Medication Administered in Error Clinical Trial
— DREAMOfficial title:
Effect of Bar-code-assisted Medication Administration on Medication Error Rates: a Controlled Randomized Multicentre Trial
Verified date | March 2018 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | one month after the intervention | |
Secondary | Severity of error | Each error will be classified by a multidisciplinary committee according to the potential harm using the NCCMERP classification. | One month after intervention | |
Secondary | 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. | One month after intervention | |
Secondary | 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. | One month after intervention |
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