Preventing Drug Errors Related to Caregiver Interruptions

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Medication Administered in Error

Intervention / Treatment
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* Device: Medication safety vest


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication safety vest<br>During administration rounds, nurses will wear the medication safety vest. | Device: Medication safety vest<br>* 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.<br>|
| No Intervention: Control<br>During administration rounds, nurses will be dressed as usual without a safety vest. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication administration errors rate | The 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). | two weeks after implementation of the medication safety vests and flyers | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of wearing medication safety vest | Observers will note if the nurse is wearing the medication safety vest when arrival in the unit to observe the drug distribution. | two weeks after implementation of the medication safety vests and flyers | 
| Type of medication errors | Each administration error will be classified by senior pharmacists according to the type of error using the ASHP classification in 9 categories. | two weeks after implementation of the medication safety vests and flyers | 
| Description of nurse's interruptions | During 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. | two weeks after implementation of the medication safety vests and flyers | 
| Percentage of nurse's interruptions | During 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. | two weeks after implementation of the medication safety vests and flyers | 
| Severity of error | Each error will be classified by a multidisciplinary committee according to the potential harm using the australian classification from Westbrook in 5 categories. | two weeks after implementation of the medication safety vests and flyers | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication Systems, Hospital/organization & administration, Medication Errors/prevention & control, Nursing Staff, Hospital/organization & administration, Drug Therapy/nursing, Safety Management