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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Medication Dosing Error

Intervention / Treatment
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* Other: EHR-Based Approach


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Dosing Error | Dosing error will be defined as >20% deviation from the prescribed dose | Within 8 weeks of index visit (Visit 2) | 
| Caregiver Large Dosing Error | 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 |  | Within 4 weeks of index visit (Visit 1) | 
| Pharmacy Provision of Optimal Dosing Tool |  | Within 4 weeks of index visit (Visit 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electronic Prescriptions (e-Rx), Pharmacy Dispensing Practices