Bridging the Gap to Adult Diabetes Care

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03781973
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
484
5
3
52
96.8
1.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Data platform +Quality Performance feedback reports
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
484 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
An intervention with integrated componentsAn intervention with integrated components
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Bridging the Gap to Optimize Care and Outcomes for Youth With Diabetes Between Pediatric and Adult Diabetes Care
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

    Hemoglobin A1c

Secondary Outcome Measures

  1. Number of Diabetes-related admissions, ED visits, death [number of occurrences up to12 months after the final pediatric visit.]

    The occurrence of at least one diabetes-related admissions or emergency department visit or death

  2. Time from the final pediatric visit to the first adult diabetes visit [Time in months up to 12 months after the final pediatric visit]

    identified using physician service claims and defined as the first diabetes office visit by an adult endocrinologist, internist, or family physician

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 McMaster Children's Hospital Hamilton Ontario Canada
2 Children's Hospital, London Health Sciences Centre London Ontario Canada N6A 5W9
3 Markham Stouffville Hospital, Clinic 4 Markham Ontario Canada L3P 7P7
4 Trillium Health Partners Mississauga Ontario Canada
5 The Hospital for Sick Children Toronto Ontario Canada M5G1X8

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Rayzel Shulman, Md, PhD, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rayzel Shulman, Scientist Track Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT03781973
Other Study ID Numbers:
  • CTO project ID: 1581
First Posted:
Dec 20, 2018
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rayzel Shulman, Scientist Track Investigator, The Hospital for Sick Children
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2022