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

Hospital-to-Home Care Coordination for Children and Youth With Special Health Care Needs

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatrics; Health Care; Comparative Effectiveness; Transitional Care; Family Engagement
• Intervention / Treatment: Behavioral: Focused Dose Hospital-to-Home Transitional Care Interventions; Behavioral: Extended Dose Hospital-to-Home Transitional Care Interventions

Detailed Description

Primary Aims 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.

Hypothesis: Extended H2H-TCI will be associated with lower acute care use and higher confidence than focused H2H-TCI.

Secondary Aims 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.

The study populations consist of adult parent/caregivers' dyad and children/youth with special health care needs. Participants will be randomized to focused dose intervention after discharge or an extended dose intervention. the single dose will receive one phone call from an interventionist post discharge, the extended dose group will receive weekly phone calls for one month from an interventionist.

Analysis of data from the confidence-mediated and vulnerable patient/family characteristics-moderated pathways will address Aims 1 and 2, respectively.

During extraction of data from each site's Electronic Health Record (EHR) data security risks will be mitigated by following established standard operating procedures at Duke and the University of North Carolina (UNC). During preparation of site-based analytical datasets risks will be mitigated by limiting Protected Health Information (PHI) as much as and as early as is practical. All datasets will be stored and reviewed on a secure, cloud-based Protected Analytical and Computing Environment (PACE) at Duke and at UNC in the Secure Research Workspace (SRW).

The investigators will plan to create a Data Safety and Monitoring Board (DSMB) that includes expert clinicians who are not active study team members and are independent of the study sponsor. The DSMB will oversee the safety of volunteers participating in the study as needed.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Thomas, MPH; Phone Number: (919) 613-5953; Email: jennifer.thomas@duke.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • UNC Hospitals
      • Contact: Kelly Chason; Phone Number: 704-750-0747; Email: chason@email.unc.edu
    • Durham, North Carolina, United States, 27701
      • Recruiting
      • DUHS
      • Contact: Jennifer Thomas; Phone Number: 919-613-5953; Email: jennifer.thomas@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Focused Dose Hospital-to-Home Transitional Care 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.
Active Comparator: Extended Dose Hospital-to-Home Transitional Care Interventions	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day acute care use	All-cause composite readmission and ED visit rate at 7 days	7-days post-discharge
14-day acute care use	All-cause composite readmission and ED visit rate at 14 days	14 days post-discharge
Readmissions	All-cause readmission rate at 7, 14, and 30 days	7, 14, 30 days post-discharge
Emergency Department (ED) visits	All-cause ED visits at 7, 14, and 30 days	7, 14, 30 days post-discharge
Outpatient follow-up visit attendance	Completed outpatient visits by clinical area (primary, specialty, allied health)	7, 14, 30 days post-discharge
Days at home	Annualized days without clinical visits (clinical days without healthcare visits)	30 and 90 days post-discharge
Caregiver strain	Change in caregiver-reported strain (measured by scores on seven-item Caregiver Strain Questionnaire Short Form 7, CGSQ-SF7 survey), where a higher score indicates a higher level of caregiver strain.	Baseline, 7, 14, 30, and 90-days post-discharge
Global health status	Change in caregiver-reporter PROMIS global health status survey. PROMIS assessments are scored on a T-score metric. High scores mean more of the concept being measured. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population.	Baseline, 7, 14, 30, and 90-days post-discharge
Caregiver mental health-related quality of life (HR-QOL)	Change in caregiver-reported mental HR-QOL as scored on the Medical Outcomes Short Form 12 (SF12) survey.	Baseline, 7, 14, 30, and 90-days post-discharge
Quality of hospital-to-home care transitions	Pediatric Transition Experience Measure (P-TEM): eight-item, parent-reported measure of overall process and quality of hospital-to-home transitions.	30 days post-discharge
Fidelity	Percentage of intervention core components delivered as planned (goal: ≥80%)	approximately 90 days post-discharge
Feasibility Acceptability Appropriateness	Clinical staff and caregiver-reported composite score responses to Feasibility of Implementation, Acceptability of Implementation, and Implementation Appropriateness surveys (4 items each)	approximately 90 days post-discharge

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: David Ming, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Trial; Special Needs; Hospital to Home Care; Children and Youth with Special Health Care Needs
• Other Study ID Numbers: Pro00114934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No