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)

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the EHR-Based Approach treatment for reducing medication dosing errors?

The use of electronic health records (EHRs) has been shown to improve the quality of patient care by enabling better monitoring and evidence-based practices, as seen in the implementation of electronic chemotherapy ordering. Additionally, EHRs help in efficiently collecting patient-specific performance measures and outcomes, which can enhance quality improvement projects.12345

Is the EHR-Based Approach for reducing medication dosing errors safe for humans?

The use of electronic health records (EHRs) can improve patient safety by helping prevent medication errors, but there are also risks. Studies have shown that EHR-related medication errors can occur, especially during the ordering stage, and these errors can potentially cause serious harm. Therefore, while EHRs have safety benefits, they also require careful implementation and monitoring to minimize risks.678910

How does the EHR-Based Approach treatment reduce medication dosing errors?

The EHR-Based Approach is unique because it uses electronic health records to specifically target and reduce medication dosing errors by improving the prescription process and addressing system design flaws that lead to errors. This approach is different from traditional methods as it focuses on optimizing electronic systems to prevent errors rather than relying solely on manual checks or standard prescribing practices.1112131415

Research Team

HS

H. Shonna Yin, MD, MS

Principal Investigator

NYU Langone Health

Eligibility Criteria

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 7 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

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

Treatment Details

Interventions

  • EHR-Based Approach
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Post-Implementation - EHR-Based ApproachExperimental Treatment1 Intervention
Group II: Pre-Implementation - Usual CareActive Control1 Intervention
In pre-implementation phase, patient e-Rxs will be generated by the EHR in the usual fashion.

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+

Findings from Research

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]
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]

References

Implementation of electronic chemotherapy ordering: an opportunity to improve evidence-based oncology care. [2016]
Using electronic health records to collect patient-specific performance measures and outcomes. [2019]
All together now: findings from a PCORI workshop to align patient-reported outcomes in the electronic health record. [2018]
Quality of Hospital Electronic Health Record (EHR) Data Based on the International Consortium for Health Outcomes Measurement (ICHOM) in Heart Failure: Pilot Data Quality Assessment Study. [2021]
Leveraging Digital Data to Inform and Improve Quality Cancer Care. [2021]
Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study. [2018]
EHR-related medication errors in two ICUs. [2021]
Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. [2012]
Assessing the safety of electronic health records: a national longitudinal study of medication-related decision support. [2020]
EHR safety: the way forward to safe and effective systems. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
The ART of Electronic Prescribing. [2022]
Elimination of Emergency Department Medication Errors Due To Estimated Weights. [2020]
Analysis of electronic medication orders with large overdoses: opportunities for mitigating dosing errors. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
An Interdisciplinary Approach to Reducing Errors in Extracted Electronic Health Record Data for Research. [2021]
Impact of Electronic Health Record Systems on Prescribing Errors in Pediatric Clinics. [2020]