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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2025-09-30

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.

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Detailed Description

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Conditions

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Medication Dosing Error

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Single (Outcomes Assessor) Two raters will independently assess dosing errors. Raters will be kept blinded to each other's estimated dose volumes and dosing error assessment in order to minimize bias.

Study Groups

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Pre-Implementation - Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-Implementation - EHR-Based Approach

Group Type EXPERIMENTAL

EHR-Based Approach

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No