- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02116439
Evaluation of the Manifestation of Patient Aggresivity in an Emergency Department (ASAU)
Study Overview
Status
Conditions
Detailed Description
This observational study will take place via a representative sample of 90 observation periods. One observation period consists of 7.5 consecutive hours between two team rotations during the day and 10 consecutive hours at night. These observational periods include the moment when health-care teams are debriefed during a shift-change, which we suspect to be a sensitive time point.
Observation periods are randomly selected over a period of 1 year, and stratified for time of day (morning, afternoon, evening), day of the week and month.
The secondary objectives of the observation phase are to identify factors associated with the average number of violent events per work period (number of patients attending the emergency department, time of staff debriefing during shift change, time of day, week or weekend, individual patient characteristics (gender, age, patient or accompanying a patient, waiting time from arrival in the emergency room to emergency consultation, reason for consultation), characteristics of victims of violence, characteristics of the health care team ...)
The anticipated total number of violent events is unknown at the beginning of the study; we indicated '50' as a guess.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nîmes Cedex 09, France, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Persons manifesting violence according to a pre-determined list of watched-for events will be observed
- The victims of the above-mentioned violence will also be observed and interviewed
Exclusion Criteria:
- Persons not manifesting violence according to a pre-determined list of watched-for events
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Violent events
People in this group were observed to manifest violence.
|
Victims
People in this group are the victims of the other group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of violent events occuring per work period
Time Frame: Baseline to end of period (maximum of 10 hours)
|
Baseline to end of period (maximum of 10 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Date
Time Frame: Baseline (hour 0)
|
Baseline (hour 0)
|
|
Day of the week
Time Frame: Baseline (hour 0)
|
Baseline (hour 0)
|
|
Time at the beginning of the observation period
Time Frame: Baseline (hour 0)
|
Baseline (hour 0)
|
|
Number of male nurses present in the department
Time Frame: Baseline to end of observation period (maximum 10 hours)
|
Baseline to end of observation period (maximum 10 hours)
|
|
Number of female nurses present in the department
Time Frame: Baseline to end of observation period (maximum 10 hours)
|
Baseline to end of observation period (maximum 10 hours)
|
|
Number of nursing assistants present in the department
Time Frame: Baseline to end of observation period (maximum 10 hours)
|
Baseline to end of observation period (maximum 10 hours)
|
|
Number of doctors present in the department
Time Frame: Baseline to end of observation period (maximum 10 hours)
|
Baseline to end of observation period (maximum 10 hours)
|
|
Number of patients present in the department
Time Frame: Baseline (hour 0)
|
Baseline (hour 0)
|
|
Number of accompaning persons (bringing in patients) present in the department
Time Frame: Baseline (hour 0)
|
Baseline (hour 0)
|
|
Number of accompaning persons (bringing in patients) present in the waiting room
Time Frame: Baseline (hour 0)
|
Baseline (hour 0)
|
|
Number of patients present in the department
Time Frame: End of observation period (maximum 10 hours)
|
End of observation period (maximum 10 hours)
|
|
Number of accompaning persons (bringing in patients) present in the department
Time Frame: End of observation period (maximum 10 hours)
|
End of observation period (maximum 10 hours)
|
|
Number of accompaning persons (bringing in patients) present in the waiting room
Time Frame: End of observation period (maximum 10 hours)
|
End of observation period (maximum 10 hours)
|
|
Time of day at the beginning of a staff debriefing during a shift change.
Time Frame: During an observation period (maximum 10 hours)
|
During an observation period (maximum 10 hours)
|
|
Time of day at the end of a staff debriefing during a shift change.
Time Frame: During an observation period (maximum 10 hours)
|
During an observation period (maximum 10 hours)
|
|
Time at the beginning of a violent event
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Time at the end of a violent event
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Was the event correctly declared according to current procedures? yes/no
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Sex (m/f)
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Is the person a patient or a person accompanying a patient?
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Reason why the patient is coming to the emergency department.
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Time (delay) patient has been waiting before manifestation of violence.
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Age (years)
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each victim of a person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Sex (m/f)
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each victim of a person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Years of work experience
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each victim of a person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Professional category
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each victim of a person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Presence/absence of difference in what was observed and what the victim remembers
Time Frame: 72 hours after a violent event
|
72 hours after a violent event
|
|
Violence severity scale
Time Frame: During an observation period (maximum 10 hours)
|
To be recorded for each event for each person manifesting violence.
|
During an observation period (maximum 10 hours)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Muriel Chazel, CHRU de Nîmes - Hôpital Universitaire Carémeau
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRIP/2013/MC-01
- 1739572 v 0 (Other Identifier: CNIL number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emergency Room
-
Albany Medical CollegeCompletedNon-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room VisitUnited States
-
University of PennsylvaniaCompletedUnderstanding Emergency Room ProceduresUnited States
-
University of PennsylvaniaOscar Health InsuranceWithdrawnEmergency Room Utilization
-
Duke UniversityEnrolling by invitationEmergency Department Waiting Room CongestionUnited States
-
Lille Catholic UniversityCompletedAging | Risk Factors | Emergency RoomFrance
-
University of Wisconsin, MadisonPatient-Centered Outcomes Research Institute; Community Place; Jewish Family... and other collaboratorsCompletedHospitalization | Emergency Room | Wellness ProgramsUnited States
-
University of New MexicoSociety of Family PlanningCompleted
-
Ziv HospitalCompletedParental Satisfaction of Using Video Otoscopy in Pediatric Emergency Room
-
University Hospital, CaenCompleted
-
Region SkaneUnknownSepsis | Critical IllnessSweden, Canada, Switzerland