Clinical trial NCT03781973: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Keywords: Transition to adult care
Glycemic control
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-12-20
Enrollment: 484
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: An intervention with integrated components
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: HbA1c
timeFrame: HbA1c value up to 12 months after the final pediatric visit.
Secondary outcomes:
measure: Number of Diabetes-related admissions, ED visits, death
timeFrame: number of occurrences up to12 months after the final pediatric visit.
measure: Time from the final pediatric visit to the first adult diabetes visit
timeFrame: Time in months up to 12 months after the final pediatric visit
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital, London Health Sciences Centre
state: Ontario
city: Markham
country: Canada
facility: Markham Stouffville Hospital, Clinic 4
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Rayzel Shulman, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.