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

• ClinicalTrials.gov Identifier: NCT03832283
• Recruitment Status: Completed
• First Posted: February 6, 2019
• Last Update Posted: April 30, 2021
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

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.

Condition or disease	Intervention/treatment	Phase
Depression; Depressive Disorder, Major	Diagnostic Test: CAD-MDD/CAT-DI screening via MyChart; Diagnostic Test: CAD-MDD/CAT-DI screening during clinic visit; Other: CAT-DI monitoring via MyChart; Other: PHQ-9 monitoring during clinic visits	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4161 participants
• Allocation: Randomized
• Intervention 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.
• Primary Purpose: Health Services Research
• Official Title: Patient Outcomes Reporting for Timely Assessments of Life With Depression: PORTAL-Depression
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: March 1, 2021
• Actual Study Completion Date: March 1, 2021

Arms and Interventions

Arm	Intervention/treatment
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 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).; 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).
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: 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.; 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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Patients screened for depression using the BPA by study arm [ Time Frame: 12 months ]
2. Percentage of patients who have MDD remission [ Time Frame: 12 months ]
3. Time to MDD remission [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Percentage of logins to MyChart in response to the email invitations [ Time Frame: 12 months ]
2. Percentage of opened MyChart depression screening messages [ Time Frame: 12 months ]
3. Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following depression screening [ Time Frame: 12 months ]
4. Percentage of patients who start the CAT-MH assessment [ Time Frame: 12 months ]
5. Percentage of patients who complete the CAT-MH assessment [ Time Frame: 12 months ]
6. Percentage of positive screens [ Time Frame: 12 months ]
7. Number of appointments scheduled and completed (primary care and psychiatry/psychology) [ Time Frame: 12 months ]
8. Number of telephone encounters in the week following the positive depression screen [ Time Frame: 12 months ]
9. Number of emergency department visits or hospitalizations due to MDD [ Time Frame: 12 months ]
10. Percentage of logins to MyChart in response to MyChart emails [ Time Frame: 12 months ]
11. Percentage of opened MyChart depression symptom measurement messages [ Time Frame: 12 months ]
12. Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following completion of the CAT-DI [ Time Frame: 12 months ]
13. Percentage of patients who start CAT-DI assessments [ Time Frame: 12 months ]
14. Depression severity scores (CAT-DI) [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

More Information

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT03832283
• Other Study ID Numbers: QI18-90
• First Posted: February 6, 2019
• Last Update Posted: April 30, 2021
• Last Verified: April 2021

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

Additional relevant MeSH terms:

Depression; Depressive Disorder; Depressive Disorder, Major; Behavioral Symptoms; Mood Disorders; Mental Disorders