APP Co-Management and E-Consults for Urinary Incontinence

(OUTPACE Trial)

Recruiting at 2 trial locations

Overseen By Jennifer Anger, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Pregnant, Severe memory impairment, Psychiatric history

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

The burden of urinary incontinence (UI) on American women is immense in both human and financial terms, and continues to rise with the aging US population. Although numerous non-surgical management strategies have proven efficacy for both stress and urge urinary incontinence, there remains a lack of appropriate UI management in the primary care setting. The goal of this multi-site cluster randomized comparative effectiveness trial is to compare the effects of two methods of nonsurgical UI care delivery - electronic consult vs. advanced practice provider (APP) co-management. These two evidence-based, practice-changing strategies are designed to improve the quality of care for an ethnically diverse population of women with UI, and, by reducing deficits in care, obtain better patient-reported outcomes. Both arms of the study will include basic physician education (academic detailing) and electronic clinical decision support. In Arm 1, the investigators will implement an electronic referral system (electronic referral), in which specialists will electronically review referrals and make additional recommendations if appropriate primary UI care was not provided. 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).

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment APP Co-Management and E-Consults for Urinary Incontinence?

Research shows that using internet-based tools and mobile apps can improve patient engagement and self-management for chronic conditions, which may suggest potential benefits for managing urinary incontinence through APP Co-Management and E-Consults. ^{1 2 3 4 5}

Is app-based treatment for urinary incontinence safe for humans?

The research does not specifically mention safety concerns, suggesting that app-based treatments for urinary incontinence are generally considered safe for humans. ^{6 7 8 9 10}

How is the APP Co-Management and E-Consult treatment for urinary incontinence different from other treatments?

The APP Co-Management and E-Consult treatment is unique because it involves collaboration with advanced practice providers and utilizes electronic consultations, which can enhance access to care and support personalized management of urinary incontinence, unlike traditional in-person visits. ^{6 7 8 9 10}

Eligibility Criteria

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.

Inclusion Criteria

I am older than 18 years.

I am female.

You have indicated positive responses to an incontinence screening questionnaire and agree to take part in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nonsurgical UI care through either electronic consult or APP co-management

6 months

Regular visits as per study arm protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• APP Co-management
• E-consult

Trial Overview 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.

Participant Groups

Group I: Electronic Consult (E-consult) Experimental Treatment 1 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-management Experimental Treatment 1 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).

APP Co-management is already approved in United States for the following indications:

Approved in United States as APP Co-management for:

• Urinary Incontinence Management

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

HIV Care Providers' Attitudes regarding Mobile Phone Applications and Web-Based Dashboards to support Patient Self-Management and Care Coordination: Results from a Qualitative Feasibility Study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Consumer Mobile Health Apps: Current State, Barriers, and Future Directions. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Improving patient-clinician communication about chronic conditions: description of an internet-based nurse E-coach intervention. [2008]

4. Canada pubmed.ncbi.nlm.nih.gov

Early-Stage Feasibility of a Mobile Health Intervention (Copilot) to Enhance Exacerbation-Related Self-Management in Patients With Chronic Obstructive Pulmonary Disease: Multimethods Approach. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Professional continuous glucose monitoring and endocrinology eConsult for adults with type 2 diabetes in primary care: Results of a clinical pilot program. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The impact of a mobile application-based treatment for urinary incontinence in adult women: Design of a mixed-methods randomized controlled trial in a primary care setting. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

Mobile App for Treatment of Stress Urinary Incontinence: A Cost-Effectiveness Analysis. [2018]

9. England pubmed.ncbi.nlm.nih.gov

One year effectiveness of an app-based treatment for urinary incontinence in comparison to care as usual in Dutch general practice: A pragmatic randomised controlled trial over 12 months. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators Associated With App-Based Treatment for Female Urinary Incontinence: Mixed Methods Evaluation. [2021]