Bridging the Gap to Adult Diabetes Care

NCT03781973 | Completed

• 1 other identifier: CTO project ID: 1581
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 5

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.

Conditions

Type1diabetes

Keywords

Transition to adult care; Glycemic control

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Hemoglobin A1c

  HbA1c value up to 12 months after the final pediatric visit.

Secondary Outcomes (2)

• Number of Diabetes-related admissions, ED visits, death

  number of occurrences up to12 months after the final pediatric visit.

• Time from the final pediatric visit to the first adult diabetes visit

  Time in months up to 12 months after the final pediatric visit

Study Arms (3)

Pre-intervention

NO 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.

Early Intervention

OTHER

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 : 1. Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. . 2. 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. 3. Patient transition experience surveys at the final pediatric visit and 12 months later. 4. Diabetes teams may direct patients and families to online transition resources.

Behavioral: Data platform +Quality Performance feedback reports

Post-Intervention

OTHER

Those whose last pediatric visit was in the second year after the intervention (2020). The intervention includes the following : 1. Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. . 2. 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. 3. Patient transition experience surveys at the final pediatric visit and 12 months later. 4. Diabetes teams may direct patients and families to online transition resources.

Behavioral: Data platform +Quality Performance feedback reports

Interventions

Data platform +Quality Performance feedback reports BEHAVIORAL

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.

Early Intervention; Post-Intervention

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (5)

McMaster Children's Hospital

Hamilton, Ontario, Canada

Location

Children's Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Markham Stouffville Hospital, Clinic 4

Markham, Ontario, L3P 7P7, Canada

Location

Trillium Health Partners

Mississauga, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (2)

• Ahmad SZ, Ivers N, Zenlea I, Parsons JA, Shah BR, Mukerji G, Punthakee Z, Shulman R. An assessment of adaptation and fidelity in the implementation of an audit and feedback-based intervention to improve transition to adult type 1 diabetes care in Ontario, Canada. Implement Sci Commun. 2024 Mar 18;5(1):25. doi: 10.1186/s43058-024-00563-2.

  PMID: 38500183 DERIVED

• 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.

  PMID: 31766999 DERIVED

Study Officials

• Rayzel Shulman, Md, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist Track Investigator

Model Details: An intervention with integrated components

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 20, 2018
• Study Start: June 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)