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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

OPTIMA Trial 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.Check my eligibility

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.See study design

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.

OPTIMA Trial 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.

OPTIMA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to evidence-based quality-of-care indicators

Secondary outcome measures

ICIQ-SF

PFAKS

PGI-I

+3 more

OPTIMA 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

Find a Location

Who is running the clinical trial?

RANDOTHER

137 Previous Clinical Trials

508,649 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,519,444 Total Patients Enrolled

10 Trials studying Urinary Incontinence

4,330 Patients Enrolled for Urinary Incontinence

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,820,748 Total Patients Enrolled

3 Trials studying Urinary Incontinence

2,818 Patients Enrolled for Urinary Incontinence

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research still have available slots for participants?

"The latest update on clinicaltrials.gov presents that this medical study is actively seeking out participants; the protocol was initially posted on September 7th 2022 and modified most recently during October 5th 2023."

Answered by AI

What is the current subject number for this experiment?

"Affirmative. The information published on clinicaltrials.gov shows that this trial is presently recruiting participants, having been initially posted on September 7th 2022 and edited most recently on October 5th 2023. To complete the study, 1600 volunteers must be enlisted from 4 different medical sites."

Answered by AI

Recent research and studies

Implementation ScienceJournal

Fostering Implementation of Health Services Research Findings into Practice: A Consolidated Framework for Advancing Implementation Science

Damschroder, Laura J, David C Aron, Rosalind E Keith, Susan R Kirsh, Jeffery A Alexander, and Julie C Lowery. 2009. “Fostering Implementation of Health Services Research Findings into Practice: A Consolidated Framework for Advancing Implementation Science”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/1748-5908-4-50.

Clinical TrialsJournal

Determinants of the Intracluster Correlation Coefficient in Cluster Randomized Trials: The Case of Implementation Research

Campbell, Marion K, Peter M Fayers, and Jeremy M Grimshaw. 2005. “Determinants of the Intracluster Correlation Coefficient in Cluster Randomized Trials: The Case of Implementation Research”. Clinical Trials. SAGE Publications. doi:10.1191/1740774505cn071oa.

Obstetrics & GynecologyJournal

Epidemiology of Surgically Managed Pelvic Organ Prolapse and Urinary Incontinence

OLSEN, A, V SMITH, J BERGSTROM, J COLLING, and A CLARK. 1997. “Epidemiology of Surgically Managed Pelvic Organ Prolapse and Urinary Incontinence”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0029-7844(97)00058-6.

JamaJournal