A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
282 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Visit 2 (Day 0-1)2
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.
Time frame
Visits 3-4 (Days 1-45)3
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.
Time frame
Visit 4 (Day 30-45)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov