A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence (OPTIMA)

March 10, 2026 updated by: Jennifer Anger, University of California, San Diego

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California, San Diego
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai
      • Torrance, California, United States, 90502
        • Harbor-UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Practice-Based Intervention
The intervention will include physician education, electronic decision support, implementation of an electronic referral system, and patient education/co-management by an advance practice provider.
Other: Academic Detailing
  1. Provider Assessment. Physicians and advance practice providers will complete questionnaires before the intervention that assess their knowledge about the treatment for UI in women.
  2. Mealtime Lecture. A group meeting will take place for the physicians in the intervention groups. All aspects of incontinence care will be addressed-including elements of the history and physical examination, initiation of conservative treatment, as well as when to refer for second-line therapies performed by specialists-utilizing the the principles of Academic Detailing.
  3. Monthly individual feedback. Physicians and their clinical champion specialist will meet for individual coaching one month after the mealtime lecture to discuss and review the physician's previous performance as measured by the baseline chart abstraction. Physicians will have monthly check-ins with their clinical champion via a combination of quarterly synchronous Zooms and monthly asynchronous emails.
Other: Electronic Clinical Decision Support
Intervention physicians will have access to electronic clinical decision support consisting of note templates, order sets, interruptive alerts, and a notification of patients who screen positive for UI.
Other: APP Co-management

To reduce additional burden of care on the PCPs, the investigators will incorporate Advanced Practices Providers into the patient education and self-management portion of care. The APPs will be trained together with the intervention physicians, but they will also undergo additional standardized training on patient education, UI knowledge, providing instruction on Kegel exercises, shared decision making, and self management.

Patients will then be scheduled for a UI education and self-management session with the APP by telemedicine (video visit or telephone visit) within one month of their initial visit. For patients in need of an annual pelvic examination, and if the patient's PCP prefers to have the APP conduct the pelvic exam, a separate visit will be scheduled with the APP. A followup televisit will then be scheduled within three months of the initial APP visit, in order to assess the outcome of non-surgical treatment and determine if a specialist referral is indicated.

Other: Electronic Referral
In implementing the electronic consultation system in the private sector, the investigators will model the Expected Practice developed by the Los Angeles County Specialty-Primary Care Work Group. This eConsult system utilizes a "kickback" mechanism by which a specialist, who reviews the referral, can return it if it has not met certain baseline criteria (e.g. for a woman with OAB/urinary urgency: document negative UA, scheduled voids, titrate fluids to thirst, Kegels, antimuscarinics, optimize diuretic control, adjust any diuretics).
No Intervention: Control
Offices in this group will not receive the four-pronged intervention. However, after the study trial, there will be a "validation phase" in which the initial control group will then receive the intervention. This cross-over deign will then allow all 60 offices to receive the intervention. Data from the cross-over intervention group will be analyzed as a separate cohort to confirm improvements in patient care and outcomes as measured in the intervention group under the study trial can be duplicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to evidence-based quality-of-care indicators
Time Frame: Baseline, 3 months, 6 months
Adherence to the QIs for patients who screen positive for UI will be compared across the two randomized arms at baseline and again at 3 and 6 months after intervention implementation.
Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Referral rates to a specialist
Time Frame: Baseline, 6 months

The number of referrals to a specialist over the intervention period (urologist or gynecologist) will be quantified and compared between intervention and control groups.

For patients screened as positive for new or worsening UI at their primary care physician office from Specific Aim 1, the investigators will record if and when the patient was referred to a specialist for treatment. Dates of each level of care provided will be incorporated into each chart abstraction so that the timing can be calculated. Investigators will also record the baseline rate of specialty referrals for each office during the baseline chart review.
Baseline, 6 months
ICIQ-SF
Time Frame: Baseline, 3 months, 6 months
Four-item questionnaire that evaluates frequency, severity and impact on quality of life of UI.
Baseline, 3 months, 6 months
UDI-6
Time Frame: Baseline, 3 months, 6 months
Six-item questionnaire that measures quality of life and symptom distress for UI in women.
Baseline, 3 months, 6 months
PGI-I
Time Frame: 3 months, 6 months
Global index (transition scale) that measures symptom improvement.
3 months, 6 months
PFAKS
Time Frame: Baseline, 6 months
Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life.
Baseline, 6 months
SDM-Q-9
Time Frame: 6 months
Nine-item questionnaire that measures the extent to which patients are involved in the process of decision-making.
6 months
Net Promoter Score
Time Frame: 3 months, 6 months
Single-item questionnaire to evaluate the patient's willingness to refer their provider to a friend
3 months, 6 months
IIQ-7
Time Frame: Baseline, 3 months, 6 months
Seven-item questionnaire to assess quality-of-life impact of UI
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

University of California, Los Angeles
Cedars-Sinai Medical Center
RAND
Agency for Healthcare Research and Quality (AHRQ)
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Actual)

January 30, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 802004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available by request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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