Medication Administered in ErrorPERMISNCT03062852
Preventing Drug Errors Related to Caregiver Interruptions
A study testing Medication safety vest in people with Medication Administered in Error, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Medication Administered in Error
- What is being tested?
- Medication safety vest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2017to 17 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Voluntary nurses of the 30 care units who have drugs to deliver during medication administration rounds will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Medication Administered in Error
- Being tested
- Medication safety vest
- Keywords
- Medication Errors/prevention & control, Nursing Staff, Hospital/organization & administration, Drug Therapy/nursing, Safety Management, Medication Systems, Hospital/organization & administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Medication safety vest | Experimental | During administration rounds, nurses will wear the medication safety vest. Receives: Device: Medication safety vest |
| Control | No intervention | During administration rounds, nurses will be dressed as usual without a safety vest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: two weeks after implementation of the medication safety vests and flyers
Secondary outcomes (5)
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.
Measured: two weeks after implementation of the medication safety vests and flyers
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.
Measured: two weeks after implementation of the medication safety vests and flyers
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.
Measured: two weeks after implementation of the medication safety vests and flyers
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.
Measured: two weeks after implementation of the medication safety vests and flyers
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.
Measured: two weeks after implementation of the medication safety vests and flyers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start15 Mar 2017
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Medication Administered in ErrorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Brigitte Sabatier, PharmD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062852
- Sponsor's protocol ID
- NI15027
- Other IDs
- ID-RCB number, Ministry of Health, France
- Acronym
- PERMIS
- Status last verified
- Oct 2020
- First submitted
- 20 Feb 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22409837Berdot 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.
PubMed 23818992Berdot 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.
PubMed 26365701Westbrook 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.
PubMed 20421552Relihan 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.
PubMed 20511596Berdot 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.
PubMed 34429095
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03062852
- Acronym / sponsor ID
- PERMIS / NI15027
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication safety vest | Experimental | Device: Medication safety vestDuring administration rounds, nurses will wear the medication safety vest. |
| Control | No intervention | –During administration rounds, nurses will be dressed as usual without a safety vest. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Voluntary nurses of the 30 care units who have drugs to deliver during medication administration rounds will be included.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication safety vestThe 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. | Device | Medication safety vest |
Primary outcome
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).
5 secondary outcomes
Percentage of wearing medication safety vest
Time frame: two weeks after implementation of the medication safety vests and flyers
Type of medication errors
Time frame: two weeks after implementation of the medication safety vests and flyers
Description of nurse's interruptions
Time frame: two weeks after implementation of the medication safety vests and flyers
Percentage of nurse's interruptions
Time frame: two weeks after implementation of the medication safety vests and flyers
Severity of error
Time frame: two weeks after implementation of the medication safety vests and flyers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 22409837Berdot 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.
- Background: PubMed 23818992Berdot 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.
- Background: PubMed 26365701Berdot 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.
- Background: PubMed 20421552Westbrook 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.
- Background: PubMed 20511596Relihan 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.
- Derived from this study: PubMed 34429095Berdot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Sabatier, PharmD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication safety vest in people with Medication Administered in Error, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication administration errors rate (time frame: two weeks after implementation of the medication safety vests and flyers). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03062852, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.