Clinical trial NCT06583525: Evaluation of the TAC Program
Official title: Evaluation of the Transition to Adult Care (TAC) Program for High-Risk Youth with Multimorbidity or Rare Disease: a Prospective Observation Cohort Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Youth with Multimorbidity or Rare Dieases
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 126
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a mixed-methods evaluative study examining the effectiveness of the Transition to Adult Care Program at the Hospital for Sick Children (TAC) Program on high-risk youth with medical and psychosocial complexity transitioning to adult and/or primary care services.

The overarching aim is to study the effectiveness of a new interdisciplinary and holistic Transition to Adult Care Program (TAC) on health-related outcomes for high-risk youth with multimorbidity or rare diseases and their caregivers by:

1. Assess the effect of the TAC program on the youth's transition readiness, self-efficacy, self-management, health-related quality of life, and satisfaction.
2. Assess the effect of the TAC program on the caregiver's satisfaction.
3. Explore the experiences, perceptions, needs, and priorities of youth and caregivers participating in the TAC program using qualitative research methods.
4. Describe the feasibility of the TAC program (defined as success in patient recruitment, attendance, participation, retention and transfer).


Eligibility criteria: Inclusion Criteria:

Aged 16-18 years old and have a complex medical history, as defined by:

1. Clinical Characteristics: Multi-morbidity (≥ 3 long-term chronic physical and/or mental health conditions (with primary condition being a physical health condition AND/OR Rare disease/ genetic condition.
2. High Risk: No clearly identified adult provider/services following transfer AND/OR experiencing significant barriers related to Social and Structural Determinants of Health.

Exclusion Criteria:

1. Moderate to severe developmental/intellectual disabilities
2. Followed by services at SickKids which has an established transition program/provider
3. Does not provide consent

Primary outcomes:
measure: Early Identification and Transition Readiness
timeFrame: Baseline,12 months and 24 months
measure: Early Identification and Transition Readiness
timeFrame: Baseline,12 months and 24 months
measure: Early Identification and Transition Readiness
timeFrame: Baseline,12 months and 24 months
measure: Early Identification and Transition Readiness - Service Satisfaction
timeFrame: Baseline,12 months and 24 months
measure: Information Sharing and Support
timeFrame: 6 to 24 months
measure: Information Sharing and Support
timeFrame: 6 to 24 months
measure: Transition Plan
timeFrame: 6 to 24 months
measure: Coordinated Transition
timeFrame: 6 to 24 months
measure: Introduction to Adult Services
timeFrame: 24 to 36 months
measure: Transition Completion
timeFrame: 24 to 36 months
measure: Health-Related Quality of Life
timeFrame: Baseline, 12 months and 24 months
measure: Experience in the process
timeFrame: 24 to 36 months
Secondary outcomes:
measure: Program Feasibility
timeFrame: 24 to 36 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
Study officials:
References: