Promoting Intensive Transitions for Children and Youth With Medical Complexity From Pediatric to Adult Care

Overview

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?

Interventions

• Other Intensive Transition Support
  Participants assigned to the intervention arm will transfer their transition support leadership to a transition team composed of a transition navigator (an advance practice nurse), a nurse navigator (a registered nurse) and a social worker over 2 years to support them through the multiple phases of CMC transitions including guidance, monitoring, planning, care transfer and transfer completion. CMC and their caregivers will be offered support in care planning, receiving funding, and connecting wi

Primary outcome measures

• Transfer Completion [Time frame: 6 to 30 months]

Secondary outcome measures (12)

• Transfer Completion [Time frame: Baseline to 24 months]
• Transfer Completion [Time frame: 6 to 30 months]
• Transfer Completion [Time frame: 6 to 30 months]
• Transfer Completion [Time frame: Baseline to 24 months]
• Transfer Completion [Time frame: Baseline to 24 months]
• Transfer Completion [Time frame: Baseline to 24 months]
• Early Identification and Transition Readiness- Satisfaction with Transitional Healthcare [Time frame: Baseline, 12 months and 24 months]
• Early Identification and Transition Readiness- Self-Care [Time frame: Baseline, 12 months and 24 months]
• Early Identification and Transition Readiness- Self-Care [Time frame: Baseline]
• Information Sharing and Support, Transition Plan and Coordinated Transition [Time frame: Baseline, 12 months and 24 months]
• Introduction to Adult Services [Time frame: 24 months]
• Use of Services [Time frame: Baseline to 24 months]

Eligibility criteria

Inclusion criteria

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

• technology dependence and/or users of high-intensity care,
• fragility (severe and/or life-threatening condition,
• chronicity (expected to last at least 6 months),
• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Canada · 1 center

• The Hospital for Sick Children — Toronto

Publications

• Santos S, Thomson D, Diaz S, Soscia J, Adams S, Amin R, Bernstein S, Blais B, Bruno N, Colapinto K, Espin S, Fayed N, Greenaway J, Henze M, Ivers NM, LeGrow K, Lim A, Lippett R, Lunsky Y, Macarthur C, Mahant S, Malecki S, Miranda S, Moharir M, Moretti ME, Phillips L, Robeson P, Taryan M, Thorpe K, Toulany A, Vandepoele E, Weitzner B, Orkin J, Cohen E. Promoting Intensive Transitions for Children a PMID 39653557

Identifiers

NCT: NCT06093386 · 1000080621

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗