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/NCT05979077</url>
    </required_header>
    <id_info>
      <org_study_id>22/99X</org_study_id>
      <nct_id>NCT05979077</nct_id>
    </id_info>
    <brief_title>Children's Hospital Academic Medical Organization (CHAMO) MyChart Study</brief_title>
    <official_title>Improving Quality of Care in Diabetes Clinic Through Patient-Entered Electronic Health Data?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Hospital of Eastern Ontario</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Hospital of Eastern Ontario</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>
        Evolving technology and clinical innovation have led to dramatic changes in the management of&#xD;
        type 1 diabetes (T1D). These changes have led to a need to collect a growing number of&#xD;
        details from families during their visits. As a result, much of the physician-patient visit&#xD;
        is spent transferring information instead of focusing on diabetes care, contributing to&#xD;
        increased time pressures in clinic and unmet needs for patients.&#xD;
  &#xD;
        In response to this reality, the investigators have developed a tool that allows families to&#xD;
        input their diabetes-related information into their physicians' electronic health record&#xD;
        (EHR) documentation tool before their clinic visit, using a questionnaire administered via&#xD;
        CHEO's secure patient portal (MyChart®). The investigators will evaluate the impact of an&#xD;
        integrated electronic patient questionnaire, on quality of care (patient-reported), diabetes&#xD;
        control and clinic efficiency. The investigators hope that our study will determine whether&#xD;
        having families input clinical data prior to a visit is an effective strategy to improve the&#xD;
        quality of diabetes care. The investigators believe that the findings will be of interest to&#xD;
        all those studying the value of incorporating patient-entered data both within diabetes care&#xD;
        and beyond.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 3, 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the impact of a patient-facing EHR-enabled questionnaire on patient-perceived quality of care.</measure>
      <time_frame>12 months</time_frame>
      <description>The EHR-enabled questionnaire will be completed through the online MyChart portal. Patients' parents are required to complete diabetes-related questions across a total of 10 pages, including questions regarding the visit, insulin dosing, injection dose, insulin delivery, blood sugar monitoring, high blood glucose and ketones, hypoglycemia, nutrition, physical activity, and general health. These questions are typically addressed during routine clinic visits; however, they will be completed prior to the clinic visit and automatically entered into the patient's medical chart.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patients' Evaluation of Quality of Diabetes Care (PEQD)</measure>
      <time_frame>12 months</time_frame>
      <description>The PEQD is a brief and validated questionnaire designed to assess the participants' judgement about the quality of their diabetes care. It is scored on a scale of 0-100 with 100 representing the best possible quality of care.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Quality of Medical Care (PQMC)</measure>
      <time_frame>12 months</time_frame>
      <description>The PQMC is a validated instrument designed to provide a simple, general measure of patients' overall quality of medical care they receive. Alpha reliability estimates should be expected to be above .90 for this instrument. It is scored on a scale from 6-42, with lower scores representing better perceived quality of medical care.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participant Tool and Workflow Survey</measure>
      <time_frame>12 months</time_frame>
      <description>This study-specific questionnaire was developed during pilot work for this study and was designed to specifically assess the myChart questionnaire being completed before each clinic visit. This questionnaire will only be given to those participants randomized to the intervention group. While this questionnaire has not been validated, it has been used in previously published research by our study team.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To evaluate the impact of a patient-facing EHR-enabled questionnaire on glycemic control and visit efficiency.</measure>
      <time_frame>12 months</time_frame>
      <description>Changes in glycemic control will be obtained from the patient's medical chart. Glycemic control will include: hemoglobin A1c (HbA1c, (%)), percent time in range (TIR - percentage of time in previous 14 days spent within target glucose range of 70-180 mg/dL or 3.9-10 mmol/L), and glucose management indicator (GMI, %).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Diabetes Mellitus, Type 1</condition>
    <arm_group>
      <arm_group_label>MyChart Questionnaire (Intervention Group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants within the intervention group will complete the patient-facing EHR-enabled MyChart® questionnaire.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Clinical Care (Control Group)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants within the control group will undergo standard clinical care with no study intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>MyChart Questionnaire</intervention_name>
      <description>Prior to clinic visits, families completing the MyChart Questionnaire will enter details about their current management and visit goals, automatically populating their electronic health record for subsequent review/revision by the health care team before and during the visit, reallocating clinic time previously used for data acquisition to individual patient priorities</description>
      <arm_group_label>MyChart Questionnaire (Intervention Group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of T1D&#xD;
  &#xD;
            -  Age &lt;11 years at enrollment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients ≥ 11 years of age at enrollment&#xD;
  &#xD;
            -  Patients who are not fluent enough in English to complete all study related procedures&#xD;
  &#xD;
            -  Patients unable or unwilling to provide consent and/or assent&#xD;
  &#xD;
            -  Patients followed in Eating Disorder Clinic or Child and Youth Protection Clinic&#xD;
               (there are MyChart activation restrictions for individuals followed in these clinics)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>131 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Elias Abou-Assaly, BA</last_name>
      <phone>613-737-7600</phone>
      <phone_ext>6940</phone_ext>
      <email>eabouassaly@cheo.on.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Saunya Dover, MSc</last_name>
      <phone>613-737-7600</phone>
      <phone_ext>4874</phone_ext>
      <email>sdover@cheo.on.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Children's Hospital of Eastern Ontario - Research Institute</name>
        <address>
          <city>Ottawa</city>
          <state>Ontario</state>
          <zip>K1H 8L1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elias Abou-Assaly, BA</last_name>
        <phone>613-737-7600</phone>
        <phone_ext>6940</phone_ext>
        <email>eabouassaly@cheo.on.ca</email>
      </contact>
      <contact_backup>
        <last_name>Saunya Dover, MSc</last_name>
        <phone>613-737-7600</phone>
        <phone_ext>4874</phone_ext>
        <email>sdover@cheo.on.ca</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Hospital of Eastern Ontario</investigator_affiliation>
      <investigator_full_name>Ellen Goldbloom</investigator_full_name>
      <investigator_title>Pedatric Endocrinologist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 22, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT05979077/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05979077
  org study id: 22/99X
  nct id: NCT05979077
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Evolving technology and clinical innovation have led to dramatic changes in the management of
        type 1 diabetes (T1D). These changes have led to a need to collect a growing number of
        details from families during their visits. As a result, much of the physician-patient visit
        is spent transferring information instead of focusing on diabetes care, contributing to
        increased time pressures in clinic and unmet needs for patients.
  
        In response to this reality, the investigators have developed a tool that allows families to
        input their diabetes-related information into their physicians' electronic health record
        (EHR) documentation tool before their clinic visit, using a questionnaire administered via
        CHEO's secure patient portal (MyChart®). The investigators will evaluate the impact of an
        integrated electronic patient questionnaire, on quality of care (patient-reported), diabetes
        control and clinic efficiency. The investigators hope that our study will determine whether
        having families input clinical data prior to a visit is an effective strategy to improve the
        quality of diabetes care. The investigators believe that the findings will be of interest to
        all those studying the value of incorporating patient-entered data both within diabetes care
        and beyond.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: To evaluate the impact of a patient-facing EHR-enabled questionnaire on patient-perceived quality of care.
  time frame: 12 months
  description: The EHR-enabled questionnaire will be completed through the online MyChart portal. Patients' parents are required to complete diabetes-related questions across a total of 10 pages, including questions regarding the visit, insulin dosing, injection dose, insulin delivery, blood sugar monitoring, high blood glucose and ketones, hypoglycemia, nutrition, physical activity, and general health. These questions are typically addressed during routine clinic visits; however, they will be completed prior to the clinic visit and automatically entered into the patient's medical chart.
  measure: Patients' Evaluation of Quality of Diabetes Care (PEQD)
  time frame: 12 months
  description: The PEQD is a brief and validated questionnaire designed to assess the participants' judgement about the quality of their diabetes care. It is scored on a scale of 0-100 with 100 representing the best possible quality of care.
  measure: Perceived Quality of Medical Care (PQMC)
  time frame: 12 months
  description: The PQMC is a validated instrument designed to provide a simple, general measure of patients' overall quality of medical care they receive. Alpha reliability estimates should be expected to be above .90 for this instrument. It is scored on a scale from 6-42, with lower scores representing better perceived quality of medical care.
  measure: Participant Tool and Workflow Survey
  time frame: 12 months
  description: This study-specific questionnaire was developed during pilot work for this study and was designed to specifically assess the myChart questionnaire being completed before each clinic visit. This questionnaire will only be given to those participants randomized to the intervention group. While this questionnaire has not been validated, it has been used in previously published research by our study team.
  measure: To evaluate the impact of a patient-facing EHR-enabled questionnaire on glycemic control and visit efficiency.
  time frame: 12 months
  description: Changes in glycemic control will be obtained from the patient's medical chart. Glycemic control will include: hemoglobin A1c (HbA1c, (%)), percent time in range (TIR - percentage of time in previous 14 days spent within target glucose range of 70-180 mg/dL or 3.9-10 mmol/L), and glucose management indicator (GMI, %).
  arm group label: MyChart Questionnaire (Intervention Group)
  arm group type: Experimental
  description: Participants within the intervention group will complete the patient-facing EHR-enabled MyChart® questionnaire.
  arm group label: Standard Clinical Care (Control Group)
  arm group type: No Intervention
  description: Participants within the control group will undergo standard clinical care with no study intervention.
  intervention type: Other
  intervention name: MyChart Questionnaire
  description: Prior to clinic visits, families completing the MyChart Questionnaire will enter details about their current management and visit goals, automatically populating their electronic health record for subsequent review/revision by the health care team before and during the visit, reallocating clinic time previously used for data acquisition to individual patient priorities
  arm group label: MyChart Questionnaire (Intervention Group)
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 131 Months
  healthy volunteers: No
  last name: Elias Abou-Assaly, BA
  phone: 613-737-7600
  phone ext: 6940
  email: eabouassaly@cheo.on.ca
  last name: Saunya Dover, MSc
  phone: 613-737-7600
  phone ext: 4874
  email: sdover@cheo.on.ca
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Children's Hospital of Eastern Ontario
  investigator full name: Ellen Goldbloom
  investigator title: Pedatric Endocrinologist
  mesh term: Diabetes Mellitus, Type 1
  provided document: 