Community Support for Primary Care for Urinary Incontinence

(WI-INTUIT Trial)

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This project seeks to determine whether primary care practices that receive supplemental partnership building implement UI-Assist with higher fidelity than practices that receive streamlined practice facilitation alone.

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 data supports the effectiveness of the treatment Partnership Building, UI-Assist for urinary incontinence?

Research shows that app-based treatments for urinary incontinence can be effective over a year, and nurse-led continence care interventions have improved outcomes for patients with urinary symptoms. These findings suggest that community support and structured interventions, like Partnership Building, UI-Assist, may also be beneficial. ^{1 2 3 4 5}

How is the UI-Assist treatment for urinary incontinence different from other treatments?

UI-Assist is unique because it involves community support and possibly the involvement of nurse specialists in primary care, which can improve the management of urinary incontinence compared to standard care. This approach may offer more personalized and effective support for patients. ^{1 2 6 7 8}

Research Team

Joan Neuner, MD, MPH

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Experiences and attitudes of nurse specialists in primary care regarding their role in care for patients with urinary incontinence. [2018]

2. England pubmed.ncbi.nlm.nih.gov

One year effectiveness of an app-based treatment for urinary incontinence in comparison to care as usual in Dutch general practice: A pragmatic randomised controlled trial over 12 months. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The role of general practitioners in the initial management of women with urinary incontinence in France, Germany, Spain and the UK. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Effectiveness of Nurse-Led Continence Care Treatments for Chinese Primary Care Patients with Lower Urinary Tract Symptoms. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The effects of implementation of the Agency for Health Care Policy and Research urinary incontinence guidelines in primary care practices. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Treatment of urinary incontinence in women in general practice: observational study. [2019]

7. India pubmed.ncbi.nlm.nih.gov

Effectiveness of involving a nurse specialist for patients with urinary incontinence in primary care: results of a pragmatic multicentre randomised controlled trial. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Adult female urinary incontinence guidelines: a systematic review of evaluation guidelines across clinical specialties. [2021]