Preventing Drug Errors Related to Caregiver Interruptions

Medication Administered in Error Clinical Trial

— PERMIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062852
• Other study ID #: NI15027
• Secondary ID: ID-RCB numberMin
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: April 17, 2018

Study information

• Verified date: October 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15000
• Est. completion date: April 17, 2018
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Medication Administered in Error

Intervention

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.

Locations

Country	Name	City	State
France	AP-HP	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (5)

Berdot S, Gillaizeau F, Caruba T, Prognon P, Durieux P, Sabatier B. Drug administration errors in hospital inpatients: a systematic review. PLoS One. 2013 Jun 20;8(6):e68856. doi: 10.1371/journal.pone.0068856. Print 2013. Review. — View Citation

Berdot S, Roudot M, Schramm C, Katsahian S, Durieux P, Sabatier B. Interventions to reduce nurses' medication administration errors in inpatient settings: A systematic review and meta-analysis. Int J Nurs Stud. 2016 Jan;53:342-50. doi: 10.1016/j.ijnurstu.2015.08.012. Epub 2015 Sep 7. Review. — View Citation

Berdot S, Sabatier B, Gillaizeau F, Caruba T, Prognon P, Durieux P. Evaluation of drug administration errors in a teaching hospital. BMC Health Serv Res. 2012 Mar 12;12:60. doi: 10.1186/1472-6963-12-60. — View Citation

Relihan E, O'Brien V, O'Hara S, Silke B. The impact of a set of interventions to reduce interruptions and distractions to nurses during medication administration. Qual Saf Health Care. 2010 Oct;19(5):e52. doi: 10.1136/qshc.2009.036871. Epub 2010 May 28. — View Citation

Westbrook JI, Woods A, Rob MI, Dunsmuir WT, Day RO. Association of interruptions with an increased risk and severity of medication administration errors. Arch Intern Med. 2010 Apr 26;170(8):683-90. doi: 10.1001/archinternmed.2010.65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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