Pediatrics Clinical Trial
— H2H-CYSHCNOfficial title:
Hospital-to-Home Care Transition Intervention (H2H-CTI) for Children and Youth With Special Health Care Needs (CYSHCN)
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Duke University |
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 |
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