跳至主要内容
临床试验/NCT05534412
NCT05534412进行中(未招募)不适用

A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence

University of California, San Diego4 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2022年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,600
试验地点
4
主要终点
Adherence to evidence-based quality-of-care indicators

研究概览

简要总结

The main goal of this clinical trial is to improve the care for urinary incontinence (UI) provided to adult women by primary care providers. The main questions it aims to answer are:

  • Can a practice-based intervention involving primary care providers lead to improved quality of incontinence care?
  • Will this intervention reduce the utilization of specialist care for urinary incontinence?
  • What effect will this intervention have on patient outcomes, including disease-specific outcomes, symptom severity, quality of life, and patient knowledge?
  • Does our intervention reduce disparities in care?

Provider participants will be randomized at the office level to either an intervention group or a delayed intervention (control) group. The intervention group will receive an intervention consisting of academic detailing, clinical decision support tools, electronic referral, and the ability to refer to an advanced practice provider for co-management. The delayed intervention group will provide usual care until the crossover phase of the study, at which point they will receive the same intervention as the intervention group.

Patient participants will bring up urinary incontinence with their primary care provider and complete three electronic surveys.

Researchers will compare the intervention group to the delayed intervention (control) group to see if the intervention results in increased adherence to evidence-based quality indicators.

详细描述

The burden of urinary incontinence (UI) on American women is immense in human and financial terms, and continues to rise with the growing population of older adults. The goal of this proposal is to improve the care for UI provided to women and, in doing so, decrease the utilization of specialty care while improving patient outcomes. Specific Aim 1 seeks to improve the quality of incontinence care provided to an ethnically diverse population of women through a controlled practice-based intervention involving primary care providers. The intervention involves the implementation of PCOR measures. Four Southern California medical groups will participate in a cluster randomized controlled trial in which 60 offices (15 per site) will be randomized to undergo a practice-based incontinence intervention led by a "clinical champion dyad" comprised of a primary care provider and urologist/urogynecologist, both of whom are members of that specific medical group. The intervention will include physician education, individual performance feedback, electronic decision support, patient education using dedicated advanced practice providers (APPs), and the implementation of an electronic referral service. The quality of patient care, as evidenced by compliance with primary care UI quality indicators the investigators developed and pilot-tested, will be measured across the two randomized arms after implementation of the intervention. Compliance with these quality indicators will be the key means to implement PCOR evidence, while, at the same time, measure quality. In Specific Aim 2, utilization of specialists will be compared before and after the intervention. The investigators hypothesize that improved care at the level of the primary care physician will reduce the number of specialty referrals. Specific Aim 3 will seek to measure the effect of the intervention on patient outcomes. Under the hypothesis that a practice-based intervention will improve disease-specific outcomes, symptom severity, quality of life, and patient knowledge will be measured at baseline using validated questionnaires. After implementation of the intervention, these questionnaires will be given a second time six months later and outcomes will be compared between control and intervention groups. The investigators expect that this intervention will also reduce disparities in care for underrepresented minorities.

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
Single (Participant)

盲法说明

Patients will be aware that their primary care physician is participating in the study. However, they will not be informed of which arm the physician belongs to. Primary care physicians will be aware of which arm their office was assigned to based on whether or not they receive the intervention.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
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 four participating sites: Cedars-Sinai, Harbor-UCLA, UCLA, UCSD
  • Inclusion Criteria of Patients
  • Age >18 y/o
  • English or Spanish fluency
  • Answers "yes" 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 <18 y/o
  • Answers "no" to incontinence screening tool and/or does not agree to participate
  • Patient seen by a urinary incontinence specialist (urologist/urogynecologist) for urinary incontinence in the past two years
  • 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

Practice-Based Intervention

Experimental

The intervention will include physician education, electronic decision support, implementation of an electronic referral system, and patient education/co-management by an advance practice provider.

干预措施: Electronic Referral (Other)

Practice-Based Intervention

Experimental

The intervention will include physician education, electronic decision support, implementation of an electronic referral system, and patient education/co-management by an advance practice provider.

干预措施: Academic Detailing (Other)

Practice-Based Intervention

Experimental

The intervention will include physician education, electronic decision support, implementation of an electronic referral system, and patient education/co-management by an advance practice provider.

干预措施: Electronic Clinical Decision Support (Other)

Practice-Based Intervention

Experimental

The intervention will include physician education, electronic decision support, implementation of an electronic referral system, and patient education/co-management by an advance practice provider.

干预措施: APP Co-management (Other)

Control

No Intervention

Offices in this group will not receive the four-pronged intervention. However, after the study trial, there will be a "validation phase" in which the initial control group will then receive the intervention. This cross-over deign will then allow all 60 offices to receive the intervention. Data from the cross-over intervention group will be analyzed as a separate cohort to confirm improvements in patient care and outcomes as measured in the intervention group under the study trial can be duplicated.

结局指标

主要结局

Adherence to evidence-based quality-of-care indicators

时间窗: Baseline, 3 months, 6 months

Adherence to the QIs for patients who screen positive for UI will be compared across the two randomized arms at baseline and again at 3 and 6 months after intervention implementation.

次要结局

  • Referral rates to a specialist(Baseline, 6 months)
  • ICIQ-SF(Baseline, 3 months, 6 months)
  • UDI-6(Baseline, 3 months, 6 months)
  • PGI-I(3 months, 6 months)
  • PFAKS(Baseline, 6 months)
  • SDM-Q-9(6 months)
  • Net Promoter Score(3 months, 6 months)
  • IIQ-7(Baseline, 3 months, 6 months)

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 (4)

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