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Clinical Trials/NCT05664451
NCT05664451
Active, not recruiting
Not Applicable

Improving Nonsurgical Treatment of Urinary Incontinence Among Women in Primary Care in Wisconsin: Bridging Community-based Continence Promotion and Primary Care

Medical College of Wisconsin3 sites in 1 country40 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
Medical College of Wisconsin
Enrollment
40
Locations
3
Primary Endpoint
Differences in Screening Rates for Urinary Incontinence
Status
Active, not recruiting
Last Updated
10 months ago

Overview

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.

Detailed Description

This quality improvement research project is one of five across the country funded by the Agency for Healthcare Research and Quality (AHRQ) through the EvidenceNOW Managing Urinary Incontinence initiative titled: "Improving Nonsurgical Treatment of Urinary Incontinence among women in Primary Care." The purpose of this national initiative is to identify implementation strategies that best support primary care practices in delivering high quality care for urinary incontinence. Components of high-quality care including screening, diagnosing, and offering non-surgical first-line treatments for urinary incontinence in women, all of which already occur in primary care. The WI-INTUIT quality improvement project compares two implementation strategies to implement UI-Assist, an intervention to support primary care practices in increasing their rates of screening, diagnosing, and treating urinary incontinence in their adult female patients: (1) streamlined practice facilitation (SPF) and (2) streamlined practice facilitation in combination with partnership building (SPF+PB).

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
April 2026
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathryn Flynn

Professor

Medical College of Wisconsin

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • No additional exclusion criteria

Outcomes

Primary Outcomes

Differences in Screening Rates for Urinary Incontinence

Time Frame: 3 months, 10 months

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.

Secondary Outcomes

  • Difference in scores of the Change Process Capability Questionnaire (CPCQ) Strategies Scale(1 month, 9 months)
  • Organizational Readiness for Implementing Change(1 month, 9 months)
  • Differences in scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Constipation(10 months, 13 months)
  • Self-reported changes: change in pad use(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)
  • Global perception of improvement (GPI)(13 months)
  • Practice contextual factors - reach(1 month)
  • Clinical Staff Questionnaire in the National Demonstration Project - Community knowledge(1 month, 9 months)
  • 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)
  • Change in response to a single-item burnout measure(1 month, 9 months)
  • Self-reported changes: urinary incontinence treatments adopted(10 months, 13 months)
  • Clinical Staff Questionnaire in the National Demonstration Project - Practice adaptive reserve(1 month, 9 months)
  • Change in response to Urinary Incontinence Assist Project Practice Survey(6 months, 9 months, and 12 months)
  • Differences in scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)(10 months, 13 months)
  • Differences in scores of Incontinence Impact Questionnaire (IIQ-7)(10 months, 13 months)
  • Patients' health literacy level(10 months)

Study Sites (3)

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