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Hospital-to-Home Care Transition Interventions (H2H-CTI) Children/Youth With Special Health Care Needs (CYSHCN) — H2H-CYSHCN  

Pediatrics Clinical Trial

Official title:
Hospital-to-Home Care Transition Intervention (H2H-CTI) for Children and Youth With Special Health Care Needs (CYSHCN)

Clinical Trial Summary

Aim 1: Compare the effectiveness of focused dose vs extended dose hospital-to-home care transition interventions (H2H-CTI) on health service use and parent-reported confidence for hospitalized CYSHCN. Aim 2: Compare the effectiveness of focused and extended dose H2H-CTI among vulnerable CYSHCN subgroups. Hypothesis: Both H2H-CTI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity; while extended H2H-CTI will better mitigate racial/ethnic outcome disparities than focused H2H-CTI. Aim 3: Evaluate implementation context, processes, and mechanisms via a multi-phase mixed methods study design.

Clinical Trial Description

Primary Aims Aim 1: Compare the effectiveness of focused dose vs extended dose hospital-to-home care transition interventions (H2H-CTI) on health service use and parent-reported confidence for hospitalized CYSHCN. Hypothesis: Extended H2H-CTI will be associated with lower acute care use and higher confidence than focused H2H-CTI. Secondary Aims Aim 2: Compare the effectiveness of focused and extended dose H2H-CTI among vulnerable CYSHCN subgroups. Hypothesis: Both H2H-CTI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity; while extended H2H-CTI will better mitigate racial/ethnic outcome disparities than focused H2H-CTI. 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06428175
Study type Interventional
Source Duke University
Contact Shannon A Widman
Phone 919-681-7252
Email shannon.widman@duke.edu
Status Not yet recruiting
Phase N/A
Start date March 2025
Completion date February 2028
View Details
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