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

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment HELPix, HELPix+Tech for preventing medication errors after NICU discharge?

Research shows that educational interventions in NICUs can reduce medication errors, suggesting that HELPix, which likely includes educational components, might help parents prevent errors after discharge. ^{1 2 3 4 5}

Is the Parental Medication Education program safe for humans?

The research articles focus on reducing medication errors in NICUs through educational strategies, but they do not provide specific safety data for the Parental Medication Education program or its variants like HELPix or HELPix+Tech. ^{1 2 3 4 5}

How does the treatment HELPix, HELPix+Tech differ from other treatments for preventing medication errors after NICU discharge?

HELPix, HELPix+Tech is unique because it combines parental education with technology to prevent medication errors after NICU discharge. This approach focuses on improving parents' understanding and skills in medication management, which is not typically addressed by standard treatments. ^{2 4 6 7 8}

Research Team

Hsiang Sharon Yin

Principal Investigator

NYU Langone

Eligibility Criteria

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

I speak English or Spanish.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Personalised performance feedback reduces narcotic prescription errors in a NICU. [2022]

2. Norway pubmed.ncbi.nlm.nih.gov

Educational strategy to reduce medication errors in a neonatal intensive care unit. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

National Survey of Neonatal Intensive Care Unit Medication Safety Practices. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The effect of a multifaceted educational intervention on medication preparation and administration errors in neonatal intensive care. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

NICU medication errors: identifying a risk profile for medication errors in the neonatal intensive care unit. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Parents can dose liquid medication accurately. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of Parent-Targeted eHealth on Parent and Infant Health Outcomes: A Scoping Review. [2019]

8. Poland pubmed.ncbi.nlm.nih.gov

[Role of the nurse and midwife in educating parents of neonates treated at intensive care units]. [2011]