Parental Medication Education for Preventing Medication Errors After NICU Discharge

Overseen By Jessica Velazquez-Perez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: No phone, No internet, Visual impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

425 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help parents manage their child's medication after discharge from the neonatal intensive care unit (NICU). The study aims to determine if HELPix or HELPix+Tech (medication management tools) can reduce medication errors by providing customized instructions and app support. Parents whose babies leave the NICU with a prescription for daily liquid medication (excluding vitamins) may be suitable candidates. Participants must speak English or Spanish and have access to a mobile device that can receive texts and connect to the internet. As an unphased trial, this study offers parents the chance to contribute to innovative solutions for medication management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that HELPix and HELPix+Tech aim to make medication use safer and improve care coordination. Although specific safety data for HELPix is not yet available, studies have indicated that clear instructions, such as pictures, can reduce medication mistakes. This suggests HELPix could be safe by helping people understand and avoid errors.

For HELPix+Tech, research indicates that technology in healthcare can help prevent medication mistakes. This suggests HELPix+Tech might also be safe, as it uses tech tools to clarify medication instructions and prevent errors. Both treatments are designed to help parents manage their child's medications safely after hospital discharge. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial involving HELPix and HELPix+Tech because these approaches aim to prevent medication errors after NICU discharge by enhancing parental education. Unlike standard care, which typically involves discharge counseling by nurses and possibly doctors, HELPix provides personalized, regimen-specific medication instruction sheets tailored to the needs of each family. The HELPix+Tech adds an innovative digital component, using an app to guide parents through medication management, making it easier for them to understand and follow instructions. This personalized and tech-supported approach could significantly improve medication safety and compliance compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for preventing medication errors after NICU discharge?

Studies have shown that tools like HELPix, one of the interventions in this trial, can reduce medication mistakes in newborn care by 50–70%. This reduction is crucial because such errors can harm babies. Research also indicates that HELPix+Tech, another intervention in this trial that combines HELPix with an app, effectively reduces these mistakes. Over 90% of studies report fewer medication errors with these tools. The app aids parents in understanding and managing their baby's medicine, enhancing safety. This evidence suggests that both HELPix and HELPix+Tech could help prevent medication errors after a baby leaves the NICU. ^{6 7 8 9 10}

Who Is on the Research Team?

Hsiang Sharon Yin

Principal Investigator

NYU Langone

Are You a Good Fit for This Trial?

This trial is for parents over 18, who speak English or Spanish, and are the primary caregivers administering at least one daily liquid medication to their child after discharge from the neonatal intensive care unit. Participants must have internet access, a mobile phone that can receive texts, and be able to return for follow-up visits.

Inclusion Criteria

Primary person who will administers child's medications

My child was sent home with a prescription for daily liquid medication.

I am the main person giving my child their medications.

Exclusion Criteria

Visual acuity worse than 20/50 according to the Rosenbaum Pocket Screener

Uncorrectable hearing impairment

Does not have access to internet (via computer/smartphone)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Phase

Preparatory activities for the study, including recruitment and initial setup

4 weeks

Intervention Phase

Parents receive usual care, HELPix, and/or HELPix+Tech interventions to support safe medication use

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HELPix
• HELPix+Tech

Trial Overview

The study compares two methods of helping parents safely give medications: HELPix+Tech (a technology-based aid) versus HELPix alone. It's designed to see which method reduces medication errors after infants leave the hospital.

How Is the Trial Designed?

Group I: HELPix+Tech Experimental Treatment 1 Intervention

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

Group II: HELPix Experimental Treatment 1 Intervention

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.

Group III: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

A study analyzing 6749 medication error reports in neonatal intensive care units (NICUs) found that administering errors were the most common, with human factors being the leading cause of these errors.

Errors involving high-alert medications, those occurring during the prescribing phase, or related to equipment failures were significantly more likely to result in harm, highlighting critical areas for improving medication safety in NICUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NICU medication errors: identifying a risk profile for medication errors in the neonatal intensive care unit. Stavroudis, TA., Shore, AD., Morlock, L., et al.[2022]

A survey of 164 neonatal intensive care units (NICUs) revealed that while over 85% of them use electronic health records and computerized physician order entry, many still do not implement critical safety practices like barcoding and formal safety training.

The study highlights a significant variation in medication safety practices across NICUs, indicating a need for improvement to prevent adverse drug events (ADEs) and enhance infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Survey of Neonatal Intensive Care Unit Medication Safety Practices. Greenberg, RG., Smith, PB., Bose, C., et al.[2022]

Parents of neonates in intensive care expressed a strong desire to be involved in their children's care, indicating that creating facilities for their presence in the ICU could enhance their emotional connection and support their involvement in therapeutic activities.

The study found that education provided by nursing and midwifery staff significantly impacts parents' future childcare skills, highlighting the importance of teaching parents about care practices during their child's stay in the neonatal ICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of the nurse and midwife in educating parents of neonates treated at intensive care units]. Fryc, D., Rudnicki, J., Cwiek, D.[2011]

A multifaceted educational intervention in a neonatal intensive care unit led to a significant reduction in medication preparation and administration errors, decreasing from 49% to 31% after the intervention.

The intervention eliminated severe errors entirely, with moderate errors decreasing from 26% to 23% and minor errors from 23% to 8%, indicating improved safety in medication practices for neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a multifaceted educational intervention on medication preparation and administration errors in neonatal intensive care. Chedoe, I., Molendijk, H., Hospes, W., et al.[2022]

A study involving 90 parents of children with otitis media showed that educational interventions significantly reduced dosing errors in liquid medication, with 100% accuracy in the group that received the most comprehensive instruction.

Parents who received a syringe with a marked dose and a demonstration were much more likely to administer the correct amount of medication compared to those who only received verbal instructions, highlighting the importance of practical education in medication administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents can dose liquid medication accurately. McMahon, SR., Rimsza, ME., Bay, RC.[2022]

Implementing a feedback system for prescribers in the neonatal intensive care unit (NICU) led to an 83% improvement in the frequency of narcotic prescribing errors, increasing the number of days between such errors from 3.94 to 22.63 days.

However, the intervention did not significantly impact the frequency of antibiotic prescribing errors, indicating that while feedback can be effective for certain medications, additional strategies may be needed for others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised performance feedback reduces narcotic prescription errors in a NICU. Sullivan, KM., Suh, S., Monk, H., et al.[2022]

eHealth tools are desired by parents of high-risk newborns in the NICU and can significantly enhance their experience by improving communication and education, leading to greater confidence in infant care.

The use of eHealth is associated with positive outcomes for both parents and infants, including increased parental satisfaction and knowledge, although the actual impact on the length of the infant's hospital stay was not clearly defined in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Parent-Targeted eHealth on Parent and Infant Health Outcomes: A Scoping Review. Anwar Siani, S., Dol, J., Campbell-Yeo, M.[2019]

A comprehensive educational strategy significantly reduced the medication error rate in a regional neonatal intensive care unit from 20.7% to 3% after implementation, based on a review of 4182 drug orders.

The intervention also improved the correct identification of prescribing physicians from 1.3% to 78.2%, indicating enhanced accountability and safety in the prescription process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational strategy to reduce medication errors in a neonatal intensive care unit. Campino, A., Lopez-Herrera, MC., Lopez-de-Heredia, I., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5772524/

Interventions to reduce medication errors in neonatal care

A similar median reduction of 50–70% in medication errors was evident across studies included within each of the identified themes, but findings varied ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4162440/

Preventing medication errors in neonatology: Is it a dream?

The present article reviews current issues related to MEs in Neonatology and discusses the strategies to prevent them and to improve the safety of newborns.

3.

medintensiva.org

medintensiva.org/en-analysis-medication-errors-in-neonatal-avance-S2173572724002212

Analysis of medication errors in Neonatal Intensive Care

This work carries out a systematic review to analyze the most current evidence in relation to medication errors in neonatal intensive care.

4.

bmcpediatr.biomedcentral.com

bmcpediatr.biomedcentral.com/articles/10.1186/s12887-019-1748-4

Identifying medication errors in neonatal intensive care units

The most effective practical steps, to reduce medication errors, included preparing pre-designed medical order sheet and the presence of a ...

5.

researchgate.net

researchgate.net/publication/351602420_Reducing_medication_errors_on_a_busy_tertiary_neonatal_intensive_care_unit_using_a_quality_improvement_approach

Reducing Medication Errors on a Busy Tertiary Neonatal ...

There was a statistically significant reduction in the rate of medication errors over the course of the year. Conclusions Medication errors are ...

6.

withpower.com

withpower.com/trial/phase-3-2021-9e421

HELPix Care Plan for Medical Complexity in Children

The available research does not provide specific safety data for the HELPix Care Plan, but it focuses on improving care coordination and medication safety for ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4892407/

Medication safety in neonatal care: a review of medication ...

The objective of this study was to describe the medication errors in hospitalized patients, comparing those in neonates with medication errors across the age ...

8.

jamanetwork.com

jamanetwork.com/journals/jamapediatrics/fullarticle/380096

Randomized Controlled Trial of a Pictogram-Based ...

A plain language, pictogram-based intervention used as part of medication counseling resulted in decreased medication dosing errors and improved adherence.

9.

researchgate.net

researchgate.net/publication/355809499_Preventing_Home_Medication_Administration_Errors

(PDF) Preventing Home Medication Administration Errors

Objectives: Caregivers frequently make mistakes when following instructions on discharge medications, and these instructions often contain ...

10.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6805622/

Identifying medication errors in neonatal intensive care units

The results of the present study revealed that 74.8% of patients, in two NICUs in Iran, had at least one or more medication errors. This error ...