UTI - Urinary Tract InfectionIMUNIFINCT03520010
Facilitated Implementation of Antibiotic Stewardship in Wisconsin Nursing Homes
A study testing Externally-facilitated implementation and Internally-driven implementation in people with UTI - Urinary Tract Infection, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- UTI - Urinary Tract Infection
- What is being tested?
- Externally-facilitated implementation and Internally-driven implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 24 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- Assisted living facility wards
- Specialty care (ventilator or strict rehabilitation) wards
- Criteria for Nursing Home staff (for interviews and observations, sample size 400)
- For the interviews and observations, nursing home staff responsible for the care of at most 3 residents.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53705
About this study
Official title: A Cluster Randomized Trial to Assess the Impact of Facilitated Implementation on Antibiotic Stewardship in Wisconsin Nursing Homes
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.
- Conditions
- UTI - Urinary Tract Infection
- Being tested
- Externally-facilitated implementation, Internally-driven implementation
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Externally-facilitated implementationBehavioural
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.
Internally-driven implementationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Internally-driven implementation | Active comparator | Not described Receives: Behavioral: Internally-driven implementation |
| Externally-facilitated implementation | Experimental | Not described Receives: Behavioral: Externally-facilitated implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine culture orders per 1,000 resident-days
Measured: 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
Measured: Up to 12 months pre-implementation and up to 12 months post-implementation
Secondary outcomes (8)
Days of therapy for treatment of suspected UTI per 1,000 resident-days
Measured: Up to 12 months pre-implementation and up to 12 months post-implementation
Fluoroquinolone antibiotic starts and days of therapy per 1000 resident-days
Measured: Up to 12 months pre-implementation and up to 12 months post-implementation
Percentage of antibiotic starts for UTI meeting appropriateness criteria
Measured: Up to 12 months pre-implementation and up to 12 months post-implementation
Percentage of urine cultures meeting appropriateness criteria
Measured: Up to 12 months pre-implementation and up to 12 months post-implementation
Percentage of urine cultures positive for resistant bacteria
Measured: Up to 12 months pre-implementation and up to 12 months post-implementation
Number of positive clostridium difficile tests
Measured: 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
Measured: Up to 12 months pre-implementation and up to 12 months post-implementation
Number of resident deaths per 1000 resident-days
Measured: Up to 12 months pre-implementation and up to 12 months post-implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start1 Jun 2018
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UTI - Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher J Crnich, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520010
- Sponsor's protocol ID
- 2018-0125
- Other IDs
- A534265, SMPH/MEDICINE/MEDICINE*I, Protocol Version 6/16/2020
- Acronym
- IMUNIFI
- Status last verified
- Dec 2021
- First submitted
- 26 Apr 2018
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ford JH 2nd, Nora AT, Crnich CJ. Moving behavioral interventions in nursing homes from planning to action: a work system evaluation of a urinary tract infection toolkit implementation. Implement Sci Commun. 2023 Dec 12;4(1):156. doi: 10.1186/s43058-023-00535-y.
PubMed 38087393Ford 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.
PubMed 31509204
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial to Assess the Impact of Facilitated Implementation on Antibiotic Stewardship in Wisconsin Nursing Homes
- ClinicalTrials.gov ID
- NCT03520010
- Acronym / sponsor ID
- IMUNIFI / 2018-0125
- Conditions
- UTI - Urinary Tract Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internally-driven implementation | Active comparator | Behavioral: Internally-driven implementation |
| Externally-facilitated implementation | Experimental | Behavioral: Externally-facilitated implementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 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.
Key exclusion criteria (4 listed)
- Assisted living facility wards
- Specialty care (ventilator or strict rehabilitation) wards
- Criteria for Nursing Home staff (for interviews and observations, sample size 400)
- For the interviews and observations, nursing home staff responsible for the care of at most 3 residents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Externally-facilitated implementationNHs 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. | Behavioural | Externally-facilitated implementation |
| Internally-driven implementationStudy 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. | Behavioural | Internally-driven implementation |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Derived from this study: PubMed 38087393Ford JH 2nd, Nora AT, Crnich CJ. Moving behavioral interventions in nursing homes from planning to action: a work system evaluation of a urinary tract infection toolkit implementation. Implement Sci Commun. 2023 Dec 12;4(1):156. doi: 10.1186/s43058-023-00535-y.
- Derived from this study: PubMed 31509204Ford 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Crnich, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Externally-facilitated implementation and Internally-driven implementation in people with UTI - Urinary Tract Infection, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine culture orders per 1,000 resident-days (time frame: Up to 12 months pre-implementation and up to 12 months post-implementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03520010, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.