A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Inco… (NCT05534412) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence
United States1,600 participantsStarted 2022-09-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adherence to evidence-based quality-of-care indicators