<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/NCT03781973</url>
  </required_header>
  <id_info>
    <org_study_id>CTO project ID: 1581</org_study_id>
    <nct_id>NCT03781973</nct_id>
  </id_info>
  <brief_title>Bridging the Gap to Adult Diabetes Care</brief_title>
  <official_title>Bridging the Gap to Optimize Care and Outcomes for Youth With Diabetes Between Pediatric and Adult Diabetes Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hospital for Sick Children</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>
      Adolescents with type 1 diabetes face particular challenges related to having a chronic&#xD;
      illness that requires daily intensive self-management and medical follow-up during a period&#xD;
      when their social, developmental, educational, and family situations are in flux. When&#xD;
      transitioning from pediatric to adult care, over a third of youth have a care gap of &gt;6&#xD;
      months. During this vulnerable period youth are at risk for acute life-threatening&#xD;
      complications such as diabetic ketoacidosis, and for poor glycemic control, which confers an&#xD;
      increased risk of chronic diabetes complications. Gaps in care may be a result of&#xD;
      deficiencies in transition processes causing some young people to be poorly prepared for&#xD;
      adult care and dissatisfied with the transition process. Ineffective transition can lead to&#xD;
      decreased frequency of diabetes visits and an increased risk of adverse events in young&#xD;
      adulthood. Further, risk factors such as psychiatric comorbidity and behavioural problems in&#xD;
      adolescents with type 1 diabetes are associated with poor outcomes in early adulthood.&#xD;
      Quality improvement initiatives can be designed to optimize care processes such as referral&#xD;
      systems to adult diabetes providers.&#xD;
&#xD;
      Our overall objective is to optimize care and outcomes for youth with diabetes as they&#xD;
      transition to adult care.&#xD;
&#xD;
      Specific Aim 1: To improve glycemic control in youth around the time of transition from&#xD;
      pediatric to adult diabetes care Specific Aim 2: To evaluate the fidelity and quality of a&#xD;
      quality improvement intervention designed to improve transition care processes and to&#xD;
      identify contextual factors associated with variation in outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>An intervention with integrated components</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>HbA1c value up to 12 months after the final pediatric visit.</time_frame>
    <description>Hemoglobin A1c</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Diabetes-related admissions, ED visits, death</measure>
    <time_frame>number of occurrences up to12 months after the final pediatric visit.</time_frame>
    <description>The occurrence of at least one diabetes-related admissions or emergency department visit or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from the final pediatric visit to the first adult diabetes visit</measure>
    <time_frame>Time in months up to 12 months after the final pediatric visit</time_frame>
    <description>identified using physician service claims and defined as the first diabetes office visit by an adult endocrinologist, internist, or family physician</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">484</enrollment>
  <condition>Type1diabetes</condition>
  <arm_group>
    <arm_group_label>Pre-intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Those whose last pediatric visit was in the year before the intervention (2018).&#xD;
Medical record data abstracted from patient charts at the time of the final pediatric visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Those whose last pediatric visit was in the year immediately after the start of the intervention (2019).&#xD;
The intervention will begin on Jan 1, 2019 and includes the following :&#xD;
Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. .&#xD;
Quality performance feedback reports: We will generate centre-level performance reports. Centres will be able to compare their performance to that of all other centres and to achievable benchmarks.&#xD;
Patient transition experience surveys at the final pediatric visit and 12 months later.&#xD;
Diabetes teams may direct patients and families to online transition resources.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Those whose last pediatric visit was in the second year after the intervention (2020).&#xD;
The intervention includes the following :&#xD;
Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. .&#xD;
Quality performance feedback reports: We will generate centre-level performance reports. Centres will be able to compare their performance to that of all other centres and to achievable benchmarks.&#xD;
Patient transition experience surveys at the final pediatric visit and 12 months later.&#xD;
Diabetes teams may direct patients and families to online transition resources.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Data platform +Quality Performance feedback reports</intervention_name>
    <description>Teams from each of the participating sites will attend the webinars. Each site will share an example of a QI initiative that they are executing and describe the success and challenges.</description>
    <arm_group_label>Early Intervention</arm_group_label>
    <arm_group_label>Post-Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All youth with a clinical diagnosis of type 1 diabetes followed at participating&#xD;
             centres at the time of their final pediatric clinic visit between Jan 1, 2018 and Dec&#xD;
             31, 2020.&#xD;
&#xD;
          -  Participants will be transitioning to Adult Care (ages ~16-19 yrs).&#xD;
&#xD;
          -  Capacity to read and understand English (we estimate that &gt;95% of participants will&#xD;
             fulfill this requirement).&#xD;
&#xD;
          -  Capacity to consent for themselves.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with non-type 1 diabetes.&#xD;
&#xD;
          -  Individuals with type 1 diabetes who move out of Ontario within 12 months after their&#xD;
             final pediatric visit.&#xD;
&#xD;
          -  Individuals with type 1 diabetes who do not have the capacity to consent for&#xD;
             themselves.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rayzel Shulman, Md, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McMaster Children's Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital, London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Markham Stouffville Hospital, Clinic 4</name>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <zip>L3P 7P7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trillium Health Partners</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Rayzel Shulman</investigator_full_name>
    <investigator_title>Scientist Track Investigator</investigator_title>
  </responsible_party>
  <keyword>Transition to adult care</keyword>
  <keyword>Glycemic control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT03781973
org study id: CTO project ID: 1581
nct id: NCT03781973
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adolescents with type 1 diabetes face particular challenges related to having a chronic
      illness that requires daily intensive self-management and medical follow-up during a period
      when their social, developmental, educational, and family situations are in flux. When
      transitioning from pediatric to adult care, over a third of youth have a care gap of >6
      months. During this vulnerable period youth are at risk for acute life-threatening
      complications such as diabetic ketoacidosis, and for poor glycemic control, which confers an
      increased risk of chronic diabetes complications. Gaps in care may be a result of
      deficiencies in transition processes causing some young people to be poorly prepared for
      adult care and dissatisfied with the transition process. Ineffective transition can lead to
      decreased frequency of diabetes visits and an increased risk of adverse events in young
      adulthood. Further, risk factors such as psychiatric comorbidity and behavioural problems in
      adolescents with type 1 diabetes are associated with poor outcomes in early adulthood.
      Quality improvement initiatives can be designed to optimize care processes such as referral
      systems to adult diabetes providers.

      Our overall objective is to optimize care and outcomes for youth with diabetes as they
      transition to adult care.

      Specific Aim 1: To improve glycemic control in youth around the time of transition from
      pediatric to adult diabetes care Specific Aim 2: To evaluate the fidelity and quality of a
      quality improvement intervention designed to improve transition care processes and to
      identify contextual factors associated with variation in outcomes.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: An intervention with integrated components
primary purpose: Health Services Research
masking: None (Open Label)
measure: HbA1c
time frame: HbA1c value up to 12 months after the final pediatric visit.
description: Hemoglobin A1c
measure: Number of Diabetes-related admissions, ED visits, death
time frame: number of occurrences up to12 months after the final pediatric visit.
description: The occurrence of at least one diabetes-related admissions or emergency department visit or death
measure: Time from the final pediatric visit to the first adult diabetes visit
time frame: Time in months up to 12 months after the final pediatric visit
description: identified using physician service claims and defined as the first diabetes office visit by an adult endocrinologist, internist, or family physician
arm group label: Pre-intervention
arm group type: No Intervention
description: Those whose last pediatric visit was in the year before the intervention (2018).
Medical record data abstracted from patient charts at the time of the final pediatric visit.
arm group label: Early Intervention
arm group type: Other
description: Those whose last pediatric visit was in the year immediately after the start of the intervention (2019).
The intervention will begin on Jan 1, 2019 and includes the following :
Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. .
Quality performance feedback reports: We will generate centre-level performance reports. Centres will be able to compare their performance to that of all other centres and to achievable benchmarks.
Patient transition experience surveys at the final pediatric visit and 12 months later.
Diabetes teams may direct patients and families to online transition resources.
arm group label: Post-Intervention
arm group type: Other
description: Those whose last pediatric visit was in the second year after the intervention (2020).
The intervention includes the following :
Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. .
Quality performance feedback reports: We will generate centre-level performance reports. Centres will be able to compare their performance to that of all other centres and to achievable benchmarks.
Patient transition experience surveys at the final pediatric visit and 12 months later.
Diabetes teams may direct patients and families to online transition resources.
intervention type: Behavioral
intervention name: Data platform +Quality Performance feedback reports
description: Teams from each of the participating sites will attend the webinars. Each site will share an example of a QI initiative that they are executing and describe the success and challenges.
arm group label: Early Intervention
arm group label: Post-Intervention
criteria: 
gender: All
minimum age: 16 Years
maximum age: 19 Years
healthy volunteers: No
last name: Rayzel Shulman, Md, PhD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Rayzel Shulman
investigator title: Scientist Track Investigator
mesh term: Diabetes Mellitus
sharing ipd: No