<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/NCT03241992</url>
  </required_header>
  <id_info>
    <org_study_id>H-35695</org_study_id>
    <nct_id>NCT03241992</nct_id>
  </id_info>
  <brief_title>MyChart in Patients With Inflammatory Bowel Disease.</brief_title>
  <acronym>MyIBD</acronym>
  <official_title>Utility of MyChart for Improving Quality of Life and Patient Satisfaction in Patients With Inflammatory Bowel Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be the first to assess the use of an electronic health records patient portal&#xD;
      for patients with Inflammatory Bowel Disease. Patients with Inflammatory Bowel Disease (IBD),&#xD;
      have reduced quality of life, high rates of depression and anxiety, do not receive routine&#xD;
      preventative health maintenance (such as vaccines) at the same rate as the general public,&#xD;
      and have low adherence to medications. The investigators are seeking to understand whether an&#xD;
      electronic health record patient portal (EPIC's MyChart), can be utilized to improve quality&#xD;
      of life in this patient population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a single site randomized control trial.&#xD;
&#xD;
      Patients will be randomized into a control arm and intervention arm. At baseline the&#xD;
      investigators will obtain demographic data, quality of life measures, and satisfaction with&#xD;
      MyChart for those patients who are alrealy active portal users. The control arm will receive&#xD;
      periodic messages through MyChart that are not specific to IBD. The intervention arm will&#xD;
      receive more specific disease related information such as IBD educational information,&#xD;
      reminders to take their medications, and reminders to get vaccinated. The intervention arm&#xD;
      will also receive questionnaires that assess their mood (depression and anxiety). The&#xD;
      investigators will then inform the primary gastroenterologist for those patients in whom&#xD;
      mild, moderate or severe depression and anxiety is identified. At the end the study, in both&#xD;
      groups investigators will measure quality of life as measured by the Short Inflammatory Bowel&#xD;
      Disease Questionnaire (SIBDQ), a validated questionnaire for measuring health-related quality&#xD;
      of life in patients with Crohn's and Ulcerative Colitis. Secondary outcomes will include:&#xD;
      Satisfaction with Mychart as measured by a MyChart satisfaction survey, time to referral to&#xD;
      mental health provider for patients identified with mild, moderate, or severe depression, or&#xD;
      anxiety (PROMIS Depression and Anxiety Questionnaires), and Vaccine uptake (using a simple&#xD;
      yes/no questionnaire asking patients if they received Flu, PCV13 or PPSV23.&#xD;
&#xD;
      The findings of this study will allow future clinicians to better understand how a patient&#xD;
      portal can be utilized as a tool for the management of patients with IBD. This findings may&#xD;
      lead to increased physician and patient engagement with the MyChart patient portal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Actual">January 20, 2019</completion_date>
  <primary_completion_date type="Actual">January 20, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life based on the SIBDQ</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life will be measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) which is a 10 item health-related quality of life (HRQoL) tool measuring physical, social, and emotional status (scores can range from 10-70, poor to good HRQoL).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with MyChart</measure>
    <time_frame>6-months</time_frame>
    <description>The 14 item embedded MyChart Satisfaction Survey will be used to measure satisfaction. Responses for 12 of the questions are answered on a scale of 0 to 10 where 10=Strongly Agree, 5=Neither Agree nor Disagree, and 0=Strongly Disagree, so the higher the score for those questions the greater the satisfaction. there is also a question about the number of times myChart was used and an open-ended comments question..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influenza vaccine uptake</measure>
    <time_frame>6-months</time_frame>
    <description>To measure vaccine uptake for flu the patients will be asked if they received the flu shot in the previous year. A chart review will be done to confirm the self reported information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pneumococcal pneumonia (PCV13, PPSV23) vaccine uptake</measure>
    <time_frame>6-months</time_frame>
    <description>To measure PCV13, PPSV23 vaccine uptake for pneumococcal pneumonia the patients will be asked if they received the vaccine in the previous year. A chart review will be done to confirm the self reported information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Referral for Behavioral Health</measure>
    <time_frame>6-months</time_frame>
    <description>After a patient has been identified as having anxiety or depression and a message has been sent to their healthcare provider the time it takes the provider to refer the patient to behavioral health will be measured.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>MyChart Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the control arm will be enrolled in MyChart during the consent process and receive MyChart Disease Specific targeted IBD information and reminders as well as mood questionnaires. At week 2 subjects will receive reminders to get vaccinated with another reminder sent at 3 months. At month 1, subjects will receive the Promis Adult Short Form questionnaires for depression and anxiety through MyChart. If a subject is identified as having mild, moderate or a severe mood disorder a message will be sent to their gastroenterologist with a recommendation to discuss the results with the patient and to consider a referral to mental health services. Subjects will also receive educational information about IBD every 6 weeks along with reminders to take their medications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in the control arm will be enrolled in MyChart during the consent process if they are not previously enrolled. Enrollment in MyChart will provide them with access to their medical record and the ability to send or receive messages with their gastroenterologist or any other providers they see at our institution. For patients with IBD it is standard practice to discuss medication adherence, vaccinations, and their mood at each appointment. Subjects will receive generic, non-IBD related messages through MyChart.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MyChart Disease Specific</intervention_name>
    <description>Subjects receive targeted IBD information and reminders as well as mood questionnaires.</description>
    <arm_group_label>MyChart Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and Women 18 years and older with a diagnosis of Inflammatory Bowel Disease&#xD;
             (Crohn's or Ulcerative Colitis, or Indeterminate Colitis by standard criteria) who are&#xD;
             scheduled for an upcoming appointment at the outpatient gastroenterology clinic or&#xD;
             infusion unit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
&#xD;
          -  Patients identified by their physicians as being too cognitively impaired to&#xD;
             participate&#xD;
&#xD;
          -  Patients without access to computer with internet&#xD;
&#xD;
          -  Patients not expected to be in the study area for the duration of the study such as&#xD;
             patients only seen for a one time second opinion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Reich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>92118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Medical Center</investigator_affiliation>
    <investigator_full_name>Jason Reich</investigator_full_name>
    <investigator_title>Fellow, Gastroenterology. General Internal Medicine Department</investigator_title>
  </responsible_party>
  <keyword>Inflammatory Bowel Disease</keyword>
  <keyword>IBD</keyword>
  <keyword>Electronic Health Record</keyword>
  <keyword>Patient Portal</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03241992
org study id: H-35695
nct id: NCT03241992
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be the first to assess the use of an electronic health records patient portal
      for patients with Inflammatory Bowel Disease. Patients with Inflammatory Bowel Disease (IBD),
      have reduced quality of life, high rates of depression and anxiety, do not receive routine
      preventative health maintenance (such as vaccines) at the same rate as the general public,
      and have low adherence to medications. The investigators are seeking to understand whether an
      electronic health record patient portal (EPIC's MyChart), can be utilized to improve quality
      of life in this patient population.
This study will be a single site randomized control trial.

      Patients will be randomized into a control arm and intervention arm. At baseline the
      investigators will obtain demographic data, quality of life measures, and satisfaction with
      MyChart for those patients who are alrealy active portal users. The control arm will receive
      periodic messages through MyChart that are not specific to IBD. The intervention arm will
      receive more specific disease related information such as IBD educational information,
      reminders to take their medications, and reminders to get vaccinated. The intervention arm
      will also receive questionnaires that assess their mood (depression and anxiety). The
      investigators will then inform the primary gastroenterologist for those patients in whom
      mild, moderate or severe depression and anxiety is identified. At the end the study, in both
      groups investigators will measure quality of life as measured by the Short Inflammatory Bowel
      Disease Questionnaire (SIBDQ), a validated questionnaire for measuring health-related quality
      of life in patients with Crohn's and Ulcerative Colitis. Secondary outcomes will include:
      Satisfaction with Mychart as measured by a MyChart satisfaction survey, time to referral to
      mental health provider for patients identified with mild, moderate, or severe depression, or
      anxiety (PROMIS Depression and Anxiety Questionnaires), and Vaccine uptake (using a simple
      yes/no questionnaire asking patients if they received Flu, PCV13 or PPSV23.

      The findings of this study will allow future clinicians to better understand how a patient
      portal can be utilized as a tool for the management of patients with IBD. This findings may
      lead to increased physician and patient engagement with the MyChart patient portal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of life based on the SIBDQ
time frame: 6 months
description: Quality of life will be measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) which is a 10 item health-related quality of life (HRQoL) tool measuring physical, social, and emotional status (scores can range from 10-70, poor to good HRQoL).
measure: Satisfaction with MyChart
time frame: 6-months
description: The 14 item embedded MyChart Satisfaction Survey will be used to measure satisfaction. Responses for 12 of the questions are answered on a scale of 0 to 10 where 10=Strongly Agree, 5=Neither Agree nor Disagree, and 0=Strongly Disagree, so the higher the score for those questions the greater the satisfaction. there is also a question about the number of times myChart was used and an open-ended comments question..
measure: Influenza vaccine uptake
time frame: 6-months
description: To measure vaccine uptake for flu the patients will be asked if they received the flu shot in the previous year. A chart review will be done to confirm the self reported information.
measure: Pneumococcal pneumonia (PCV13, PPSV23) vaccine uptake
time frame: 6-months
description: To measure PCV13, PPSV23 vaccine uptake for pneumococcal pneumonia the patients will be asked if they received the vaccine in the previous year. A chart review will be done to confirm the self reported information.
measure: Time to Referral for Behavioral Health
time frame: 6-months
description: After a patient has been identified as having anxiety or depression and a message has been sent to their healthcare provider the time it takes the provider to refer the patient to behavioral health will be measured.
arm group label: MyChart Intervention
arm group type: Experimental
description: Subjects in the control arm will be enrolled in MyChart during the consent process and receive MyChart Disease Specific targeted IBD information and reminders as well as mood questionnaires. At week 2 subjects will receive reminders to get vaccinated with another reminder sent at 3 months. At month 1, subjects will receive the Promis Adult Short Form questionnaires for depression and anxiety through MyChart. If a subject is identified as having mild, moderate or a severe mood disorder a message will be sent to their gastroenterologist with a recommendation to discuss the results with the patient and to consider a referral to mental health services. Subjects will also receive educational information about IBD every 6 weeks along with reminders to take their medications.
arm group label: Usual Care
arm group type: No Intervention
description: Subjects in the control arm will be enrolled in MyChart during the consent process if they are not previously enrolled. Enrollment in MyChart will provide them with access to their medical record and the ability to send or receive messages with their gastroenterologist or any other providers they see at our institution. For patients with IBD it is standard practice to discuss medication adherence, vaccinations, and their mood at each appointment. Subjects will receive generic, non-IBD related messages through MyChart.
intervention type: Behavioral
intervention name: MyChart Disease Specific
description: Subjects receive targeted IBD information and reminders as well as mood questionnaires.
arm group label: MyChart Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason Reich, MD
role: Principal Investigator
affiliation: Boston Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Medical Center
investigator full name: Jason Reich
investigator title: Fellow, Gastroenterology. General Internal Medicine Department
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: No