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

NCT06428175 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

Focused Dose Hospital-to-Home Transitional Care Interventions

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.

BEHAVIORAL

Extended Dose Hospital-to-Home Transitional Care Interventions

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.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • Duke University

    lead OTHER

Principal Investigators

  • David Ming, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2028-08-31
Completion
2029-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06428175 on ClinicalTrials.gov