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

Primary Purpose

Depression, Depressive Disorder, Major

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAD-MDD/CAT-DI screening via MyChart
CAD-MDD/CAT-DI screening during clinic visit
CAT-DI monitoring via MyChart
PHQ-9 monitoring during clinic visits
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Other

Experimental

Arm Label

Usual Care Depression Screening

Population MyChart Depression Screening

Usual Care Depression Monitoring

Population MyChart Depression Monitoring

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Patients screened for depression using the BPA by study arm
Percentage of patients who have MDD remission
Time to MDD remission

Secondary Outcome Measures

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

Full Information

First Posted
February 1, 2019
Last Updated
April 28, 2021
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03832283
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Major

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
4161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Depression Screening
Arm Type
Other
Arm Description
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.
Arm Title
Population MyChart Depression Screening
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Depression Monitoring
Arm Type
Other
Arm Description
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.
Arm Title
Population MyChart Depression Monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
CAD-MDD/CAT-DI screening via MyChart
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
CAD-MDD/CAT-DI screening during clinic visit
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
CAT-DI monitoring via MyChart
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PHQ-9 monitoring during clinic visits
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients screened for depression using the BPA by study arm
Time Frame
12 months
Title
Percentage of patients who have MDD remission
Time Frame
12 months
Title
Time to MDD remission
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of logins to MyChart in response to the email invitations
Time Frame
12 months
Title
Percentage of opened MyChart depression screening messages
Time Frame
12 months
Title
Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following depression screening
Time Frame
12 months
Title
Percentage of patients who start the CAT-MH assessment
Time Frame
12 months
Title
Percentage of patients who complete the CAT-MH assessment
Time Frame
12 months
Title
Percentage of positive screens
Time Frame
12 months
Title
Number of appointments scheduled and completed (primary care and psychiatry/psychology)
Time Frame
12 months
Title
Number of telephone encounters in the week following the positive depression screen
Time Frame
12 months
Title
Number of emergency department visits or hospitalizations due to MDD
Time Frame
12 months
Title
Percentage of logins to MyChart in response to MyChart emails
Time Frame
12 months
Title
Percentage of opened MyChart depression symptom measurement messages
Time Frame
12 months
Title
Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following completion of the CAT-DI
Time Frame
12 months
Title
Percentage of patients who start CAT-DI assessments
Time Frame
12 months
Title
Depression severity scores (CAT-DI)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36127535
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.
Results Reference
derived

Learn more about this trial

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

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