Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Improving hospital-to-home transitions for children with complex medical needs

Official title: A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity

Run by NYU Langone Health · NCT04867395 · Data updated 2026-11-12

This study is testing a new tool to help parents better understand hospital discharge instructions for their children with complex medical needs, to make the transition home easier and safer.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment282 (estimated)
SponsorNYU Langone Health
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedJuly 23, 2021
Main results expectedSeptember 30, 2027
Study endsSeptember 30, 2027
Registry record updatedJuly 16, 2026
Trial IDNCT04867395 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are parents or legal guardians of children with medical complexity who are English or Spanish-speaking and have been recently discharged from the hospital.

Probably not a fit

Patients who may not benefit include those whose caregivers are under 18 years old or have significant visual or hearing impairments.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to facilitate the transition of children with medical complexity (CMC) from hospital to home by enhancing parental understanding of discharge instructions. It involves three phases: first, interviewing parents and pediatricians to identify challenges in following discharge instructions; second, developing a user-friendly tool based on these insights; and third, conducting a randomized controlled trial to evaluate the tool's effectiveness in improving parental comprehension and reducing post-discharge complications. The study will take place at Bellevue Hospital Center and Hassenfeld Children's Hospital.

Why it matters

Potential benefit: If successful, this study could significantly reduce hospital readmissions and improve the quality of life for children with medical complexity and their families.

How similar studies have gone: Other studies have shown success in improving discharge processes for complex patients, indicating that this approach has potential based on prior findings.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • NYU Langone Health
    New York, New York, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.