NCT03062852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2018

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

February 20, 2017

Last Update Submit

November 2, 2020

Conditions

Medication Administered in Error

Keywords

Medication Errors/prevention & controlNursing Staff, Hospital/organization & administrationDrug Therapy/nursingSafety ManagementMedication Systems, Hospital/organization & administration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Percentage of wearing medication safety vest

    two weeks after implementation of the medication safety vests and flyers

  • Type of medication errors

    two weeks after implementation of the medication safety vests and flyers

  • Description of nurse's interruptions

    two weeks after implementation of the medication safety vests and flyers

  • Percentage of nurse's interruptions

    two weeks after implementation of the medication safety vests and flyers

  • Severity of error

    two weeks after implementation of the medication safety vests and flyers

Study Arms (2)

Medication safety vest

EXPERIMENTAL

During administration rounds, nurses will wear the medication safety vest.

Device: Medication safety vest

Control

NO INTERVENTION

During administration rounds, nurses will be dressed as usual without a safety vest.

Interventions

Medication safety vestDEVICE

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.

Medication safety vest

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Voluntary nurses of the 30 care units who have drugs to deliver during medication administration rounds will be included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP

Paris, 75015, France

Location

Related Publications (6)

  • 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.

    PMID: 22409837BACKGROUND

  • 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.

    PMID: 23818992BACKGROUND

  • 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.

    PMID: 26365701BACKGROUND

  • 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.

    PMID: 20421552BACKGROUND

  • 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.

    PMID: 20511596BACKGROUND

  • 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.

    PMID: 34429095DERIVED

Study Officials

  • Brigitte Sabatier, PharmD, PhD

    Assistance Publique - Hôpitaux de Paris (AP-HP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2017

First Posted

February 23, 2017

Study Start

March 15, 2017

Primary Completion

April 17, 2018

Study Completion

April 17, 2018

Last Updated

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)