Actively Recruiting
A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
Led by NYU Langone Health · Updated on 2025-12-24
282
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating ways to help parents of children with medical complexity (CMC) better manage their child's care after leaving the hospital. CMC are children with multiple chronic or progressive conditions, or who rely on medical technology, and they face a high risk of complications like readmissions after discharge. This study aims to reduce these risks by improving how discharge instructions are communicated and followed. The study is conducted in three phases at two hospitals. First, parents and pediatricians will be interviewed to understand challenges in following hospital discharge instructions. Next, a new web-based tool called HELPix Care Plan will be developed to provide clear, health literacy-informed discharge instructions tailored to each child's needs. Finally, a randomized controlled trial will compare usual care, which includes standard verbal and written instructions, to the new tool to see if it improves parent understanding, adherence, and reduces post-discharge health issues. Participants will be parents or legal guardians of CMC under 18 years old who speak English or Spanish and have children discharged with at least one daily medication. The study will assess parent comprehension and adherence to discharge instructions shortly after discharge and track any post-discharge health complications over 30 to 45 days. The study includes surveys and interviews to gather feedback on the tool's usability. The total involvement covers multiple visits during this follow-up period to measure outcomes and monitor progress.
CONDITIONS
Brief Title
A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English or Spanish-speaking parent or legal guardian who is the primary caregiver
- Child has medical complexity with significant chronic or progressive conditions or technology dependence for more than 6 months
- Child is 18 years old or younger
- Child was discharged or is expected to be discharged home on at least one daily medication
- Willingness to be randomized to the intervention group
- Willingness and ability to participate in study procedures
You will not qualify if you...
- Caregiver under 18 years old
- Poor visual acuity (less than 20/50 corrected) for in-person recruitment or by self-report for phone recruitment
- Self-reported hearing difficulty
- Previously enrolled in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or phone)
Duration - Day 0 to Day 1
Participants receive discharge counseling either as usual care or using a health literacy-informed discharge instruction tool to support care at home.
1 baseline visit at discharge
Duration - Days 1 to 45
Participants follow discharge instructions and their adherence and health outcomes are monitored post-discharge.
2 follow-up visits between Day 1 and Day 45
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
A
Alexander F Glick, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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