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OpenTrials
Completed

NCT Number: NCT05146388

Working With Doctors and Pharmacists to Help Parents Give Children's Liquid Medicines Safely

The study objective is to assess the impact of an automated electronic health record (EHR)-based intervention that leverages e-prescriptions to support pharmacist adherence to recommended dispensing practices, with the goal of reducing parent dosing errors.

Specifically, the study aims are to: 1) Examine the efficacy of the EHR-based intervention in improving pharmacy dispensing practices, including a) adherence to mL-only dosing and b) provision of optimal dosing tools; 2) Examine the efficacy of the EHR-based intervention in reducing parent dosing errors. The study will also explore whether implementation of the EHR-based intervention will reduce disparities in dosing errors by parent health literacy and LEP, and explore the efficacy of the EHR-based intervention in reducing ADEs.

A pre-/post-implementation study will be performed with English- and Spanish-speaking parents of children prescribed oral liquid medications in the pediatric emergency room, outpatient general pediatric clinic, and pediatric subspecialty clinics of 2 New York City hospital systems (NYU Langone Health - Brooklyn and NYC Health+Hospitals - Bellevue Hospital). Prior to implementation, e-Rx's will be generated by the EHR in the usual fashion; after implementation, e-Rx's will be generated by the EHR with instructions to the dispensing pharmacy to: 1) keep the dosing instructions in mL-only, and 2) dispense a specific dosing tool based on the amount prescribed.

The proposed project is consistent with a growing national focus on promoting the adoption of evidence-based strategies to improve disease management that address the needs of those with low health literacy and LEP from groups like the Joint Commission and the AHRQ.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health - Brooklyn, Brooklyn, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Caregiver/Child

  • English or Spanish-speaking
  • Parent or legal guardian of a child prescribed a liquid medicine in the NYU Langone Health - Brooklyn or Bellevue ED, general outpatient pediatric clinic, or specialty care clinics
  • 18 years of age or older
  • Child ≤8y discharged home with a Rx for ≥1 daily liquid medication dose ≤10mL, for use as a chronic or short course (≤14 days) medication
  • Primary person who will administer child's medications
  • Access to a smartphone that can take photos and send/receive text messages
  • Willingness and ability to participate

Pharmacy staff

  • Works at a pharmacy that dispensed index medicine to one of our study participants.

Exclusion criteria

Caregiver/Child

  • Does not have a working phone number
  • Not able to return for in-person follow-up visit
  • Was told to stop medication by provider after doctor/ED visit
  • Parent no longer having index medication bottle
  • Uncorrected hearing impairment
  • Self-reported poor visual acuity

Pharmacy staff

  • Staff with no responsibility in determining unit of measure to include on Rx's or type/capacity of the dosing tool to dispense for pediatric oral liquid medications.

Treatment and study plan

EHR-Based Approach

Other

The intervention will be built directly into the EHR. E-prescriptions will be generated with pharmacy instructions for all prescription medications. The intervention will impart: 1) inclusion with e-Rx request for pharmacy to keep metric-only (mL-only) dosing on Rx label and 2) inclusion of guidance on the e-Rx requesting that the pharmacy give an optimal tool based on an algorithm. Algorithm for dosing tool recommendation: 1) for a prescribed dose of <= 1mL, optimal tool is 1 mL syringe, 2) for >1 mL to 5 mL, use a 5 mL syringe, 3) for >5mL to 10mL, use 10 mL syringe.

Primary outcomes

  1. Caregiver Dosing Error

    Time frame: Within 8 weeks of index visit (Visit 2)

    Dosing error will be defined as >20% deviation from the prescribed dose

  2. Caregiver Large Dosing Error

    Time frame: Within 8 weeks of index visit (Visit 2)

    Large dosing error will be defined as >40% deviation from the prescribed dose

  3. Pharmacy Use of mL-only on Rx Label

    Time frame: Within 4 weeks of index visit (Visit 1)

  4. Pharmacy Provision of Optimal Dosing Tool

    Time frame: Within 4 weeks of index visit (Visit 1)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

Leveraging the EHR to Promote Pharmacy Adoption of Dosing Best Practices and Reduce Parent Errors in Administering Pediatric Liquid Medications: A Health Literacy-Informed Approach

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2021
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.