Hospital-to-Home Transitional Care Interventions (H2H-TCI) Children/Youth With Special Health Care Needs (CYSHCN)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Age of hospitalized child is under 18 years old
Child hospitalized on a general pediatrics inpatient service line at participating site
Adult parent/caregiver for the child is 18 years or older
Disqualifiers
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)
Child is a ward of the state or has an ongoing social services investigation
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.
Age less than 18 years old
Trial design
Design model
Parallel
Treatments tested in this trial
Focused Dose Hospital-to-Home Transitional Care Interventions
BehavioralFocused dose H2H-TCIs 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-TCI 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 Transitional Care Interventions
BehavioralExtended dose H2H-TCIs 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-TCI 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-TCI that is the basis for the extended dose arm.
Treatment groups
480 Participants
are divided into 2 treatment groupsGroup A: Focused Dose Hospital-to-Home Transitional Care InterventionsActive comparator 1 intervention
Group B: Extended Dose Hospital-to-Home Transitional Care InterventionsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
30-day acute care use
30-day, all-cause composite readmission and emergency department (ED) visit rate
Time frame
30 days post-hospital discharge2
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)
Time frame
Baseline, 30 days post-dischargeSecondary outcomes
1
7-day acute care use
All-cause composite readmission and ED visit rate at 7 days
Time frame
7-days post-discharge2
14-day acute care use
All-cause composite readmission and ED visit rate at 14 days
Time frame
14 days post-discharge3
Readmissions
All-cause readmission rate at 7, 14, and 30 days
Time frame
7, 14, 30 days post-discharge4
Emergency Department (ED) visits
All-cause ED visits at 7, 14, and 30 days
Time frame
7, 14, 30 days post-dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov