APP Co-Management and E-Consults for Urinary Incontinence (OUTPACE Trial)

N/A

Waitlist Available

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 y/o

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to compare two methods of non-surgical urinary incontinence care delivery in women. One method involves electronic consults with specialists, while the other involves advanced practice providers (APPs)

Who is the study for?

This trial is for women over 18 who experience urinary incontinence, can communicate in English or Spanish, and have a primary care physician at one of the participating sites: UCSD, UCLA, KUMC. They must acknowledge their condition using an incontinence screening tool.

What is being tested?

The study compares two non-surgical UI care methods: electronic consults where specialists review referrals online (E-consult), and co-management with Advanced Practice Providers offering direct UI care via televisits (APP Co-management). Both groups receive basic doctor education and decision support tools.

What are the potential side effects?

Since this trial involves management strategies rather than medications, traditional side effects are not expected. However, there may be indirect issues such as privacy concerns with telehealth or potential miscommunication during e-consults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in provider quality of care measured by evidence-based quality indicators

Provider Quality of Care - Evidence-Based Quality Indicators

Secondary study objectives

Change in impact of UI on patients' quality of life as measure by the Incontinence Impact Questionnaire (IIQ-7)

Change in patients' knowledge as measured by the P-FAKS

Change in patients' urinary incontinence symptoms as measured by ICIQ-SF

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Electronic Consult (E-consult)Experimental Treatment1 Intervention

In Arm 1, the investigators will implement an electronic referral system (electronic co-management), in which specialists will electronically review referrals and make additional recommendations if appropriate primary UI care was not provided.

Group II: Advanced Practice Provider (APP) Co-managementExperimental Treatment1 Intervention

In Arm 2, Advanced Practice Provider (APP) co-management will reduce the burden of care on the PCPs by providing UI care, patient education, and assisting with patient self-management through dedicated televisits (APP co-management).

0 / 1Eligibility criteria met