Clinical trial NCT06428175: Hospital-to-Home Transitional Care Interventions (H2H-TCI) Children/Youth With Special Health Care Needs (CYSHCN)
Official title: Hospital-to-Home Care Coordination for Children and Youth With Special Health Care Needs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Care
Pediatrics
Transitional Care
Comparative Effectiveness
Family Engagement
Keywords: Special Needs
Hospital to Home Care
Children and Youth with Special Health Care Needs
Randomized Trial
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-05-24
Enrollment: 480
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: 30-day acute care use
timeFrame: 30 days post-hospital discharge
measure: Caregiver confidence
timeFrame: Baseline, 30 days post-discharge
Secondary outcomes:
measure: 7-day acute care use
timeFrame: 7-days post-discharge
measure: 14-day acute care use
timeFrame: 14 days post-discharge
measure: Readmissions
timeFrame: 7, 14, 30 days post-discharge
measure: Emergency Department (ED) visits
timeFrame: 7, 14, 30 days post-discharge
measure: Outpatient follow-up visit attendance
timeFrame: 7, 14, 30 days post-discharge
measure: Days at home
timeFrame: 30 and 90 days post-discharge
measure: Caregiver strain
timeFrame: Baseline, 7, 14, 30, and 90-days post-discharge
measure: Global health status
timeFrame: Baseline, 7, 14, 30, and 90-days post-discharge
measure: Caregiver mental health-related quality of life (HR-QOL)
timeFrame: Baseline, 7, 14, 30, and 90-days post-discharge
measure: Quality of hospital-to-home care transitions
timeFrame: 30 days post-discharge
measure: Fidelity
timeFrame: approximately 90 days post-discharge
measure: Feasibility Acceptability Appropriateness
timeFrame: approximately 90 days post-discharge
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: David Ming, MD
role: PRINCIPAL_INVESTIGATOR
References: