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Bridging the Gap to Adult Diabetes Care

Primary Purpose

Type1diabetes

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Data platform +Quality Performance feedback reports
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type1diabetes focused on measuring Transition to adult care, Glycemic control

Eligibility Criteria

16 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All youth with a clinical diagnosis of type 1 diabetes followed at participating centres at the time of their final pediatric clinic visit between Jan 1, 2018 and Dec 31, 2020.
  • Participants will be transitioning to Adult Care (ages ~16-19 yrs).
  • Capacity to read and understand English (we estimate that >95% of participants will fulfill this requirement).
  • Capacity to consent for themselves.

Exclusion Criteria:

  • Individuals with non-type 1 diabetes.
  • Individuals with type 1 diabetes who move out of Ontario within 12 months after their final pediatric visit.
  • Individuals with type 1 diabetes who do not have the capacity to consent for themselves.

Sites / Locations

  • McMaster Children's Hospital
  • Children's Hospital, London Health Sciences Centre
  • Markham Stouffville Hospital, Clinic 4
  • Trillium Health Partners
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Other

Arm Label

Pre-intervention

Early Intervention

Post-Intervention

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

HbA1c
Hemoglobin A1c

Secondary Outcome Measures

Number of Diabetes-related admissions, ED visits, death
The occurrence of at least one diabetes-related admissions or emergency department visit or death
Time from the final pediatric visit to the first adult diabetes visit
identified using physician service claims and defined as the first diabetes office visit by an adult endocrinologist, internist, or family physician

Full Information

First Posted
December 13, 2018
Last Updated
April 10, 2023
Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03781973
Brief Title
Bridging the Gap to Adult Diabetes Care
Official Title
Bridging the Gap to Optimize Care and Outcomes for Youth With Diabetes Between Pediatric and Adult Diabetes Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
Keywords
Transition to adult care, Glycemic control

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
An intervention with integrated components
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
484 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-intervention
Arm Type
No Intervention
Arm 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 Title
Early Intervention
Arm Type
Other
Arm 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 Title
Post-Intervention
Arm Type
Other
Arm 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(s)
Data platform +Quality Performance feedback reports
Intervention 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.
Primary Outcome Measure Information:
Title
HbA1c
Description
Hemoglobin A1c
Time Frame
HbA1c value up to 12 months after the final pediatric visit.
Secondary Outcome Measure Information:
Title
Number of Diabetes-related admissions, ED visits, death
Description
The occurrence of at least one diabetes-related admissions or emergency department visit or death
Time Frame
number of occurrences up to12 months after the final pediatric visit.
Title
Time from the final pediatric visit to the first adult diabetes visit
Description
identified using physician service claims and defined as the first diabetes office visit by an adult endocrinologist, internist, or family physician
Time Frame
Time in months up to 12 months after the final pediatric visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All youth with a clinical diagnosis of type 1 diabetes followed at participating centres at the time of their final pediatric clinic visit between Jan 1, 2018 and Dec 31, 2020. Participants will be transitioning to Adult Care (ages ~16-19 yrs). Capacity to read and understand English (we estimate that >95% of participants will fulfill this requirement). Capacity to consent for themselves. Exclusion Criteria: Individuals with non-type 1 diabetes. Individuals with type 1 diabetes who move out of Ontario within 12 months after their final pediatric visit. Individuals with type 1 diabetes who do not have the capacity to consent for themselves.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rayzel Shulman, Md, PhD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Children's Hospital, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Markham Stouffville Hospital, Clinic 4
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 7P7
Country
Canada
Facility Name
Trillium Health Partners
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31766999
Citation
Shulman R, Zenlea I, Shah BR, Clarson C, Harrington J, Landry A, Punthakee Z, Palmert MR, Mukerji G, Austin PC, Parsons J, Ivers N. Testing an audit and feedback-based intervention to improve glycemic control after transfer to adult diabetes care: protocol for a quasi-experimental pre-post design with a control group. BMC Health Serv Res. 2019 Nov 25;19(1):885. doi: 10.1186/s12913-019-4690-0.
Results Reference
derived

Learn more about this trial

Bridging the Gap to Adult Diabetes Care

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