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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832283
• Other study ID #: QI18-90
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2021
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4161
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Diagnostic Test:
• 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).
• 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).

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients screened for depression using the BPA by study arm		12 months
Primary	Percentage of patients who have MDD remission		12 months
Primary	Time to MDD remission		12 months
Secondary	Percentage of logins to MyChart in response to the email invitations		12 months
Secondary	Percentage of opened MyChart depression screening messages		12 months
Secondary	Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following depression screening		12 months
Secondary	Percentage of patients who start the CAT-MH assessment		12 months
Secondary	Percentage of patients who complete the CAT-MH assessment		12 months
Secondary	Percentage of positive screens		12 months
Secondary	Number of appointments scheduled and completed (primary care and psychiatry/psychology)		12 months
Secondary	Number of telephone encounters in the week following the positive depression screen		12 months
Secondary	Number of emergency department visits or hospitalizations due to MDD		12 months
Secondary	Percentage of logins to MyChart in response to MyChart emails		12 months
Secondary	Percentage of opened MyChart depression symptom measurement messages		12 months
Secondary	Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following completion of the CAT-DI		12 months
Secondary	Percentage of patients who start CAT-DI assessments		12 months
Secondary	Depression severity scores (CAT-DI)		12 months