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

About

Brief Summary

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.

Primary Purpose
Health Services Research
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A

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
  • 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

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Study Stats
Protocol No.
22-5017
Category
Genitourinary Disorders
Contact
KRISTEN WILLIAMS
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05534412
For detailed technical eligibility, visit ClinicalTrials.gov.