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

NCT04867395 | Recruiting DMC

• 1 other identifier: 21-00180
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (3)

• Parent Comprehension of Discharge Instructions

  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

  Visit 2 (Day 0-1)

• Parent Adherence to Discharge Instructions

  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.

  Visits 3-4 (Days 1-45)

• Number of CMC with any type of post-discharge morbidity

  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.

  Visit 4 (Day 30-45)

Study Arms (2)

Usual Care

NO INTERVENTION

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

Intervention group

EXPERIMENTAL

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

Behavioral: HELPix Care Plan

Interventions

HELPix Care Plan BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

• Alexander F Glick, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander F Glick, MD, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: April 30, 2021
• Study Start: July 23, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to alexander.glick@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)