Evaluation of the Manifestation of Patient Aggresivity in an Emergency Department

Emergency Room Clinical Trial

— ASAU  

Official title:

Evaluation of the Manifestation of Patient Aggresivity in an Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116439
• Other study ID #: PHRIP/2013/MC-01
• Secondary ID: 1739572 v 0
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: November 30, 2016
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emergencies
• Emergency Room

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of violent events occuring per work period		Baseline to end of period (maximum of 10 hours)	Yes
Secondary	Date		Baseline (hour 0)	No
Secondary	Day of the week		Baseline (hour 0)	No
Secondary	Time at the beginning of the observation period		Baseline (hour 0)	No
Secondary	Number of male nurses present in the department		Baseline to end of observation period (maximum 10 hours)	No
Secondary	Number of female nurses present in the department		Baseline to end of observation period (maximum 10 hours)	No
Secondary	Number of nursing assistants present in the department		Baseline to end of observation period (maximum 10 hours)	No
Secondary	Number of doctors present in the department		Baseline to end of observation period (maximum 10 hours)	No
Secondary	Number of patients present in the department		Baseline (hour 0)	No
Secondary	Number of accompaning persons (bringing in patients) present in the department		Baseline (hour 0)	No
Secondary	Number of accompaning persons (bringing in patients) present in the waiting room		Baseline (hour 0)	No
Secondary	Number of patients present in the department		End of observation period (maximum 10 hours)	No
Secondary	Number of accompaning persons (bringing in patients) present in the department		End of observation period (maximum 10 hours)	No
Secondary	Number of accompaning persons (bringing in patients) present in the waiting room		End of observation period (maximum 10 hours)	No
Secondary	Time of day at the beginning of a staff debriefing during a shift change.		During an observation period (maximum 10 hours)	No
Secondary	Time of day at the end of a staff debriefing during a shift change.		During an observation period (maximum 10 hours)	No
Secondary	Time at the beginning of a violent event	To be recorded for each event for each person manifesting violence.	During an observation period (maximum 10 hours)	No
Secondary	Time at the end of a violent event	To be recorded for each event for each person manifesting violence.	During an observation period (maximum 10 hours)	No
Secondary	Was the event correctly declared according to current procedures? yes/no	To be recorded for each event for each person manifesting violence.	During an observation period (maximum 10 hours)	No
Secondary	Sex (m/f)	To be recorded for each event for each person manifesting violence.	During an observation period (maximum 10 hours)	No
Secondary	Is the person a patient or a person accompanying a patient?	To be recorded for each event for each person manifesting violence.	During an observation period (maximum 10 hours)	No
Secondary	Reason why the patient is coming to the emergency department.	To be recorded for each event for each person manifesting violence.	During an observation period (maximum 10 hours)	No
Secondary	Time (delay) patient has been waiting before manifestation of violence.	To be recorded for each event for each person manifesting violence.	During an observation period (maximum 10 hours)	No
Secondary	Age (years)	To be recorded for each event for each victim of a person manifesting violence.	During an observation period (maximum 10 hours)	No
Secondary	Sex (m/f)	To be recorded for each event for each victim of a person manifesting violence.	During an observation period (maximum 10 hours)	No
Secondary	Years of work experience	To be recorded for each event for each victim of a person manifesting violence.	During an observation period (maximum 10 hours)	No
Secondary	Professional category	To be recorded for each event for each victim of a person manifesting violence.	During an observation period (maximum 10 hours)	No
Secondary	Presence/absence of difference in what was observed and what the victim remembers		72 hours after a violent event	No
Secondary	Violence severity scale	To be recorded for each event for each person manifesting violence.	During an observation period (maximum 10 hours)	No