Hospital to Home Transitions for Children With Medical Complexity

This study aims to improve how parents of children with medical complexity (CMC) manage their child's care after leaving the hospital. We are testing a web application called the HELPix Care Plan. This tool provides easy-to-understand discharge instructions about your child's condition and medications. The goal is to help parents better understand and follow these instructions, which could reduce problems like hospital readmissions after discharge. We are looking for parents who speak English or Spanish and are the primary caregivers for a child with medical complexity. Success will be measured by how well parents understand and follow the instructions, and if there are fewer health problems for children after they go home. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 282 participants. It will involve three phases, including a randomized controlled trial in the final phase.
What's involved
Parents will participate in interviews and testing of the HELPix Care Plan tool. Parent comprehension of instructions will be measured at Visit 2 (Day 0-1), adherence at Visits 3-4 (Days 1-45), and post-discharge morbidity at Visit 4 (Day 30-45).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 45 days after discharge to assess adherence to instructions and post-discharge morbidity.

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NCT04867395

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

Recruiting
NAAges 18+InterventionalHealth services
NYU Langone Health
~282 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:HELPix Care Plan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parent Comprehension of Discharge Instructions
Measured over Visit 2 (Day 0-1)
+2 more outcomes measured
Children With Medical Complexity (CMC)
1 sites across 1 states
New York1
  • Alexander F Glick, MD, MS · PRINCIPAL_INVESTIGATOR · NYU Langone Health

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Eligibility criteria

Inclusion

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

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.
  • Parent Comprehension of Discharge InstructionsVisit 2 (Day 0-1)

    The proportion of parents making errors in comprehension of their child's discharge instructions will be assessed. The visit will consist of a structured survey. Parents will be asked open-ended questions about their child's discharge instructions for their medications, appointments , return precautions , restrictions , equipment. Parents will be encouraged to use their written instructions when answering survey questions. The total proportion of parents making comprehension errors in an individual domain and across domains will be calculated. Errors in domains are defined by parent report of not following instructions properly. Comprehension in a given domain will be dichotomized into no errors vs. ≥1 error

  • Parent Adherence to Discharge InstructionsVisits 3-4 (Days 1-45)

    The proportion of parents making errors in adherence to their child's discharge instructions will be assessed with a structured survey. Parents will be asked open ended questions about their child's discharge instructions for their medications, appointments attended, return precautions, restrictions being followed, and equipment. Parents will be encouraged to use their written instructions when answering questions. Parents will be asked to measure out any liquid medications using a standard medication bottle as they would measure them at home.The total proportion of parents making adherence errors in an individual domain and across domains will be calculated.Medication dosing errors will be defined by \>20% deviation from the prescribed dose for ≥1 medication as assessed by visual inspection as part of in-person dosing assessment. Appointment attendance errors will be defined by missing ≥1 scheduled appointment after discharge.

  • Number of CMC with any type of post-discharge morbidityVisit 4 (Day 30-45)

    The total proportion of children with medical complexity (CMC) with any type of post-discharge morbidity (30-day readmissions, ED visits, outpatient visits, adverse drug events, surgical complications, infections) within 30 days of discharge will be calculated. Subjects will be dichotomized into those with no post-discharge morbidity vs. ≥1 type of postdischarge morbidity.