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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03832283
Enrollment
4161
Registered
2019-02-06
Start date
2019-05-01
Completion date
2021-03-01
Last updated
2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Depressive Disorder, Major

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.

Interventions

DIAGNOSTIC_TESTCAD-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_TESTCAD-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).

OTHERCAT-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.

OTHERPHQ-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.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of Patients screened for depression using the BPA by study arm12 months
Percentage of patients who have MDD remission12 months
Time to MDD remission12 months

Secondary

MeasureTime frame
Percentage of patients who start the CAT-MH assessment12 months
Percentage of patients who complete the CAT-MH assessment12 months
Percentage of positive screens12 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 screen12 months
Percentage of logins to MyChart in response to the email invitations12 months
Percentage of logins to MyChart in response to MyChart emails12 months
Percentage of opened MyChart depression symptom measurement messages12 months
Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following completion of the CAT-DI12 months
Percentage of patients who start CAT-DI assessments12 months
Depression severity scores (CAT-DI)12 months
Number of emergency department visits or hospitalizations due to MDD12 months
Percentage of opened MyChart depression screening messages12 months
Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following depression screening12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026