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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-24

Study Completion Date

2026-09-30

Brief Summary

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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?

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Detailed Description

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Conditions

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Children and Youth With Medical Complexity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Group Type EXPERIMENTAL

Intensive Transition Support

Intervention Type 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.

Control/ Usual Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 with a primary care provider and adult subspecialists.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

210 Months

Maximum Eligible Age

213 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No