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

NCT06093386 | Recruiting

• 1 other identifier: 1000080621
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.Does intensive transition support improve the patient's continuity of care over 2 years compared with usual care?
2. 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. 3.What are the experiences of youth, parents, the transition team, and other clinicians involved in the intensive transition support process?

Conditions

Children and Youth With Medical Complexity

Keywords

transition; complex care

Outcome Measures

Primary Outcomes (1)

• Transfer Completion

  Successful transfer of primary and subspecialty care to continuous primary care and a prioritized subspecialty in adult care will be measured using a relational continuity of care measure - the Bice Boxerman Index (modified for the study population).

  6 to 30 months

Secondary Outcomes (17)

• Transfer Completion

  Baseline to 24 months

• Transfer Completion

  6 to 30 months

• Transfer Completion

  6 to 30 months

• Transfer Completion

  Baseline to 24 months

• Transfer Completion

  Baseline to 24 months

Other Outcomes (4)

• Implementation Progress Outcomes- Care Planning

  Baseline to 24 months

• Implementation Progress Outcomes- Integration with Primary Care Providers

  Baseline to 24 months

• Implementation Progress Outcomes- Adult Subspecialty Facilitation

  Baseline to 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

Other: Intensive Transition Support

Control/ Usual Care

NO INTERVENTION

Standard of care in the control group will involve the utilization of existing tools within clinical programs which may include preparation for transitions, but there will be no systematic follow-up by a paediatric provider beyond age 18. Care will be transferred to adult providers (primary care and specialists) via a transition guide that will be offered to participants and their referring providers. This is the current model of care for virtually all CMC in Ontario.

Interventions

Intensive Transition Support OTHER

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 with a primary care provider and adult subspecialists.

Intervention

Eligibility Criteria

• Age: 210 Months - 213 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.).

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

Related Publications (1)

• 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 and Youth with Medical Complexity from Paediatric to Adult Care: the PITCare study-protocol for a randomised controlled trial. BMJ Open. 2024 Dec 9;14(12):e086088. doi: 10.1136/bmjopen-2024-086088.

  PMID: 39653557 DERIVED

Central Study Contacts

Sara Santos

CONTACT

416-813-7654; sara.santos@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Head and Senior Scientist, Child Health Evaluative Sciences

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 23, 2023
• Study Start: November 24, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)