Supporting Safe Use of Medications by Parents After Infant Discharge From the Neonatal Intensive Care Unit

Official title

A Randomized, Controlled Study of a Health Literacy-informed Technology-based Approach to Support Safe Medication Use by Parents After Discharge of Infants From the Neonatal Intensive Care Unit.

Overview

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 425 subjects will be recruited across two sites over preparatory phases and two primary study phases.

Detailed description

Our overarching goal is to promote safe medication use/adherence for high-risk infants, by leveraging health literacy approaches and mobile technology to reinforce provider counseling and support parent medication management after discharge from the NICU. We will adapt/integrate evidence-based strategies studied in less complex populations, for this vulnerable group. The HELPix (Health Education and Literacy for Parents) pictogram-based intervention, developed by our team, incorporates these strategies, with sizeable improvements found in medication knowledge, dosing errors, and adherence in outpatient general pediatric settings, but to date, HELPix has not been studied in NICU settings

Interventions

• Other HELPix
  HELPix parents will receive usual care as above, after which trained staff will generate HELPix patient-/regimen-specific medication instruction sheets and review them with the parent. Instruction sheets include optimized instructions (mL-only, doses appropriately rounded, visuals of recommended tool (e.g. 1-mL syringe best for doses of \<1 mL), explicit frequency information (e.g. 'morning and night' instead of '2x/day') reinforced by pictograms (e.g. sun/moon icons)). For each medication, staf
• Other HELPix+Tech
  After parent receives usual care and HELPix , trained staff will walk parent through the app on-boarding process to overcome initial barriers to use. Steps: 1) Parent texted link to personalized on-line instructions. 2) Parent clicks link to app. For each medicine: A. Dosing module with optimized instructions (c/w HELPix); parent teachback/showback of dose B. Frequency module supports simplified, explicit intervals (e.g. 'morning and night'), parent chooses convenient times (text reminders sent

Primary outcome measures

• Improvement in Dosing with HELPix+TECH and HELPix in comparison to usual care. [Time frame: Visit 3 (Day 30)]
• Improvement in medication adherence with HELPix+TECH and HELPix in comparison to usual care [Time frame: Visit 3 (Day 30)]

Eligibility criteria

Inclusion criteria

• English or Spanish-speaking
• 18 years of age and older
• Child discharged home with a Rx for >1 daily liquid medication (other than multivitamin)
• Primary person who will administers child's medications.
• Willingness and ability to participate

Exclusion criteria

• Does not have a working phone number
• Does not have access to internet (via computer/smartphone)
• Does not have a mobile phone that receives texts.
• Not able to return to the hospital for their child's follow-up visit
• Visual acuity worse than 20/50 according to the Rosenbaum Pocket Screener
• Uncorrectable hearing impairment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• NYU Langone Health — New York

Identifiers

NCT: NCT04278690 · 19-01294

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗