Clinical trial NCT03062852: Preventing Drug Errors Related to Caregiver Interruptions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2017-02-23
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Medication administration errors rate
timeFrame: two weeks after implementation of the medication safety vests and flyers
Secondary outcomes:
measure: Percentage of wearing medication safety vest
timeFrame: two weeks after implementation of the medication safety vests and flyers
measure: Type of medication errors
timeFrame: two weeks after implementation of the medication safety vests and flyers
measure: Description of nurse's interruptions
timeFrame: two weeks after implementation of the medication safety vests and flyers
measure: Percentage of nurse's interruptions
timeFrame: two weeks after implementation of the medication safety vests and flyers
measure: Severity of error
timeFrame: two weeks after implementation of the medication safety vests and flyers
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris (AP-HP)
name: Brigitte Sabatier, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
citation: Berdot S, Vilfaillot A, Bezie Y, Perrin G, Berge M, Corny J, Thi TTP, Depoisson M, Guihaire C, Valin N, Decelle C, Karras A, Durieux P, Le LMM, Sabatier B. Effectiveness of a 'do not interrupt' vest intervention to reduce medication errors during medication administration: a multicenter cluster randomized controlled trial. BMC Nurs. 2021 Aug 24;20(1):153. doi: 10.1186/s12912-021-00671-7.