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Clinical Trials/NCT05146388
NCT05146388
Completed
Not Applicable

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

NYU Langone Health6 sites in 1 country500 target enrollmentApril 21, 2022

Overview

Phase
Not Applicable
Intervention
Pre-Implementation - Usual Care
Conditions
Medication Dosing Error
Sponsor
NYU Langone Health
Enrollment
500
Locations
6
Primary Endpoint
Pharmacy Provision of Optimal Dosing Tool
Status
Completed
Last Updated
26 days ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 21, 2022
End Date
February 5, 2025
Last Updated
26 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • 1\. 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
  • 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.

Arms & Interventions

Pre-Implementation - Usual Care

In pre-implementation phase, patient e-Rxs will be generated by the EHR in the usual fashion.

Post-Implementation - EHR-Based Approach

Intervention: EHR-Based Approach

Outcomes

Primary Outcomes

Pharmacy Provision of Optimal Dosing Tool

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

Pharmacy Use of mL-only on Rx Label

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

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

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

Study Sites (6)

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