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

March 6, 2024 updated by: NYU Langone Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Caregiver/Child

  1. English or Spanish-speaking
  2. 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
  3. 18 years of age or older
  4. 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
  5. Primary person who will administer child's medications
  6. Access to a smartphone that can take photos and send/receive text messages
  7. Willingness and ability to participate

Pharmacy staff

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

Exclusion Criteria:

Caregiver/Child

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

Pharmacy staff

1. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-Implementation - Usual Care
In pre-implementation phase, patient e-Rxs will be generated by the EHR in the usual fashion.
Experimental: Post-Implementation - EHR-Based Approach
Other: EHR-Based Approach
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 8 weeks of index visit (Visit 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
Within 8 weeks of index visit (Visit 2)
Pharmacy Use of mL-only on Rx Label
Time Frame: Within 4 weeks of index visit (Visit 1)
Within 4 weeks of index visit (Visit 1)
Pharmacy Provision of Optimal Dosing Tool
Time Frame: Within 4 weeks of index visit (Visit 1)
Within 4 weeks of index visit (Visit 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

Food and Drug Administration (FDA)

Investigators

  • Principal Investigator: H. Shonna Yin, MD, MS, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Estimated)

August 15, 2024

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21-00972

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Hsiang.Yin@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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