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

NCT06428175 | Recruiting DMC

• 1 other identifier: Pro00114934
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Special Needs; Hospital to Home Care; Children and Youth with Special Health Care Needs; Randomized Trial

Outcome Measures

Primary Outcomes (2)

• 30-day acute care use

  30-day, all-cause composite readmission and emergency department (ED) visit rate

  30 days post-hospital discharge

• Caregiver confidence

  Change in caregiver-reported confidence that their child can avoid hospitalization within the next one month (1=not confident; 10=fully confident; \<5 is low confidence)

  Baseline, 30 days post-discharge

Secondary Outcomes (12)

• 7-day acute care use

  7-days post-discharge

• 14-day acute care use

  14 days post-discharge

• Readmissions

  7, 14, 30 days post-discharge

• Emergency Department (ED) visits

  7, 14, 30 days post-discharge

• Outpatient follow-up visit attendance

  7, 14, 30 days post-discharge

Study Arms (2)

Focused Dose Hospital-to-Home Transitional Care Interventions

ACTIVE COMPARATOR

Behavioral: Focused Dose Hospital-to-Home Transitional Care Interventions

Extended Dose Hospital-to-Home Transitional Care Interventions

ACTIVE COMPARATOR

Behavioral: Extended Dose Hospital-to-Home Transitional Care Interventions

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.

Focused Dose Hospital-to-Home Transitional Care Interventions

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.

Extended Dose Hospital-to-Home Transitional Care Interventions

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 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.
• Age less than 18 years old
• Diminished capacity to provide consent/participate
• Primary language for parent/caregiver is any language besides English or Spanish

Sponsors & Collaborators

• Duke University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

RECRUITING

DUHS

Durham, North Carolina, 27701, United States

RECRUITING

Study Officials

• David Ming, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Thomas, MPH

CONTACT

(919) 613-5953; jennifer.thomas@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: August 28, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)