A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity (NCT04867395) | Clinical Trial Compass
RecruitingNot Applicable
A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
United States282 participantsStarted 2021-07-23
Plain-language summary
The overarching objective of this study is to make it easier for parents of children with medical complexity (CMC) to take care of their children after discharge home from the hospital and reduce the chance of post-hospitalization morbidity (meaning bad outcomes such as readmissions) after discharge. CMC, or those with multiple chronic conditions, progressive conditions, or technology dependence, are at high risk for post-hospitalization morbidity.
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:
Parents
* English or Spanish-speaking
* Parent or legal guardian and primary caregiver of child who has medical complexity (defined by significant chronic conditions in ≥2 body systems, progressive conditions associated with decreased life expectancy, dependence on technology for \>6 months \[e.g., respiratory equipment, central lines, feeding tubes\], or progressive/metastatic malignancies) who was admitted to the acute or intensive care units
* The individual's child is ≤18 years old
* The individual's child was discharged home or is expected be discharged home on ≥1 daily medication.
* Willingness to be randomized to intervention group
* Willingness and ability to participate in study procedures
Exclusion Criteria:
Parents
* Caregiver \<18 years old
* Poor visual acuity (\<20/50 corrected on Rosenbaum screener for in-person recruitment; by subject report for phone recruitment)
* Self-reported hearing difficulty
* Previously enrolled.
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.
What they're measuring
1
Parent Comprehension of Discharge Instructions
Timeframe: Visit 2 (Day 0-1)
2
Parent Adherence to Discharge Instructions
Timeframe: Visits 3-4 (Days 1-45)
3
Number of CMC with any type of post-discharge morbidity