Evaluation of the TAC Program
NCT Number: NCT06583525
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Youth with Multimorbidity or Rare Dieases
Sponsor: The Hospital for Sick Children
Sex: ALL
Age: CHILD, ADULT
Enrollment: 126
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2027-05-31

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).

Primary Outcome Measures: 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: 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