Clinical trial NCT02325336: Detection Medication Administration Errors Using Bar-code and RFID Technology (DREAM)
Official title: Effect of Bar-code-assisted Medication Administration on Medication Error Rates: a Controlled Randomized Multicentre Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Medication Administered in Error
Keywords: Medication Errors
nurses
hospital
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Nurses of the 6 care units who have drugs to deliver during medication administration rounds will be included

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Medication administration errors rate
timeFrame: one month after the intervention
Secondary outcomes:
measure: type of errors
timeFrame: one month after the intervention
measure: Severity of error
timeFrame: One month after intervention
measure: Satisfaction of nurses
timeFrame: One month after intervention
measure: Relevance of the system
timeFrame: One month after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Hopital Europeen Georges Pompidou
name: Brigitte Sabatier, PharmD, PhD
role: STUDY_CHAIR
References: