Intensive Transition Support for Chronic Illness

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Developmental disabilities, No consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

126 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Intensive Transition Support for Children and Youth with Medical Complexity?

Research shows that coordinated models of care can improve health outcomes for children with medical complexity during transitions. Additionally, a core outcome set for transitional care includes important factors like disease management and quality of life, which are essential for evaluating the effectiveness of such interventions. ^{1 2 3 4 5}

Is Intensive Transition Support for Chronic Illness safe for humans?

The research highlights that children with medical complexity face risks during transitions in care, but coordinated care models can improve outcomes. Families of these children can identify safety gaps, suggesting that while there are safety concerns, improvements are possible with better care coordination. ^{1 6 7 8 9}

How is the Intensive Transition Support treatment different from other treatments for children with medical complexity?

Intensive Transition Support is unique because it focuses on providing coordinated care during the transition from pediatric to adult healthcare, addressing both the medical and emotional needs of children with medical complexity and their families. This approach involves a multidisciplinary team to ensure a smooth transition and improve health outcomes, which is not typically emphasized in standard treatments. ^{1 10 11 12 13}

What is the purpose of this trial?

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

The TAC Program trial is for high-risk youth with multiple chronic physical and/or mental health conditions, or a rare disease/genetic condition. Participants must lack an identified adult care provider post-transfer or face significant social and structural health barriers.

Inclusion Criteria

I am 16-18 years old with multiple chronic conditions and face significant health care or social challenges.

Exclusion Criteria

Does not provide consent

Moderate to severe developmental/intellectual disabilities

Followed by services at SickKids which has an established transition program/provider

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transition Intervention

Participants co-create an individualized transition plan and receive a patient-specific transfer package

6 to 24 months

Multiple visits as needed for transition planning

Introduction to Adult Services

A joint clinic visit facilitated by the transition team with the identified receiving adult care provider

24 to 36 months

1 joint clinic visit

Follow-up

Participants are monitored for satisfaction and quality of life improvements after transition

12 to 24 months

Treatment Details

Interventions

• Intensive Transition Support

Trial Overview This study evaluates the Transition to Adult Care (TAC) Program's effectiveness on transition readiness, self-efficacy, self-management, quality of life, and satisfaction in both youth and caregivers during the shift to adult care services.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Findings from Research

Transitions in care for children with medical complexity (CMC) and their parents often lead to emotional distress and high expectations, highlighting the psychological challenges faced during these periods.

However, when collaborative models of care are implemented, CMC experience improvements in quality of life and emotional health after transitioning from hospital to home, indicating the potential benefits of coordinated care approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Care- A Systematic Scoping Review of Transitions for Children with Medical Complexities. Mantler, T., Jackson, KT., Baer, J., et al.[2021]

This systematic review analyzed 50 studies and identified 172 outcomes related to hospital-to-home transitions for children with medical complexity, ultimately categorizing them into 25 unique outcomes across six domains, including mortality, physical health, and life impact.

The findings highlight significant variability in both the outcomes reported and the methods used to measure them, suggesting a need for standardized outcome measures to improve the evaluation of transitional care interventions for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital-to-home transitions for children with medical complexity: part 1, a systematic review of reported outcomes. de Lange, A., Alsem, MW., Haspels, HN., et al.[2023]

A study involving 29 parents and 37 healthcare professionals identified 25 important and feasible transitional care interventions for children with medical complexity, focusing on family engagement, care coordination, and education.

The expert elicitation process revealed that while both parents and healthcare professionals agreed on the importance of these interventions, healthcare professionals were generally more cautious about their feasibility compared to parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance and Feasibility of Transitional Care for Children With Medical Complexity: Results of a Multistakeholder Delphi Process. Leyenaar, JK., Rizzo, PA., Khodyakov, D., et al.[2020]

A scoping review of 14 studies identified three main types of interventions to support the transition of medically complex children from hospital to home: Comprehensive Care Plans, Complex Care Programs, and Integrated Delivery Models.

The overall quality of the studies was moderate, highlighting a significant need for more high-quality research and consensus on definitions for medically complex children to improve transition outcomes and reduce hospital readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to support transitions from hospital to home for children with medical complexity: A scoping review. Breneol, S., Belliveau, J., Cassidy, C., et al.[2018]

A study involving 208 families of children with medical complexity revealed that families identified critical areas for improving hospital safety and quality, including unmet expectations, communication lapses, and the need for consistent care.

Families emphasized their expertise in their child's care, suggesting that hospitals should actively involve them in safety discussions to address quality concerns that could impact patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In their own words: Safety and quality perspectives from families of hospitalized children with medical complexity. Mauskar, S., Ngo, T., Haskell, H., et al.[2023]

Parents generally rated communication and care coordination positively, but they expressed concerns about transitions from other facilities to the emergency department, indicating a need for improvement in these areas.

Healthcare providers and nurses rated overall care and discharge preparation highly, but there was a notable gap in communication and coordination between units, highlighting the importance of inclusive and collaborative approaches to care for hospitalized children with medical complexity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives: Communication, care coordination, and transitions in care for children with medical complexity. Williams, LJ., Waller, K., Chenoweth, RP., et al.[2022]

Parents of children with medical complexity (CMC) expressed a strong need for high-quality, consistent medication education at discharge, emphasizing the importance of receiving information in their preferred language and from knowledgeable experts.

The study highlighted that personalized education, which considers parents' literacy levels and specific information needs, is crucial for building their confidence in managing complex medication regimens at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent Perceptions and Experiences Regarding Medication Education at Time of Hospital Discharge for Children With Medical Complexity. Gold, JM., Chadwick, W., Gustafson, M., et al.[2021]

A needs assessment involving a literature review, benchmarking survey, and key informant interviews highlighted that while pediatric Complex Care Programs in Ontario excel in transition planning, there are significant gaps in ensuring readiness and completion of care transfer for youth with medical complexity (YMC).

Successful transitions are supported by collaboration among stakeholders, early planning, and knowledgeable providers, but challenges such as limited time, poor access to adult services, and inadequate support for adult healthcare providers hinder the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition to adult care for youth with medical complexity: Assessing needs and setting priorities for a health care improvement initiative. Li, L., Polanski, A., Lim, A., et al.[2022]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Changes in Care- A Systematic Scoping Review of Transitions for Children with Medical Complexities. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Hospital-to-home transitions for children with medical complexity: part 1, a systematic review of reported outcomes. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Importance and Feasibility of Transitional Care for Children With Medical Complexity: Results of a Multistakeholder Delphi Process. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Improving transitions in care for children with complex and medically fragile needs: a mixed methods study. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Hospital-to-home transitions for children with medical complexity: part 2-a core outcome set. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Strategies to support transitions from hospital to home for children with medical complexity: A scoping review. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

In their own words: Safety and quality perspectives from families of hospitalized children with medical complexity. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives: Communication, care coordination, and transitions in care for children with medical complexity. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Parent Perceptions and Experiences Regarding Medication Education at Time of Hospital Discharge for Children With Medical Complexity. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Transition to adult care for youth with medical complexity: Assessing needs and setting priorities for a health care improvement initiative. [2022]

11. France pubmed.ncbi.nlm.nih.gov

[Accompanying the pediatric/adult service transition in chronically ill patients]. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Children With Medical Complexity: The 10-Year Experience of a Single Center. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Optimizing the multidisciplinary team to enhance care coordination across the continuum for children with medical complexity. [2022]