Evaluation of the TAC Program

Evaluation of the Transition to Adult Care (TAC) Program for High-Risk Youth with Multimorbidity or Rare Disease: a Prospective Observation Cohort Study

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Youth with Multimorbidity or Rare Dieases

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Identification and Transition Readiness	The change in the patients demonstration of their self-management skills and transition readiness will be assessed using the Transition Readiness Assessment Questionnaire (20-item survey). A scoring of 4 or more across all domains is considered an indicator of transition readiness.	Baseline,12 months and 24 months
Early Identification and Transition Readiness	The change in the patients self-efficacy in their ability to manage their health and demonstrate transition readiness will be assessed using the General Self-Efficacy Scale (10 item survey). A total score is achieved from a range of 10 to 40, with high scores as an indication of better perceived general self-efficacy.	Baseline,12 months and 24 months
Early Identification and Transition Readiness	The change in the patients knowledge and confidence in their ability to manage their health and demonstrate transition readiness will be assessed using the Patient Activation Measure (10-item survey). An average net 6-point score increase demonstrating improvement	Baseline,12 months and 24 months
Early Identification and Transition Readiness - Service Satisfaction	The change in the patients and caregivers satisfaction with transitional health care services will be measured using the Larsen Client Satisfaction Questionnaire (8-item survey).	Baseline,12 months and 24 months
Information Sharing and Support	The transition intervention will include providing the patients and caregivers with information on available needs-based services and support. The number of patients who receive this intervention will be assessed via report in the patients medical record.	6 to 24 months
Information Sharing and Support	The transition intervention will include offering support from the time of discharge from pediatric services until the first appointment with adult services. The number of patients who receive this intervention will be assessed via report in the patients medical record.	6 to 24 months
Transition Plan	The transition intervention will include the co-creating an individualized transition plan to identify the patients transition goals and set timelines. The number of patients who receive this intervention will be assessed via report in the patients medical record.	6 to 24 months
Coordinated Transition	The transition intervention will include developing a patient-specific transfer package. The number of patients who receive this intervention will be assessed via report in the patients medical record.	6 to 24 months
Introduction to Adult Services	A joint clinic visit will be facilitated by the transition team with the identified receiving adult care provider. The number of patients who have received a warm handover visit with the transition team, primary care provider/service team, will be assessed via report in the patients medical record.	24 to 36 months
Transition Completion	Successful transfer will be measured by the attendance of the first appointment with a primary care and/or subspecialty adult care provider between the first 6 to 12 months of transfer from the pediatric provider.	24 to 36 months
Health-Related Quality of Life	The change in the patients quality of life will be measured using the The Pediatric Quality of Life Inventory 4.0 Generic Core Scale Teen Report The 23-item survey will assess four core health dimensions (physical functioning, emotional functioning, social functioning and school functioning) transformed into total scores ranging from 0 to 100. An increase in 12 and 24 months follow-up scores from baseline will be measured.	Baseline, 12 months and 24 months
Experience in the process	Semi-structured qualitative interviews will be conducted with a subset of participants to explore participants; experiences working with the transition team, and satisfaction with the tools and resources used.	24 to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program Feasibility	The successful implementation of the intervention will be evaluated by assessing the feasibility of the program. The percentage of attended appointments, completed questionnaires, individualized transition plans created, warm handovers completed prior to participants' 18th birthday, and additional clinic visits required will be documented for each participant.	24 to 36 months

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1000081574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No