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

NYU Langone Health

Status: Enrolling

Conditions: Medication Administered in Error

Treatments: Other: HELPix; Other: HELPix+Tech

Study type: Interventional

Funder types: Other

Identifiers

NCT04278690

19-01294

Details and patient eligibility

About

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.

Full 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

Enrollment: 425 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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425 participants in 3 patient groups

Usual Care

No Intervention group

Description:

Current usual care includes standard discharge counseling by a nurse, with or without additional MD counseling.

HELPix

Experimental group

Description:

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.

Treatment:

Other: HELPix

HELPix+Tech

Experimental group

Description:

After parent receives usual care and HELPix (as above), 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

Treatment:

Other: HELPix+Tech