Clinical trial NCT06040645: Outcomes of Urinary Incontinence Treatment in Primary Care: APP Co-Management and Electronic Consult
Official title: Outcomes of Urinary Incontinence Treatment in Primary Care: APP Co-Management and Electronic Consult
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Urinary Incontinence
Keywords: Practice-based intervention
Patient-centered outcomes research
Disparities
Referrals
Quality of care indicators
Primary care
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of Kansas
name: Patient-Centered Outcomes Research Institute
First posted: 2023-09-15
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).

Detailed description: 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. 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%. The lifetime risk of undergoing surgery for UI or pelvic organ prolapse is 20%. With the aging of the baby boomers it is projected that the number of women with UI will increase by 55% by 2050. UI negatively impacts health-related quality of life and is associated with embarrassment, stigma, and social isolation.

Primary Care Interventions for UI are Needed. In prior research by our team to provide background for the current proposal, the investigators 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. 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. 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. Current physician shortages affect subspecialties disproportionately, and will be exacerbated as our population ages. 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, yet may receive inferior care than other ethnic groups. The investigators conducted focus groups to compare perceptions and barriers between Spanish and English speaking women in public and private hospitals being treated for UI. Knowledge gaps were greater among Spanish speakers. 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. This work identified obstacles in communication-barriers that only Spanish speaking women face. In this proposal the investigators 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 the investigators 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. 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. The investigators 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, 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. The investigators 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, 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, the investigators 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.

Eligibility criteria: 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 \&gt;18 y/o
* English or Spanish fluency
* Female
* Answers \&#34;yes\&#34; 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 \&lt;18 y/o
* Answers \&#34;no\&#34; 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

Primary outcomes:
measure: Provider Quality of Care - Evidence-Based Quality Indicators
timeFrame: Baseline
measure: Provider Quality of Care - Evidence-Based Quality Indicators
timeFrame: 6 months
measure: Change in provider quality of care measured by evidence-based quality indicators
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
timeFrame: Baseline
measure: Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
timeFrame: 3 months
measure: Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
timeFrame: 6 months
measure: Change in patients' urinary incontinence symptoms as measured by ICIQ-SF
timeFrame: Baseline, 3 months, 6 months
measure: Patient Symptoms - Urogenital Distress Inventory (UDI-6)
timeFrame: Baseline
measure: Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)
timeFrame: 3 months
measure: Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)
timeFrame: 6 months
measure: Change in patients' urinary symptoms as measured by UDI-6
timeFrame: Baseline, 3 months, 6 months
measure: Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
timeFrame: Baseline
measure: Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
timeFrame: 3 months
measure: Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
timeFrame: 6 months
measure: Change in impact of UI on patients' quality of life as measure by the Incontinence Impact Questionnaire (IIQ-7)
timeFrame: Baseline, 3 months, 6 months
measure: Patient Decision Making - Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: 3 months
measure: Patient Satisfaction - Net Promoter Score
timeFrame: 3 months
measure: Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
timeFrame: Baseline
measure: Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
timeFrame: 6 months
measure: Change in patients' knowledge as measured by the P-FAKS
timeFrame: Baseline, 6 months
measure: Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
timeFrame: Baseline
measure: Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)
timeFrame: 6 months
measure: Change in provider knowledge as measured by the P-FAKS
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
Study officials:
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