500 Participants Needed

EHR-Based Approach for Reducing Medication Dosing Errors

Recruiting at 2 trial locations
JM
HS
Overseen ByH. Shonna Yin, MD, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an electronic system designed to reduce mistakes when parents measure doses of liquid medications for their children. It uses electronic health records (EHRs) to guide pharmacies in labeling medications in milliliters and provides tools for accurate dose measurement. The goal is to determine if this EHR-based approach can help parents make fewer dosing errors and improve safety for children taking liquid medications. This trial suits English- or Spanish-speaking parents or guardians with a child under 8 years old prescribed liquid medicine from certain clinics in New York City, who will administer the medication. As an unphased trial, it offers a chance to contribute to innovative solutions that enhance medication safety for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on improving how liquid medications are dispensed and dosed, rather than changing existing medications.

What prior data suggests that this EHR-based approach is safe for reducing medication dosing errors?

Research shows that electronic health record (EHR) systems can enhance healthcare safety. For example, studies have found that EHRs help reduce medication errors and adverse drug events (ADEs). One study highlighted how digital tools in EHRs lowered medication errors.

However, not all results are positive. Some hospitals experienced more medication errors after implementing EHR systems. This suggests that the system's setup and usage can impact safety. Overall, while there is potential, results vary depending on EHR implementation.12345

Why are researchers excited about this trial?

Researchers are excited about the EHR-Based Approach for reducing medication dosing errors because it leverages technology to enhance patient safety. Unlike traditional methods where prescriptions are manually checked, this approach integrates directly with Electronic Health Records (EHR) to automatically ensure correct dosing. This method aims to minimize human error and streamline the prescription process, potentially leading to fewer mistakes and improved patient outcomes. By harnessing digital systems, this approach could revolutionize how medication errors are addressed in healthcare settings.

What evidence suggests that this EHR-based approach is effective for reducing medication dosing errors?

Research has shown that electronic health record (EHR) systems can enhance medication safety by reducing errors. Some studies found that EHR tools, when combined with digital technology, decrease harmful drug events and medication errors. Features like checklists and error reporting, often included in EHRs, help prevent complications and ensure correct medication doses. However, evidence also suggests that if not managed carefully, the initial implementation of EHRs might lead to more mistakes. This trial will compare the usual care approach before EHR implementation with the EHR-Based Approach post-implementation. Overall, EHR-based solutions have shown promise in improving pharmacy practices and reducing dosing errors.12367

Who Is on the Research Team?

HS

H. Shonna Yin, MD, MS

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking parents or guardians over 18 years old, who are the primary caregivers of children aged ≤8 years prescribed liquid medications in specific New York City hospitals. Participants must have a smartphone and be willing to participate. Pharmacists involved must dispense medication to study participants.

Inclusion Criteria

Pharmacy staff
Willingness and ability to participate
English or Spanish-speaking
See 6 more

Exclusion Criteria

You have a hearing problem that has not been fixed or corrected.
You have reported having difficulty seeing clearly.
Does not have a working phone number
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Implementation

Patient e-Rxs are generated by the EHR in the usual fashion

8 weeks
1 visit (in-person)

Post-Implementation

EHR generates e-Rxs with instructions for mL-only dosing and specific dosing tools

8 weeks
1 visit (in-person)

Follow-up

Participants are monitored for dosing errors and adherence to new dispensing practices

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EHR-Based Approach
Trial Overview The trial tests an EHR-based intervention aimed at helping pharmacists stick to mL-only dosing instructions and provide appropriate dosing tools, with the goal of reducing parental dosing errors with children's liquid medicines.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Post-Implementation - EHR-Based ApproachExperimental Treatment1 Intervention
Group II: Pre-Implementation - Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Food and Drug Administration (FDA)

Collaborator

Trials
184
Recruited
1,553,000+

Published Research Related to This Trial

The effective use of electronic health records (EHRs) is crucial for improving health care quality and patient safety, but there are documented risks of EHRs contributing to system flaws and patient harm.
To mitigate these risks, the authors recommend a coordinated approach that includes integrating EHR implementation with health care process improvement, ensuring safety in EHR design, conducting safety testing, and facilitating rapid communication of any safety issues.
EHR safety: the way forward to safe and effective systems.Walker, JM., Carayon, P., Leveson, N., et al.[2021]
The FDA's ASTER pilot study demonstrated that electronic health record (EHR)-triggered adverse event reports can provide valuable postmarketing safety information, particularly for known adverse drug events (ADEs).
However, the quality of the reports varied, with many lacking critical details such as informative descriptions and relevant laboratory data, highlighting the need for improved data quality to enhance the utility of EHR-triggered ADE reporting.
Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.Brajovic, S., Piazza-Hepp, T., Swartz, L., et al.[2012]

Citations

Impact of Implementing Electronic Health Records on ...This study showed that an HIMSS stage 6 hospital could experience an increase in medication errors following implementation of EHRs.
Evaluating EHR-Integrated Digital Technologies for ...Outcome (O): Improvements in medication-related outcomes, such as adverse drug event (ADE) rates, and medication errors driven by EHR-digital ...
The effectiveness of checklists and error reporting systems ...The review highlights evidence supporting the efficacy of checklists in reducing medication errors, surgical complications, and other adverse events.
The effect of electronic medical records on medication errors ...This study examines the position of the qualified nursing staff regarding the impact of electronic medical records systems on factors related to patient safety.
EHR-Based Approach for Reducing Medication Dosing ...Studies have shown that EHR-related medication errors can occur, especially during the ordering stage, and these errors can potentially cause serious harm.
Evaluating EHR-Integrated Digital Technologies for ...These technologies demonstrated potential to reduce ADE, medication errors, medication discrepancies, potentially inappropriate medications, ...
A Qualitative Analysis of the Impact of Electronic Health ...This study aims to explore the lived experiences of clinicians, to assess the role of EHR in improving the quality and safety of healthcare.
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