A randomized controlled multi-center study of health literacy-informed technology-based approaches to support safe medication use by parents after discharge of infants from the neonatal intensive care unit

Brief description of study

This is a randomized controlled study of parents of children to be discharged from the neonatal intensive care unit at Bellevue and Elmhurst hospitals. A total of 345 subjects will be recruited across two sites over two study phases. Subjects will be assigned to 1 of 3 intervention groups: usual care, HELPix (health literacy-informed written materials and verbal counseling in addition to usual care), or HELPix + TECH (a health literacy-informed web application in addition to HELPix and usual care). Phase A is a pilot study, in which 120 parents will be enrolled at Bellevue Hospital and randomly assigned to usual care or HELPix + TECH. Phase B will take place at both Bellevue and Elmhurst Hospitals, and 225 subjects will be randomly assigned to usual care, HELPix, or HELPix + TECH. Parents will be screened and recruited, written informed consent will be obtained, and a brief survey will be administered on the day of the child’s expected discharge from the neonatal intensive care unit (Visit 1, Day 0). Subjects will later receive usual care followed by the intervention if randomized to one of those groups (Visit 2, Day 0). Medication knowledge, dosing, and adherence will be assessed in-person at a subsequent follow-up visit (Visit 3, Days 1-7). Adverse events will be assessed via phone call (Visit 4, Days 30-45). Additional data will be assessed using a chart review.

Clinical Study Identifier: s19-01294
ClinicalTrials.gov Identifier: NCT04278690
Principal Investigator: Hsiang Yin.

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