The Effectiveness of De-escalation in Management of Aggression

NCT05166278 | Completed

• 1 other identifier: IRP-2018/01-09
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 6

Brief Summary

A multicenter, intervention study will be conducted in all psychiatric hospitals in Slovenia. The purpose of the study is to evaluate the effect of verbal and non-verbal de-escalation techniques on the incidence and severity of aggressive behavior and on the incidence and duration of physical restraints. The proposed hypothesis is that de-escalation training and regular use of de-escalation can reduce aggressive incidents and the use of physical restraints in the acute psychiatric ward. In Slovenia, inpatient psychiatric treatment is provided by six psychiatric hospitals. There are two acute psychiatric wards in each hospital, one for male and one for female patients. All hospitals will be invited to participate in the study. The study will be carried out in two phases, a baseline period of five consecutive months and an intervention period of the same five consecutive months in the following year. At the end of the baseline period, hospitals will be randomly assigned to either the experimental or control group. The intervention will include training on verbal and nonverbal de-escalation techniques for staff teams in experimental wards. The first part of the education is based on theoretical backgrounds: aggressive behavior in a psychiatric patient, risk factors, communication, de-escalation. The second part is a practical workshop. The training will be 16-hour duration in total. A short handbook and a list of verbal and non-verbal approaches will be prepared for all staff members involved in the training. For the baseline and intervention phase, data on the number and severity of aggressive incidents, the number and duration of physical restraint episodes, and the number of aggressive or restrained patients will be obtained.

Conditions

Aggression; Physical Restraint; Education

Keywords

aggression; coercion; physical restraint; de-escalation training; intervention; effectiveness

Outcome Measures

Primary Outcomes (2)

• Number of aggressive incidents before and after the intervention.

  Aggressive incidents will be measured using the SOAS-R scale. The number of aggressive incidents for the baseline period will be arranged according to which group the individual hospitals will be allocated to after randomization. The number of aggressive incidents will be calculated per 100 treatment days.

  Data for five months at baseline and for five months during the intervention period.

• Number of physical restraint episodes before and after the intervention.

  Data on restraint episodes will be obtained from the standardized documentation required by the Mental Health Act. The number of restraint episodes for the baseline period will be arranged according to which group the individual hospitals will be allocated to after randomization. The number of restraint episodes will be calculated per 100 treatment days.

  Data for five months at baseline and for five months during the intervention period.

Secondary Outcomes (2)

• Severity of aggressive incidents before and after the intervention.

  Data for five months at baseline and for five months during the intervention period.

• Duration of physical restraints episodes before and after the intervention.

  Data for five months at baseline and for five months during the intervention period.

Other Outcomes (2)

• Proportion of aggressive patients before and after the intervention.

  Data for five months at baseline and for five months during the intervention period.

• Proportion of restraint patients before and after the intervention.

  Data for five months at baseline and for five months during the intervention period.

Study Arms (2)

EXPER

EXPERIMENTAL

Deescalation training.

Behavioral: De-escalation training

CONTR

NO INTERVENTION

Management of aggressive behaviour as usual.

Interventions

De-escalation training BEHAVIORAL

The intervention will include training on verbal and nonverbal de-escalation techniques. The training will be prepared according to the recommendations of the Beta Project of the American Association for Emergency Psychiatry, the World Health Organization Quality Rights training to act, unite and empower for mental health and a handbook for the use of de-escalation skills in a hospital setting by Amdur E. The first part of the education is based on theoretical backgrounds: aggressive behavior in a psychiatric patient, risk factors, focusing on factors that can be modified, communication, de-escalation. The second part is a practical workshop. The training will be 16 hour duration in total. A short handbook and a list of verbal and non-verbal approaches will be prepared for all staff members involved in the training.

Also known as: Education

EXPER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• acute psychiatric ward - all patients, hospitalized during the study

You may not qualify if:

• acute psychogeriatric ward, acute psychiatric ward for adolescent, acute forensic psychiatric ward

Sponsors & Collaborators

• University Medical Centre Maribor: lead

Study Sites (6)

Psychiatric Hospital Begunje

Begunje na Gorenjskem, 4275, Slovenia

Location

Psychiatric Hospital Idrija

Idrija, 5280, Slovenia

Location

University Pychiatric Clinic Ljubljana

Ljubljana, 1260, Slovenia

Location

Department of Psychiatry, University Medical Centre Maribor

Maribor, 2000, Slovenia

Location

Psychiatric Hospital Ormoz

Ormož, 2270, Slovenia

Location

Psychiatric Hospital Vojnik

Vojnik, 3212, Slovenia

Location

Related Publications (1)

• Celofiga A, Kores Plesnicar B, Koprivsek J, Moskon M, Benkovic D, Gregoric Kumperscak H. Effectiveness of De-Escalation in Reducing Aggression and Coercion in Acute Psychiatric Units. A Cluster Randomized Study. Front Psychiatry. 2022 Apr 7;13:856153. doi: 10.3389/fpsyt.2022.856153. eCollection 2022.

  PMID: 35463507 DERIVED

MeSH Terms

Conditions

Aggression

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Andreja Celofiga

  University Medical Centre Maribor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The hospital staff will be unaware of the aim and the design of the study. All psychiatric hospitals will be informed that de-escalation training will be provided within 2 years. Data from the SOAS-R forms and documentation for the use of physical restraint will be transferred to electronic databases by an independent collaborator who is not familiar with the design of the study. The randomization will be performed after the baseline period, so the baseline data could not be biased.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: During the five months of the baseline period, the management of aggressive behavior in all psychiatric hospitals will be the same as usual. Before the five months of the intervention period, hospitals will be randomly assigned to either an experimental or control group in the 1:1 ratio. The staff in the experimental group will receive training in verbal and nonverbal de-escalation techniques, and in the control group, the staff will manage aggressive behavior as usual. Regular annual training on the use of coercive measures will be conducted as usual in all hospitals during the study.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: December 21, 2021
• Study Start: April 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2020
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available on request after data processing and publication of results (expected by the end of 2022).
• Access Criteria: For research purposes.

Locations

SL (6)