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Practice-Based Intervention for Urinary Incontinence (OPTIMA Trial)

N/A

Recruiting

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

Female

Age >18 y/o

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve primary care for women with UI, and to reduce specialist care and disparities in care.

Who is the study for?

This trial is for adult women over 18 who speak English or Spanish and have urinary incontinence. They must confirm their condition with a screening tool and agree to participate. Primary care physicians from certain sites can also join, provided they're part of the recruited offices.

What is being tested?

The study tests if an intervention involving academic detailing, electronic decision support, app co-management, and electronic referrals by primary care providers improves urinary incontinence care compared to usual practices.

What are the potential side effects?

Since this trial focuses on practice-based interventions rather than medications or invasive procedures, traditional side effects are not applicable. However, there may be indirect effects on patient satisfaction or changes in healthcare utilization patterns.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am female.

Select...

I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Adherence to evidence-based quality-of-care indicators

Secondary study objectives

ICIQ-SF

PFAKS

PGI-I

+3 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

Active Control

Group I: Practice-Based InterventionExperimental Treatment4 Interventions

The intervention will include physician education, electronic decision support, implementation of an electronic referral system, and patient education/co-management by an advance practice provider.

Group II: ControlActive Control1 Intervention

Offices in this group will not receive the four-pronged intervention. However, after the study trial, there will be a "validation phase" in which the initial control group will then receive the intervention. This cross-over deign will then allow all 60 offices to receive the intervention. Data from the cross-over intervention group will be analyzed as a separate cohort to confirm improvements in patient care and outcomes as measured in the intervention group under the study trial can be duplicated.

0 / 2Eligibility criteria met