Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT04867395

Conditions

Children With Medical Complexity (CMC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

HELPix Care Plan

Study Details

Brief 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.

Conditions

Children With Medical Complexity (CMC)

Study ID

NCT04867395

Start date

Jul 23, 2021

Status verified date

Dec, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

282 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Usual Care

75 participants will receive standard care, consisting of verbal discharge counseling given by doctors and nurses supplemented by written instructions (all unstandardized).

experimental: Intervention group

75 participants will be randomized to receive behavioral intervention, consisting of discharge counseling using the health literacy-informed discharge instructions

Interventions

HELPix Care Plan

A web application tool for CMC - Health literacy-informed, disease and medication-specific, standardized discharge instructions that will: 1) facilitate plain language provider/parent communication at hospital discharge and 2) act as "stand-alone" handouts that parents can use at home.

Primary outcome measure

  • Parent Comprehension of Discharge Instructions [ Time Frame: Visit 2 (Day 0-1) ]
  • Parent Adherence to Discharge Instructions [ Time Frame: Visits 3-4 (Days 1-45) ]
  • Number of CMC with any type of post-discharge morbidity [ Time Frame: Visit 4 (Day 30-45) ]

Central Contacts and Locations

Central contacts

Alexander F Glick, MD, MS

212-263-8198alexander.glick@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Andrew Glick, MD, MS

212-263-8198andrew.glick@nyulangone.org

Principal Investigator:

Andrew Glick, MD, MS

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 16, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-16.