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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Depressive Disorder, Major
• Intervention / Treatment: Diagnostic test: CAD-MDD/CAT-DI screening during clinic visit; Diagnostic test: CAD-MDD/CAT-DI screening via MyChart; Other: PHQ-9 monitoring during clinic visits; Other: CAT-DI monitoring via MyChart

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.

• Study Type: Interventional
• Enrollment (Actual): 4161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Diagnostic test: CAD-MDD/CAT-DI screening during clinic visit; During routine in-clinic visits, medical assistants or providers will ask patients to complete the CAD-MDD to screen for major depressive disorder (MDD). For patients who screen positive for MDD, CAT-DI will launch automatically and assess depression severity. CAT-DI assigns a score of 0 to 100 in four severity categories (<50=normal, 50 to 65=mild, 66 to 75=moderate, and >75=severe).
EXPERIMENTAL: 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.	Diagnostic test: CAD-MDD/CAT-DI screening during clinic visit; During routine in-clinic visits, medical assistants or providers will ask patients to complete the CAD-MDD to screen for major depressive disorder (MDD). For patients who screen positive for MDD, CAT-DI will launch automatically and assess depression severity. CAT-DI assigns a score of 0 to 100 in four severity categories (<50=normal, 50 to 65=mild, 66 to 75=moderate, and >75=severe).; Diagnostic test: CAD-MDD/CAT-DI screening via MyChart; Patients will receive invitations via MyChart to complete the CAD-MDD to screen for major depressive disorder (MDD). For patients who screen positive for MDD, CAT-DI will launch automatically and assess depression severity. CAT-DI assigns a score of 0 to 100 in four severity categories (<50=normal, 50 to 65=mild, 66 to 75=moderate, and >75=severe).
OTHER: 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.	Other: PHQ-9 monitoring during clinic visits; During routine in-clinic visits, medical assistants or providers will ask patients to complete the PHQ-9 to assess MDD severity and remission. A PHQ-9 score < 5 will indicate that a patient's MDD is in remission.
EXPERIMENTAL: 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.	Other: PHQ-9 monitoring during clinic visits; During routine in-clinic visits, medical assistants or providers will ask patients to complete the PHQ-9 to assess MDD severity and remission. A PHQ-9 score < 5 will indicate that a patient's MDD is in remission.; Other: CAT-DI monitoring via MyChart; Patients with active MDD will receive invitations via MyChart to complete the CAT-DI to assess MDD severity and remission. A normal CAT-DI score (<50) will indicate that a patient's MDD is in remission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Patients screened for depression using the BPA by study arm	12 months
Percentage of patients who have MDD remission	12 months
Time to MDD remission	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of logins to MyChart in response to the email invitations	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 depression screening	12 months
Percentage of patients who start the CAT-MH assessment	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
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
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

Collaborators and Investigators

• Sponsor: University of Chicago

Publications and helpful links

General Publications

• 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. 2022 Sep 20:1-8. doi: 10.1007/s11606-022-07779-9. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): March 1, 2021
• Study Completion (ACTUAL): March 1, 2021

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (ACTUAL): February 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: QI18-90

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No