Clinical Trials Directory

Trials / Completed

CompletedNCT03832283

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
4,161 (actual)
Sponsor
University of Chicago · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTCAD-MDD/CAT-DI screening via MyChartPatients 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 visitDuring 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 MyChartPatients 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 visitsDuring 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.

Timeline

Start date
2019-05-01
Primary completion
2021-03-01
Completion
2021-03-01
First posted
2019-02-06
Last updated
2021-04-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03832283. Inclusion in this directory is not an endorsement.