Improving hospital-to-home transitions for children with complex medical needs
A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 282 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04867395 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who may not benefit include those whose caregivers are under 18 years old or have significant visual or hearing impairments.
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 performed: Other studies have shown success in improving discharge processes for complex patients, indicating that this approach has potential based on prior findings.
Eligibility criteria
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 this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Alexander F Glick, MD, MS — NYU Langone Health
- Study coordinator: Alexander F Glick, MD, MS
- Email: alexander.glick@nyulangone.org
- Phone: 212-263-8198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.