Hospital-to-Home Transitional Care Interventions (H2H-TCI) Children/Youth With Special Health Car… (NCT06428175) | Clinical Trial Compass
RecruitingNot Applicable
Hospital-to-Home Transitional Care Interventions (H2H-TCI) Children/Youth With Special Health Care Needs (CYSHCN)
United States480 participantsStarted 2025-08-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. Diminished capacity to provide consent/participate
. Primary language for parent/caregiver is any language besides English or Spanish