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

Sponsor: Duke University • ClinicalTrials.gov ID: NCT06428175

Registry updated: 2026-09-03

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Description

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.

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.

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

Conditions

Health Care Pediatrics Transitional Care Comparative Effectiveness Family Engagement

Locations

UNC Hospitals — Chapel Hill, North Carolina, United States
DUHS — Durham, North Carolina, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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