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

Conditions

• Medication Administered in Error

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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+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 .

Study Details

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.

Key Dates

Start date

Mar 10, 2021

Status verified

Aug 2025

Primary completion

Dec 31, 2026

Completion

Feb 28, 2027

Study Design

Enrollment

425 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Usual Care
  Current usual care includes standard discharge counseling by a nurse, with or without additional MD counseling.
• Experimental: 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.
• Experimental: 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 Measure

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

Central Contacts

• Hsiang Shonna Yin
  646-501-4284
  [email protected]
• Jessica Velazquez-Perez
  212-562-2821
  [email protected]

Locations (1)

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