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

NCT04278690 | Recruiting DMC

• 1 other identifier: 19-01294
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Administered in Error

Outcome Measures

Primary Outcomes (2)

• Improvement in Dosing with HELPix+TECH and HELPix in comparison to usual care.

  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).

  Visit 3 (Day 30)

• Improvement in medication adherence with HELPix+TECH and HELPix in comparison to usual care

  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).

  Visit 3 (Day 30)

Study Arms (3)

Usual Care

NO INTERVENTION

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

HELPix

EXPERIMENTAL

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.

Other: HELPix

HELPix+Tech

EXPERIMENTAL

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

Other: HELPix+Tech

Interventions

HELPix OTHER

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, staff will: 1) review the dose (refer to the pictographic dose diagram, which illustrates optimal dosing tool filled to correct amount), 2) demonstrate the dose using optimal dosing tool, 3) ask parent to 'teachback'/'showback' dose (e.g. parent shows provider how much they would give by pulling back plunger on syringe to right level), 4) provide optimal dosing tool for the parent to take home. We anticipate this process will take \~5-10 minutes.

HELPix

HELPix+Tech OTHER

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 based on preferences). Time for TECH depends on # medicines and parent baseline knowledge; structured protocol used to see # teachback rounds needed .

HELPix+Tech

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English or Spanish-speaking
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

• Hsiang Sharon Yin

  NYU Langone

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiang Shonna Yin

CONTACT

646-501-4284; hsiang.yin@nyulangone.org

Jessica Velazquez-Perez

CONTACT

212-562-2821; jessica.velazquez@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: February 20, 2020
• Study Start: March 10, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request

Locations

US (1)