Bridging the Gap to Adult Diabetes Care

Bridging the Gap to Optimize Care and Outcomes for Youth With Diabetes Between Pediatric and Adult Diabetes Care

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type1diabetes
• Intervention / Treatment: Behavioral: Data platform +Quality Performance feedback reports

• Study Type: Interventional
• Enrollment (Actual): 484
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • McMaster Children's Hospital
    • London, Ontario, Canada, N6A 5W9
      • Children's Hospital, London Health Sciences Centre
    • Markham, Ontario, Canada, L3P 7P7
      • Markham Stouffville Hospital, Clinic 4
    • Mississauga, Ontario, Canada
      • Trillium Health Partners
    • Toronto, Ontario, Canada, M5G1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-intervention; 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.
Other: Early Intervention; 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.	Behavioral: Data platform +Quality Performance feedback reports; 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.
Other: Post-Intervention; 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.	Behavioral: Data platform +Quality Performance feedback reports; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Hemoglobin A1c	HbA1c value up to 12 months after the final pediatric visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Diabetes-related admissions, ED visits, death	The occurrence of at least one diabetes-related admissions or emergency department visit or death	number of occurrences up to12 months after the final pediatric visit.
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	Time in months up to 12 months after the final pediatric visit

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Rayzel Shulman, Md, PhD, The Hospital for Sick Children

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Glycemic control; Transition to adult care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: CTO project ID: 1581

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No