Using Barcode Technology to Improve Medication Safety

NCT ID: NCT00243373

Last Updated: 2012-01-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

6700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-03-31

Brief Summary

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This study will investigate the impact of barcode technology on medication errors made by nursing. In addition, it will measure the impact of this technology on nursing workflow and satisfaction.

Detailed Description

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Patient safety is a critical issue in healthcare1. Medications are the most commonly used form of medical therapy and the single most frequent cause of adverse events2. The medication use process has several stages: ordering, transcribing, dispensing, administering and monitoring. Medication errors have been shown to be common3,4, and a large proportion (61%) of them occur in the dispensing, transcribing and administering stages5. Barcode technology in conjunction with an electronic medication administration record (eMAR) system has been proposed as a promising way to reduce medication errors at the transcribing, dispensing, and administering stages6. However, its efficacy for reducing medication error rates, its acceptance by staff, and its cost-benefit ratio remain unknown. Without evidence to clarify these issues, it is difficult for health care organizations to prioritize this technology among many other potential safety interventions7. We therefore propose to answer 3 related questions in this study: i) What is the impact of barcode and electronic medication administration record (barcode/eMAR) technology on reducing medication errors in hospitalized patients? ii) What is the impact of barcode/eMAR technology on nursing and pharmacy efficiency and satisfaction? iii) Can the cost of barcode/eMAR technology be justified by its benefits? We propose to address these questions at the Brigham and Women's Hospital (BWH), which has a long-standing tradition of innovation in healthcare and research in medication safety. In particular, it was one of the first hospitals to assess the impact of computerized physician order entry (CPOE) on medication safety8,9. While CPOE is important for improving medication safety, it addresses errors primarily in the ordering stage of the medication use process, leaving patients vulnerable to errors that occur at the dispensing, transcribing and administering stages. Therefore, as part of a multi-disciplinary patient safety initiative, BWH has committed 3 million dollars to build a state-of-the-art barcode/eMAR system. This system will include sophisticated decision support to reduce medication errors made beyond the physician ordering stage. Design work is near completion and the hospital plans to implement the system in phases over 9 months beginning in the 4th quarter of 2003. This offers us a window of opportunity to formally study the broad impact of barcode/eMAR technology. We propose to perform a prospective, controlled, multidisciplinary randomized controlled trial of barcode/eMAR's impact on medication errors, as well as evaluations of impact on hospital efficiency, staff satisfaction, and hospital finances.

Specific Aims:

We plan to address the following 3 specific aims over the proposed 24 months of the study:

1. To evaluate the impact of barcode/eMAR technology on the rate of serious medication transcribing and administration errors.
2. To evaluate the impact of barcode/eMAR technology on nursing workflow and satisfaction in an acute care hospital.

Conditions

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Impact of Barcode Technology on Medication Errors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Barcode technology/eMAR

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Nurses who agree to be observed during the medication administration process before barcode technology
* Nurses who agree to be observed during the medication administration process after barcode technology is implemented

The goal is 6700 medication administration observations in the pre and the post periods

Exclusion Criteria

* Nurses who refuse to be observed
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tejal Gandhi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tejal Gandhi, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Poon EG, Keohane CA, Yoon CS, Ditmore M, Bane A, Levtzion-Korach O, Moniz T, Rothschild JM, Kachalia AB, Hayes J, Churchill WW, Lipsitz S, Whittemore AD, Bates DW, Gandhi TK. Effect of bar-code technology on the safety of medication administration. N Engl J Med. 2010 May 6;362(18):1698-707. doi: 10.1056/NEJMsa0907115.

Reference Type DERIVED
PMID: 20445181 (View on PubMed)

Other Identifiers

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HS14053-02

Identifier Type: -

Identifier Source: org_study_id

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