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NCT Number: NCT05534412

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence, Stress Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego, La Jolla, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Academic Detailing

Other
  • Provider Assessment. Physicians and advance practice providers will complete questionnaires before the intervention that assess their knowledge about the treatment for UI in women.
  • 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.
  • 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.

Electronic Clinical Decision Support

Other

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.

APP Co-management

Other

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.

Electronic Referral

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. ICIQ-SF

    Time frame: Baseline, 3 months, 6 months

    Four-item questionnaire that evaluates frequency, severity and impact on quality of life of UI.

  3. UDI-6

    Time frame: Baseline, 3 months, 6 months

    Six-item questionnaire that measures quality of life and symptom distress for UI in women.

  4. PGI-I

    Time frame: 3 months, 6 months

    Global index (transition scale) that measures symptom improvement.

  5. 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.

  6. 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.

  7. 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

  8. IIQ-7

    Time frame: Baseline, 3 months, 6 months

    Seven-item questionnaire to assess quality-of-life impact of UI

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

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

Registry information

Acronym: OPTIMA

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 9, 2022
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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