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Preventing Drug Errors Related to Caregiver Interruptions (PERMIS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2017 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT03062852
First received: February 20, 2017
Last updated: February 22, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention
Medication Administered in Error
Device: Medication safety vest

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Health Services Research
Official 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 15000
Anticipated Study Start Date: March 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medication safety vest
During administration rounds, nurses will wear the medication safety vest.
Device: Medication 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.
No Intervention: Control
During administration rounds, nurses will be dressed as usual without a safety vest.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03062852

Contacts
Contact: Brigitte Sabatier, PharmD, PhD 1 56 09 31 51 ext +33 brigitte.sabatier@aphp.fr
Contact: Sarah Berdot, PharmD, PhD 1 56 09 29 70 ext +33 sarah.berdot@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Brigitte Sabatier, PharmD, PhD Assistance Publique - Hôpitaux de Paris (AP-HP)
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03062852     History of Changes
Other Study ID Numbers: K150902  ID-RCB number  Ministry of Health, France 
Study First Received: February 20, 2017
Last Updated: February 22, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Medication Errors/prevention & control
Nursing Staff, Hospital/organization & administration
Drug Therapy/nursing
Safety Management
Medication Systems, Hospital/organization & administration

ClinicalTrials.gov processed this record on February 23, 2017