Medication Administered in ErrorNCT04278690
Supporting Safe Use of Medications by Parents After Infant Discharge From the Neonatal Intensive Care Unit
A study testing HELPix and HELPix+Tech in people with Medication Administered in Error, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Administered in Error
- What is being tested?
- HELPix and HELPix+Tech
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 8 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish-speaking
- 18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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.
Read the 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
- Conditions
- Medication Administered in Error
- Being tested
- HELPix, HELPix+Tech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HELPixOther
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+TechOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: HELPix+Tech |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Visit 3 (Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start10 Mar 2021
- Primary completion9 Jan 2026
- Study completion8 Apr 2026
Why it stopped: The study was terminated early due to challenges with recruitment and staffing, resulting in the target sample size not being reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Administered in ErrorStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiang Sharon Yin, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278690
- Sponsor's protocol ID
- 19-01294
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2020
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).