A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
NCT ID: NCT04867395
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
282 participants
INTERVENTIONAL
2021-07-23
2027-03-31
Brief Summary
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Detailed Description
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* In Aim 1, parents of CMC and pediatricians will be interviewed to understand their views on what makes it challenging, and what can make it easier, for parents to understand and follow the instructions they get from the hospital about how to take care of their CMC after leaving the hospital. The study team will also ask pediatricians what may make it difficult to provide relevant education to families.
* In Aim 2, a tool will be designed to make it easier for parents to understand and follow the discharge instructions for their CMC. The study team will use structure of existing tool, findings from Aim 1, and extensive interviews and testing of the tool with parents and pediatricians as the new tool is designed.
* In Aim 3, a randomized controlled trial (RCT) will be conducted to study the impact of the tool on parent comprehension and adherence (or how well they can follow) their child's discharge instructions, as well as its impact on post-discharge morbidity (such as readmissions and emergency department visits). Parents will be randomized to either receive usual hospital care and instructions or the intervention/tool (in addition to the usual care and instructions). The study team will also ask parents who receive the intervention about its usability.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Usual Care
75 participants will receive standard care, consisting of verbal discharge counseling given by doctors and nurses supplemented by written instructions (all unstandardized).
No interventions assigned to this group
Intervention group
75 participants will be randomized to receive behavioral intervention, consisting of discharge counseling using the health literacy-informed discharge instructions
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Alexander F Glick, MD, MS
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Andrew Glick, MD, MS
Role: primary
Other Identifiers
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21-00180
Identifier Type: -
Identifier Source: org_study_id