Rudeness/Incivility, Aggression or Violence Against Healthcare Workers in an Ophthalmic Emergencies Unit.PREVURGONCT02015884
Antisocial Behavior on Healthcare Professionals in an Emergency Unit.
An observational study of Rudeness/Incivility, Aggression or Violence Against Healthcare Workers in an Ophthalmic Emergencies Unit., run by Hospices Civils de Lyon at 1 site in France.
Trial summary
At the hospital, the attacks against health professionals are becoming commonplace, making working conditions difficult. The ophthalmological emergencies are a perfect testing ground to evaluate the effectiveness of a series of original actions to prevent the occurrence of violence against healthcare workers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rudeness/Incivility, Aggression or Violence Against Healthcare Workers in an Ophthalmic Emergencies Unit.
- How many people
- 58,465 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Sep 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted to the ophthalmologic emergency unit will be included in the study.
Who may be able to join
- Patient admitted to the ophthalmologic emergency unit
- No Exclusion Criteria
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Program to Prevent the Risk of Antisocial Behavior and Attacks of Patients or Attendant on Healthcare Workers in an Ophthalmic Emergency Unit.
At the hospital, the attacks against health professionals are becoming commonplace, making working conditions difficult. The ophthalmological emergencies are a perfect testing ground to evaluate the effectiveness of a series of original actions to prevent the occurrence of violence against healthcare workers. The main objective is to measure the impact of an integrated prevention of the occurrence of antisocial behavior or attacks against the healthcare workers.
The prevention program combines five interventions (steps): 1) a computer sorting algorithm and specific screens for calling patients in waiting rooms, 2) a clear signage to direct patients between waiting rooms, treatment rooms and administrative et medical offices, 3) Posts information on the activity of emergency services displayed on screens, in the waiting rooms, 4) a mediator/go-between/conciliator, 5) and a dummy surveillance camera.
This is an interrupted time series study. All patients admitted to the ophthalmological emergency unit of a university hospital located in Lyon, France, are included in the study, from June 2013 to Sept 2015
- Keywords
- Incivility, Rudeness, Aggression, Violent act, Healthcare workers, Emergency unit
- Medical subject headings
- Incivility, Aggression, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients admitted to the ophthalmologic emergency unit. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients (or their attendants) who committed a rudeness/incivility or aggression or violence against healthcare workers.
When seeking to characterize the violent behavior, three levels of increasing aggressiveness are typically distinguished: a) incivility i.e. the lack of respect for others characterized by relatively mild acts, b) physical or verbal aggression (insults, threats, assault), and c) the violent act.
Measured: Patients will be followed for the duration of the ophthalmic emergency unit stay, an expected average of 2 hours.
Secondary outcomes (4)
Occurrence of antisocial behavior or assaults against other patients or carers attending the ophthalmological emergencies.
Proportion of incivility or assaults against other patients or attendant present (number of incivility or assaults on the number of patients admitted to the emergency)
Measured: Patients will be followed for the duration of the ophthalmic emergency unit stay, an expected average of 2 hours.
Waiting times for patients
Average waiting times for patients with ophthalmic emergencies before they were taken care of by a doctor.
Measured: Patients will be followed for the duration of the ophthalmic emergency unit stay, an expected average of 2 hours.
Stress of healthcare personnel
Stress at work of health personnel engaged in an ophthalmic emergency unit measured by the Karasek questionnaire. 30 mn are necessary to complete the questionnaire.
Measured: 30 minutes
Satisfaction of patients
Measured: Patients will be followed for the duration of the ophthalmic emergency unit stay, an expected average of 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rudeness/Incivility, Aggression or Violence Against Healthcare Workers in an Ophthalmic Emergencies Unit.Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 58,465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015884
- Sponsor's protocol ID
- D50794
- Acronym
- PREVURGO
- Status last verified
- Oct 2015
- First submitted
- 10 Dec 2013
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Touzet S, Occelli P, Denis A, Cornut PL, Fassier JB, Le Pogam MA, Duclos A, Burillon C. Impact of a comprehensive prevention programme aimed at reducing incivility and verbal violence against healthcare workers in a French ophthalmic emergency department: an interrupted time-series study. BMJ Open. 2019 Sep 5;9(9):e031054. doi: 10.1136/bmjopen-2019-031054.
PubMed 31492791Touzet S, Cornut PL, Fassier JB, Le Pogam MA, Burillon C, Duclos A. Impact of a program to prevent incivility towards and assault of healthcare staff in an ophtalmological emergency unit: study protocol for the PREVURGO On/Off trial. BMC Health Serv Res. 2014 May 19;14:221. doi: 10.1186/1472-6963-14-221.
PubMed 24885544
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Program to Prevent the Risk of Antisocial Behavior and Attacks of Patients or Attendant on Healthcare Workers in an Ophthalmic Emergency Unit.
- ClinicalTrials.gov ID
- NCT02015884
- Acronym / sponsor ID
- PREVURGO / D50794
- Keywords
- Incivility, Rudeness, Aggression, Violent act, Healthcare workers, Emergency unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58,465 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Dec 2013 (estimated)
- 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.
At the hospital, the attacks against health professionals are becoming commonplace, making working conditions difficult. The ophthalmological emergencies are a perfect testing ground to evaluate the effectiveness of a series of original actions to prevent the occurrence of violence against healthcare workers. The main objective is to measure the impact of an integrated prevention of the occurrence of antisocial behavior or attacks against the healthcare workers.
The prevention program combines five interventions (steps): 1) a computer sorting algorithm and specific screens for calling patients in waiting rooms, 2) a clear signage to direct patients between waiting rooms, treatment rooms and administrative et medical offices, 3) Posts information on the activity of emergency services displayed on screens, in the waiting rooms, 4) a mediator/go-between/conciliator, 5) and a dummy surveillance camera.
This is an interrupted time series study. All patients admitted to the ophthalmological emergency unit of a university hospital located in Lyon, France, are included in the study, from June 2013 to Sept 2015
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients admitted to the ophthalmologic emergency unit. | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to the ophthalmologic emergency unit will be included in the study.
Key inclusion criteria (2 listed)
- Patient admitted to the ophthalmologic emergency unit
- No Exclusion Criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients (or their attendants) who committed a rudeness/incivility or aggression or violence against healthcare workers.
Time frame: Patients will be followed for the duration of the ophthalmic emergency unit stay, an expected average of 2 hours.
When seeking to characterize the violent behavior, three levels of increasing aggressiveness are typically distinguished: a) incivility i.e. the lack of respect for others characterized by relatively mild acts, b) physical or verbal aggression (insults, threats, assault), and c) the violent act.
4 secondary outcomes
Occurrence of antisocial behavior or assaults against other patients or carers attending the ophthalmological emergencies.
Time frame: Patients will be followed for the duration of the ophthalmic emergency unit stay, an expected average of 2 hours.
Waiting times for patients
Time frame: Patients will be followed for the duration of the ophthalmic emergency unit stay, an expected average of 2 hours.
Stress of healthcare personnel
Time frame: 30 minutes
Satisfaction of patients
Time frame: Patients will be followed for the duration of the ophthalmic emergency unit stay, an expected average of 2 hours.
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 23 Oct 2015.
- Derived from this study: PubMed 31492791Touzet S, Occelli P, Denis A, Cornut PL, Fassier JB, Le Pogam MA, Duclos A, Burillon C. Impact of a comprehensive prevention programme aimed at reducing incivility and verbal violence against healthcare workers in a French ophthalmic emergency department: an interrupted time-series study. BMJ Open. 2019 Sep 5;9(9):e031054. doi: 10.1136/bmjopen-2019-031054.
- Derived from this study: PubMed 24885544Touzet S, Cornut PL, Fassier JB, Le Pogam MA, Burillon C, Duclos A. Impact of a program to prevent incivility towards and assault of healthcare staff in an ophtalmological emergency unit: study protocol for the PREVURGO On/Off trial. BMC Health Serv Res. 2014 May 19;14:221. doi: 10.1186/1472-6963-14-221.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rudeness/Incivility, Aggression or Violence Against Healthcare Workers in an Ophthalmic Emergencies Unit., run by Hospices Civils de Lyon 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 2 inclusion and 0 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 23 Oct 2015. 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?
Proportion of patients (or their attendants) who committed a rudeness/incivility or aggression or violence against healthcare workers. (time frame: Patients will be followed for the duration of the ophthalmic emergency unit stay, an expected average of 2 hours.). 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 NCT02015884, which also lists 2 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 23 Oct 2015.