Evaluation of the Manifestation of Patient Aggresivity in an Emergency Department (ASAU)

November 30, 2016 updated by: Centre Hospitalier Universitaire de Nīmes
The main objective of this study is to determine the average total number of violent events per observation period occurring in the emergency department at the Nîmes University Hospital. The list of violent events is pre-determined and based on a series of interviews with emergency department staff.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nîmes Cedex 09, France, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Persons manifesting violence (and their victims) according to a pre-determined list of watched-for events will be observed.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Muriel Chazel, CHRU de Nîmes - Hôpital Universitaire Carémeau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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