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临床试验/NCT03832283
NCT03832283已完成不适用

Patient Outcomes Reporting for Timely Assessments of Life With Depression: PORTAL-Depression

University of Chicago2 个研究点 分布在 1 个国家目标入组 4,161 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,161
试验地点
2
主要终点
Time to MDD remission

研究概览

简要总结

Currently, very little research exists on whether patient portals could be used to integrate patient-reported outcome (PRO) measurement into the electronic health record (EHR) and clinical practice, even though 87% of ambulatory care practices have EHRs and 88% of U.S. adults have access to the internet. To date, no randomized controlled trial has examined whether patient portals can be used to collect PRO measures. The goal of this study is to implement the integration of a computerized adaptive test (CAT) for patient-reported outcome (PRO) measurement of depression symptoms into an electronic health record (EHR) and evaluate the effectiveness of collecting CAT PROs via an EHR patient portal in two randomized controlled trials. This study will advance the science of implementation of patient-centered outcomes research into clinical practice, as well as the evidence for high quality, accessible care.

详细描述

The overall goal of this proposal is to implement the integration of the Computerized Adaptive Test for Mental Health (CAT-MH) into an EHR for a healthcare system and evaluate the effectiveness of collecting CAT-MH PROs via an EHR-tethered patient portal (MyChart) vs. usual care in two randomized controlled trials. The first aim of this study will consist of a randomized controlled trial comparing screening rates among adult primary care patients with an active patient portal account (MyChart) and due for depression screening who receive usual care (CAT-MH screenings during routine clinic visits) vs. MyChart population-based CAT-MH screenings. The second aim of this study involves a randomized controlled trial comparing depression remission rates among patients with active moderate-to-severe MDD who receive usual care vs. MyChart CAT-MH measurement-based care. In addition, we will examine the resources needed to integrate the CAT-MH into the EHR and design the health IT strategy for collecting PROs via the patient portal.

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

盲法说明

Patients randomized to MyChart will not be blinded to the intervention. Patients who are randomized to usual screening will not be informed about the intervention arm and, thus, will be blinded to trial assignment. PCPs will not be informed of the randomization; however, they will receive results whenever their patients complete the CAT-MH via MyChart.

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

  • 18 years or older
  • considered an active clinic patient at the start date of the intervention
  • have an active MyChart account that is not managed by a proxy
  • receive care from a participating PCP
  • due for depression screening (screening arms) or active depression (monitoring arms)

排除标准

  • under 18 years of age
  • bipolar disorder

结局指标

主要结局

Time to MDD remission

时间窗: 12 months

Percentage of Patients screened for depression using the BPA by study arm

时间窗: 12 months

Percentage of patients who have MDD remission

时间窗: 12 months

次要结局

  • Percentage of patients who complete the CAT-MH assessment(12 months)
  • Percentage of logins to MyChart in response to the email invitations(12 months)
  • Percentage of positive screens(12 months)
  • Number of appointments scheduled and completed (primary care and psychiatry/psychology)(12 months)
  • Number of telephone encounters in the week following the positive depression screen(12 months)
  • Percentage of opened MyChart depression screening messages(12 months)
  • Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following completion of the CAT-DI(12 months)
  • Percentage of patients who start CAT-DI assessments(12 months)
  • Depression severity scores (CAT-DI)(12 months)
  • Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following depression screening(12 months)
  • Percentage of patients who start the CAT-MH assessment(12 months)
  • Number of emergency department visits or hospitalizations due to MDD(12 months)
  • Percentage of logins to MyChart in response to MyChart emails(12 months)
  • Percentage of opened MyChart depression symptom measurement messages(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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