident-days
timeFrame: Up to 12 months pre-implementation and up to 12 months post-implementation
measure: Percentage of antibiotic starts for UTI meeting appropriateness criteria
timeFrame: Up to 12 months pre-implementation and up to 12 months post-implementation
measure: Percentage of urine cultures meeting appropriateness criteria
timeFrame: Up to 12 months pre-implementation and up to 12 months post-implementation
measure: Percentage of urine cultures positive for resistant bacteria
timeFrame: Up to 12 months pre-implementation and up to 12 months post-implementation
measure: Number of positive clostridium difficile tests
timeFrame: Up to 12 months pre-implementation and up to 12 months post-implementation
measure: Number of transfers to hospitals or emergency departments per 1000 resident-days
timeFrame: Up to 12 months pre-implementation and up to 12 months post-implementation
measure: Number of resident deaths per 1000 resident-days
timeFrame: Up to 12 months pre-implementation and up to 12 months post-implementation
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Christopher J Crnich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.