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

NCT03832283 | Completed

• 1 other identifier: QI18-90
• Study Type: interventional
• Target: 4,161
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depressive Disorder, Major

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• 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

Study Arms (4)

Usual Care Depression Screening

OTHER

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

Population MyChart Depression Screening

EXPERIMENTAL

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; Diagnostic Test: CAD-MDD/CAT-DI screening during clinic visit

Usual Care Depression Monitoring

OTHER

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

Population MyChart Depression Monitoring

EXPERIMENTAL

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; Other: PHQ-9 monitoring during clinic visits

Interventions

CAD-MDD/CAT-DI screening via MyChart DIAGNOSTIC_TEST

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).

Population MyChart Depression Screening

CAD-MDD/CAT-DI screening during clinic visit DIAGNOSTIC_TEST

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).

Population MyChart Depression Screening; Usual Care Depression Screening

CAT-DI monitoring via MyChart OTHER

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.

Population MyChart Depression Monitoring

PHQ-9 monitoring during clinic visits OTHER

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.

Population MyChart Depression Monitoring; Usual Care Depression Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• under 18 years of age
• bipolar disorder

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

• Staab EM, Franco MI, Zhu M, Wan W, Gibbons RD, Vinci LM, Beckman N, Yohanna D, Laiteerapong N. Population Health Management Approach to Depression Symptom Monitoring in Primary Care via Patient Portal: A Randomized Controlled Trial. Am J Med Qual. 2023 Jul-Aug 01;38(4):188-195. doi: 10.1097/JMQ.0000000000000126. Epub 2023 Jun 15.

  PMID: 37314235 DERIVED

• 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.

  PMID: 36127535 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 6, 2019
• Study Start: May 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

US (1)