Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID06428175

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

Led by Duke University · Updated on 2025-09-11

480

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the hospital-to-home transitional care interventions (H2H-TCI) for children and youth with special health care needs (CYSHCN) who are hospitalized. The study aims to compare the effectiveness of two approaches—focused dose versus extended dose interventions—on health service use and parent-reported confidence. It also examines how these interventions work among vulnerable subgroups and studies the implementation process using a mixed methods design. Participants will be randomly assigned to receive either a focused dose or an extended dose H2H-TCI. The focused dose group receives a single phone call from a clinical interventionist within 72 hours after hospital discharge, which follows a structured template including follow-up care access, medication review, and family education. The extended dose group receives the same initial call plus weekly phone calls for one month, delivered by a trained transition coach using the Care Transitions Intervention© model. During the study, data will be collected from electronic health records and caregiver reports to measure acute care use within 30 days post-discharge and caregiver confidence at baseline and 30 days after discharge. Secondary outcomes include emergency visits, readmissions, follow-up visit attendance, caregiver strain, mental health-related quality of life, and quality of care transitions assessed at various time points up to 90 days post-discharge. The study includes safety oversight by a Data Safety and Monitoring Board and secure data handling procedures, with participation lasting through these follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child is a child or youth with special health care needs (CYSHCN) who has seen two or more different specialty doctors for outpatient visits in the 12 months before hospital admission
  • Child is younger than 18 years old
  • Child is hospitalized on a general pediatrics inpatient service line at a participating site
  • Adult parent or caregiver for the child is 18 years or older
Not Eligible

You will not qualify if you...

  • Child will be discharged to any location other than home, such as long-term care, skilled nursing, inpatient rehabilitation, or psychiatric facility
  • Child is a ward of the state or has an active social services investigation
  • Child is already receiving transitional care or intensive longitudinal care coordination within the same hospital system
  • Parent or caregiver is younger than 18 years old
  • Parent or caregiver has diminished capacity to provide consent or participate
  • Parent or caregiver's primary language is not English or Spanish

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 30 days post-discharge

Participants receive either a focused dose or extended dose hospital-to-home transitional care intervention involving phone calls with a clinical interventionist after hospital discharge.

1 phone call for focused dose; weekly phone calls for 4 weeks for extended dose

Follow-up

Duration - Up to 90 days post-discharge

Participants are monitored for health service use, caregiver confidence, and other outcomes through 90 days post-discharge.

Assessments at baseline, 7, 14, 30, and 90 days post-discharge

Trial Site Locations

Total: 2 locations

1

UNC Hospitals

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

2

DUHS

Durham, North Carolina, United States, 27701

Actively Recruiting

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Research Team

J

Jennifer Thomas, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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