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

Pediatrics Clinical Trial

— H2H-CYSHCN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06428175
• Other study ID #: Pro00114934
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2025
• Est. completion date: February 2028

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Shannon A Widman
• Phone: 919-681-7252
• Email: shannon.widman[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: February 2028
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

• 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

Related Conditions & MeSH terms

• Comparative Effectiveness
• Family Engagement
• Health Care
• Pediatrics
• Transitional Care

Intervention

Behavioral:
• Focused Dose Hospital-to-Home Care Transition Intervention
Focused dose H2H-CTIs 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-CTI 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 Care Transition Intervention
Extended dose H2H-CTIs 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-CTI 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-CTI that is the basis for the extended dose arm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day acute care use	30-day, all-cause composite readmission and emergency department (ED) visit rate	30 days post-hospital discharge
Primary	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)	Baseline, 30 days post-discharge
Secondary	7-day acute care use	All-cause composite readmission and ED visit rate at 7 days	7-days post-discharge
Secondary	14-day acute care use	All-cause composite readmission and ED visit rate at 14 days	14 days post-discharge
Secondary	Readmissions	All-cause readmission rate at 7, 14, and 30 days	7, 14, 30 days post-discharge
Secondary	Emergency Department (ED) visits	All-cause ED visits at 7, 14, and 30 days	7, 14, 30 days post-discharge
Secondary	Outpatient follow-up visit attendance	Completed outpatient visits by clinical area (primary, specialty, allied health)	7, 14, 30 days post-discharge
Secondary	Days at home	Annualized days without clinical visits (clinical days without healthcare visits)	30 and 90 days post-discharge
Secondary	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.	Baseline, 7, 14, 30, and 90-days post-discharge
Secondary	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.	Baseline, 7, 14, 30, and 90-days post-discharge
Secondary	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.	Baseline, 7, 14, 30, and 90-days post-discharge
Secondary	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.	30 days post-discharge
Secondary	Fidelity	Percentage of intervention core components delivered as planned (goal: =80%)	approximately 90 days post-discharge
Secondary	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)	approximately 90 days post-discharge