Clinical trial NCT06093386: Promoting Intensive Transitions for Children and Youth With Medical Complexity From Pediatric to Adult Care
Official title: Promoting Intensive Transitions for Children and Youth With Medical Complexity From Pediatric to Adult Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Children and Youth With Medical Complexity
Keywords: transition
complex care
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-10-23
Enrollment: 150
Sex: ALL
Minimum age (years): 210
Maximum age (years): 213
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Medical advances have allowed many more children and youth with medical complexity (CMC) to survive well into adulthood. However, this has not been matched with increases in knowledge of complex conditions or the availability of supports as they transition into the adult care system. The goal of this randomized control trial is to compare intensive transition support from a transition team, led by an advance practice nurse, during transition to adult care for 2 years, with usual care in CMC. Participants assigned to the intervention group will be offered support in care planning, receiving funding, and connecting with a primary care provider and adult subspecialists.

The main questions it aims to answer are:

1. Does intensive transition support improve the patient's continuity of care over 2 years compared with usual care?
2. Will there be differences between intervention and control groups with respect to other outcomes related to the youth/family's satisfaction with care, care coordination, self-care, health service utilization, cost-effectiveness, and quality of life?
3. What are the experiences of youth, parents, the transition team, and other clinicians involved in the intensive transition support process?


Eligibility criteria: Inclusion Criteria:

* Patients 17 years 6 months- 17 years 9 months old (inclusive) who meet Ontario's CMC definition:

  1. technology dependence and/or users of high-intensity care,
  2. fragility (severe and/or life-threatening condition,
  3. chronicity (expected to last at least 6 months),
  4. complexity (involvement of ≥5 healthcare practitioners/teams and healthcare services in ≥ 3 locations such as home, school, hospital, etc.).

Exclusion Criteria:

* are expected to die within 2 years of recruitment (e.g., those receiving active end-of-life care)
* do not have a stable primary caregiver (e.g., those who reside in residential or long-term care facilities, and those in foster care as the intervention is focused on a patient-caregiver dyad)

Primary outcomes:
measure: Transfer Completion
timeFrame: 6 to 30 months
Secondary outcomes:
measure: Transfer Completion
timeFrame: Baseline to 24 months
measure: Transfer Completion
timeFrame: 6 to 30 months
measure: Transfer Completion
timeFrame: 6 to 30 months
measure: Transfer Completion
timeFrame: Baseline to 24 months
measure: Transfer Completion
timeFrame: Baseline to 24 months
measure: Transfer Completion
timeFrame: Baseline to 24 months
measure: Early Identification and Transition Readiness- Satisfaction with Transitional Healthcare
timeFrame: Baseline, 12 months and 24 months
measure: Early Identification and Transition Readiness- Self-Care
timeFrame: Baseline, 12 months and 24 months
measure: Early Identification and Transition Readiness- Self-Care
timeFrame: Baseline
measure: Information Sharing and Support, Transition Plan and Coordinated Transition
timeFrame: Baseline, 12 months and 24 months
measure: Introduction to Adult Services
timeFrame: 24 months
measure: Use of Services
timeFrame: Baseline to 24 months
measure: Use of Services- Incremental Cost-Utility Ratio (ICUR)
timeFrame: Baseline to 24 months
measure: Health-Related Quality of Life
timeFrame: Baseline, 12 months and 24 months
measure: Health-Related Quality of Life-Caregiver Fatigue
timeFrame: Baseline, 12 months and 24 months
measure: Health-Related Quality of Life- Family Distress
timeFrame: Baseline, 12 months and 24 months
measure: Experiences in The Process
timeFrame: 12 to 24 months
Other outcomes:
measure: Implementation Progress Outcomes- Care Planning
timeFrame: Baseline to 24 months
measure: Implementation Progress Outcomes- Integration with Primary Care Providers
timeFrame: Baseline to 24 months
measure: Implementation Progress Outcomes- Adult Subspecialty Facilitation
timeFrame: Baseline to 24 months
measure: Implementation Progress Outcomes- Facilitation of Funding
timeFrame: Baseline to 24 months
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: