Clinical trial NCT05534412: A Practice-Based Intervention to Improve Care for a Diverse Population of Women with Urinary Incontinence
Official title: A Practice-Based Intervention to Improve Care for a Diverse Population of Women with Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Keywords: Practice-based intervention
Patient-centered outcomes research
Disparities
Quality of care indicators
Primary care
Urinary incontinence
Stress incontinence
Urge incontinence
Mixed incontinence
Overactive bladder
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Cedars-Sinai Medical Center
name: University of California, Los Angeles
name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: RAND
First posted: 2022-09-09
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four Southern California medical groups will participate in a cluster randomized controlled trial in which 60 offices (15 per site) will be randomized to undergo a practice-based incontinence intervention or control for 6 months. After the study trial, the control offices will then undergo the intervention as part of a "validation phase" of the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main goal of this clinical trial is to improve the care for urinary incontinence (UI) provided to adult women by primary care providers. The main questions it aims to answer are:

* Can a practice-based intervention involving primary care providers lead to improved quality of incontinence care?
* Will this intervention reduce the utilization of specialist care for urinary incontinence?
* What effect will this intervention have on patient outcomes, including disease-specific outcomes, symptom severity, quality of life, and patient knowledge?
* Does our intervention reduce disparities in care?

Provider participants will be randomized at the office level to either an intervention group or a delayed intervention (control) group. The intervention group will receive an intervention consisting of academic detailing, clinical decision support tools, electronic referral, and the ability to refer to an advanced practice provider for co-management. The delayed intervention group will provide usual care until the crossover phase of the study, at which point they will receive the same intervention as the intervention group.

Patient participants will bring up urinary incontinence with their primary care provider and complete three electronic surveys.

Researchers will compare the intervention group to the delayed intervention (control) group to see if the intervention results in increased adherence to evidence-based quality indicators.

Detailed description: The burden of urinary incontinence (UI) on American women is immense in human and financial terms, and continues to rise with the growing population of older adults. The goal of this proposal is to improve the care for UI provided to women and, in doing so, decrease the utilization of specialty care while improving patient outcomes. Specific Aim 1 seeks to improve the quality of incontinence care provided to an ethnically diverse population of women through a controlled practice-based intervention involving primary care providers. The intervention involves the implementation of PCOR measures. Four Southern California medical groups will participate in a cluster randomized controlled trial in which 60 offices (15 per site) will be randomized to undergo a practice-based incontinence intervention led by a "clinical champion dyad" comprised of a primary care provider and urologist/urogynecologist, both of whom are members of that specific medical group. The intervention will include physician education, individual performance feedback, electronic decision support, patient education using dedicated advanced practice providers (APPs), and the implementation of an electronic referral service. The quality of patient care, as evidenced by compliance with primary care UI quality indicators the investigators developed and pilot-tested, will be measured across the two randomized arms after implementation of the intervention. Compliance with these quality indicators will be the key means to implement PCOR evidence, while, at the same time, measure quality. In Specific Aim 2, utilization of specialists will be compared before and after the intervention. The investigators hypothesize that improved care at the level of the primary care physician will reduce the number of specialty referrals. Specific Aim 3 will seek to measure the effect of the intervention on patient outcomes. Under the hypothesis that a practice-based intervention will improve disease-specific outcomes, symptom severity, quality of life, and patient knowledge will be measured at baseline using validated questionnaires. After implementation of the intervention, these questionnaires will be given a second time six months later and outcomes will be compared between control and intervention groups. The investigators expect that this intervention will also reduce disparities in care for underrepresented minorities.

Eligibility criteria: Inclusion Criteria of Primary Care Physicians:

* Primary care physician belonging to a recruited office among one of four participating sites: Cedars-Sinai, Harbor-UCLA, UCLA, UCSD

Inclusion Criteria of Patients

* Age \>18 y/o
* English or Spanish fluency
* Female
* Answers "yes" to incontinence screening tool and agrees to participate

Exclusion Criteria of Primary Care Physicians:

* Non-primary care specialty
* Does not belong to one of the participating offices

Exclusion Criteria of Patients

* Age \<18 y/o
* Answers "no" to incontinence screening tool and/or does not agree to participate
* Patient seen by a urinary incontinence specialist (urologist/urogynecologist) for urinary incontinence in the past two years
* Primary care provider (who reviews a list of patients that screen positive) deems patient ineligible due to pregnant, severe memory impairment, or psychiatric history preventing participation

Primary outcomes:
measure: Adherence to evidence-based quality-of-care indicators
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Referral rates to a specialist
timeFrame: Baseline, 6 months
measure: ICIQ-SF
timeFrame: Baseline, 3 months, 6 months
measure: UDI-6
timeFrame: Baseline, 3 months, 6 months
measure: PGI-I
timeFrame: 3 months, 6 months
measure: PFAKS
timeFrame: Baseline, 6 months
measure: SDM-Q-9
timeFrame: 6 months
measure: Net Promoter Score
timeFrame: 3 months, 6 months
measure: IIQ-7
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
Study officials:
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