Helping parents safely manage medications for infants after NICU discharge
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.
This study is testing a new way to help parents safely manage their infants' medications after leaving the NICU to see if it improves their understanding and use of the medicines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 425 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04278690 on ClinicalTrials.gov |
What this trial studies
This randomized controlled study focuses on parents of infants being discharged from the neonatal intensive care unit at Bellevue and Elmhurst hospitals. The study aims to enhance safe medication use and adherence for high-risk infants by utilizing health literacy approaches and mobile technology. The HELPix intervention, which has shown promise in improving medication knowledge and adherence in other pediatric settings, will be adapted for this vulnerable population. A total of 425 subjects will be recruited across two sites to evaluate the effectiveness of this intervention.
Who should consider this trial
Good fit: Ideal candidates include English or Spanish-speaking parents aged 18 and older who are responsible for administering their child's medications after discharge from the NICU.
Not a fit: Patients who do not have access to a mobile phone or the internet, or who have significant visual or hearing impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce medication errors and improve adherence among parents managing their infants' medications post-discharge.
How similar studies have performed: Previous studies have shown success with similar health literacy interventions in outpatient pediatric settings, but this approach has not yet been tested in NICU populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. English or Spanish-speaking 2. 18 years of age and older 3. Child discharged home with a Rx for \>1 daily liquid medication (other than multivitamin) 4. Primary person who will administers child's medications. 5. Willingness and ability to participate Exclusion Criteria: 1. Does not have a working phone number 2. Does not have access to internet (via computer/smartphone) 3. Does not have a mobile phone that receives texts. 4. Not able to return to the hospital for their child's follow-up visit 5. Visual acuity worse than 20/50 according to the Rosenbaum Pocket Screener 6. Uncorrectable hearing impairment
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Hsiang Sharon Yin — NYU Langone
- Study coordinator: Hsiang Shonna Yin
- Email: hsiang.yin@nyulangone.org
- Phone: 646-501-4284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.