NCT05664451

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

3 years

First QC Date

November 7, 2022

Last Update Submit

June 13, 2025

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Differences in Screening Rates for Urinary Incontinence

    Defined as the rate of eligible patients screened for urinary incontinence (UI) at preventive visits. Data on UI screening and patient eligibility will be ascertained through responses to a short post-visit patient survey. Patients will be asked five questions to determine if their healthcare team screened for and, if necessary, provided them with treatment options for UI. Preventive visits include visits classified as: a preventive visit, a physical exam, or a Medicare annual wellness visit.

    3 months, 10 months

Secondary Outcomes (18)

  • Differences in scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health

    10 months, 13 months

  • Differences in bowel leakage symptoms

    10 months, 13 months

  • Differences in scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Constipation

    10 months, 13 months

  • Self-reported changes: changes in usage of urinary incontinence coping strategies

    10 months, 13 months

  • Self-reported changes: change in money-spent on incontinence treatments

    10 months, 13 months

  • +13 more secondary outcomes

Study Arms (2)

Streamlined Practice Facilitation (SPF) implementation of UI-Assist

ACTIVE COMPARATOR

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.

Behavioral: UI-Assist

Streamlined Practice Facilitation (SPF) + Partnership Building (PB) implementation of UI-Assist

EXPERIMENTAL

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.

Behavioral: UI-AssistOther: Partnership Building

Interventions

UI-AssistBEHAVIORAL

To support primary care in implementing guideline-based care, it is helpful to distill interventions to their key components, such as the five major intervention steps for tobacco use and dependence (the "5 A's"). The 5 A's (Ask, Advise, Assess, Assist, Arrange) has been shown to help primary care providers implement clinical practice guidelines with minimal additional burden. The 5 A's can be similarly simplified for urinary incontinence (UI) screening and treatment to Ask (screen for UI); Advise (inform that effective nonsurgical treatments exist); and Assist (help patient get treatment with pharmacotherapy, referral to community classes, physiotherapy or urology / urogynecology).

Streamlined Practice Facilitation (SPF) + Partnership Building (PB) implementation of UI-AssistStreamlined Practice Facilitation (SPF) implementation of UI-Assist
Partnership BuildingOTHER

In addition to the strategies described above, those practices allocated to streamlined practice facilitation and partnership building will have facilitation and configurable solutions that engage community resources and enable coalition building. In addition to a 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. After initiating academic detailing, these practices will have further access to Drs. Brown and Neuner for ongoing consultation. An online learning community will also be created where information can be shared and exchanged throughout the duration of the project and beyond the maintenance phase.

Streamlined Practice Facilitation (SPF) + Partnership Building (PB) implementation of UI-Assist

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients are eligible to participate in this study if they were assigned female at birth.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be 18 years or older and be assigned female at birth
  • Practices must have and be willing to provide key data from electronic health records
  • Practices willing to participate in partnership building activities (randomly allocated)
  • Practices willing to work with a practice facilitator to implement UI-Assist in their practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaiser Permanente

San Diego, California, 92110, United States

Location

MetaStar, Inc.

Madison, Wisconsin, 53713, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Patel UJ, Moureau MK, Neuner JM, Brown HW. Screening and Treating Urinary Incontinence in Primary Care: A Missed Opportunity. OBM Geriat. 2023;7(4):252. doi: 10.21926/obm.geriatr.2304252. Epub 2023 Oct 5.

    PMID: 38567050BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joan Neuner, MD, MPH

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 7, 2022

First Posted

December 23, 2022

Study Start

May 1, 2022

Primary Completion

April 25, 2025

Study Completion

April 1, 2026

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)