Detection Medication Administration Errors Using Bar-code and RFID Technology (DREAM)

NCT02325336 | Withdrawn

• 1 other identifier: K121202
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Medication Administered in Error

Keywords

Medication Errors; nurses; hospital

Outcome Measures

Primary Outcomes (1)

• 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.

  one month after the intervention

Secondary Outcomes (4)

• type of errors

  one month after the intervention

• Severity of error

  One month after intervention

• Satisfaction of nurses

  One month after intervention

• Relevance of the system

  One month after intervention

Study Arms (2)

bar-code-assisted administration

EXPERIMENTAL

during administration rounds, nurses will use the BCMA system to help preventing administration errors

Device: BCMA (bar-code-assisted medication administration)

control

NO INTERVENTION

during administration rounds, nurses will administer drugs as usual

Interventions

BCMA (bar-code-assisted medication administration) DEVICE

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.

Also known as: ADIM preparation, ADIM administration

bar-code-assisted administration

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Officials

• Brigitte Sabatier, PharmD, PhD

  Hopital Europeen Georges Pompidou

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 25, 2014
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 14, 2018

Record last verified: 2018-03