Health CareH2H-CYSHCNNCT06428175
Hospital-to-Home Transitional Care Interventions (H2H-TCI) Children/Youth With Special Health Care Needs (CYSHCN)
A study testing Focused Dose Hospital-to-Home Transitional Care Interventions and Extended Dose Hospital-to-Home Transitional Care Interventions in people with Health Care and Pediatrics, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Health Care, Pediatrics, Transitional Care
- What is being tested?
- Focused Dose Hospital-to-Home Transitional Care Interventions and Extended Dose Hospital-to-Home Transitional Care Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2025to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
- 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
Who cannot join
- Child exclusion criteria:
- 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.
- Parent/caregiver exclusion criteria include:
- Age less than 18 years old
- Diminished capacity to provide consent/participate
- Primary language for parent/caregiver is any language besides English or Spanish
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UNC Hospitals
Chapel Hill, North Carolina, 27514
Kelly Chason, 704-750-0747, chason@email.unc.edu
- Recruiting
DUHS
Durham, North Carolina, 27701
Jennifer Thomas, 919-613-5953, jennifer.thomas@duke.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Focused Dose Hospital-to-Home Transitional Care Interventions, Extended Dose Hospital-to-Home Transitional Care Interventions
- Keywords
- Special Needs, Hospital to Home Care, Children and Youth with Special Health Care Needs, Randomized Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Dose Hospital-to-Home Transitional Care InterventionsBehavioural
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 InterventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Focused Dose Hospital-to-Home Transitional Care Interventions | Active comparator | Not described Receives: Behavioral: Focused Dose Hospital-to-Home Transitional Care Interventions |
| Extended Dose Hospital-to-Home Transitional Care Interventions | Active comparator | Not described Receives: Behavioral: Extended Dose Hospital-to-Home Transitional Care Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day acute care use
30-day, all-cause composite readmission and emergency department (ED) visit rate
Measured: 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)
Measured: Baseline, 30 days post-discharge
Secondary outcomes (12)
7-day acute care use
All-cause composite readmission and ED visit rate at 7 days
Measured: 7-days post-discharge
14-day acute care use
All-cause composite readmission and ED visit rate at 14 days
Measured: 14 days post-discharge
Readmissions
All-cause readmission rate at 7, 14, and 30 days
Measured: 7, 14, 30 days post-discharge
Emergency Department (ED) visits
All-cause ED visits at 7, 14, and 30 days
Measured: 7, 14, 30 days post-discharge
Outpatient follow-up visit attendance
Completed outpatient visits by clinical area (primary, specialty, allied health)
Measured: 7, 14, 30 days post-discharge
Days at home
Annualized days without clinical visits (clinical days without healthcare visits)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days post-discharge
Fidelity
Percentage of intervention core components delivered as planned (goal: ≥80%)
Measured: 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)
Measured: approximately 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start28 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health CareStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- David Ming, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428175
- Sponsor's protocol ID
- Pro00114934
- Acronym
- H2H-CYSHCN
- Status last verified
- Sep 2026
- First submitted
- 20 May 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-to-Home Care Coordination for Children and Youth With Special Health Care Needs
- ClinicalTrials.gov ID
- NCT06428175
- Acronym / sponsor ID
- H2H-CYSHCN / Pro00114934
- Keywords
- Special Needs, Hospital to Home Care, Children and Youth with Special Health Care Needs, Randomized Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (8 listed)
- Child exclusion criteria:
- Parent/caregiver exclusion criteria include:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused Dose Hospital-to-Home Transitional Care InterventionsFocused 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. | Behavioural | Focused Dose Hospital-to-Home Transitional Care Interventions |
| Extended Dose Hospital-to-Home Transitional Care InterventionsExtended 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. | Behavioural | Extended Dose Hospital-to-Home Transitional Care Interventions |
Primary outcome
30-day acute care use
Time frame: 30 days post-hospital discharge
30-day, all-cause composite readmission and emergency department (ED) visit rate
Caregiver confidence
Time frame: Baseline, 30 days post-discharge
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)
12 secondary outcomes
7-day acute care use
Time frame: 7-days post-discharge
14-day acute care use
Time frame: 14 days post-discharge
Readmissions
Time frame: 7, 14, 30 days post-discharge
Emergency Department (ED) visits
Time frame: 7, 14, 30 days post-discharge
Outpatient follow-up visit attendance
Time frame: 7, 14, 30 days post-discharge
Days at home
Time frame: 30 and 90 days post-discharge
Caregiver strain
Time frame: Baseline, 7, 14, 30, and 90-days post-discharge
Global health status
Time frame: Baseline, 7, 14, 30, and 90-days post-discharge
Caregiver mental health-related quality of life (HR-QOL)
Time frame: Baseline, 7, 14, 30, and 90-days post-discharge
Quality of hospital-to-home care transitions
Time frame: 30 days post-discharge
Fidelity
Time frame: approximately 90 days post-discharge
Feasibility Acceptability Appropriateness
Time frame: approximately 90 days post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Ming, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Dose Hospital-to-Home Transitional Care Interventions and Extended Dose Hospital-to-Home Transitional Care Interventions in people with Health Care and Pediatrics, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Thomas, MPH ((919) 613-5953, jennifer.thomas@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day acute care use (time frame: 30 days post-hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.