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Using Barcode Technology to Improve Medication Safety

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ClinicalTrials.gov Identifier: NCT00243373
Recruitment Status : Completed
First Posted : October 24, 2005
Last Update Posted : January 19, 2012
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Tejal Gandhi, Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Impact of Barcode Technology on Medication Errors Device: Barcode technology/eMAR Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6700 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using Barcode Technology to Improve Medication Safety
Study Start Date : April 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Transcription errors
  2. Administration errors
  3. Serious medication errors

Secondary Outcome Measures :
  1. Nursing satisfaction
  2. % nursing time spent on medication administration
  3. ADEs


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243373


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Tejal Gandhi, MD Brigham and Women's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tejal Gandhi, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00243373     History of Changes
Other Study ID Numbers: HS14053-02
First Posted: October 24, 2005    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012
Keywords provided by Tejal Gandhi, Brigham and Women's Hospital:
Patient safety
Medication safety
Barcode technology