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

Not Applicable

Recruiting

• Conditions: Medication Dosing Error
• Interventions: Other: EHR-Based Approach

• Registration Number: NCT05146388
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-06
• Study Start: 2022-04-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-Implementation - EHR-Based Approach	EHR-Based Approach	-

Primary Outcome Measures

Name	Time	Method
Pharmacy Provision of Optimal Dosing Tool	Within 4 weeks of index visit (Visit 1)
Pharmacy Use of mL-only on Rx Label	Within 4 weeks of index visit (Visit 1)
Caregiver Large Dosing Error	Within 8 weeks of index visit (Visit 2)	Large dosing error will be defined as \>40% deviation from the prescribed dose
Caregiver Dosing Error	Within 8 weeks of index visit (Visit 2)	Dosing error will be defined as \>20% deviation from the prescribed dose

Trial Locations

Locations (3)

NYC Health + Hospitals / Bellevue; 🇺🇸 New York, New York, United States

NYU Langone Health - Brooklyn; 🇺🇸 Brooklyn, New York, United States

Sunset Park Family Health Center at NYU Langone; 🇺🇸 Brooklyn, New York, United States