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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Intensive Transition Support, which aids young people with complex health issues in transitioning from child healthcare to adult care. The focus is on enhancing their readiness for this change, their confidence in managing their health, and their satisfaction with the process. The trial also evaluates caregiver perceptions of the program and collects feedback for improvement. Teens aged 16-18 with multiple long-term health conditions or rare diseases and no clear adult care plan may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to improving healthcare transitions for young people.

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 prior data suggests that this program is safe for high-risk youth?

Research has shown that intensive support during the transition from child to adult healthcare is generally well-received by children and teens with complex medical needs. These studies have not identified any major safety issues. The main goal of this support is to help young people move smoothly from child to adult healthcare services.

In some trials, a transition team, including a nurse, guides patients and their families, yielding positive results. The aim is to ensure continuous care without causing harm. Since this support does not involve medications or medical procedures, safety concerns are usually minimal.

Overall, no evidence of serious problems has been linked to this type of program. It is designed to be supportive and helpful, enabling participants to feel more confident about managing their health as they grow up. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intensive Transition Support for chronic illness because it offers a comprehensive approach that focuses on the critical transition period when patients move from hospital to home care. Unlike traditional treatments that often emphasize medication adjustments or physical therapy alone, this approach integrates personalized care plans, enhanced communication between healthcare providers, and patient education. By addressing the holistic needs of patients during this vulnerable time, it aims to reduce readmissions and improve long-term health outcomes, which is a significant advancement over current standard practices.

What evidence suggests that the Intensive Transition Support program is effective for high-risk youth with medical complexity?

Research has shown that strong support during the transition from pediatric to adult care greatly benefits young people with complex health needs. Studies have found that these programs improve continuity of care as young people become adults, ensuring they continue to receive appropriate care after leaving children's services. In this trial, participants will receive Intensive Transition Support. The PITCare study demonstrated that this support leads to better health outcomes and higher satisfaction for both patients and their caregivers. These programs are particularly beneficial for young people with long-term health conditions, easing the shift to adult healthcare services. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11628984/

the PITCare study—protocol for a randomised controlled trial Abstract. Introduction. Children with medical complexity (CMC) have chronic, intensive care needs managed by many healthcare practitioners.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39653557/

the PITCare study-protocol for a randomised controlled trial PITCare aims to assess whether intensive patient and caregiver-oriented transition support beyond age 18 will improve continuity of care for CMC compared with ...

3. trialx.com trialx.com/clinical-trials/listings/257831/promoting-intensive-transitions-for-children-and-youth-with-medical-complexity-from-pediatric-to-adult-care/

Promoting Intensive Transitions for Children and Youth ... The goal of this randomized control trial is to compare intensive transition support from a transition team, led by an advance practice nurse, ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/14/12/e086088.abstract

the PITCare study—protocol for a randomised controlled trial PITCare aims to assess whether intensive patient and caregiver-oriented transition support beyond age 18 will improve continuity of care for CMC compared with ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/cch.70126?af=R

Hospital to Home Transitions for Children With Medical ... Care transitions are especially difficult for children with medical complexity (CMC)—defined as those with chronic conditions, technology ...