Clinical trial NCT05664451: WI-INTUIT: Bridging Community Based Continence Promotion and Primary Care
Official title: Improving Nonsurgical Treatment of Urinary Incontinence Among Women in Primary Care in Wisconsin: Bridging Community-based Continence Promotion and Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: MetaStar, Inc.
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-12-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: This is an organizational intervention. Outcomes will be evaluated at the population-level by facility.

Primary Care practices in Wisconsin serving female adults:

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

Primary outcomes:
measure: Differences in Screening Rates for Urinary Incontinence
timeFrame: 3 months, 10 months
Secondary outcomes:
measure: Differences in scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health
timeFrame: 10 months, 13 months
measure: Differences in bowel leakage symptoms
timeFrame: 10 months, 13 months
measure: Differences in scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Constipation
timeFrame: 10 months, 13 months
measure: Self-reported changes: changes in usage of urinary incontinence coping strategies
timeFrame: 10 months, 13 months
measure: Self-reported changes: change in money-spent on incontinence treatments
timeFrame: 10 months, 13 months
measure: Self-reported changes: urinary incontinence treatments adopted
timeFrame: 10 months, 13 months
measure: Self-reported changes: change in pad use
timeFrame: 10 months, 13 months
measure: Global perception of improvement (GPI)
timeFrame: 13 months
measure: Practice contextual factors - reach
timeFrame: 1 month
measure: Difference in scores of the Change Process Capability Questionnaire (CPCQ) Strategies Scale
timeFrame: 1 month, 9 months
measure: Organizational Readiness for Implementing Change
timeFrame: 1 month, 9 months
measure: Clinical Staff Questionnaire in the National Demonstration Project - Community knowledge
timeFrame: 1 month, 9 months
measure: Clinical Staff Questionnaire in the National Demonstration Project - Practice adaptive reserve
timeFrame: 1 month, 9 months
measure: Change in response to a single-item burnout measure
timeFrame: 1 month, 9 months
measure: Change in response to Urinary Incontinence Assist Project Practice Survey
timeFrame: 6 months, 9 months, and 12 months
measure: Differences in scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)
timeFrame: 10 months, 13 months
measure: Differences in scores of Incontinence Impact Questionnaire (IIQ-7)
timeFrame: 10 months, 13 months
measure: Patients' health literacy level
timeFrame: 10 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Madison
country: United States
facility: MetaStar, Inc.
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Joan Neuner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.