Recruiting

H2H-TCI vs. H2H-TCI

Sponsor:

Duke University

Code:

NCT06428175

Conditions

Health Care

Pediatrics

Transitional Care

Comparative Effectiveness

Family Engagement

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Focused Dose Hospital-to-Home Transitional Care Interventions

Extended Dose Hospital-to-Home Transitional Care Interventions

Study Details

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

Study ID

NCT06428175

Start date

Aug 28, 2025

Status verified date

Sep, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Focused Dose Hospital-to-Home Transitional Care Interventions

active comparator: Extended Dose Hospital-to-Home Transitional Care Interventions

Interventions

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.

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.

Primary outcome measure

  • 30-day acute care use [ Time Frame: 30 days post-hospital discharge ]
  • Caregiver confidence [ Time Frame: Baseline, 30 days post-discharge ]

Central Contacts and Locations

Central contacts

Locations

UNC Hospitals

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

DUHS

Recruiting

Durham, North Carolina, United States, 27701

Contacts

More Information

Sponsor

Duke University

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-03.