NCT06428175NARecruiting

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

Duke University

Start Date

8/28/2025

Completion Date

2/1/2029

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.

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.

Eligibility Criteria

Age Range: No minimum to 18 years

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

Interventions

BEHAVIORAL

Focused Dose Hospital-to-Home Transitional Care Interventions

BEHAVIORAL

Extended Dose Hospital-to-Home Transitional Care Interventions

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Conditions

Health CarePediatricsTransitional CareComparative EffectivenessFamily Engagement

Locations

UNC Hospitals

Chapel Hill, North Carolina 27514

United States

DUHS

Durham, North Carolina 27701

United States