Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05166278 |
| Other study ID # |
IRP-2018/01-09 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2018 |
| Est. completion date |
August 31, 2020 |
Study information
| Verified date |
December 2021 |
| Source |
University Medical Centre Maribor |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Aggression is a serious problem in acute psychiatric settings, often followed using physical
restraints. Guidelines for the management of aggressive behavior recommend the use of
de-escalation techniques as the first choice but evidence of their effectiveness is still
limited. Aggression management studies often involve several organizational and structural
interventions in the ward environment, staff, and patient management, which can be expensive
and time consuming. Two Cochrane reviews (Du M et al. 2017, Spencer S et al. 2018) revealed a
lack of relevant studies on the effectiveness of de-escalation techniques in managing
aggression. The method of measuring the impact of de-escalation is often assessing the
frequency of coercive measures, especially physical restraints. A significant proportion of
physical restraints are not a consequence of aggression, so it is important to monitor
aggressive incidents and physical restraints according to the reason for the application.
This research will be carried out within the National project of Slovenian Psychiatric
Association, aimed to reducing aggressive behavior and the use of coercive measures in acute
psychiatric units. Following visits by the CPT's (European Committee for the Prevention of
Torture and Inhuman or Degrading Treatment or Punishment) to Slovenian psychiatric hospitals
with recommendations for greater emphasis on the use of de-escalation before the introduction
of coercive measures, a decision was made to prepare de-escalation training for all
psychiatric hospitals. During this project, we will conduct the research to evaluate the
effectiveness of de-escalation on the incidence and severity of aggressive behavior and on
the incidence and duration of physical restraints due to aggression and other reasons.
A multicenter, cluster randomized controlled trial will be performed in all six psychiatric
hospitals in Slovenia and will include twelve acute psychiatric wards. The trial will be
prepared in accordance with the Consort guidelines.
The aims of the study are:
- To evaluate the effectiveness of verbal and non-verbal de-escalation techniques on the
aggression incidence and severity.
- To evaluate the effectiveness of verbal and non-verbal de-escalation techniques on the
incidence and duration of physical restraints.
Prior to the study, an information letter describing the study with a request to participate
in the study will be sent to the professional managers in all psychiatric hospitals.
In Slovenia, six psychiatric hospitals provide inpatient psychiatric treatment. There are two
acute psychiatric wards in each hospital, one for male and one for female patients.
Subspecialized psychiatric wards, as the psychogeriatric ward, the acute psychiatric ward for
adolescent and the acute forensic psychiatric ward will not be included.
We anticipate that approximately 6,000 subjects will be hospitalized in all twelve wards
during the study.
The study will be conducted in two phases, a baseline period of five consecutive months and
an intervention period during the same five consecutive months in the following year.
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. Randomization will be performed at the level of hospitals, not wards, to avoid
possible transmission of the effect of the intervention among psychiatric hospital staff. 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.
The randomization will be performed after the baseline period, so the baseline data could not
be biased. The hospital staff will be unaware of the aim and the design of the study.
Psychiatric hospital managers will be informed that de-escalation training in all hospitals
will be provided within 2 years.
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.
Data on aggressive incidents and the use of restraints will be obtained in the baseline and
intervention phase. Aggressive incidents and severity will be measured using the Staff
Observation Aggression Scale (SOAS-R). Data on physical restraints will be obtained from the
standardized documentation required by the Mental Health Act, where the reason for the
introduction is described (aggressive behavior, other reasons). Sociodemographic and clinical
data of patients and data on bed capacities and the number of nursing staff will be
summarized at the end of each study period from the hospital documentation and from medical
records.
Data will be collected each month in all psychiatric hospitals. One of the staff members will
be assigned to regularly remind the staff and to monitor the recording of incidents in each
hospital. Data from SOAS-R forms and documentation for the use of physical restraint will be
transferred to electronic databases by independent collaborators who are not familiar with
the design of the study. All data will be anonymized The principal investigator and other
researchers will regularly assess the compliance of the data collection with the protocol and
verify the accuracy in relation to the source documents.
Protecting the benefits of the comparison group:
After the intervention period of the research, staff from the acute wards of psychiatric
hospitals from the control group will receive de-escalation training.
Reasons for participant withdrawal from study:
Hospitals included in the study will be able to withdraw from the study at any time upon
request.
Premature termination of study:
This study may be terminated prematurely if there is sufficient reasonable cause
(insufficient compliance with protocol requirements and insufficiently complete data).
Written notification, documenting the reason for study suspension, will be provided by the
suspending party to investigator, funding agency and National Medical Ethics Committee.
Assessment of safety:
The principal investigator and collaborators from the psychiatric hospitals involved in the
study will closely monitor the progress of the study to ensure the protection of human
rights, the study to be conducted in accordance with the protocol and the quality and
integrity of the study.
Ethics:
The study will be conducted in accordance with the principles of the World Medical
Association Declaration of Helsinki, the Convention for the Protection of Human Rights and
Dignity of the Human Being regarding the Application of Biology and Medicine and the
Convention on Human Rights and Biomedicine. The study was approved from the National Medical
Ethics Committee, Ministry of Health, Republic of Slovenia (0120-74/2018/).
Statistical analysis plan:
Primary outcomes: The incidence of aggressive events and restraint episodes will be presented
as incident rates per 100 treatment days, with a 95% confidence interval. The incidence rate
ratio (IRR) for an aggressive incident and physical restraint episodes between the
experimental and control groups will be calculated for the baseline and intervention periods,
then the change in IRR between the baseline and intervention period will be calculated. The
difference in the incidence of aggression and restraints between the experimental and control
groups will be tested using the Wald z-test. The effect of the intervention on the number of
aggressive incidents and episodes of restraints, controlling for potential confounding
patient characteristics will be examined using regression analyses.
Secondary outcomes: The severity of incidents will be measured using the SOAS-R scoring
system, ranging from 0 to 22 points. The severity of aggressive incidents is defined
categorically as the presence or the absence of a severe aggressive incident and numerically
with the number of SOAS-R points. Incidents with a severity of nine or more points on the
SOAS-R score will be regarded as severe incidents, as recommended by the authors of the
SOAS-R (personal communication) and used in most research in recent years. The severity of
aggressive incidents will be presented as the mean value of SOAS-R points, median and
interquartile range. The difference in the severity of incidents between groups in each phase
of the study will be calculated using the t-test or the Mann-Whitney U test. Differences in
the duration of restraint episodes between the experimental and control groups will be
presented by comparing the sum of restraint hours with the sum of treatment hours for all
patients in each group and the study period. Then the risk ratios for the restraint hour
between the experimental and control groups will be calculated for each study period.
The proportion of patients with at least one incident and then the risk ratio (RR) of
aggression and restraints with 95% confidence interval in patients between the experimental
and control groups will be calculated for the baseline and intervention period.
The characteristics of aggressive patients will be analyzed using descriptive statistical
methods. For statistical analysis the IBM Statistical Package for the Social Sciences,
version 25 and the Software environment for data analysis R will be used. The significance
level of all statistical tests is determined at p < 0.05, two-sided.
