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Enrolling by Invitation

NCT Number: NCT06583525

Evaluation of the TAC Program

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).

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Key information

Age range

16 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.
  • 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

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

Treatment and study plan

Intensive Transition Support

Other

A multidisciplinary transition team (nurse practitioner and social worker) will coordinate the transition process for each patient across multiple settings, focused on the youth's highest priority needs while also supporting the caregivers. Participants will receive case management and care navigation using an intensive transition support model provided through the partnership of a transition team. The transition team will collaborate with the participants existing care team to help coordinate care, provide consultation, and support adult and primary care accepting these youth for 1 year following the transfer. This Intervention is modelled on best practices by Health Quality Ontario's Quality Standards for Transition from Youth to Adult Health Care Services to support youth at high risk of having poor transitional outcomes as they move from pediatric to adult care.

Primary outcomes

  1. Early Identification and Transition Readiness

    Time frame: Baseline,12 months and 24 months

    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.

  2. Early Identification and Transition Readiness

    Time frame: Baseline,12 months and 24 months

    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.

  3. Early Identification and Transition Readiness

    Time frame: Baseline,12 months and 24 months

    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

  4. Early Identification and Transition Readiness - Service Satisfaction

    Time frame: Baseline,12 months and 24 months

    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).

  5. Information Sharing and Support

    Time frame: 6 to 24 months

    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. Information Sharing and Support

    Time frame: 6 to 24 months

    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.

  7. Transition Plan

    Time frame: 6 to 24 months

    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.

  8. Coordinated Transition

    Time frame: 6 to 24 months

    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.

  9. Introduction to Adult Services

    Time frame: 24 to 36 months

    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.

  10. Transition Completion

    Time frame: 24 to 36 months

    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.

  11. Health-Related Quality of Life

    Time frame: Baseline, 12 months and 24 months

    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.

  12. Experience in the process

    Time frame: 24 to 36 months

    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.

Secondary outcomes

  1. Program Feasibility

    Time frame: 24 to 36 months

    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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.