Medication Administered in ErrorDREAMNCT02325336
Detection Medication Administration Errors Using Bar-code and RFID Technology (DREAM)
A study testing BCMA (bar-code-assisted medication administration) in people with Medication Administered in Error, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Serious medication administration errors are common in hospitals. Various interventions were developed to help prevention of such errors such as bar-code technology. Investigators aimed to study the effect of bar-code-assisted medication administration (BCMA) system on the rate of medication errors in two hospitals. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Medication Administered in Error
- What is being tested?
- BCMA (bar-code-assisted medication administration)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2017
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Nurses of the 6 care units who have drugs to deliver during medication administration rounds will be included
Who cannot join
- Nurses who refuse to be observed during medication administration rounds and nurses replacement that did not work usually in the studied units will not be included.
- Medication administrations during emergencies (e.g., cardiopulmonary resuscitation) will also be excluded from this study.
About this study
Official title: Effect of Bar-code-assisted Medication Administration on Medication Error Rates: a Controlled Randomized Multicentre Trial
Serious medication administration errors are common in hospitals. Various interventions were developed to help prevention of such errors such as bar-code technology. Investigators aimed to study the effect of bar-code-assisted medication administration (BCMA) system on the rate of medication errors in two hospitals.
They will conduct a randomized controlled trial in 6 care units of two hospitals in Paris, France. Each unit will be randomized in either the control group or the intervention group using the bar-code system to help drug administration. The observation method will be used to evaluate the error rates in the 2 groups at baseline and when BCMA will be implanted. Nurses of the unit will be randomized to determine who will be observed during the administration rounds.
Considering the results of a passed observational study in 4 units (Berdot, BMC Health Serv Research 2012) and the results of the study by Poon and al. (NEJM 2010), investigators estimated that 5.981 TOE (Total Opportunities for Errors) are needed to detect a relative reduction of 45% of error rate.
Read the detailed description
The ADIM system (Aide a la Distribution Informatisee des Medicaments) consists of 2 machines with photographic reconnaissance and readers: one for preparation assistance that can be placed at the pharmacy or in the clinical service and one to assist the administration by the nurse in the clinical service.
The system ADIM preparation consists of a working area with 2 reader devices (a RFID reader and a bar code reader) and a touch screen . It allows selection from the list of patients, the patient's prescription for which the preparation will be made. It is linked to the drug data base.
The system ADIM administration is composed of a laptop with touch screen, 2 readers (a RFID reader and a barcode reader) , the elements needed to care and a work plan and drawers containing unit dose drugs for patients for a specific nurse. The nurse scans her/his badge, the patient's wristband and each dose administered and prepared by the pharmacy. If the dose is not prepared by the pharmacy, the nurse takes the dose in the automat cabinet. The nurse scans the drug's barcode or select on the touch screen the drug and the required dose of the drug. In case of discrepancy with the prescription, there is a visual alert. However, the alert can be override by the nurse if she/he gives a justification.
- Conditions
- Medication Administered in Error
- Being tested
- BCMA (bar-code-assisted medication administration)
- Keywords
- Medication Errors, nurses, hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA (bar-code-assisted medication administration)Device
Also called ADIM preparation, ADIM administration
Implementation of ADIM system (Aide a la Distribution Informatisee des Medicaments) which consists of 2 machines with photographic reconnaissance and readers: one for preparation assistance that can be placed at the pharmacy or in the clinical service and one to assist the administration by the nurse in the clinical service.
In case of discrepancy with the prescription, there is a visual alert. However, the alert can be override by the nurse if she/he gives a justification.
| Study group | Role | What they receive |
|---|---|---|
| bar-code-assisted administration | Experimental | during administration rounds, nurses will use the BCMA system to help preventing administration errors Receives: Device: BCMA (bar-code-assisted medication administration) |
| control | No intervention | during administration rounds, nurses will administer drugs as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication administration errors rate
Investigators will use the direct-observation method to measure error rates. Observers will shadow staff nurses while administering drugs to patients, without knowing the physician's medication orders, and will record details about the administration. After completing the observation session, medication administration errors will be assessed, by two senior pharmacists, blinded to the unit allocation, by comparing the observed medication administered to the medication intended for that patient. The rate of medication administration errors will be calculated by dividing the number of errors by the total opportunities for errors (TOE). The TOE is defined as the sum of observed administrations and omitted medications. As wrong-time errors are generally considered less severe, overall error rate will be calculated without this type of error.
Measured: one month after the intervention
Secondary outcomes (4)
type of errors
Each administration error will be classified by the two senior pharmacists according to the type of error using the ASHP classification in 9 categories. Wrong-time error is defined as an administration that is early or late by more than 1 hour.
Measured: one month after the intervention
Severity of error
Each error will be classified by a multidisciplinary committee according to the potential harm using the NCCMERP classification.
Measured: One month after intervention
Satisfaction of nurses
Satisfaction with the bar-code system will be assessed using a validated questionnaire. It will be filled anonymously by nurses at the end of the observation period in the unit. Evaluation of administration rounds time will be studied also to evaluate satisfaction with the system.
Measured: One month after intervention
Relevance of the system
Relevance of the system will be assessed by studying the system alerts: false negative rates, rates of modifications in preparation/administration of drugs in case of system alerts, rates of unjustified or wrong alerts. During the observation in the intervention group, number and causes of non-use of the bar-code system will be assessed.
Measured: One month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Technical difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Administered in ErrorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Sabatier, PharmD, PhD, Study chair, Hopital Europeen Georges Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325336
- Sponsor's protocol ID
- K121202
- Acronym
- DREAM
- Status last verified
- Mar 2018
- First submitted
- 19 Dec 2014
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bar-code-assisted Medication Administration on Medication Error Rates: a Controlled Randomized Multicentre Trial
- ClinicalTrials.gov ID
- NCT02325336
- Acronym / sponsor ID
- DREAM / K121202
- Conditions
- Medication Administered in Error
- Keywords
- Medication Errors, nurses, hospital
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Dec 2014 (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.
Serious medication administration errors are common in hospitals. Various interventions were developed to help prevention of such errors such as bar-code technology. Investigators aimed to study the effect of bar-code-assisted medication administration (BCMA) system on the rate of medication errors in two hospitals.
They will conduct a randomized controlled trial in 6 care units of two hospitals in Paris, France. Each unit will be randomized in either the control group or the intervention group using the bar-code system to help drug administration. The observation method will be used to evaluate the error rates in the 2 groups at baseline and when BCMA will be implanted. Nurses of the unit will be randomized to determine who will be observed during the administration rounds.
Considering the results of a passed observational study in 4 units (Berdot, BMC Health Serv Research 2012) and the results of the study by Poon and al. (NEJM 2010), investigators estimated that 5.981 TOE (Total Opportunities for Errors) are needed to detect a relative reduction of 45% of error rate.
Detailed description
The ADIM system (Aide a la Distribution Informatisee des Medicaments) consists of 2 machines with photographic reconnaissance and readers: one for preparation assistance that can be placed at the pharmacy or in the clinical service and one to assist the administration by the nurse in the clinical service.
The system ADIM preparation consists of a working area with 2 reader devices (a RFID reader and a bar code reader) and a touch screen . It allows selection from the list of patients, the patient's prescription for which the preparation will be made. It is linked to the drug data base.
The system ADIM administration is composed of a laptop with touch screen, 2 readers (a RFID reader and a barcode reader) , the elements needed to care and a work plan and drawers containing unit dose drugs for patients for a specific nurse. The nurse scans her/his badge, the patient's wristband and each dose administered and prepared by the pharmacy. If the dose is not prepared by the pharmacy, the nurse takes the dose in the automat cabinet. The nurse scans the drug's barcode or select on the touch screen the drug and the required dose of the drug. In case of discrepancy with the prescription, there is a visual alert. However, the alert can be override by the nurse if she/he gives a justification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bar-code-assisted administration | Experimental | Device: BCMA (bar-code-assisted medication administration)during administration rounds, nurses will use the BCMA system to help preventing administration errors |
| control | No intervention | –during administration rounds, nurses will administer drugs as usual |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nurses of the 6 care units who have drugs to deliver during medication administration rounds will be included
Key exclusion criteria (2 listed)
- Nurses who refuse to be observed during medication administration rounds and nurses replacement that did not work usually in the studied units will not be included.
- Medication administrations during emergencies (e.g., cardiopulmonary resuscitation) will also be excluded from this study.
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 |
|---|---|---|
| BCMA (bar-code-assisted medication administration)Also: ADIM preparation, ADIM administrationImplementation of ADIM system (Aide a la Distribution Informatisee des Medicaments) which consists of 2 machines with photographic reconnaissance and readers: one for preparation assistance that can be placed at the pharmacy or in the clinical service and one to assist the administration by the nurse in the clinical service. In case of discrepancy with the prescription, there is a visual alert. However, the alert can be override by the nurse if she/he gives a justification. | Device | bar-code-assisted administration |
Primary outcome
Medication administration errors rate
Time frame: one month after the intervention
Investigators will use the direct-observation method to measure error rates. Observers will shadow staff nurses while administering drugs to patients, without knowing the physician's medication orders, and will record details about the administration. After completing the observation session, medication administration errors will be assessed, by two senior pharmacists, blinded to the unit allocation, by comparing the observed medication administered to the medication intended for that patient. The rate of medication administration errors will be calculated by dividing the number of errors by the total opportunities for errors (TOE). The TOE is defined as the sum of observed administrations and omitted medications. As wrong-time errors are generally considered less severe, overall error rate will be calculated without this type of error.
4 secondary outcomes
type of errors
Time frame: one month after the intervention
Severity of error
Time frame: One month after intervention
Satisfaction of nurses
Time frame: One month after intervention
Relevance of the system
Time frame: One month after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
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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.
Brigitte Sabatier, PharmD, PhD study chair
Hopital Europeen Georges Pompidou
Questions about this trial
What is this clinical trial studying?
A study testing BCMA (bar-code-assisted medication administration) in people with Medication Administered in Error, run by Assistance Publique - Hôpitaux de Paris.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Medication administration errors rate (time frame: one month after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2018.