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Preventing Drug Errors Related to Caregiver Interruptions

Prévention Des Erreurs médicamenteuses liées Aux Interruptions de tâches Des Soignants Lors de la préparation et de l'Administration Des médicaments : Essai contrôlé randomisé Multicentrique en Clusters

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03062852
Acronym
PERMIS
Enrollment
15000
Registered
2017-02-23
Start date
2017-03-15
Completion date
2018-04-17
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Administered in Error

Keywords

Medication Errors/prevention & control, Nursing Staff, Hospital/organization & administration, Drug Therapy/nursing, Safety Management, Medication Systems, Hospital/organization & administration

Brief summary

Serious medication administration errors are common in hospitals and nurse's interruptions during medication preparation and administration is associated with errors. Various interventions were developed to help prevention of errors such as visual intervention. Investigators aimed to study the effect of a medication safety vest to reduce medication errors. The vest serves as a visible signal to inform others that the nurse is preparing and administering medications and should not be disturbed. Patients and visitors are provided with an informational flyer to inform them about the use of medication safety vests. The hypothesis is that the vest will reduce nurse's interruptions during medication preparation and administration, and ultimately reduce medication errors. The study is a randomized controlled trial in 30 care units of four hospitals in France. Each unit will be randomized in either the control group or the experimental group using the medication safety vest. Nurses of the unit will be selected at random to determine who will be observed during the administration rounds.The observation method will be used to evaluate the error rates in the 2 groups. The number of interruptions and error rates will be evaluated.

Detailed description

Serious medication administration errors are common in hospitals. Significant association between medication administration errors rate and the frequency of nurse's interruptions was shown. The estimated risk of error without interruption during preparation and administration is 2.3% whereas it doubles with 4 or more interruptions. Various interventions were developed to help prevention of errors such as visual interventions and technology interventions. Investigators aimed to study the effect of a medication safety vest to reduce medication errors. The vest serves as a visible signal to inform others that the nurse is preparing and administering medications and should not be disturbed. On the back of the vest is written Do not disturb me. I am preparing medications. Patients and visitors are provided with an informational flyer to inform them about the use of medication safety vests The hypothesis is that the vest will reduce nurse's interruptions during medication preparation and administration, and ultimately reduce medication errors. The study is a randomized controlled trial in 30 care units of four hospitals in France. Each unit will be randomized in either the control group or the experimental group using the medication safety vest. Nurses of the unit will be randomized to determine who will be observed during the administration rounds.The observation method will be used to evaluate the error rates in the 2 groups. The number of interruptions and error rates will be evaluated.

Interventions

DEVICEMedication safety vest

The nurses preparing and administering medication will wear a medication safety vest. On the back of the vest, the sentance Do not disturb me. I am preparing medications is written to inform others professional, patients and visitors. A informational flyer will be put in the units to inform patients and visitors about the intervention.

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

\- Voluntary nurses of the 30 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. * Nurses in the European G. Pompidou hospital who work in the 4 units involved in an other research project. * Medication administrations during emergencies (e.g., cardiopulmonary resuscitation) will also be excluded from this study.

Design outcomes

Primary

MeasureTime frameDescription
Medication administration errors ratetwo weeks after implementation of the medication safety vests and flyersThe primary outcome is the medication errors rate measured by the observation technique (technique of reference). Observers will follow nurses during drug distribution (preparation and administration) to patients, without knowing the physician's medication orders, and will record details about the drugs and interruptions. After completing the observation session, medication administration errors will be assessed 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 preparation/administration with at least one error by the total opportunities for errors (TOE).

Secondary

MeasureTime frameDescription
Percentage of wearing medication safety vesttwo weeks after implementation of the medication safety vests and flyersObservers will note if the nurse is wearing the medication safety vest when arrival in the unit to observe the drug distribution.
Type of medication errorstwo weeks after implementation of the medication safety vests and flyersEach administration error will be classified by senior pharmacists according to the type of error using the ASHP classification in 9 categories.
Description of nurse's interruptionstwo weeks after implementation of the medication safety vests and flyersDuring the drug distribution, the observers will note if the nurse is interrupted and by who. An interruption is defined as a stop in the nurse's task during the medication process and will be classified in 10 categories using the classification from Relihan.
Percentage of nurse's interruptionstwo weeks after implementation of the medication safety vests and flyersDuring the drug distribution, the observers will note if the nurse is interrupted. An interruption is defined as a stop in the nurse's task during the medication process and will be classified in 10 categories using the classification from Relihan.
Severity of errortwo weeks after implementation of the medication safety vests and flyersEach error will be classified by a multidisciplinary committee according to the potential harm using the australian classification from Westbrook in 5 categories.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026