A Practice-Based Intervention to Improve Care for a Diverse Population of Women with Urinary Incontinence
NCT ID: NCT05534412
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1600 participants
INTERVENTIONAL
2022-09-07
2026-02-28
Brief Summary
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* 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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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.
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.
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.
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.
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).
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.
No interventions assigned to this group
Interventions
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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.
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.
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.
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).
Eligibility Criteria
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Inclusion Criteria
* Age \>18 y/o
* English or Spanish fluency
* Female
* Answers "yes" to incontinence screening tool and agrees to participate
Exclusion Criteria
* Does not belong to one of the participating offices
* 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
18 Years
ALL
Yes
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
Cedars-Sinai Medical Center
OTHER
University of California, Los Angeles
OTHER
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
OTHER
RAND
OTHER
University of California, San Diego
OTHER
Responsible Party
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Jennifer Anger
Professor of Urology, Vice Chair of Research
Locations
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University of California, San Diego
La Jolla, California, United States
Cedars-Sinai
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
Countries
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Central Contacts
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Facility Contacts
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Jennifer T Anger, MD, MPH
Role: primary
Maxwell B Moore, MS
Role: backup
Allison Mays, MD
Role: primary
Teryl Nuckols, MD
Role: backup
Tamara Grisales, MD
Role: primary
Kristen Williams, MA
Role: backup
Tajnoos Yazdany, MD
Role: primary
Elizabeth Hernandez
Role: backup
References
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Related Links
Access external resources that provide additional context or updates about the study.
Care ICI. The Chronic Care Model
L.A. WL. Race Ethnicity Pie Chart.
Quality AfHRa. Nonsurgical Treatments for Urinary Incontinence in Women: A Systematic Review Update
Institute P-COR. Pilot Evidence Maps: Pelvic Floor Muscle Training for Urinary Incontinence.
Institute P-COR. Treating Urinary Incontinence in Women without Surgery - Evidence Update for Women
CFIR Research Team-Center for Clinical Management Research. Consolidated Framework for Implementation Research (CFIR)
Bureau USC. QuickFacts, Los Angeles County, California
Institute P-COR. Using a New Survey to Learn About Women's Experiences with Hospital Care for Childbirth
Other Identifiers
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802004
Identifier Type: -
Identifier Source: org_study_id