跳至主要内容
临床试验/NCT06040645
NCT06040645Enrolling By Invitation不适用

Outcomes of Urinary Incontinence Treatment in Primary Care: APP Co-Management and Electronic Consult

University of California, San Diego3 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2024年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,200
试验地点
3
主要终点
Provider Quality of Care - Evidence-Based Quality Indicators

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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
  • Answers &#34;yes&#34; to incontinence screening tool and agrees to participate

排除标准

  • 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

研究组 & 干预措施

Electronic Consult (E-consult)

Experimental

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.

干预措施: E-consult (Other)

Advanced Practice Provider (APP) Co-management

Experimental

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).

干预措施: APP Co-management (Other)

结局指标

主要结局

Provider Quality of Care - Evidence-Based Quality Indicators

时间窗: 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

时间窗: 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.

Provider Quality of Care - Evidence-Based Quality Indicators

时间窗: Baseline

Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.

次要结局

  • Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)(6 months)
  • Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)(6 months)
  • Patient Symptoms - Urogenital Distress Inventory (UDI-6)(Baseline)
  • Change in impact of UI on patients' quality of life as measure by the Incontinence Impact Questionnaire (IIQ-7)(Baseline, 3 months, 6 months)
  • Change in patients' urinary incontinence symptoms as measured by ICIQ-SF(Baseline, 3 months, 6 months)
  • Patient Decision Making - Shared Decision Making Questionnaire (SDM-Q-9)(3 months)
  • Patient Satisfaction - Net Promoter Score(3 months)
  • Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)(6 months)
  • Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)(6 months)
  • Change in patients' urinary symptoms as measured by UDI-6(Baseline, 3 months, 6 months)
  • Change in patients' knowledge as measured by the P-FAKS(Baseline, 6 months)
  • Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)(6 months)
  • Change in provider knowledge as measured by the P-FAKS(Baseline, 6 months)
  • Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)(Baseline)
  • Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)(3 months)
  • Patient Symptoms - Urinary symptoms as measured by Urogenital Distress Inventory (UDI-6)(3 months)
  • Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)(Baseline)
  • Patient Quality of Life - Incontinence Impact Questionnaire (IIQ-7)(3 months)
  • Patient Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)(Baseline)
  • Provider Knowledge - Pelvic Floor Awareness and Knowledge Survey (P-FAKS)(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Anger

Professor of Urology, Vice Chair of Research

University of California, San Diego

研究点 (3)

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