NCT06093386 Promoting Intensive Transitions for Children and Youth With Medical Complexity From Pediatric to Adult Care
| NCT ID | NCT06093386 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Children and Youth With Medical Complexity |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-11-24 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-11-24 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06093386 clinical trial?
This trial is open to participants of all sexes, aged 210 Months or older, up to 213 Months, studying Children and Youth With Medical Complexity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06093386 currently recruiting?
Yes, NCT06093386 is actively recruiting participants. Contact the research team at sara.santos@sickkids.ca for enrollment information.
Where is the NCT06093386 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06093386 clinical trial?
NCT06093386 is sponsored by The Hospital for Sick Children. The trial plans to enroll 150 participants.