NCT06428175 Hospital-to-Home Transitional Care Interventions (H2H-TCI) Children/Youth With Special Health Care Needs (CYSHCN)
| NCT ID | NCT06428175 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Health Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 480 participants in total. It began in 2025-08-28 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aim 1: Compare the effectiveness of focused dose vs extended dose hospital-to-home Transitional Care Interventions (H2H-TCI) on health service use and parent-reported confidence for hospitalized CYSHCN. Aim 2: Compare the effectiveness of focused and extended dose H2H-TCI among vulnerable CYSHCN subgroups. Hypothesis: Both H2H-TCI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity; while extended H2H-TCI will better mitigate racial/ethnic outcome disparities than focused H2H-TCI. Aim 3: Evaluate implementation context, processes, and mechanisms via a multi-phase mixed methods study design.
Eligibility Criteria
Inclusion Criteria: * For this study, eligible children/youth with special health care needs (CYSHCN) and adult parent/caregiver dyads will be those who meet the following inclusion criteria: 1. Child is a CYSHCN, defined as having seen two or more distinct specialty areas for outpatient visits during the 12 months prior to index hospitalization admission date 2. Age of hospitalized child is under 18 years old 3. Child hospitalized on a general pediatrics inpatient service line at participating site 4. Adult parent/caregiver for the child is 18 years or older Exclusion Criteria: * Child exclusion criteria: 1. Child will be discharged to any location besides home (e.g., long-term care or residential facility, skilled nursing facility, inpatient acute rehabilitation, psychiatric facility) 2. Child is a ward of the state or has an ongoing social services investigation 3. Child is already receiving transitional care, intensive longitudinal care coordination (e.g., organ/disease-specific clinical program, clinical division within the same institution as the hospital \[e.g., Children's Complex Care Program at UNC; Complex Care Service at Duke\]), and/or longitudinal population health care coordination as part of a bundled alternative payment care model. * Parent/caregiver exclusion criteria include: 1. Age less than 18 years old 2. Diminished capacity to provide consent/participate 3. Primary language for parent/caregiver is any language besides English or Spanish
Contact & Investigator
David Ming, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06428175 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Health Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06428175 currently recruiting?
Yes, NCT06428175 is actively recruiting participants. Contact the research team at jennifer.thomas@duke.edu for enrollment information.
Where is the NCT06428175 trial being conducted?
This trial is being conducted at Chapel Hill, United States, Durham, United States.
Who is sponsoring the NCT06428175 clinical trial?
NCT06428175 is sponsored by Duke University. The principal investigator is David Ming, MD at Duke University. The trial plans to enroll 480 participants.