Intensive Transition Support for Medically Complex Youth

(PITCare Trial)

Overseen By Sara Santos

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: End-of-life care, No stable caregiver

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

Compensation: Varies

Number of Visits: Unknown

150 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 seems focused on providing support during the transition to adult care, so it's best to ask the trial coordinators for more details.

What data supports the effectiveness of the treatment Intensive Transition Support for Medically Complex Youth?

Research shows that coordinated care models can improve health outcomes for children with medical complexity during transitions. Additionally, interventions focusing on hospital-to-home transitions have been linked to better life impact and resource use outcomes, suggesting that structured support can be beneficial. ^{1 2 3 4 5}

Is Intensive Transition Support for Medically Complex Youth safe for humans?

The available research highlights the importance of coordinated care and communication for children with medical complexity, but it does not provide specific safety data for Intensive Transition Support. Families of these children often identify safety and quality gaps in hospital care, suggesting that while the approach aims to improve transitions, safety concerns may still exist. ^{1 4 6 7 8}

How is the Intensive Transition Support treatment different from other treatments for medically complex youth?

The Intensive Transition Support treatment is unique because it focuses on providing coordinated care and support during the transition from pediatric to adult care for medically complex youth, addressing both physical and mental challenges. This approach aims to improve health outcomes by easing the transition process, which is often complex due to differences in pediatric and adult healthcare systems. ^{1 9 10 11 12}

What is the purpose of this trial?

Medical advances have allowed many more children and youth with medical complexity (CMC) to survive well into adulthood. However, this has not been matched with increases in knowledge of complex conditions or the availability of supports as they transition into the adult care system. The goal of this randomized control trial is to compare intensive transition support from a transition team, led by an advance practice nurse, during transition to adult care for 2 years, with usual care in CMC. Participants assigned to the intervention group will be offered support in care planning, receiving funding, and connecting with a primary care provider and adult subspecialists. The main questions it aims to answer are: 1. Does intensive transition support improve the patient's continuity of care over 2 years compared with usual care? 2. Will there be differences between intervention and control groups with respect to other outcomes related to the youth/family's satisfaction with care, care coordination, self-care, health service utilization, cost-effectiveness, and quality of life? 3. What are the experiences of youth, parents, the transition team, and other clinicians involved in the intensive transition support process?

Eligibility Criteria

This trial is for children and youth with complex medical needs who rely on technology, face severe or life-threatening conditions, expect their condition to last at least 6 months, and are involved with multiple healthcare teams in various locations. It's not specified who can't join.

Inclusion Criteria

You have a complex involvement of at least five healthcare practitioners/teams and healthcare services in three or more locations, including home, school, hospital, etc.

You have a serious and/or potentially fatal medical condition.

The condition is expected to persist for a minimum of 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Transition Support

Participants receive intensive transition support from a transition team, led by an advance practice nurse, during transition to adult care

24 months

Regular visits as needed for transition support

Follow-up

Participants are monitored for continuity of care, satisfaction, and other outcomes after transition support

12 months

Treatment Details

Interventions

• Intensive Transition Support

Trial Overview The study tests if intensive support during the shift from pediatric to adult care improves continuity of care over two years versus usual care. Support includes help with care plans, funding access, and connecting with primary providers and specialists.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Group II: Control/ Usual Care Active Control 1 Intervention

Standard of care in the control group will involve the utilization of existing tools within clinical programs which may include preparation for transitions, but there will be no systematic follow-up by a paediatric provider beyond age 18. Care will be transferred to adult providers (primary care and specialists) via a transition guide that will be offered to participants and their referring providers. This is the current model of care for virtually all CMC in Ontario.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

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]

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]

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]

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]

The Plans for Action and Care Transitions (PACT) intervention significantly reduced hospitalization rates among children with medical complexity, with an adjusted rate of 81 hospitalizations per 100 child-years compared to 101 in usual care.

PACT also led to a substantial decrease in healthcare costs, with adjusted mean charges per patient being $14,206 lower, and it was associated with fewer deaths (0 in PACT vs 4 in usual care), indicating improved safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex Care Hospital Use and Postdischarge Coaching: A Randomized Controlled Trial. Coller, RJ., Klitzner, TS., Lerner, CF., 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]

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 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]

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]

The Complex Care for Kids Ontario (CCKO) program significantly improved the perceived utility of care planning tools among children with medical complexity compared to usual care, with a notable adjusted odds ratio of 9.3 at 12 months.

While the CCKO program did not show differences in other primary outcomes or secondary health outcomes, it resulted in lower total health care costs in the second year, suggesting potential economic benefits of structured complex care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Structured Care Coordination for Children With Medical Complexity: The Complex Care for Kids Ontario (CCKO) Randomized Clinical Trial. Cohen, E., Quartarone, S., Orkin, J., et al.[2023]

The DigiComp Kids system, designed for children with medical complexity, received strong usability scores from 15 participants, indicating it effectively supports the transition from hospital to home care.

Participants highlighted the importance of tailoring the system to individual user needs and streamlining features to enhance user experience, emphasizing its role in maintaining connections between hospital and home care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Hospital-to-Home System for Children With Medical Complexities: Usability Testing Study. Bird, M., Carter, N., Lim, A., et al.[2022]

A survey of 441 families of children with medical complexity revealed that enrollment in a structured clinical program at a tertiary care center significantly improved the fulfillment of 14 specific health service needs, including primary care checkups and mental health care.

Before enrollment, many families reported unmet needs, but after joining the program, there was a notable increase in access to essential services, indicating that specialized care coordination can effectively address gaps in health services for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Services and Health Care Needs Fulfilled by Structured Clinical Programs for Children with Medical Complexity. Kuo, DZ., Berry, JG., Glader, L., et al.[2018]

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. 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]

3. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

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

Complex Care Hospital Use and Postdischarge Coaching: A Randomized Controlled Trial. [2020]

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

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

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

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

9. 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]

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

Effectiveness of Structured Care Coordination for Children With Medical Complexity: The Complex Care for Kids Ontario (CCKO) Randomized Clinical Trial. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

A Novel Hospital-to-Home System for Children With Medical Complexities: Usability Testing Study. [2022]

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

Health Services and Health Care Needs Fulfilled by Structured Clinical Programs for Children with Medical Complexity. [2018]