Hospital-to-Home Transitional Care Interventions (H2H-TCI) Children/Youth With Special Health Care Needs (CYSHCN)

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Duke University
Study ID
NCT06428175
Status
Recruiting
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Conditions

  • Comparative Effectiveness
  • Family Engagement
  • Health Care
  • Pediatrics
  • Transitional Care

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Focused Dose Hospital-to-Home Transitional Care Interventions — BEHAVIORAL
    Focused dose H2H-TCIs will consist of a one-time post-discharge phone call completed within 72 hours post-hospital discharge by a clinical interventionist (e.g., nurse care coordinator or care manager). Calls will follow a structured template that provides empirically supported core H2H-TCI functions (follow-up care access, contingency planning, medication review, family education). The interventionist will also conduct a pre-hospital discharge clinical needs assessment with the parent.
  • Extended Dose Hospital-to-Home Transitional Care Interventions — BEHAVIORAL
    Extended dose H2H-TCIs will include a pre-discharge clinical needs assessment and initial phone call within 72 hours post-discharge, similar to the focused arm. After the initial contact, the dose of the extended H2H-TCI will increase as subjects receive high-intensity support during weekly post-discharge phone contacts through 30 days post-discharge. All contacts in the extended dose arm will be completed by a transition coach interventionist (e.g., nurse care coordinator or care manager) who will be formally trained on pillars of the Care Transitions Intervention© (CTI), a multi-faceted H2H-TCI that is the basis for the extended dose arm.

Study Details

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 Dates

Start date
Aug 28, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Focused Dose Hospital-to-Home Transitional Care Interventions
  • Active Comparator: Extended Dose Hospital-to-Home Transitional Care Interventions

Primary Outcome Measure

30-day acute care use [ Time Frame: 30 days post-hospital discharge ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UNC HospitalsChapel HillNorth Carolina27514
Kelly Chason
[email protected]
704-750-0747
DUHSDurhamNorth Carolina27701
Jennifer Thomas
[email protected]
919-613-5953

Find similar trials in Chapel Hill, NC

By research site
UNC Hospitals· Chapel Hill, NCDUHS· Durham, NC

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