Impact of Barcode Technology on Medication ErrorsNCT00243373
Using Barcode Technology to Improve Medication Safety
A study testing Barcode technology/eMAR in people with Impact of Barcode Technology on Medication Errors, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Impact of Barcode Technology on Medication Errors
- What is being tested?
- Barcode technology/eMAR
- Type of treatment
- Medical device
- How many people
- 6,700 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nurses who refuse to be observed
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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:
- To evaluate the impact of barcode/eMAR technology on the rate of serious medication transcribing and administration errors.
- To evaluate the impact of barcode/eMAR technology on nursing workflow and satisfaction in an acute care hospital.
- Being tested
- Barcode technology/eMAR
- Keywords
- Patient safety, Medication safety, Barcode technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barcode technology/eMARDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcription errors
Administration errors
Serious medication errors
Secondary outcomes (3)
Nursing satisfaction
% nursing time spent on medication administration
ADEs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startApr 2005
- Primary completionDec 2005
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impact of Barcode Technology on Medication ErrorsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Tejal Gandhi, Brigham and Women's Hospital
- Investigators
- Tejal Gandhi, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243373
- Sponsor's protocol ID
- HS14053-02
- Status last verified
- Jan 2012
- First submitted
- 21 Oct 2005
- Last updated
- 19 Jan 2012
- Results posted
- No
Publications
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.
PubMed 20445181
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Barcode Technology to Improve Medication Safety
- ClinicalTrials.gov ID
- NCT00243373
- Acronym / sponsor ID
- HS14053-02
- Keywords
- Patient safety, Medication safety, Barcode technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,700 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 24 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- To evaluate the impact of barcode/eMAR technology on the rate of serious medication transcribing and administration errors.
- To evaluate the impact of barcode/eMAR technology on nursing workflow and satisfaction in an acute care hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Nurses who refuse to be observed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barcode technology/eMAR | Device | – |
Primary outcome
Transcription errors
Administration errors
Serious medication errors
3 secondary outcomes
Nursing satisfaction
% nursing time spent on medication administration
ADEs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
- Derived from this study: PubMed 20445181Poon 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tejal Gandhi, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barcode technology/eMAR in people with Impact of Barcode Technology on Medication Errors, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcription errors. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00243373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.