Patient Outcomes Reporting for Timely Assessments of Life With Depression: PORTAL-Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,161
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Usual Care Depression Screening
Patients randomized to this intervention arm will receive usual care annual depression screening when they come in for a clinic visit and are due for screening. When the patient comes in for a visit, a best practice alert in the EHR will indicate that the patient requires depression screening. The CAD-MDD/CAT-DI screening during clinic visit will occur in a patient room, prior to their appointment with a primary care provider.
干预措施: CAD-MDD/CAT-DI screening during clinic visit (Diagnostic Test)
Population MyChart Depression Screening
Patients randomized to this intervention arm will continue to receive usual care annual depression screening when they come in for a clinic visit and are due for screening. In addition, they will receive email invitations to complete the CAD-MDD/CAT-DI screening via MyChart. Email invitations will be sent at preset intervals until depression screening is completed, or the end of the 1-year follow-up period, whichever comes first.
干预措施: CAD-MDD/CAT-DI screening via MyChart (Diagnostic Test)
Population MyChart Depression Screening
Patients randomized to this intervention arm will continue to receive usual care annual depression screening when they come in for a clinic visit and are due for screening. In addition, they will receive email invitations to complete the CAD-MDD/CAT-DI screening via MyChart. Email invitations will be sent at preset intervals until depression screening is completed, or the end of the 1-year follow-up period, whichever comes first.
干预措施: CAD-MDD/CAT-DI screening during clinic visit (Diagnostic Test)
Usual Care Depression Monitoring
Patients who have depression and are randomized to this intervention arm will receive usual care PHQ-9 monitoring during clinic visits. When the patient comes in for a visit, a best practice alert in the EHR will indicate that the patient requires depression assessment.
干预措施: PHQ-9 monitoring during clinic visits (Other)
Population MyChart Depression Monitoring
Patients who have depression and are randomized to this intervention arm will continue to receive usual care depression monitoring when they come for clinic visits. In addition, they will receive email invitations at preset intervals to complete the CAT-DI monitoring via MyChart. Invitations will be sent until major depressive disorder (MDD) remission is achieved, or the 1-year follow-up period ends, whichever comes first.
干预措施: CAT-DI monitoring via MyChart (Other)
Population MyChart Depression Monitoring
Patients who have depression and are randomized to this intervention arm will continue to receive usual care depression monitoring when they come for clinic visits. In addition, they will receive email invitations at preset intervals to complete the CAT-DI monitoring via MyChart. Invitations will be sent until major depressive disorder (MDD) remission is achieved, or the 1-year follow-up period ends, whichever comes first.
干预措施: PHQ-9 monitoring during clinic visits (Other)
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
- Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following completion of the CAT-DI(12 months)
- Percentage of logins to MyChart in response to the email invitations(12 months)
- Percentage of patients who complete the CAT-MH assessment(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)
- 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)