A Practice-Based Intervention to Improve Care for a Diverse Population of Women with Urinary Incontinence
- Conditions
- Urinary Incontinence
- Interventions
- Other: Academic DetailingOther: Electronic Clinical Decision SupportOther: APP Co-managementOther: Electronic Referral
- Registration Number
- NCT05534412
- Lead Sponsor
- University of California, San Diego
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Practice-Based Intervention Electronic Referral 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. Practice-Based Intervention Academic Detailing 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. Practice-Based Intervention Electronic Clinical Decision Support 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. Practice-Based Intervention APP Co-management 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.
- Primary Outcome Measures
Name Time Method Adherence to evidence-based quality-of-care indicators 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 Outcome Measures
Name Time Method Referral rates to a specialist 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.ICIQ-SF Baseline, 3 months, 6 months Four-item questionnaire that evaluates frequency, severity and impact on quality of life of UI.
UDI-6 Baseline, 3 months, 6 months Six-item questionnaire that measures quality of life and symptom distress for UI in women.
PGI-I 3 months, 6 months Global index (transition scale) that measures symptom improvement.
PFAKS 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.
SDM-Q-9 6 months Nine-item questionnaire that measures the extent to which patients are involved in the process of decision-making.
Net Promoter Score 3 months, 6 months Single-item questionnaire to evaluate the patient's willingness to refer their provider to a friend
IIQ-7 Baseline, 3 months, 6 months Seven-item questionnaire to assess quality-of-life impact of UI
Trial Locations
- Locations (4)
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