Practice-Based Intervention for Urinary Incontinence

(OPTIMA Trial)

Recruiting at 3 trial locations

Overseen By Maxwell B Moore, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Pregnant, Severe memory impairment, Psychiatric history, others

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

Compensation: Varies

Number of Visits: 3

1600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to improve how primary care doctors manage urinary incontinence (UI) in women. The goal is to determine if training and support tools for doctors, such as Academic Detailing (a practice-based intervention), can lead to better care and reduce the need for specialist visits. It also examines whether this approach can improve symptoms and quality of life for patients. Women who have experienced urinary leakage and are willing to discuss it with their primary care doctor might be a good fit. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance primary care for urinary incontinence.

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 primary care provider.

What prior data suggests that this practice-based intervention is safe for improving urinary incontinence care?

Research shows that the treatments studied in this trial, such as personalized education for doctors and electronic decision-making tools, have positively impacted patient care. Personalized education has improved medication prescribing in other studies, suggesting it might help primary care providers better manage urinary incontinence.

Studies on electronic decision-making tools indicate they can enhance patient outcomes by aiding healthcare providers in making better decisions. Although specific safety data for these tools related to urinary incontinence isn't detailed, they have generally been well-received in other healthcare settings.

Another part of the trial involves Advanced Practice Providers (APPs) working alongside doctors. Other studies have used this approach to successfully reduce the workload on primary care providers and improve care for urinary incontinence.

Lastly, electronic referral systems have been studied and found to enhance patient care efficiency. While specific safety outcomes for urinary incontinence weren't highlighted, these tools are generally considered safe and effective in improving healthcare processes.

Overall, each part of the intervention has been used in various healthcare settings with positive results, suggesting they are likely safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a comprehensive approach to managing urinary incontinence. Unlike traditional treatments that might focus solely on medication or lifestyle changes, this intervention combines several innovative strategies: academic detailing for physician education, electronic clinical decision support to streamline care, electronic referral systems for better patient management, and co-management by advanced practice providers for personalized patient education. This multifaceted approach aims to enhance the overall quality of care, improve patient outcomes, and could potentially set a new standard in managing urinary incontinence effectively.

What evidence suggests that this practice-based intervention is effective for improving urinary incontinence care?

This trial will evaluate a practice-based intervention for urinary incontinence, incorporating several strategies. Research has shown that educating healthcare providers through academic detailing can improve care for women with urinary incontinence (UI). Studies have found that this method not only enhances patient outcomes but is also cost-effective. In this trial, some participants will share care responsibilities with Advanced Practice Providers (APPs), who educate patients and improve care quality. Additionally, electronic tools that support doctors in making treatment decisions can lead to better patient results. The trial will also assess electronic referral systems, which simplify access to specialist care and have improved outcomes for patients with UI. Together, these strategies aim to enhance the quality of care and patient experiences with urinary incontinence. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am female.

Inclusion Criteria of Patients

I am older than 18 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of a practice-based intervention involving physician education, electronic decision support, and patient education/co-management by an advanced practice provider

6 months

Regular visits as per intervention protocol

Crossover Validation

Control group receives the intervention to validate improvements in patient care and outcomes

6 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

6 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Academic Detailing
• APP Co-management
• Electronic Clinical Decision Support
• Electronic Referral

Trial Overview 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.

How Is the Trial Designed?

Group I: Practice-Based Intervention Experimental Treatment 4 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: Control Active Control 1 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.

Academic Detailing is already approved in United States for the following indications:

Approved in United States as Academic Detailing Intervention for:

• Improving quality of incontinence care
• Reducing utilization of specialist care for urinary incontinence
• Enhancing patient outcomes

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

RAND

Collaborator

Trials

145

Recruited

617,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborator

Trials

105

Recruited

46,600+

Published Research Related to This Trial

Current comparative studies of commercially available drug information (DI) databases are limited and often lack transparency, making it difficult for clinicians to make informed purchasing decisions.

Future research should focus on integrating DI resources with clinical decision support systems (CDSS) to ensure that alerts and information are consistent and relevant to the specific needs of healthcare practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of drug information database research for clinical decision support. Hoody, DW., Beckett, CF., Zielenski, C., et al.[2021]

Computer decision support systems are effective tools that help clinicians make better diagnostic and therapeutic decisions by providing patient-specific recommendations and alerts, ultimately improving patient care.

Despite challenges in implementation, such as the need for robust computing infrastructure and changes to workflow, evidence from various clinical trials shows that these systems significantly enhance clinician performance across different healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer decision support systems. Payne, TH.[2019]

The study assessed the current state of patient-centered clinical decision support (PC CDS) tools, highlighting the need for improved shareability and standardization to enhance patient care and clinical outcomes.

Despite significant progress in developing PC CDS, the research identified ten key technical challenges that need to be addressed to facilitate better dissemination of best practices in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Technology Landscape of Patient-Centered Clinical Decision Support - Where Are We and What Is Needed? Dullabh, P., Heaney-Huls, K., Hovey, L., et al.[2022]

A survey of 153 primary care providers revealed that 98% of those using clinical pathways found them to provide evidence-based information and improve patient care, highlighting their perceived efficacy in clinical decision-making.

The main barriers to using these pathways were forgetfulness among users and a lack of awareness among non-users, indicating a need for better dissemination and education about these tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EHR-Integrated Clinical Pathways Promote Education, Confidence, and Save Time for Primary Care Providers. Macke, LB., Sieja, A., Suresh, K., et al.[2023]

A pediatric cardiovascular disease (CVD) risk factor tool was positively received by clinicians, indicating its potential to improve the evaluation and prevention of CVD in children and teens.

Feedback from pediatricians led to important revisions for the tool, such as enhancing user-friendliness on mobile devices and refining recommendations, which are crucial for effective clinical decision support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Testing and Adaptation of the Pediatric Cardiovascular Risk Reduction Clinical Decision Support Tool. Williams, PA., Furberg, RD., Bagwell, JE., et al.[2023]

Clinics affiliated with health systems utilized more clinical decision support (CDS) tools, such as automated reminders, but also faced greater barriers related to resources and user acceptance, indicating a complex relationship between support and challenges in implementation.

Rural clinics reported higher barriers to training, suggesting that targeted resources and support are needed to enhance CDS utilization, particularly in these settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to using clinical decision support in ambulatory care: Do clinics in health systems fare better? Shi, Y., Amill-Rosario, A., Rudin, RS., et al.[2022]

Implementation science provides essential theories and frameworks that can significantly reduce the time it takes for medical innovations to be applied in clinical settings, which currently averages 17 years.

By applying implementation science principles, clinicians can effectively lead quality improvement initiatives, such as reducing catheter-associated urinary tract infections, ensuring that evidence-based practices are successfully integrated into everyday healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying Implementation Science in Surgical Infection Quality Improvement. Golob, JF., Evans, HL., Kreiner, LA., et al.[2021]

Computerized clinical decision support systems (CCDSSs) have been shown to improve the process of care in 63% of the 40 randomized controlled trials reviewed, particularly for screening and managing dyslipidaemia in primary care.

However, the evidence for CCDSS effectiveness in other areas, such as cancer and mental health screening, is mixed, and there is limited information on their impact on patient outcomes, safety, and costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized clinical decision support systems for primary preventive care: a decision-maker-researcher partnership systematic review of effects on process of care and patient outcomes. Souza, NM., Sebaldt, RJ., Mackay, JA., et al.[2022]

A new informatics framework, including a breast cancer risk navigation (BNAV) tool, has been developed to enhance breast cancer risk assessment and promote chemoprevention in primary care, aiming to improve decision-making for high-risk women.

Usability testing with seven subjects revealed important feedback on the BNAV tool, leading to interface improvements that could help increase provider engagement and ultimately boost the uptake of effective chemoprevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing a Comprehensive Informatics Framework to Promote Breast Cancer Risk Assessment and Chemoprevention in the Primary Care Setting. Finkelstein, J., Wood, J., Crew, KD., et al.[2020]

A survey of community paediatricians in Central West Ontario revealed that 98% are interested in accessing the proposed Central West Ontario Pediatric Information Network (CWPIN), indicating a strong demand for electronic clinical support tools.

Despite high computer literacy rates among paediatricians, differences in workplace computer use by sex suggest that role allocation may influence the potential usage of CWPIN, rather than computer skills being a barrier to implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

e-Health? Clinical information network interest and impediments in a community paediatric setting. Cawdron, R., Calder, J., Issenman, RM.[2021]

A study involving ethnographic observations and interviews identified six key barriers to the effective use of clinical reminders in the Veteran's Health Administration (VHA), including workload, time to manage reminders, and training issues.

A follow-up survey of 261 participants revealed four additional barriers, such as ease of use and accessibility of workstations, highlighting the complexity of improving adherence to clinical reminders among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying barriers to the effective use of clinical reminders: bootstrapping multiple methods. Patterson, ES., Doebbeling, BN., Fung, CH., et al.[2018]

A systematic review of 15 studies involving 13,480 patients found that computer-based clinical decision support systems (CCDSS) can have marginal positive effects on patient-reported outcomes (PRO), particularly in symptom management.

No negative effects were reported from the use of CCDSS, suggesting they are safe to implement, but further development of user-friendly systems with clear evidence-based guidance is needed to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Based Clinical Decision Support Systems and Patient-Reported Outcomes: A Systematic Review. Blum, D., Raj, SX., Oberholzer, R., et al.[2018]

The article highlights the need for improved patient-centered clinical decision support (PC CDS) tools to enhance healthcare decision-making, emphasizing the importance of making research findings more shareable and publicly available.

A comprehensive assessment involving a technical expert panel, literature review, and interviews with 18 stakeholders identified key areas for improvement, including the need for standardized processes to integrate clinical guidelines and patient-generated health data into PC CDS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The technical landscape for patient-centered CDS: progress, gaps, and challenges. Dullabh, P., Heaney-Huls, K., Lobach, DF., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425001168

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 ...

2. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT06040645

Outcomes of Urinary Incontinence Treatment in Primary Care: APP ... 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 ...

3. pcori.org pcori.org/research-results/2022/comparing-effectiveness-two-ways-doctors-manage-care-urinary-incontinence

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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05534412?tab=history&a=3

Record History | ver. 3: 2024-12-04 | NCT05534412 Brief Title. A Practice-Based Intervention to Improve Care for a Diverse Population of Women with Urinary Incontinence ; Official Title. A Practice-Based ...

5. withpower.com withpower.com/trial/phase-urinary-incontinence-9-2023-c93dd

APP Co-Management and E-Consults for Urinary Incontinence The goal of this multi-site cluster randomized comparative effectiveness trial is to compare the effects of two methods of nonsurgical UI care delivery - ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40268237/

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 ...

7. ahrq.gov ahrq.gov/evidencenow/projects/urinary/interviews.html

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 ...

8. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06040645

Outcomes of Urinary Incontinence Treatment in Primary Care 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 ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429524005922

Urinary Incontinence Care in the Academic and Safety-Net ... To compare the quality of urinary incontinence (UI) care for women in the safety-net and nonsafety-net settings prior to referral to a specialist.

10. withpower.com withpower.com/trial/phase-enuresis-1-2023-d3c33

Practice-Based Intervention for Urinary Incontinence The main goal of this clinical trial is to improve the care for urinary incontinence (UI) provided to adult women by primary care providers.