DepressionNCT03832283
Patient Outcomes Reporting for Timely Assessments of Life With Depression: PORTAL-Depression
A study testing CAD-MDD/CAT-DI screening via MyChart, CAD-MDD/CAT-DI screening during clinic visit and CAT-DI monitoring via MyChart in people with Depression and Depressive Disorder, Major, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depressive Disorder, Major
- What is being tested?
- CAD-MDD/CAT-DI screening via MyChart, CAD-MDD/CAT-DI screening during clinic visit and CAT-DI monitoring via MyChart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,161 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- under 18 years of age
- bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Depression, Depressive Disorder, Major
- Being tested
- CAD-MDD/CAT-DI screening via MyChart, CAD-MDD/CAT-DI screening during clinic visit, CAT-DI monitoring via MyChart, PHQ-9 monitoring during clinic visits
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD-MDD/CAT-DI screening via MyChartDiagnostic 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 visitDiagnostic 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 MyChartOther
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 visitsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Depression Screening | Other | 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. Receives: Diagnostic Test: CAD-MDD/CAT-DI screening during clinic visit |
| Population MyChart Depression Screening | Experimental | 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. Receives: Diagnostic Test: CAD-MDD/CAT-DI screening via MyChart; Diagnostic Test: CAD-MDD/CAT-DI screening during clinic visit |
| Usual Care Depression Monitoring | Other | 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. Receives: Other: PHQ-9 monitoring during clinic visits |
| Population MyChart Depression Monitoring | Experimental | 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. Receives: Other: CAT-DI monitoring via MyChart; Other: PHQ-9 monitoring during clinic visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients screened for depression using the BPA by study arm
Measured: 12 months
Percentage of patients who have MDD remission
Measured: 12 months
Time to MDD remission
Measured: 12 months
Secondary outcomes (14)
Percentage of logins to MyChart in response to the email invitations
Measured: 12 months
Percentage of opened MyChart depression screening messages
Measured: 12 months
Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following depression screening
Measured: 12 months
Percentage of patients who start the CAT-MH assessment
Measured: 12 months
Percentage of patients who complete the CAT-MH assessment
Measured: 12 months
Percentage of positive screens
Measured: 12 months
Number of appointments scheduled and completed (primary care and psychiatry/psychology)
Measured: 12 months
Number of telephone encounters in the week following the positive depression screen
Measured: 12 months
Number of emergency department visits or hospitalizations due to MDD
Measured: 12 months
Percentage of logins to MyChart in response to MyChart emails
Measured: 12 months
Percentage of opened MyChart depression symptom measurement messages
Measured: 12 months
Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following completion of the CAT-DI
Measured: 12 months
Percentage of patients who start CAT-DI assessments
Measured: 12 months
Depression severity scores (CAT-DI)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 May 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832283
- Sponsor's protocol ID
- QI18-90
- Status last verified
- Apr 2021
- First submitted
- 1 Feb 2019
- Last updated
- 30 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Staab EM, Franco MI, Zhu M, Wan W, Gibbons RD, Vinci LM, Beckman N, Yohanna D, Laiteerapong N. Population Health Management Approach to Depression Symptom Monitoring in Primary Care via Patient Portal: A Randomized Controlled Trial. Am J Med Qual. 2023 Jul-Aug 01;38(4):188-195. doi: 10.1097/JMQ.0000000000000126. Epub 2023 Jun 15.
PubMed 37314235Franco MI, Staab EM, Zhu M, Knitter A, Wan W, Gibbons R, Vinci L, Shah S, Yohanna D, Beckman N, Laiteerapong N. Pragmatic Clinical Trial of Population Health, Portal-Based Depression Screening: the PORTAL-Depression Study. J Gen Intern Med. 2023 Mar;38(4):857-864. doi: 10.1007/s11606-022-07779-9. Epub 2022 Sep 20.
PubMed 36127535
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Outcomes Reporting for Timely Assessments of Life With Depression: PORTAL-Depression
- ClinicalTrials.gov ID
- NCT03832283
- Acronym / sponsor ID
- QI18-90
- Conditions
- Depression, Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,161 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual Care Depression Screening | Other | Diagnostic Test: CAD-MDD/CAT-DI screening during clinic visitPatients 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. |
| Population MyChart Depression Screening | Experimental | Diagnostic Test: CAD-MDD/CAT-DI screening via MyChart, Diagnostic Test: CAD-MDD/CAT-DI screening during clinic visitPatients 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. |
| Usual Care Depression Monitoring | Other | Other: PHQ-9 monitoring during clinic visitsPatients 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. |
| Population MyChart Depression Monitoring | Experimental | Other: CAT-DI monitoring via MyChart, Other: PHQ-9 monitoring during clinic visitsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- under 18 years of age
- bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAD-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 test | Population MyChart Depression Screening |
| CAD-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). | Diagnostic test | Population MyChart Depression Screening, Usual Care Depression Screening |
| CAT-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. | Other | Population MyChart Depression Monitoring |
| PHQ-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. | Other | Population MyChart Depression Monitoring, Usual Care Depression Monitoring |
Primary outcome
Percentage of Patients screened for depression using the BPA by study arm
Time frame: 12 months
Percentage of patients who have MDD remission
Time frame: 12 months
Time to MDD remission
Time frame: 12 months
14 secondary outcomes
Percentage of logins to MyChart in response to the email invitations
Time frame: 12 months
Percentage of opened MyChart depression screening messages
Time frame: 12 months
Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following depression screening
Time frame: 12 months
Percentage of patients who start the CAT-MH assessment
Time frame: 12 months
Percentage of patients who complete the CAT-MH assessment
Time frame: 12 months
Percentage of positive screens
Time frame: 12 months
Number of appointments scheduled and completed (primary care and psychiatry/psychology)
Time frame: 12 months
Number of telephone encounters in the week following the positive depression screen
Time frame: 12 months
Number of emergency department visits or hospitalizations due to MDD
Time frame: 12 months
Percentage of logins to MyChart in response to MyChart emails
Time frame: 12 months
Percentage of opened MyChart depression symptom measurement messages
Time frame: 12 months
Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following completion of the CAT-DI
Time frame: 12 months
Percentage of patients who start CAT-DI assessments
Time frame: 12 months
Depression severity scores (CAT-DI)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 37314235Staab EM, Franco MI, Zhu M, Wan W, Gibbons RD, Vinci LM, Beckman N, Yohanna D, Laiteerapong N. Population Health Management Approach to Depression Symptom Monitoring in Primary Care via Patient Portal: A Randomized Controlled Trial. Am J Med Qual. 2023 Jul-Aug 01;38(4):188-195. doi: 10.1097/JMQ.0000000000000126. Epub 2023 Jun 15.
- Derived from this study: PubMed 36127535Franco MI, Staab EM, Zhu M, Knitter A, Wan W, Gibbons R, Vinci L, Shah S, Yohanna D, Beckman N, Laiteerapong N. Pragmatic Clinical Trial of Population Health, Portal-Based Depression Screening: the PORTAL-Depression Study. J Gen Intern Med. 2023 Mar;38(4):857-864. doi: 10.1007/s11606-022-07779-9. Epub 2022 Sep 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD-MDD/CAT-DI screening via MyChart, CAD-MDD/CAT-DI screening during clinic visit and CAT-DI monitoring via MyChart in people with Depression and Depressive Disorder, Major, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients screened for depression using the BPA by study arm (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03832283, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.