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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT04867395
Status
Recruiting

Conditions

  • Children With Medical Complexity (CMC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Jul 23, 2021
Status verified
Dec 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
282 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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

Primary Outcome Measure

Parent Comprehension of Discharge Instructions [ Time Frame: Visit 2 (Day 0-1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Andrew Glick, MD, MS
212-263-8198
Andrew Glick, MD, MS (PRINCIPAL_INVESTIGATOR)

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