Outcomes of Urinary Incontinence Treatment in Primary Care: APP Co-Management and Electronic Consult (OUTPACE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06040645 |
Recruitment Status :
Not yet recruiting
First Posted : September 15, 2023
Last Update Posted : September 21, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Incontinence | Other: APP Co-management Other: E-consult | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Outcomes of Urinary Incontinence Treatment in Primary Care: APP Co-Management and Electronic Consult |
Estimated Study Start Date : | October 1, 2023 |
Estimated Primary Completion Date : | February 1, 2026 |
Estimated Study Completion Date : | April 1, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Electronic Consult (E-consult)
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.
|
Other: E-consult
In implementing the electronic consultation system in the private sector, the investigators will model the Expected Practice developed by the Los Angeles County Specialty-Primary Care Work Group. This eConsult system utilizes a "kickback" mechanism by which a specialist, who reviews the referral, can return it if it has not met certain baseline criteria (e.g. for a woman with OAB/urinary urgency: document negative UA, scheduled voids, titrate fluids to thirst, Kegels, antimuscarinics, optimize diuretic control, adjust any diuretics). |
Experimental: Advanced Practice Provider (APP) Co-management
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).
|
Other: APP Co-management
To reduce additional burden of care on the PCPs, the investigators will incorporate Advanced Practices Providers into the patient education and self-management portion of care. The APPs will be trained together with the intervention physicians, but they will also undergo additional standardized training on patient education, UI knowledge, providing instruction on Kegel exercises, shared decision making, and self management. Patients will then be scheduled for a UI education and self-management session with the APP by telemedicine (video visit or telephone visit) within one month of their initial visit. For patients in need of an annual pelvic examination, and if the patient's PCP prefers to have the APP conduct the pelvic exam, a separate visit will be scheduled with the APP. A followup televisit will then be scheduled within three months of the initial APP visit, in order to assess the outcome of non-surgical treatment and determine if a specialist referral is indicated. |
- Provider Quality of Care - Evidence-Based Quality Indicators [ Time Frame: Baseline ]Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
- Provider Quality of Care - Evidence-Based Quality Indicators [ Time Frame: 6 months ]Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
- Change in provider quality of care measured by evidence-based quality indicators [ Time Frame: Baseline, 6 months ]Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
- Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) [ Time Frame: Baseline ]The ICIQ-SF is a six item questionnaire that assesses the patient's frequency of urinary leakage and how it has negatively impacted their daily activities. The minimum ICIQ score of 0 indicates patient is not bothered by urinary incontinence, while the maximum ICIQ score of 21 indicates the patient's quality of life is negatively impacted a great deal by urinary incontinence.
- Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) [ Time Frame: 3 months ]The ICIQ-SF is a six item questionnaire that assesses the patient's frequency of urinary leakage and how it has negatively impacted their daily activities. The minimum ICIQ score of 0 indicates patient is not bothered by urinary incontinence, while the maximum ICIQ score of 21 indicates the patient's quality of life is negatively impacted a great deal by urinary incontinence.
- Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) [ Time Frame: 6 months ]The ICIQ-SF is a six item questionnaire that assesses the patient's frequency of urinary leakage and how it has negatively impacted their daily activities. The minimum ICIQ score of 0 indicates patient is not bothered by urinary incontinence, while the maximum ICIQ score of 21 indicates the patient's quality of life is negatively impacted a great deal by urinary incontinence.
- Change in patients' urinary incontinence symptoms as measured by ICIQ-SF [ Time Frame: Baseline, 3 months, 6 months ]The ICIQ-SF is a six item questionnaire that assesses the patient's frequency of urinary leakage and how it has negatively impacted their daily activities. The minimum ICIQ score of 0 indicates patient is not bothered by urinary incontinence, while the maximum ICIQ score of 21 indicates the patient's quality of life is negatively impacted a great deal by urinary incontinence.
- Patient Symptoms - Urogenital Distress Inventory (UDI-6) [ Time Frame: Baseline ]The UDI-6 is the urinary incontinence (UI) assessment tool endorsed by the American Urological Association and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). It contains only 6 questions and differentiates the type of UI (SUI vs. UUI), symptoms associated with UI, severity of symptoms and symptom bother. Furthermore, the UDI-6 gives a summative score that has been demonstrated to be sensitive to change with treatment and correlates with quality of life indices.
- Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6) [ Time Frame: 3 months ]The UDI-6 is the urinary incontinence (UI) assessment tool endorsed by the American Urological Association and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). It contains only 6 questions and differentiates the type of UI (SUI vs. UUI), symptoms associated with UI, severity of symptoms and symptom bother. Furthermore, the UDI-6 gives a summative score that has been demonstrated to be sensitive to change with treatment and correlates with quality of life indices.
- Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6) [ Time Frame: 6 months ]The UDI-6 is the urinary incontinence (UI) assessment tool endorsed by the American Urological Association and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). It contains only 6 questions and differentiates the type of UI (SUI vs. UUI), symptoms associated with UI, severity of symptoms and symptom bother. Furthermore, the UDI-6 gives a summative score that has been demonstrated to be sensitive to change with treatment and correlates with quality of life indices.
- Change in patients' urinary symptoms as measured by UDI-6 [ Time Frame: Baseline, 3 months, 6 months ]The UDI-6 is the urinary incontinence (UI) assessment tool endorsed by the American Urological Association and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). It contains only 6 questions and differentiates the type of UI (SUI vs. UUI), symptoms associated with UI, severity of symptoms and symptom bother. Furthermore, the UDI-6 gives a summative score that has been demonstrated to be sensitive to change with treatment and correlates with quality of life indices.
- Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: Baseline ]The IIQ-7 is a seven-item questionnaire that assesses the impact of UI on health-related quality of life, with the minimum score of 0 indicating no impact and a maximum score of 21 indicating significant disruption of daily activities, relationships, and feelings.
- Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: 3 months ]The IIQ-7 is a seven-item questionnaire that assesses the impact of UI on health-related quality of life, with the minimum score of 0 indicating no impact and a maximum score of 21 indicating significant disruption of daily activities, relationships, and feelings.
- Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: 6 months ]The IIQ-7 is a seven-item questionnaire that assesses the impact of UI on health-related quality of life, with the minimum score of 0 indicating no impact and a maximum score of 21 indicating significant disruption of daily activities, relationships, and feelings.
- Change in impact of UI on patients' quality of life as measure by the Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: Baseline, 3 months, 6 months ]The IIQ-7 is a seven-item questionnaire that assesses the impact of UI on health-related quality of life, with the minimum score of 0 indicating no impact and a maximum score of 21 indicating significant disruption of daily activities, relationships, and feelings.
- Patient Decision Making - Shared Decision Making Questionnaire (SDM-Q-9) [ Time Frame: 3 months ]Nine-item questionnaire that measures the extent to which patients are involved in the process of decision-making. This questionnaire requires patients to indicate how strongly they agree with given statements on a scale (completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, completely agree).
- Patient Satisfaction - Net Promoter Score [ Time Frame: 3 months ]The Net Promoter Score evaluates a patient's willingness to refer a friend to the provider from whom they received care and to the institution where they received care. Patients respond on a 5-item Likert score on how likely they would be to make the referrals. Patients are ranked as "Detractors", "Passive", and "Promoters". The Net Promoter Score is calculated by subtracting the group percentage of "Promoters" from the group percentage of "Detractors."
- Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS) [ Time Frame: Baseline ]Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life.
- Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS) [ Time Frame: 6 months ]Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life.
- Change in patients' knowledge as measured by the P-FAKS [ Time Frame: Baseline, 6 months ]Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life.
- Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS) [ Time Frame: Baseline ]Nine-item questionnaire that measures the extent to which patients are involved in the process of decision-making. This questionnaire requires patients to indicate how strongly they agree with given statements on a scale (completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, completely agree).
- Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS) [ Time Frame: 6 months ]Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life.
- Change in provider knowledge as measured by the P-FAKS [ Time Frame: Baseline, 6 months ]Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria of Primary Care Physicians:
- Primary care physician belonging to a recruited office among one of three participating sites: UCSD, UCLA, KUMC
Inclusion Criteria of Patients:
- Age >18 y/o
- English or Spanish fluency
- Female
- Answers "yes" to incontinence screening tool and agrees to participate
Exclusion Criteria of Primary Care Physicians:
- Non-primary care specialty
- Does not belong to one of the participating offices
Exclusion Criteria of Patients:
- Age <18 y/o
- Answers "no" to incontinence screening tool and/or does not agree to participate
- Primary care provider (who reviews a list of patients that screen positive) deems patient ineligible due to pregnant, severe memory impairment, or psychiatric history preventing participation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06040645
Contact: Jennifer Anger, MD | 3108479299 | janger@health.ucsd.edu |
Responsible Party: | Jennifer Anger, Professor of Urology, Vice Chair of Research, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT06040645 |
Other Study ID Numbers: |
806024 |
First Posted: | September 15, 2023 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Available by request. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Practice-based intervention Patient-centered outcomes research Disparities |
Referrals Quality of care indicators Primary care |
Urinary Incontinence Enuresis Urination Disorders Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Male Urogenital Diseases Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders |