<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03832283</url>
  </required_header>
  <id_info>
    <org_study_id>QI18-90</org_study_id>
    <nct_id>NCT03832283</nct_id>
  </id_info>
  <brief_title>Patient Outcomes Reporting for Timely Assessments of Life With Depression: PORTAL-Depression</brief_title>
  <official_title>Patient Outcomes Reporting for Timely Assessments of Life With Depression: PORTAL-Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, very little research exists on whether patient portals could be used to integrate&#xD;
      patient-reported outcome (PRO) measurement into the electronic health record (EHR) and&#xD;
      clinical practice, even though 87% of ambulatory care practices have EHRs and 88% of U.S.&#xD;
      adults have access to the internet. To date, no randomized controlled trial has examined&#xD;
      whether patient portals can be used to collect PRO measures. The goal of this study is to&#xD;
      implement the integration of a computerized adaptive test (CAT) for patient-reported outcome&#xD;
      (PRO) measurement of depression symptoms into an electronic health record (EHR) and evaluate&#xD;
      the effectiveness of collecting CAT PROs via an EHR patient portal in two randomized&#xD;
      controlled trials. This study will advance the science of implementation of patient-centered&#xD;
      outcomes research into clinical practice, as well as the evidence for high quality,&#xD;
      accessible care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of this proposal is to implement the integration of the Computerized&#xD;
      Adaptive Test for Mental Health (CAT-MH) into an EHR for a healthcare system and evaluate the&#xD;
      effectiveness of collecting CAT-MH PROs via an EHR-tethered patient portal (MyChart) vs.&#xD;
      usual care in two randomized controlled trials. The first aim of this study will consist of a&#xD;
      randomized controlled trial comparing screening rates among adult primary care patients with&#xD;
      an active patient portal account (MyChart) and due for depression screening who receive usual&#xD;
      care (CAT-MH screenings during routine clinic visits) vs. MyChart population-based CAT-MH&#xD;
      screenings. The second aim of this study involves a randomized controlled trial comparing&#xD;
      depression remission rates among patients with active moderate-to-severe MDD who receive&#xD;
      usual care vs. MyChart CAT-MH measurement-based care. In addition, we will examine the&#xD;
      resources needed to integrate the CAT-MH into the EHR and design the health IT strategy for&#xD;
      collecting PROs via the patient portal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients screened for depression using the BPA by study arm</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients who have MDD remission</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to MDD remission</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of logins to MyChart in response to the email invitations</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of opened MyChart depression screening messages</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following depression screening</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who start the CAT-MH assessment</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who complete the CAT-MH assessment</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of positive screens</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of appointments scheduled and completed (primary care and psychiatry/psychology)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of telephone encounters in the week following the positive depression screen</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of emergency department visits or hospitalizations due to MDD</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of logins to MyChart in response to MyChart emails</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of opened MyChart depression symptom measurement messages</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following completion of the CAT-DI</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who start CAT-DI assessments</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression severity scores (CAT-DI)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">4161</enrollment>
  <condition>Depression</condition>
  <condition>Depressive Disorder, Major</condition>
  <arm_group>
    <arm_group_label>Usual Care Depression Screening</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population MyChart Depression Screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Depression Monitoring</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population MyChart Depression Monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CAD-MDD/CAT-DI screening via MyChart</intervention_name>
    <description>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 (&lt;50=normal, 50 to 65=mild, 66 to 75=moderate, and &gt;75=severe).</description>
    <arm_group_label>Population MyChart Depression Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CAD-MDD/CAT-DI screening during clinic visit</intervention_name>
    <description>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 (&lt;50=normal, 50 to 65=mild, 66 to 75=moderate, and &gt;75=severe).</description>
    <arm_group_label>Population MyChart Depression Screening</arm_group_label>
    <arm_group_label>Usual Care Depression Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CAT-DI monitoring via MyChart</intervention_name>
    <description>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 (&lt;50) will indicate that a patient's MDD is in remission.</description>
    <arm_group_label>Population MyChart Depression Monitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PHQ-9 monitoring during clinic visits</intervention_name>
    <description>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 &lt; 5 will indicate that a patient's MDD is in remission.</description>
    <arm_group_label>Population MyChart Depression Monitoring</arm_group_label>
    <arm_group_label>Usual Care Depression Monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  considered an active clinic patient at the start date of the intervention&#xD;
&#xD;
          -  have an active MyChart account that is not managed by a proxy&#xD;
&#xD;
          -  receive care from a participating PCP&#xD;
&#xD;
          -  due for depression screening (screening arms) or active depression (monitoring arms)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18 years of age&#xD;
&#xD;
          -  bipolar disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03832283
org study id: QI18-90
nct id: NCT03832283
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
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.
measure: Percentage of Patients screened for depression using the BPA by study arm
time frame: 12 months
measure: Percentage of patients who have MDD remission
time frame: 12 months
measure: Time to MDD remission
time frame: 12 months
measure: Percentage of logins to MyChart in response to the email invitations
time frame: 12 months
measure: Percentage of opened MyChart depression screening messages
time frame: 12 months
measure: Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following depression screening
time frame: 12 months
measure: Percentage of patients who start the CAT-MH assessment
time frame: 12 months
measure: Percentage of patients who complete the CAT-MH assessment
time frame: 12 months
measure: Percentage of positive screens
time frame: 12 months
measure: Number of appointments scheduled and completed (primary care and psychiatry/psychology)
time frame: 12 months
measure: Number of telephone encounters in the week following the positive depression screen
time frame: 12 months
measure: Number of emergency department visits or hospitalizations due to MDD
time frame: 12 months
measure: Percentage of logins to MyChart in response to MyChart emails
time frame: 12 months
measure: Percentage of opened MyChart depression symptom measurement messages
time frame: 12 months
measure: Number of MyChart messages sent to PCPs by patients (or to patients by PCPs) following completion of the CAT-DI
time frame: 12 months
measure: Percentage of patients who start CAT-DI assessments
time frame: 12 months
measure: Depression severity scores (CAT-DI)
time frame: 12 months
arm group label: Usual Care Depression Screening
arm group type: Other
description: 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.
arm group label: Population MyChart Depression Screening
arm group type: Experimental
description: 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.
arm group label: Usual Care Depression Monitoring
arm group type: Other
description: 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.
arm group label: Population MyChart Depression Monitoring
arm group type: Experimental
description: 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.
intervention type: Diagnostic Test
intervention name: CAD-MDD/CAT-DI screening via MyChart
description: 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).
arm group label: Population MyChart Depression Screening
intervention type: Diagnostic Test
intervention name: CAD-MDD/CAT-DI screening during clinic visit
description: 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).
arm group label: Population MyChart Depression Screening
arm group label: Usual Care Depression Screening
intervention type: Other
intervention name: CAT-DI monitoring via MyChart
description: 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.
arm group label: Population MyChart Depression Monitoring
intervention type: Other
intervention name: PHQ-9 monitoring during clinic visits
description: 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.
arm group label: Population MyChart Depression Monitoring
arm group label: Usual Care Depression Monitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major