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

Not Applicable

Recruiting

• Conditions: Medication Administered in Error
• Interventions: Other: HELPix; Other: HELPix+Tech

• Registration Number: NCT04278690
• Lead Sponsor: NYU Langone Health

Brief Summary

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Study Start: 2021-03-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-26
• Primary Completion: 2024-12
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 425

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HELPix	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.
HELPix+Tech	HELPix+Tech	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

Primary Outcome Measures

Name	Time	Method
Improvement in Dosing with HELPix+TECH and HELPix in comparison to usual care.	Visit 3 (Day 30)	HELPix (health literacy-informed written materials and verbal counseling in addition to usual care) and HELPix+TECH (a health literacy-informed web application in addition to HELPix and usual care) will result in improved dosing compared to usual care alone. This will be assessed by the percentage of observed dosing error (whether clinically meaningful errors of \>20% deviation and/or large error of \>40% deviation).
Improvement in medication adherence with HELPix+TECH and HELPix in comparison to usual care	Visit 3 (Day 30)	HELPix (health literacy-informed written materials and verbal counseling in addition to usual care) and HELPix+TECH (a health literacy-informed web application in addition to HELPix and usual care) will result in improved medication adherence compared to usual care alone. This will be assessed by the percentage of poor medication adherence (\>20% deviation from # prescribed doses).

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States