xml: <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/NCT05989308</url>
    </required_header>
    <id_info>
      <org_study_id>2000034372</org_study_id>
      <nct_id>NCT05989308</nct_id>
    </id_info>
    <brief_title>MyChart Proxy Outreach to Parents (MyPOP)</brief_title>
    <acronym>MyPOP</acronym>
    <official_title>MyChart Proxy Outreach to Parents (MyPOP): Mode of Outreach to Parents for Proxy Patient Portal Enrollment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yale University</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>
        The goal of this randomized controlled trial is to assess the extent to which different modes&#xD;
        of contacting parents who have not yet enabled to access to their children's medical records&#xD;
        will result in greater proxy access. The main questions the study aims to answer are:&#xD;
  &#xD;
          -  will outreach via text or patient portal message result in more parents having access&#xD;
             than usual care (which is in-office suggestions to get access).&#xD;
  &#xD;
          -  which mode - text or portal - will get more parents access. Participants will get a text&#xD;
             message, or a portal message through their own patient portal, or no message. The&#xD;
             investigators will check access to see which group has increased more during the study&#xD;
             period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aims to evaluate the feasibility and impact of contacting parents/guardians of&#xD;
        children seen in pediatric primary care practices to establish their proxy access to the EHR&#xD;
        patient portal, called &quot;MyChart.&quot; The primary objective of the study is to determine if&#xD;
        directly messaging a guardian results in activation of proxy access to a child's MyChart at a&#xD;
        higher rate compared with no specific messaging (usual care).&#xD;
  &#xD;
        A secondary objective of the study is to compare messaging strategies, with one arm being a&#xD;
        message to the guardian's patient portal, and the other text messaging.&#xD;
  &#xD;
        Another secondary objective of the study is to ascertain whether sending information about&#xD;
        activation to a guardian via text or email (as preferred) will result in self-activating&#xD;
        their own Electronic Health Record (EHR) patient portal access.&#xD;
  &#xD;
        At the conclusion of the study, the investigators will determine best-method for activation&#xD;
        and utilize this method to invite guardians initially randomized to the usual-care arm of the&#xD;
        study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>
      <intervention_model_description>JDAT will access EHR visit data for these offices to establish the child patient pool and identify guardians.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of participants who activate MyChart Proxy Access</measure>
      <time_frame>up to 12 weeks</time_frame>
      <description>Proportion of participants who activate access to the patient portal of the child's EHR, also known as MyChart Proxy Access, of all those invited. Proxy MyChart activation is a binary function (yes, has proxy activated; no, does not have proxy activated).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of guardians' who activate a personal MyChart account</measure>
      <time_frame>up to 12 weeks</time_frame>
      <description>Proportion of guardians' who activate a personal MyChart account, for those without accounts at the outset. Investigators will report if guardians activate their patient portal as a result of activation messaging. This is a binary function (yes, has active patient portal; no, does not have active patient portal).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">5200</enrollment>
    <condition>Health Technology</condition>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Care as usual</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Preferred Modality</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Text or email message to guardian with proxy information. If the guardian has no personal MyChart access, before sending proxy information to set up access to their child's MyChart, the investigators will message the guardian up to two times with information enabling them to access their personal MyChart.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patient Portal</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patient portal message (MyChart) to guardian with proxy information. If the guardian has no personal MyChart access, before sending proxy information to set up access to their child's MyChart, the investigators will message the guardian up to two times with information enabling them to access their personal MyChart.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Email</intervention_name>
      <description>Email message sent to guardian with proxy information.</description>
      <arm_group_label>Preferred Modality</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Text</intervention_name>
      <description>Text message sent to guardian with proxy information.</description>
      <arm_group_label>Preferred Modality</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Patient Portal Message</intervention_name>
      <description>Patient portal message (MyChart) to guardian with proxy information.</description>
      <arm_group_label>Patient Portal</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Guardian of a child aged ≤12 years seen in one of the two identified health centers&#xD;
               within the last 3 years with guardian status and contact information documented in the&#xD;
               child's EHR&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Preferred method of contact for guardians with no MyChart is telephone or physical&#xD;
               letter to home&#xD;
  &#xD;
            -  Guardians with EHR proxy access already activated for all children in their care.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ada Fenick, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ada Fenick, MD</last_name>
      <phone>203-688-2475</phone>
      <email>Ada.fenick@yale.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Yale New Haven Health</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06520</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Yale School of Medicine</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06520</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Deidentified data per the PIs discretion.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989308
  org study id: 2000034372
  nct id: NCT05989308
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled trial is to assess the extent to which different modes
        of contacting parents who have not yet enabled to access to their children's medical records
        will result in greater proxy access. The main questions the study aims to answer are:
  
          -  will outreach via text or patient portal message result in more parents having access
             than usual care (which is in-office suggestions to get access).
  
          -  which mode - text or portal - will get more parents access. Participants will get a text
             message, or a portal message through their own patient portal, or no message. The
             investigators will check access to see which group has increased more during the study
             period.
  This study aims to evaluate the feasibility and impact of contacting parents/guardians of
        children seen in pediatric primary care practices to establish their proxy access to the EHR
        patient portal, called "MyChart." The primary objective of the study is to determine if
        directly messaging a guardian results in activation of proxy access to a child's MyChart at a
        higher rate compared with no specific messaging (usual care).
  
        A secondary objective of the study is to compare messaging strategies, with one arm being a
        message to the guardian's patient portal, and the other text messaging.
  
        Another secondary objective of the study is to ascertain whether sending information about
        activation to a guardian via text or email (as preferred) will result in self-activating
        their own Electronic Health Record (EHR) patient portal access.
  
        At the conclusion of the study, the investigators will determine best-method for activation
        and utilize this method to invite guardians initially randomized to the usual-care arm of the
        study.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: JDAT will access EHR visit data for these offices to establish the child patient pool and identify guardians.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Proportion of participants who activate MyChart Proxy Access
  time frame: up to 12 weeks
  description: Proportion of participants who activate access to the patient portal of the child's EHR, also known as MyChart Proxy Access, of all those invited. Proxy MyChart activation is a binary function (yes, has proxy activated; no, does not have proxy activated).
  measure: Proportion of guardians' who activate a personal MyChart account
  time frame: up to 12 weeks
  description: Proportion of guardians' who activate a personal MyChart account, for those without accounts at the outset. Investigators will report if guardians activate their patient portal as a result of activation messaging. This is a binary function (yes, has active patient portal; no, does not have active patient portal).
  arm group label: Usual Care
  arm group type: No Intervention
  description: Care as usual
  arm group label: Preferred Modality
  arm group type: Experimental
  description: Text or email message to guardian with proxy information. If the guardian has no personal MyChart access, before sending proxy information to set up access to their child's MyChart, the investigators will message the guardian up to two times with information enabling them to access their personal MyChart.
  arm group label: Patient Portal
  arm group type: Experimental
  description: Patient portal message (MyChart) to guardian with proxy information. If the guardian has no personal MyChart access, before sending proxy information to set up access to their child's MyChart, the investigators will message the guardian up to two times with information enabling them to access their personal MyChart.
  intervention type: Behavioral
  intervention name: Email
  description: Email message sent to guardian with proxy information.
  arm group label: Preferred Modality
  intervention type: Behavioral
  intervention name: Text
  description: Text message sent to guardian with proxy information.
  arm group label: Preferred Modality
  intervention type: Behavioral
  intervention name: Patient Portal Message
  description: Patient portal message (MyChart) to guardian with proxy information.
  arm group label: Patient Portal
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ada Fenick, MD
  role: Principal Investigator
  affiliation: Yale University
  last name: Ada Fenick, MD
  phone: 203-688-2475
  email: Ada.fenick@yale.edu
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Deidentified data per the PIs discretion.