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Completed

NCT Number: NCT03832283

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2019
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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