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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tracking Depression Symptoms With a Health Chatbot

NCT03990389

Depression, Postpartum Depression, Unipolar

COMPLETED NA

Internet-Based Depression Screening for College Students

NCT01326793

Major Depressive Disorder

COMPLETED NA

Depression Outpatient Cardiology Screening Study

NCT01552889

Depression Coronary Heart Disease

COMPLETED NA

Enhancing the Clinical Effectiveness of Depression Screening Using Patient-targeted Feedback in General Practices

NCT03988985

Depression

COMPLETED NA

Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial

NCT02309060

Major Depressive Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Depressive Disorder, Major

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

CAD-MDD/CAT-DI screening during clinic visit

Intervention Type 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

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.

Group Type EXPERIMENTAL

CAD-MDD/CAT-DI screening via MyChart

Intervention Type 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

Intervention Type 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).

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.

Group Type OTHER

PHQ-9 monitoring during clinic visits

Intervention Type 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

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.

Group Type EXPERIMENTAL

CAT-DI monitoring via MyChart

Intervention Type 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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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).

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)