NCT03520010: IMUNIFI

Facilitated Implementation of Antibiotic Stewardship in Wisconsin Nursing Homes

Completed NA Last updated 23 December 2021

What this trial tests

NA trial testing Externally-facilitated implementation in UTI - Urinary Tract Infection in 338 participants. Completed in 24 November 2021.

Timeline

1 June 2018

Primary endpoint
24 November 2021

24 November 2021

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	338
Start date	1 June 2018
Primary completion	24 November 2021
Estimated completion	24 November 2021
Sites	1 location across United States

Drugs / interventions tested

• Externally-facilitated implementation
• Internally-driven implementation

Conditions studied

• UTI - Urinary Tract Infection — all drugs for UTI - Urinary Tract Infection →

Sponsor

University of Wisconsin, Madison

Who can join

18 and older, any sex, with UTI - Urinary Tract Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Ford JH, Vranas L, Coughlin D, Selle KM, et al · · 2019 · cited 7× · PMID 31509204 · DOI 10.1001/jamanetworkopen.2019.9526
2. Moving behavioral interventions in nursing homes from planning to action: a work system evaluation of a urinary tract infection toolkit implementation.
   Ford JH, Nora AT, Crnich CJ. · · 2023 · cited 1× · PMID 38087393 · DOI 10.1186/s43058-023-00535-y