An interventional study of Focused Dose Hospital-to-Home Transitional Care Interventions and Extended Dose Hospital-to-Home Transitional Care Interventions in Health Care, Pediatrics and Transitional Care, sponsored by Duke University. Recruiting at 2 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Child exclusion criteria:
Parent/caregiver exclusion criteria include:
Behavioral: Focused Dose Hospital-to-Home Transitional Care Interventions
Behavioral: Extended 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 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.
30-day acute care use
30-day, all-cause composite readmission and emergency department (ED) visit rate
Time frame: 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)
Time frame: Baseline, 30 days post-discharge
7-day acute care use
All-cause composite readmission and ED visit rate at 7 days
Time frame: 7-days post-discharge
14-day acute care use
All-cause composite readmission and ED visit rate at 14 days
Time frame: 14 days post-discharge
Readmissions
All-cause readmission rate at 7, 14, and 30 days
Time frame: 7, 14, 30 days post-discharge
Emergency Department (ED) visits
All-cause ED visits at 7, 14, and 30 days
Time frame: 7, 14, 30 days post-discharge
Outpatient follow-up visit attendance
Completed outpatient visits by clinical area (primary, specialty, allied health)
Time frame: 7, 14, 30 days post-discharge
Days at home
Annualized days without clinical visits (clinical days without healthcare visits)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days post-discharge
Fidelity
Percentage of intervention core components delivered as planned (goal: ≥80%)
Time frame: 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)
Time frame: approximately 90 days post-discharge
Plan to share: No
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