480 Participants Needed

Transitional Care for Pediatrics

(H2H-CYSHCN Trial)

Recruiting at 1 trial location
SA
JT
Overseen ByJennifer Thomas, MPH
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two support systems, known as Hospital-to-Home Transitional Care Interventions, to aid children with special health care needs in transitioning from hospital to home. The goal is to determine whether a short-term or long-term support plan more effectively reduces hospital visits and boosts parents' confidence in caring for their child. The study focuses on how these plans work for children with complex needs and aims to reduce health disparities among different racial and ethnic groups. Families who might be suitable have children under 18, have consulted multiple specialists in the past year, and will be returning home after their hospital stay. As an unphased trial, this study offers families the opportunity to contribute to important research that could enhance care transitions for children with special health care needs.

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 these Hospital-to-Home Transitional Care Interventions are safe for children and youth with special health care needs?

Research has shown that Hospital-to-Home Transitional Care Interventions (H2H-TCI) are generally safe and well-received by patients. Studies have found that these programs can reduce hospital readmissions, indicating improved patient health without harm. For instance, one study showed that a more intensive program reduced hospital readmissions from 42% to 29%, demonstrating effectiveness without introducing new risks.

Additionally, a review of various programs for children leaving the hospital found they also led to reduced use of health services. This further supports the absence of major safety issues or significant side effects. While individual experiences may vary, the evidence so far supports the safety of H2H-TCI.12345

Why are researchers excited about this trial?

Researchers are excited about the hospital-to-home transitional care interventions for pediatric patients because these approaches aim to smooth the transition from hospital to home, potentially reducing readmissions and improving overall health outcomes. Unlike traditional care, which often leaves gaps in communication and support once patients leave the hospital, these interventions offer continuous, personalized care during this critical period. The unique aspect here is the tailored support, which can include follow-up visits, phone check-ins, and coordination with community healthcare providers, ensuring a seamless and supportive transition for young patients and their families.

What evidence suggests that this trial's Hospital-to-Home Transitional Care Interventions could be effective for CYSHCN?

Research has shown that assisting families in transitioning from hospital to home can significantly reduce the likelihood of readmission for children with special health needs. This trial will compare two approaches: the Focused Dose Hospital-to-Home Transitional Care Interventions and the Extended Dose Hospital-to-Home Transitional Care Interventions. One study found that a more intensive support program reduced readmissions from 42% to 29% within three months. Another review highlighted that these programs also enhance care coordination, easing the transition for children with complex medical issues. These programs provide structured support and resources to families, boosting their confidence and decreasing the need for emergency care. The overall goal is to deliver personalized care tailored to each child's specific health needs.13567

Who Is on the Research Team?

DM

David Ming, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for children with special health care needs who have been hospitalized and seen in two or more distinct specialty areas within the last year. It's designed to help these kids transition from hospital to home.

Inclusion Criteria

My child is currently hospitalized in a general pediatrics unit at a participating hospital.
My child has seen specialists in two or more areas in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a focused or extended dose of hospital-to-home Transitional Care Interventions (H2H-TCI) post-discharge

4 weeks
1 visit (phone call) for focused dose, weekly phone calls for extended dose

Follow-up

Participants are monitored for health service use and caregiver-reported outcomes post-treatment

90 days
Regular assessments at 7, 14, 30, and 90 days post-discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Hospital-to-Home Transitional Care Interventions
Trial Overview The study compares two types of transitional care interventions: a 'focused dose' which is shorter, and an 'extended dose' which lasts longer. The goal is to see which one better reduces healthcare use and increases parent confidence post-hospitalization.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Extended Dose Hospital-to-Home Transitional Care InterventionsActive Control1 Intervention
Group II: Focused Dose Hospital-to-Home Transitional Care InterventionsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Citations

A Scoping Review of Healthcare Professionals ExperiencesThis offers a comprehensive framework to understand and improve hospital‐to‐home transitional care for children with medical complexity. The ...
Comparing the Effectiveness of Two Hospital-to-Home ...This study compares the clinical effectiveness of two models of hospital-to-home care coordination among children and youth with special ...
Hospital-to-home transitions for children with medical ...In this systematic review, we identified outcomes currently reported in publications evaluating the effectiveness of hospital-to-home ...
Transitional Care Interventions From Hospital to ...Main Outcomes and Measures The primary outcomes were readmission at 30, 90, and 180 days after discharge. Secondary outcomes included emergency ...
Effectiveness of hospital-to-home transitional care ...A high-intensity intervention reduced hospital readmissions in three months from 42% to 29% in comparison to usual care. It did not reduce ...
Hospital-to-Home Transitional Care Interventions (H2H-TCI ...The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.
Hospital-to-Home Interventions, Use, and Satisfaction: A Meta ...In this study, we systematically review and meta-analyze the evidence for pediatric hospital discharge interventions that are associated with reduced health ...
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