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 — BEHAVIORALA 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 Care75 participants will receive standard care, consisting of verbal discharge counseling given by doctors and nurses supplemented by written instructions (all unstandardized).
- Experimental: Intervention group75 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
- Alexander F Glick, MD, MS212-263-8198
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | Andrew Glick, MD, MS (PRINCIPAL_INVESTIGATOR) |
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