APP Co-Management and E-Consults for Urinary Incontinence

(OUTPACE Trial)

Enrolling by invitation at 2 trial locations
JA
Overseen ByJennifer Anger, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve non-surgical management of urinary incontinence (UI) for women by comparing two care approaches. One method uses electronic consults, where specialists review care plans remotely. The other involves Advanced Practice Providers (APPs) working directly with patients through virtual visits (APP Co-management). The goal is to enhance care quality and patient satisfaction. Women who frequently experience involuntary urine leaks and speak English or Spanish may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative care strategies that could enhance their quality of life.

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 prior data suggests that these methods are safe for urinary incontinence care?

Research shows that both APP co-management and E-consult methods for managing urinary incontinence are generally well-received by patients. Studies have found that these approaches improve the quality of care and lead to better patient outcomes without major safety concerns.

In APP co-management, advanced practice providers collaborate closely with primary care doctors to manage patient care. This method emphasizes patient education and self-care, and it has not been linked to any serious side effects. Similarly, E-consults involve specialists reviewing patient information electronically to recommend additional treatments if needed, also without major safety issues.

Both strategies are non-surgical and aim to enhance the quality of care, indicating they are safe options for patients. Current research does not report any serious side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the APP Co-management and E-consults for urinary incontinence because these approaches offer innovative ways to improve care. Unlike traditional treatments that focus primarily on medication or surgery, the electronic consult system provides a seamless way for specialists to review and enhance primary care through technology, ensuring patients receive comprehensive management. Additionally, the APP Co-management approach reduces the workload on primary care physicians by involving advanced practice providers to deliver patient education and self-management support through dedicated televisits. These methods aim to make urinary incontinence care more efficient and accessible, potentially leading to better patient outcomes.

What evidence suggests that this trial's treatments could be effective for urinary incontinence?

Research has shown that both online consultations and assistance from specialized healthcare providers can enhance care for urinary incontinence (UI). In this trial, participants will join one of two treatment arms. One arm implements an electronic referral system (E-consult), where specialists review referrals electronically and offer additional recommendations if primary UI care was inadequate. Studies have found that online health tools for stress urinary incontinence (SUI) lead to better outcomes, particularly for active users. The other arm involves Advanced Practice Provider (APP) co-management, which delivers focused care and education for UI, easing the workload for regular doctors. Both methods aim to improve care quality and patient satisfaction for women with UI. These strategies offer promising ways to manage UI effectively without surgery.13567

Are You a Good Fit for This Trial?

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.
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Electronic Consult (E-consult)Experimental Treatment1 Intervention
Group II: Advanced Practice Provider (APP) Co-managementExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as APP Co-management for:

Find a Clinic Near You

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+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40268237/
Outcomes of urinary incontinence treatment in primary careOUTPACE will determine whether the E-consult or APP co-management referral mechanism has a greater impact on provider QOC, patient-reported UI outcomes, and ...
Outcomes of urinary incontinence treatment in primary care ...OUTPACE will determine whether the E-consult or APP co-management referral mechanism has a greater impact on provider QOC, patient-reported UI outcomes, and ...
Outcomes of Urinary Incontinence Treatment in Primary CareIn Arm 2, Advanced Practice Provider (APP) co-management will reduce the burden of care on the PCPs by providing UI care, patient education, and ...
Comparing the Effectiveness of Two Ways for Doctors To ...This study compares the clinical effectiveness of two ways for primary care doctors to help women best manage their symptoms of urinary ...
Record History | ver. 3: 2024-12-04 | NCT05534412Brief Title. A Practice-Based Intervention to Improve Care for a Diverse Population of Women with Urinary Incontinence ; Official Title. A Practice-Based ...
Advancing Urinary Incontinence Management in Primary ...This intervention included academic detailing, clinical decision support, Advanced Practice Provider (APP) co-management, and electronic referral. OPTIMA is ...
APP Co-Management and E-Consults for Urinary IncontinenceThe APP Co-Management and E-Consult treatment is unique because it involves collaboration with advanced practice providers and utilizes electronic consultations ...
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