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Completed

NCT Number: NCT03062852

Preventing Drug Errors Related to Caregiver Interruptions

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.

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Key information

Conditions

Medication Administered in Error

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medication safety vest

Device

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.

Primary outcomes

  1. Medication administration errors rate

    Time frame: two weeks after implementation of the medication safety vests and flyers

    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).

Secondary outcomes

  1. Percentage of wearing medication safety vest

    Time frame: two weeks after implementation of the medication safety vests and flyers

    Observers will note if the nurse is wearing the medication safety vest when arrival in the unit to observe the drug distribution.

  2. Type of medication errors

    Time frame: two weeks after implementation of the medication safety vests and flyers

    Each administration error will be classified by senior pharmacists according to the type of error using the ASHP classification in 9 categories.

  3. Description of nurse's interruptions

    Time frame: two weeks after implementation of the medication safety vests and flyers

    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.

  4. Percentage of nurse's interruptions

    Time frame: two weeks after implementation of the medication safety vests and flyers

    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.

  5. Severity of error

    Time frame: two weeks after implementation of the medication safety vests and flyers

    Each error will be classified by a multidisciplinary committee according to the potential harm using the australian classification from Westbrook in 5 categories.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: PERMIS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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