Violent Aggressive BehaviorMEDIANCT03139110
Impact of a Mediator for Patient Intake in Emergency Departments
An observational study of Violent Aggressive Behavior and Mediation, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
Violence in the workplace is becoming a serious phenomenon in the contemporary world of work. Hospital staff, like any employee working in contact with the public, is particularly exposed to this violence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Violent Aggressive Behavior, Mediation
- What is being tested?
- Presence of a mediator in the emergency departments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,378 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Nov 2017to 1 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population participating in the study is composed of: * patients admitted to the emergency department, * persons accompanying patients, * professionals of the emergency departments (nurses, MD, administrative staff).
Who may be able to join
- Patient aged 18 years or older.
- Registered at the reception of the emergency department between 8 am and 8 pm, excluding bank holidays.
Who cannot join
- Patient with psychiatric disorders or impairment of judgment related to the taking of toxic substances.
- Patients requiring medical care in less than 30 minutes (sort code).
Trial locations and contacts
4 sites in 1 country.
France4 sites
Pôle Information Médicale, Evaluation, Recherche - Hospices Civils de Lyon
Lyon, 69003
Service d'urgences médicales et chirurgicales - Hôpital Edouard Herriot - HCL
Lyon, 69003
Service médical d'accueil des urgences - Hôpital de la Croix Rousse - HCL
Lyon, 69004
Service d'accueil des urgences - Centre hospitalier Lyon Sud - HCL
Pierre-Bénite
About this study
Official title: Welcoming Patients in Emergency Departments: Impact of the Mediator
Violence in the workplace is becoming a serious phenomenon in the contemporary world of work. Hospital staff, like any employee working in contact with the public, is particularly exposed to this violence. In emergency departments, the number of patients treated and their heterogeneity, the problems of communicating with healthcare professionals, and waiting times, favor conflict situations. In the already tense context of the emergencies, the incivilities or violent acts have an impact on the well-being of professionals. In order to prevent these situations of violence, a solution could be to integrate a professional with specific skills into the teams to perform mediation functions between caregivers and patients.
The aim of the study is to evaluate the impact of the presence of a mediator in emergency services on personal (verbal or physical) attacks on professionals (caregivers, doctors, administrative staff).
- Conditions
- Violent Aggressive Behavior, Mediation
- Being tested
- Presence of a mediator in the emergency departments
- Medical subject headings
- Aggression, Negotiating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of a mediator in the emergency departmentsBehavioural
The mediator tasks are :
- Be available to patients who can solicit him and respond to their requests for information, in particular on the organization of the emergency departments and on waiting times
- Have a proactive attitude towards patients showing nervousness signs
- Report patients expressing the will to leave the emergency departments before medical care
- Manage conflicts between patients / accompanying persons and emergency staff and also between patients.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients treated in emergency departments without the presence of a mediator. | |
| Mediation | Patients treated in emergency departments with the presence of a mediator. Receives: Behavioral: Presence of a mediator in the emergency departments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of violence or aggression by patients directed towards emergency staff
The violence or aggression will be collected by professionals of the emergency department. They will be classified in 4 levels of gravity.
Measured: During the patient stay in the emergency department, an average of 3 hours, up to 8 hours.
Incidence of violence or aggression by patients's accompanying persons directed towards emergency staff
The violence or aggression will be collected by professionals of the emergency department. They will be classified in 4 levels of gravity.
Measured: During the patient stay in the emergency department, an average of 3 hours, up to 8 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start15 Nov 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
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 Violent Aggressive BehaviorStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,378 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
- NCT03139110
- Sponsor's protocol ID
- 69HCL17_0038
- Acronym
- MEDIA
- Status last verified
- Dec 2019
- First submitted
- 28 Apr 2017
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Touzet S, Buchet-Poyau K, Denis A, Occelli P, Jacquin L, Potinet V, Sigal A, Delaroche-Gaudin M, Fayard-Gonon F, Tazarourte K, Douplat M. Impact of the presence of a mediator on patient violent or uncivil behaviours in emergency departments: a cluster randomised crossover trial. Eur J Emerg Med. 2024 Jun 1;31(3):201-207. doi: 10.1097/MEJ.0000000000001121. Epub 2024 Feb 7.
PubMed 38329117Charrier P, Occelli P, Buchet-Poyau K, Douplat M, Delaroche-Gaudin M, Fayard-Gonon F, Jacquin L, Potinet V, Sigal A, Tazarourte K, Touzet S. Strategies used by emergency care professionals to handle interpersonal difficulties with patients: a qualitative study. BMJ Open. 2021 Feb 8;11(2):e042362. doi: 10.1136/bmjopen-2020-042362.
PubMed 33558353
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Welcoming Patients in Emergency Departments: Impact of the Mediator
- ClinicalTrials.gov ID
- NCT03139110
- Acronym / sponsor ID
- MEDIA / 69HCL17_0038
- Conditions
- Violent Aggressive Behavior, Mediation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,378 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 3 May 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.
Violence in the workplace is becoming a serious phenomenon in the contemporary world of work. Hospital staff, like any employee working in contact with the public, is particularly exposed to this violence. In emergency departments, the number of patients treated and their heterogeneity, the problems of communicating with healthcare professionals, and waiting times, favor conflict situations. In the already tense context of the emergencies, the incivilities or violent acts have an impact on the well-being of professionals. In order to prevent these situations of violence, a solution could be to integrate a professional with specific skills into the teams to perform mediation functions between caregivers and patients.
The aim of the study is to evaluate the impact of the presence of a mediator in emergency services on personal (verbal or physical) attacks on professionals (caregivers, doctors, administrative staff).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients treated in emergency departments without the presence of a mediator. |
| Mediation | – | Behavioral: Presence of a mediator in the emergency departmentsPatients treated in emergency departments with the presence of a mediator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population participating in the study is composed of: * patients admitted to the emergency department, * persons accompanying patients, * professionals of the emergency departments (nurses, MD, administrative staff).
Key inclusion criteria (2 listed)
- Patient aged 18 years or older.
- Registered at the reception of the emergency department between 8 am and 8 pm, excluding bank holidays.
Key exclusion criteria (2 listed)
- Patient with psychiatric disorders or impairment of judgment related to the taking of toxic substances.
- Patients requiring medical care in less than 30 minutes (sort code).
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 |
|---|---|---|
| Presence of a mediator in the emergency departmentsThe mediator tasks are : * Be available to patients who can solicit him and respond to their requests for information, in particular on the organization of the emergency departments and on waiting times * Have a proactive attitude towards patients showing nervousness signs * Report patients expressing the will to leave the emergency departments before medical care * Manage conflicts between patients / accompanying persons and emergency staff and also between patients. | Behavioural | Mediation |
Primary outcome
Incidence of violence or aggression by patients directed towards emergency staff
Time frame: During the patient stay in the emergency department, an average of 3 hours, up to 8 hours.
The violence or aggression will be collected by professionals of the emergency department. They will be classified in 4 levels of gravity.
Incidence of violence or aggression by patients's accompanying persons directed towards emergency staff
Time frame: During the patient stay in the emergency department, an average of 3 hours, up to 8 hours.
The violence or aggression will be collected by professionals of the emergency department. They will be classified in 4 levels of gravity.
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 16 Dec 2019.
- Derived from this study: PubMed 38329117Touzet S, Buchet-Poyau K, Denis A, Occelli P, Jacquin L, Potinet V, Sigal A, Delaroche-Gaudin M, Fayard-Gonon F, Tazarourte K, Douplat M. Impact of the presence of a mediator on patient violent or uncivil behaviours in emergency departments: a cluster randomised crossover trial. Eur J Emerg Med. 2024 Jun 1;31(3):201-207. doi: 10.1097/MEJ.0000000000001121. Epub 2024 Feb 7.
- Derived from this study: PubMed 33558353Charrier P, Occelli P, Buchet-Poyau K, Douplat M, Delaroche-Gaudin M, Fayard-Gonon F, Jacquin L, Potinet V, Sigal A, Tazarourte K, Touzet S. Strategies used by emergency care professionals to handle interpersonal difficulties with patients: a qualitative study. BMJ Open. 2021 Feb 8;11(2):e042362. doi: 10.1136/bmjopen-2020-042362.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Violent Aggressive Behavior and Mediation, run by Hospices Civils de Lyon at 4 sites 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 2 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Incidence of violence or aggression by patients directed towards emergency staff (time frame: During the patient stay in the emergency department, an average of 3 hours, up to 8 hours.). The study lists 2 primary outcomes in all. 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 NCT03139110, 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 16 Dec 2019.