Hospital-to-Home Transitional Care Interventions (H2H-TCI) Children/Youth With Special Health Care Needs (CYSHCN)
Recruiting now · Not applicable
Conditions studied: Health Care, Pediatrics, Transitional Care, Comparative Effectiveness, Family Engagement
In brief
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.
Key facts
- Study ID
- NCT06428175
- Run by
- Duke University
- People needed
- 480
- Starts
- 2025-08-28
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2025-09-11
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- 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
- Age of hospitalized child is under 18 years old
- Child hospitalized on a general pediatrics inpatient service line at participating site
- Adult parent/caregiver for the child is 18 years or older
You may not qualify if…
- Child exclusion criteria:
- 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)
- Child is a ward of the state or has an ongoing social services investigation
- 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:
- Age less than 18 years old
- Diminished capacity to provide consent/participate
- Primary language for parent/caregiver is any language besides English or Spanish
Where it is running
- UNC Hospitals — Chapel Hill, North Carolina, United States (enrolling)
- DUHS — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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