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

Urinary Incontinence Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

• NCT number: NCT05534412
• Study type: Interventional
• Source: University of California, San Diego
• Contact: Jennifer Anger, MD
• Phone: 3108479299
• Email: janger@health.ucsd.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2022
• Completion date: February 2025