xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040645</url>
    </required_header>
    <id_info>
      <org_study_id>806024</org_study_id>
      <nct_id>NCT06040645</nct_id>
    </id_info>
    <brief_title>Outcomes of Urinary Incontinence Treatment in Primary Care: APP Co-Management and Electronic Consult</brief_title>
    <acronym>OUTPACE</acronym>
    <official_title>Outcomes of Urinary Incontinence Treatment in Primary Care: APP Co-Management and Electronic Consult</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Diego</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Patient-Centered Outcomes Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of California, Los Angeles</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Kansas</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Diego</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The burden of urinary incontinence (UI) on American women is immense in both human and&#xD;
        financial terms, and continues to rise with the aging US population. Although numerous&#xD;
        non-surgical management strategies have proven efficacy for both stress and urge urinary&#xD;
        incontinence, there remains a lack of appropriate UI management in the primary care setting.&#xD;
        The goal of this multi-site cluster randomized comparative effectiveness trial is to compare&#xD;
        the effects of two methods of nonsurgical UI care delivery - electronic consult vs. advanced&#xD;
        practice provider (APP) co-management. These two evidence-based, practice-changing strategies&#xD;
        are designed to improve the quality of care for an ethnically diverse population of women&#xD;
        with UI, and, by reducing deficits in care, obtain better patient-reported outcomes. Both&#xD;
        arms of the study will include basic physician education (academic detailing) and electronic&#xD;
        clinical decision support. In Arm 1, the investigators will implement an electronic referral&#xD;
        system (electronic referral), in which specialists will electronically review referrals and&#xD;
        make additional recommendations if appropriate primary UI care was not provided. In Arm 2,&#xD;
        Advanced Practice Provider (APP) co-management will reduce the burden of care on the PCPs by&#xD;
        providing UI care, patient education, and assisting with patient self-management through&#xD;
        dedicated televisits (APP co-management).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Burden of Urinary Incontinence on American Women is Immense: Although a great deal of&#xD;
        research on quality of care has been conducted in many areas of medicine and surgery, there&#xD;
        remains a relative paucity of data regarding the quality of care for women with urinary&#xD;
        incontinence (UI). UI is defined by the International Continence Society as the complaint of&#xD;
        any involuntary leakage of urine.(4) The burden of UI on American women is immense in both&#xD;
        human and financial terms, and continues to rise with the aging population. According to the&#xD;
        National Health and Nutrition Examination Survey, the prevalence of UI among women ranges&#xD;
        from 38%-53%.(5,6) The lifetime risk of undergoing surgery for UI or pelvic organ prolapse is&#xD;
        20%.(1) With the aging of the baby boomers it is projected that the number of women with UI&#xD;
        will increase by 55% by 2050.(7) UI negatively impacts health-related quality of life and is&#xD;
        associated with embarrassment, stigma, and social isolation.(8) Primary Care Interventions&#xD;
        for UI are Needed. In prior research by our team to provide background for the current&#xD;
        proposal, we sought to qualitatively assess challenges and barriers that primary care&#xD;
        providers (PCPs) experience in caring for patients with UI. Twelve providers from the&#xD;
        specialties of family medicine, general internal medicine, and geriatrics were interviewed.&#xD;
        Providers described a lack of understanding of important components of a pelvic exam. Some&#xD;
        male providers mentioned their own discomfort performing a pelvic exam on women. PCPs also&#xD;
        discussed uncertainty in reaching a correct UI diagnosis (stress urinary incontinence, SUI,&#xD;
        vs. urge urinary incontinence, UUI). There were also concerns about anticholinergic drug&#xD;
        interactions and their association with cognitive impairment. There was a general lack of&#xD;
        familiarity with medication options and dosing and a lack of knowledge about logistics in&#xD;
        referring to pelvic floor physical therapy. Providers mentioned the need for an algorithm for&#xD;
        the treatment of UI. They also described systems barriers included competing priorities with&#xD;
        other medical issues, time limitations, and lack of interest in caring for patients with UI&#xD;
        (unpublished).&#xD;
  &#xD;
        The Care for Women with Urinary Incontinence Does Not Meet Recommended Standards of Care:&#xD;
        With the assistance of co-I Dr. David Reuben, indicators of high quality were developed for&#xD;
        vulnerable community-dwelling elders with urinary incontinence.(9,10) Quality of care for UI&#xD;
        was found to be grossly inadequate. In fact, pelvic examination, an important process&#xD;
        measure, was performed in only 20% of older women with UI. Only 50% of patients received&#xD;
        medical treatment for incontinence, and only 13% were prescribed behavioral modification,&#xD;
        despite its proven effectiveness.(10) In a sample of 247 women consecutively referred for new&#xD;
        or worsening bothersome UI to FPMRS group practices at Cedars-Sinai, UCLA, and Harbor-UCLA,&#xD;
        the investigators found that women ≥75 years of age were less likely than younger women to&#xD;
        have received primary care for UI. In fact, older women were less likely to have a focused&#xD;
        history obtained that differentiated between SUI and UUI (55% vs 77%, p&lt;0.05), and were less&#xD;
        likely to receive a pelvic exam (26% vs 50%, p&lt;0.01) when compared to their younger&#xD;
        counterparts. However, rates of behavioral management initiation were low in both older and&#xD;
        younger groups, with only 30% of PCPs offering behavioral management (manuscript submitted to&#xD;
        the American Journal of Medicine).&#xD;
  &#xD;
        Access to Care for Underserved Latinas with Urinary Incontinence is Poor: Access to specialty&#xD;
        care, which typically refers to in-person evaluation in a specialty clinic, is insufficient,&#xD;
        particularly for underserved populations.(11-13) Current physician shortages affect&#xD;
        subspecialties disproportionately, and will be exacerbated as our population ages.(14,15) In&#xD;
        2014, there were 3.6 million older adult Hispanics (8% of the older U.S. population); this&#xD;
        number is expected to grow to 21.5 million by 2060 (data from the National Hispanic Council&#xD;
        on Aging). Hispanic women bear a disproportionate burden of stress and mixed UI,(14,15) yet&#xD;
        may receive inferior care than other ethnic groups. We conducted focus groups to compare&#xD;
        perceptions and barriers between Spanish and English speaking women in public and private&#xD;
        hospitals being treated for UI.(16,17) Knowledge gaps were greater among Spanish&#xD;
        speakers.(17) Dr. Anger and her research team at UCLA-Olive View Medical Center (public&#xD;
        hospital-based outpatient clinics) then sought to evaluate barriers in communication and&#xD;
        disease understanding among office staff and interpreters when communicating with&#xD;
        Spanish-speaking women with UI. Sixteen office staff and interpreters were interviewed.&#xD;
        Patient-related barriers included a lack of understanding of anatomy and medical terminology&#xD;
        and inhibited discussions due to embarrassment. Provider-related barriers included poor&#xD;
        interpreter knowledge of pelvic floor vocabulary and the frequent use of office staff without&#xD;
        interpreting credentials.(17)k This work identified obstacles in communication-barriers that&#xD;
        only Spanish speaking women face. In this proposal we seek to directly measure and improve&#xD;
        the care provided to a heterogeneous population of women with UI, with the goals of improving&#xD;
        care, improving UI outcomes, and improving knowledge and shared decision making, while&#xD;
        simultaneously removing language barriers.&#xD;
  &#xD;
        SIGNIFICANCE This study is significant for several reasons. First, in both study arms the&#xD;
        investigators will bring subspecialty expertise to primary care settings, improving on&#xD;
        interventions that have been done previously. The investigators will apply a set of QIs that&#xD;
        represent the latest patient-centered outcomes research (PCOR) evidence regarding nonsurgical&#xD;
        treatments for UI in women, and are all identifiable in the medical record. The QIs we&#xD;
        developed are a more comprehensive set than the original ACOVE indicators, developed by&#xD;
        subspecialists and primary care providers. Whereas the ACOVE project focused on primary care&#xD;
        interventions for UI among older adults at risk of decline, the new indicators distinguish&#xD;
        stress vs. urge incontinence, are tailored for management of each type of incontinence, and&#xD;
        are applicable across all populations of adult women. The research team's prior work has&#xD;
        shown that, in a group of ambulatory patients aged 75+ who screened positive for UI (n=133),&#xD;
        better quality of care for UI was associated with a measurable improvement in&#xD;
        participant-reported outcomes. Composite quality scores (percentage of QIs passed per&#xD;
        participant) and change in Incontinence Quality of Life (IQOL) questionnaire scores (range&#xD;
        0-100) were used as measurements. Each 10% increment in receipt of recommended care for UI&#xD;
        was associated with a 1.4-point improvement in IQOL score (p=0.01), a clinically meaningful&#xD;
        difference.(18) The investigators expect to see a much larger impact on UI outcomes with this&#xD;
        intervention, both arms of which have been tested and shown to make great strides in quality&#xD;
        improvement.&#xD;
  &#xD;
        There is abundant evidence supporting various nonsurgical management strategies for UI,&#xD;
        including behavioral modification, pelvic floor exercises, and initiation of medication for&#xD;
        overactive bladder/urge urinary incontinence. However, there are significant barriers to&#xD;
        delivery of these strategies at the primary care level. We have identified the two&#xD;
        evidenced-based nonsurgical UI care delivery methods that have the greatest impact on care.&#xD;
        One study arm to be evaluated is electronic co-management, which has multiple elements, all&#xD;
        taken after the successful model created by the Los Angeles County Department of Health&#xD;
        Services,(19,20) the second largest public health care system in the country. eConsult&#xD;
        (eConsult Health Ltd, London, England) is an electronic asynchronous consultation tool that&#xD;
        was developed with the goals of increasing access, improving dialogue, optimizing efficiency,&#xD;
        and enhancing primary care capacity. This infrastructure allows specialists to review&#xD;
        electronic referrals and, when needed, return them and make recommendations to the PCP. This&#xD;
        model empowers PCPs to more robustly manage conditions, and to streamline care if a&#xD;
        specialist visit is necessary. The investigators will implement an electronic consultation&#xD;
        system for patients in primary care offices at all sites. We recently compared primary care&#xD;
        for UI between private and public systems, and found that the public sector provided better&#xD;
        primary care for UI.&#xD;
  &#xD;
        The other study arm will be Advanced Practice Provider (APP) co-management. APPs will conduct&#xD;
        the patient education portion of the intervention in the primary care setting. APP&#xD;
        co-management has been shown to have a greater impact on quality than other educational&#xD;
        measures for other chronic conditions affecting older persons, including dementia,(21) and&#xD;
        can substantially reduce the work needed on the part of PCPs. APP co-management will also&#xD;
        leverage the recent Covid-19 related implementation of telemedicine. This will allow an APP&#xD;
        to provide patient-centered care across different offices in a given healthcare system. In&#xD;
        addition, based our prior findings of multiple levels of barriers to care for Spanish&#xD;
        speaking women with UI, the research team will include certified bilingual APPs in the study&#xD;
        so that Spanish speaking women will have a full understanding of what is taught to them. This&#xD;
        will increase their knowledge level and allow for shared decision making (SDM) from a more&#xD;
        informed perspective. Because UI is a chronic condition, patients need to play an active role&#xD;
        in their care and be able to make their own decisions regarding UI management. Therefore, the&#xD;
        investigators will also measure whether our intervention improves knowledge and perceived&#xD;
        shared decision making. Lastly, the investigators will ensure that these approaches are&#xD;
        tested in diverse populations to promote equitable care. As a secondary analysis, we will&#xD;
        test whether our proposed intervention reduces disparities in UI care. Should one, or even&#xD;
        both, of our proposed interventions be effective in improving quality and outcomes, similar&#xD;
        interventions can be easily implemented in most settings. Success of our intervention could&#xD;
        lead to wide-scale implementation of effective, yet cost saving, quality improvement methods&#xD;
        that reduce the burden of care on PCPs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Provider Quality of Care - Evidence-Based Quality Indicators</measure>
      <time_frame>Baseline</time_frame>
      <description>Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Provider Quality of Care - Evidence-Based Quality Indicators</measure>
      <time_frame>6 months</time_frame>
      <description>Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in provider quality of care measured by evidence-based quality indicators</measure>
      <time_frame>Baseline, 6 months</time_frame>
      <description>Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)</measure>
      <time_frame>3 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in patients' urinary incontinence symptoms as measured by ICIQ-SF</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Symptoms - Urogenital Distress Inventory (UDI-6)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)</measure>
      <time_frame>3 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in patients' urinary symptoms as measured by UDI-6</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)</measure>
      <time_frame>3 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in impact of UI on patients' quality of life as measure by the Incontinence Impact Questionnaire (IIQ-7)</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Decision Making - Shared Decision Making Questionnaire (SDM-Q-9)</measure>
      <time_frame>3 months</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction - Net Promoter Score</measure>
      <time_frame>3 months</time_frame>
      <description>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 &quot;Detractors&quot;, &quot;Passive&quot;, and &quot;Promoters&quot;. The Net Promoter Score is calculated by subtracting the group percentage of &quot;Promoters&quot; from the group percentage of &quot;Detractors.&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in patients' knowledge as measured by the P-FAKS</measure>
      <time_frame>Baseline, 6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)</measure>
      <time_frame>Baseline</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in provider knowledge as measured by the P-FAKS</measure>
      <time_frame>Baseline, 6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1200</enrollment>
    <condition>Urinary Incontinence</condition>
    <arm_group>
      <arm_group_label>Electronic Consult (E-consult)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Advanced Practice Provider (APP) Co-management</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>APP Co-management</intervention_name>
      <description>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.&#xD;
  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.</description>
      <arm_group_label>Advanced Practice Provider (APP) Co-management</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>E-consult</intervention_name>
      <description>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 &quot;kickback&quot; 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).</description>
      <arm_group_label>Electronic Consult (E-consult)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria of Primary Care Physicians:&#xD;
  &#xD;
          - Primary care physician belonging to a recruited office among one of three participating&#xD;
          sites: UCSD, UCLA, KUMC&#xD;
  &#xD;
          Inclusion Criteria of Patients:&#xD;
  &#xD;
            -  Age &gt;18 y/o&#xD;
  &#xD;
            -  English or Spanish fluency&#xD;
  &#xD;
            -  Female&#xD;
  &#xD;
            -  Answers &quot;yes&quot; to incontinence screening tool and agrees to participate&#xD;
  &#xD;
          Exclusion Criteria of Primary Care Physicians:&#xD;
  &#xD;
            -  Non-primary care specialty&#xD;
  &#xD;
            -  Does not belong to one of the participating offices&#xD;
  &#xD;
          Exclusion Criteria of Patients:&#xD;
  &#xD;
            -  Age &lt;18 y/o&#xD;
  &#xD;
            -  Answers &quot;no&quot; to incontinence screening tool and/or does not agree to participate&#xD;
  &#xD;
            -  Primary care provider (who reviews a list of patients that screen positive) deems&#xD;
               patient ineligible due to pregnant, severe memory impairment, or psychiatric history&#xD;
               preventing participation&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jennifer Anger, MD</last_name>
      <phone>3108479299</phone>
      <email>janger@health.ucsd.edu</email>
    </overall_contact>
    <reference>
      <citation>Dieter AA, Wilkins MF, Wu JM. Epidemiological trends and future care needs for pelvic floor disorders. Curr Opin Obstet Gynecol. 2015 Oct;27(5):380-4. doi: 10.1097/GCO.0000000000000200.</citation>
      <PMID>26308198</PMID>
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      <PMID>24105879</PMID>
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      <PMID>17347793</PMID>
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      <PMID>11601959</PMID>
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      <PMID>15115573</PMID>
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      <PMID>21675891</PMID>
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      <PMID>23312670</PMID>
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      <citation>Mehrotra A, Forrest CB, Lin CY. Dropping the baton: specialty referrals in the United States. Milbank Q. 2011 Mar;89(1):39-68. doi: 10.1111/j.1468-0009.2011.00619.x.</citation>
      <PMID>21418312</PMID>
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      <citation>Dall TM, Gallo PD, Chakrabarti R, West T, Semilla AP, Storm MV. An aging population and growing disease burden will require a large and specialized health care workforce by 2025. Health Aff (Millwood). 2013 Nov;32(11):2013-20. doi: 10.1377/hlthaff.2013.0714.</citation>
      <PMID>24191094</PMID>
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      <citation>McKibben MJ, Kirby EW, Langston J, Raynor MC, Nielsen ME, Smith AB, Wallen EM, Woods ME, Pruthi RS. Projecting the Urology Workforce Over the Next 20 Years. Urology. 2016 Dec;98:21-26. doi: 10.1016/j.urology.2016.07.028. Epub 2016 Aug 1.</citation>
      <PMID>27491965</PMID>
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      <citation>Alas AN, Dunivan GC, Wieslander CK, Sevilla C, Barrera B, Rashid R, Maliski S, Eilber K, Rogers RG, Anger JT. Health Care Disparities Among English-Speaking and Spanish-Speaking Women With Pelvic Organ Prolapse at Public and Private Hospitals: What Are the Barriers? Female Pelvic Med Reconstr Surg. 2016 Nov/Dec;22(6):460-466. doi: 10.1097/SPV.0000000000000315.</citation>
      <PMID>27636216</PMID>
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      <citation>Khan AA, Sevilla C, Wieslander CK, Moran MB, Rashid R, Mittal B, Maliski SL, Rogers RG, Anger JT. Communication barriers among Spanish-speaking women with pelvic floor disorders: lost in translation? Female Pelvic Med Reconstr Surg. 2013 May-Jun;19(3):157-64. doi: 10.1097/SPV.0b013e318288ac1c.</citation>
      <PMID>23611934</PMID>
    </reference>
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      <citation>Min LC, Reuben DB, Adams J, Shekelle PG, Ganz DA, Roth CP, Wenger NS. Does better quality of care for falls and urinary incontinence result in better participant-reported outcomes? J Am Geriatr Soc. 2011 Aug;59(8):1435-43. doi: 10.1111/j.1532-5415.2011.03517.x. Epub 2011 Aug 1.</citation>
      <PMID>21806560</PMID>
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      <citation>Barnett ML, Yee HF Jr, Mehrotra A, Giboney P. Los Angeles Safety-Net Program eConsult System Was Rapidly Adopted And Decreased Wait Times To See Specialists. Health Aff (Millwood). 2017 Mar 1;36(3):492-499. doi: 10.1377/hlthaff.2016.1283.</citation>
      <PMID>28264951</PMID>
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      <citation>Soni SM, Giboney P, Yee HF Jr. Development and Implementation of Expected Practices to Reduce Inappropriate Variations in Clinical Practice. JAMA. 2016 May 24-31;315(20):2163-4. doi: 10.1001/jama.2016.4255. No abstract available.</citation>
      <PMID>27218624</PMID>
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      <citation>Jennings LA, Tan Z, Wenger NS, Cook EA, Han W, McCreath HE, Serrano KS, Roth CP, Reuben DB. Quality of Care Provided by a Comprehensive Dementia Care Comanagement Program. J Am Geriatr Soc. 2016 Aug;64(8):1724-30. doi: 10.1111/jgs.14251. Epub 2016 Jun 29.</citation>
      <PMID>27355394</PMID>
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      <citation>Bordeianou LG, Anger JT, Boutros M, Birnbaum E, Carmichael JC, Connell KA, De EJB, Mellgren A, Staller K, Vogler SA, Weinstein MM, Yafi FA, Hull TL; Members of the Pelvic Floor Disorders Consortium Working Groups on Patient-Reported Outcomes. Measuring Pelvic Floor Disorder Symptoms Using Patient-Reported Instruments: Proceedings of the Consensus Meeting of the Pelvic Floor Consortium of the American Society of Colon and Rectal Surgeons, the International Continence Society, the American Urogynecologic Society, and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction. Female Pelvic Med Reconstr Surg. 2020 Jan/Feb;26(1):1-15. doi: 10.1097/SPV.0000000000000817. No abstract available.</citation>
      <PMID>31833996</PMID>
    </reference>
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      <citation>McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J, DeCristofaro A, Kerr EA. The quality of health care delivered to adults in the United States. N Engl J Med. 2003 Jun 26;348(26):2635-45. doi: 10.1056/NEJMsa022615.</citation>
      <PMID>12826639</PMID>
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      <citation>Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.</citation>
      <PMID>12861145</PMID>
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      <citation>Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.</citation>
      <PMID>16021067</PMID>
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      <citation>Min LC, Reuben DB, MacLean CH, Shekelle PG, Solomon DH, Higashi T, Chang JT, Roth CP, Kamberg CJ, Adams J, Young RT, Wenger NS. Predictors of overall quality of care provided to vulnerable older people. J Am Geriatr Soc. 2005 Oct;53(10):1705-11. doi: 10.1111/j.1532-5415.2005.53520.x.</citation>
      <PMID>16181169</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, San Diego</investigator_affiliation>
      <investigator_full_name>Jennifer Anger</investigator_full_name>
      <investigator_title>Professor of Urology, Vice Chair of Research</investigator_title>
    </responsible_party>
    <keyword>Practice-based intervention</keyword>
    <keyword>Patient-centered outcomes research</keyword>
    <keyword>Disparities</keyword>
    <keyword>Referrals</keyword>
    <keyword>Quality of care indicators</keyword>
    <keyword>Primary care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Incontinence</mesh_term>
      <mesh_term>Enuresis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Available by request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040645
  org study id: 806024
  nct id: NCT06040645
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The burden of urinary incontinence (UI) on American women is immense in both human and
        financial terms, and continues to rise with the aging US population. Although numerous
        non-surgical management strategies have proven efficacy for both stress and urge urinary
        incontinence, there remains a lack of appropriate UI management in the primary care setting.
        The goal of this multi-site cluster randomized comparative effectiveness trial is to compare
        the effects of two methods of nonsurgical UI care delivery - electronic consult vs. advanced
        practice provider (APP) co-management. These two evidence-based, practice-changing strategies
        are designed to improve the quality of care for an ethnically diverse population of women
        with UI, and, by reducing deficits in care, obtain better patient-reported outcomes. Both
        arms of the study will include basic physician education (academic detailing) and electronic
        clinical decision support. In Arm 1, the investigators will implement an electronic referral
        system (electronic referral), in which specialists will electronically review referrals and
        make additional recommendations if appropriate primary UI care was not provided. 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).
  The Burden of Urinary Incontinence on American Women is Immense: Although a great deal of
        research on quality of care has been conducted in many areas of medicine and surgery, there
        remains a relative paucity of data regarding the quality of care for women with urinary
        incontinence (UI). UI is defined by the International Continence Society as the complaint of
        any involuntary leakage of urine.(4) The burden of UI on American women is immense in both
        human and financial terms, and continues to rise with the aging population. According to the
        National Health and Nutrition Examination Survey, the prevalence of UI among women ranges
        from 38%-53%.(5,6) The lifetime risk of undergoing surgery for UI or pelvic organ prolapse is
        20%.(1) With the aging of the baby boomers it is projected that the number of women with UI
        will increase by 55% by 2050.(7) UI negatively impacts health-related quality of life and is
        associated with embarrassment, stigma, and social isolation.(8) Primary Care Interventions
        for UI are Needed. In prior research by our team to provide background for the current
        proposal, we sought to qualitatively assess challenges and barriers that primary care
        providers (PCPs) experience in caring for patients with UI. Twelve providers from the
        specialties of family medicine, general internal medicine, and geriatrics were interviewed.
        Providers described a lack of understanding of important components of a pelvic exam. Some
        male providers mentioned their own discomfort performing a pelvic exam on women. PCPs also
        discussed uncertainty in reaching a correct UI diagnosis (stress urinary incontinence, SUI,
        vs. urge urinary incontinence, UUI). There were also concerns about anticholinergic drug
        interactions and their association with cognitive impairment. There was a general lack of
        familiarity with medication options and dosing and a lack of knowledge about logistics in
        referring to pelvic floor physical therapy. Providers mentioned the need for an algorithm for
        the treatment of UI. They also described systems barriers included competing priorities with
        other medical issues, time limitations, and lack of interest in caring for patients with UI
        (unpublished).
  
        The Care for Women with Urinary Incontinence Does Not Meet Recommended Standards of Care:
        With the assistance of co-I Dr. David Reuben, indicators of high quality were developed for
        vulnerable community-dwelling elders with urinary incontinence.(9,10) Quality of care for UI
        was found to be grossly inadequate. In fact, pelvic examination, an important process
        measure, was performed in only 20% of older women with UI. Only 50% of patients received
        medical treatment for incontinence, and only 13% were prescribed behavioral modification,
        despite its proven effectiveness.(10) In a sample of 247 women consecutively referred for new
        or worsening bothersome UI to FPMRS group practices at Cedars-Sinai, UCLA, and Harbor-UCLA,
        the investigators found that women ≥75 years of age were less likely than younger women to
        have received primary care for UI. In fact, older women were less likely to have a focused
        history obtained that differentiated between SUI and UUI (55% vs 77%, p<0.05), and were less
        likely to receive a pelvic exam (26% vs 50%, p<0.01) when compared to their younger
        counterparts. However, rates of behavioral management initiation were low in both older and
        younger groups, with only 30% of PCPs offering behavioral management (manuscript submitted to
        the American Journal of Medicine).
  
        Access to Care for Underserved Latinas with Urinary Incontinence is Poor: Access to specialty
        care, which typically refers to in-person evaluation in a specialty clinic, is insufficient,
        particularly for underserved populations.(11-13) Current physician shortages affect
        subspecialties disproportionately, and will be exacerbated as our population ages.(14,15) In
        2014, there were 3.6 million older adult Hispanics (8% of the older U.S. population); this
        number is expected to grow to 21.5 million by 2060 (data from the National Hispanic Council
        on Aging). Hispanic women bear a disproportionate burden of stress and mixed UI,(14,15) yet
        may receive inferior care than other ethnic groups. We conducted focus groups to compare
        perceptions and barriers between Spanish and English speaking women in public and private
        hospitals being treated for UI.(16,17) Knowledge gaps were greater among Spanish
        speakers.(17) Dr. Anger and her research team at UCLA-Olive View Medical Center (public
        hospital-based outpatient clinics) then sought to evaluate barriers in communication and
        disease understanding among office staff and interpreters when communicating with
        Spanish-speaking women with UI. Sixteen office staff and interpreters were interviewed.
        Patient-related barriers included a lack of understanding of anatomy and medical terminology
        and inhibited discussions due to embarrassment. Provider-related barriers included poor
        interpreter knowledge of pelvic floor vocabulary and the frequent use of office staff without
        interpreting credentials.(17)k This work identified obstacles in communication-barriers that
        only Spanish speaking women face. In this proposal we seek to directly measure and improve
        the care provided to a heterogeneous population of women with UI, with the goals of improving
        care, improving UI outcomes, and improving knowledge and shared decision making, while
        simultaneously removing language barriers.
  
        SIGNIFICANCE This study is significant for several reasons. First, in both study arms the
        investigators will bring subspecialty expertise to primary care settings, improving on
        interventions that have been done previously. The investigators will apply a set of QIs that
        represent the latest patient-centered outcomes research (PCOR) evidence regarding nonsurgical
        treatments for UI in women, and are all identifiable in the medical record. The QIs we
        developed are a more comprehensive set than the original ACOVE indicators, developed by
        subspecialists and primary care providers. Whereas the ACOVE project focused on primary care
        interventions for UI among older adults at risk of decline, the new indicators distinguish
        stress vs. urge incontinence, are tailored for management of each type of incontinence, and
        are applicable across all populations of adult women. The research team's prior work has
        shown that, in a group of ambulatory patients aged 75+ who screened positive for UI (n=133),
        better quality of care for UI was associated with a measurable improvement in
        participant-reported outcomes. Composite quality scores (percentage of QIs passed per
        participant) and change in Incontinence Quality of Life (IQOL) questionnaire scores (range
        0-100) were used as measurements. Each 10% increment in receipt of recommended care for UI
        was associated with a 1.4-point improvement in IQOL score (p=0.01), a clinically meaningful
        difference.(18) The investigators expect to see a much larger impact on UI outcomes with this
        intervention, both arms of which have been tested and shown to make great strides in quality
        improvement.
  
        There is abundant evidence supporting various nonsurgical management strategies for UI,
        including behavioral modification, pelvic floor exercises, and initiation of medication for
        overactive bladder/urge urinary incontinence. However, there are significant barriers to
        delivery of these strategies at the primary care level. We have identified the two
        evidenced-based nonsurgical UI care delivery methods that have the greatest impact on care.
        One study arm to be evaluated is electronic co-management, which has multiple elements, all
        taken after the successful model created by the Los Angeles County Department of Health
        Services,(19,20) the second largest public health care system in the country. eConsult
        (eConsult Health Ltd, London, England) is an electronic asynchronous consultation tool that
        was developed with the goals of increasing access, improving dialogue, optimizing efficiency,
        and enhancing primary care capacity. This infrastructure allows specialists to review
        electronic referrals and, when needed, return them and make recommendations to the PCP. This
        model empowers PCPs to more robustly manage conditions, and to streamline care if a
        specialist visit is necessary. The investigators will implement an electronic consultation
        system for patients in primary care offices at all sites. We recently compared primary care
        for UI between private and public systems, and found that the public sector provided better
        primary care for UI.
  
        The other study arm will be Advanced Practice Provider (APP) co-management. APPs will conduct
        the patient education portion of the intervention in the primary care setting. APP
        co-management has been shown to have a greater impact on quality than other educational
        measures for other chronic conditions affecting older persons, including dementia,(21) and
        can substantially reduce the work needed on the part of PCPs. APP co-management will also
        leverage the recent Covid-19 related implementation of telemedicine. This will allow an APP
        to provide patient-centered care across different offices in a given healthcare system. In
        addition, based our prior findings of multiple levels of barriers to care for Spanish
        speaking women with UI, the research team will include certified bilingual APPs in the study
        so that Spanish speaking women will have a full understanding of what is taught to them. This
        will increase their knowledge level and allow for shared decision making (SDM) from a more
        informed perspective. Because UI is a chronic condition, patients need to play an active role
        in their care and be able to make their own decisions regarding UI management. Therefore, the
        investigators will also measure whether our intervention improves knowledge and perceived
        shared decision making. Lastly, the investigators will ensure that these approaches are
        tested in diverse populations to promote equitable care. As a secondary analysis, we will
        test whether our proposed intervention reduces disparities in UI care. Should one, or even
        both, of our proposed interventions be effective in improving quality and outcomes, similar
        interventions can be easily implemented in most settings. Success of our intervention could
        lead to wide-scale implementation of effective, yet cost saving, quality improvement methods
        that reduce the burden of care on PCPs.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Provider Quality of Care - Evidence-Based Quality Indicators
  time frame: Baseline
  description: Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
  measure: Provider Quality of Care - Evidence-Based Quality Indicators
  time frame: 6 months
  description: Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
  measure: Change in provider quality of care measured by evidence-based quality indicators
  time frame: Baseline, 6 months
  description: Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.
  measure: Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
  time frame: Baseline
  description: 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.
  measure: Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
  time frame: 3 months
  description: 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.
  measure: Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
  time frame: 6 months
  description: 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.
  measure: Change in patients' urinary incontinence symptoms as measured by ICIQ-SF
  time frame: Baseline, 3 months, 6 months
  description: 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.
  measure: Patient Symptoms - Urogenital Distress Inventory (UDI-6)
  time frame: Baseline
  description: 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.
  measure: Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)
  time frame: 3 months
  description: 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.
  measure: Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)
  time frame: 6 months
  description: 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.
  measure: Change in patients' urinary symptoms as measured by UDI-6
  time frame: Baseline, 3 months, 6 months
  description: 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.
  measure: Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
  time frame: Baseline
  description: 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.
  measure: Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
  time frame: 3 months
  description: 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.
  measure: Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
  time frame: 6 months
  description: 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.
  measure: 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
  description: 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.
  measure: Patient Decision Making - Shared Decision Making Questionnaire (SDM-Q-9)
  time frame: 3 months
  description: 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).
  measure: Patient Satisfaction - Net Promoter Score
  time frame: 3 months
  description: 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."
  measure: Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
  time frame: Baseline
  description: 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.
  measure: Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
  time frame: 6 months
  description: 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.
  measure: Change in patients' knowledge as measured by the P-FAKS
  time frame: Baseline, 6 months
  description: 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.
  measure: Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
  time frame: Baseline
  description: 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).
  measure: Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
  time frame: 6 months
  description: 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.
  measure: Change in provider knowledge as measured by the P-FAKS
  time frame: Baseline, 6 months
  description: 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.
  arm group label: Electronic Consult (E-consult)
  arm group type: Experimental
  description: 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.
  arm group label: Advanced Practice Provider (APP) Co-management
  arm group type: Experimental
  description: 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).
  intervention type: Other
  intervention name: APP Co-management
  description: 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.
  arm group label: Advanced Practice Provider (APP) Co-management
  intervention type: Other
  intervention name: E-consult
  description: 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).
  arm group label: Electronic Consult (E-consult)
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jennifer Anger, MD
  phone: 3108479299
  email: janger@health.ucsd.edu
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  PMID: 26308198
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  PMID: 24105879
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  PMID: 27164512
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  PMID: 12559262
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  PMID: 16181169
  responsible party type: Principal Investigator
  investigator affiliation: University of California, San Diego
  investigator full name: Jennifer Anger
  investigator title: Professor of Urology, Vice Chair of Research
  mesh term: Urinary Incontinence
  mesh term: Enuresis
  sharing ipd: Yes
  ipd description: Available by request.