Hospital to Home Transitions for Children With Medical Complexity
This study aims to improve how parents of children with medical complexity (CMC) manage their child's care after leaving the hospital. We are testing a web application called the HELPix Care Plan. This tool provides easy-to-understand discharge instructions about your child's condition and medications. The goal is to help parents better understand and follow these instructions, which could reduce problems like hospital readmissions after discharge. We are looking for parents who speak English or Spanish and are the primary caregivers for a child with medical complexity. Success will be measured by how well parents understand and follow the instructions, and if there are fewer health problems for children after they go home. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 282 participants. It will involve three phases, including a randomized controlled trial in the final phase.
- What's involved
- Parents will participate in interviews and testing of the HELPix Care Plan tool. Parent comprehension of instructions will be measured at Visit 2 (Day 0-1), adherence at Visits 3-4 (Days 1-45), and post-discharge morbidity at Visit 4 (Day 30-45).
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 45 days after discharge to assess adherence to instructions and post-discharge morbidity.
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A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Alexander F Glick, MD, MS · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Parent Comprehension of Discharge InstructionsVisit 2 (Day 0-1)
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
- Parent Adherence to Discharge InstructionsVisits 3-4 (Days 1-45)
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.
- Number of CMC with any type of post-discharge morbidityVisit 4 (Day 30-45)
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.