Clinical trial NCT03832283: Patient Outcomes Reporting for Timely Assessments of Life With Depression: PORTAL-Depression
Official title: Patient Outcomes Reporting for Timely Assessments of Life With Depression: PORTAL-Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Disorder, Major
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 4161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* under 18 years of age
* bipolar disorder

Primary outcomes:
measure: Percentage of Patients screened for depression using the BPA by study arm
timeFrame: 12 months
measure: Percentage of patients who have MDD remission
timeFrame: 12 months
measure: Time to MDD remission
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of logins to MyChart in response to the email invitations
timeFrame: 12 months
measure: Percentage of opened MyChart depression screening messages
timeFrame: 12 months
measure: Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following depression screening
timeFrame: 12 months
measure: Percentage of patients who start the CAT-MH assessment
timeFrame: 12 months
measure: Percentage of patients who complete the CAT-MH assessment
timeFrame: 12 months
measure: Percentage of positive screens
timeFrame: 12 months
measure: Number of appointments scheduled and completed (primary care and psychiatry/psychology)
timeFrame: 12 months
measure: Number of telephone encounters in the week following the positive depression screen
timeFrame: 12 months
measure: Number of emergency department visits or hospitalizations due to MDD
timeFrame: 12 months
measure: Percentage of logins to MyChart in response to MyChart emails
timeFrame: 12 months
measure: Percentage of opened MyChart depression symptom measurement messages
timeFrame: 12 months
measure: Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following completion of the CAT-DI
timeFrame: 12 months
measure: Percentage of patients who start CAT-DI assessments
timeFrame: 12 months
measure: Depression severity scores (CAT-DI)
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References:
citation: Franco MI, Staab EM, Zhu M, Knitter A, Wan W, Gibbons R, Vinci L, Shah S, Yohanna D, Beckman N, Laiteerapong N. Pragmatic Clinical Trial of Population Health, Portal-Based Depression Screening: the PORTAL-Depression Study. J Gen Intern Med. 2023 Mar;38(4):857-864. doi: 10.1007/s11606-022-07779-9. Epub 2022 Sep 20.