Reduction of coercion and aggression in psychiatry - the aggression, coercion reduction study

ISRCTN ISRCTN17993261
DOI https://doi.org/10.1186/ISRCTN17993261
Secondary identifying numbers Quantitative Part of the Study: Reg-2016-00513; Qualitative Part of the Study: Reg-2017-00846
Submission date
14/12/2017
Registration date
07/03/2018
Last edited
22/08/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Conflicts and aggression incidents occur frequently on psychiatric hospital wards. In general professionals try to calm down the situations with communication methods. As a last resort, coercive measures are applied. Due to legal and ethical reasons coercive measures are used restrictively. Professionals regularly receive training to manage aggression incidents and coercive measures. However, training mostly focuses on situations which are in an advanced state of escalation. Often they aim to enable a clear procedure in the case of overpowering and a controlled approach in the case of coercive measure. The procedures aim to resolve the situation in the least damaging way, both for the patients and for the employees. The Safewards model explains how aggression incidents, violence and coercive measures and their influencing factors are linked. According to the model, professionals should intervene much earlier in the process of escalation, and that a good relationship and communication skills as well as safe atmosphere on psychiatric wards may improve the prevention of aggression and coercive measures. Ten interventions were developed and tested successfully in a big study in psychiatric wards around London. Another effort on this topic was the developed of a scale (the Bern Psychopathology Scale (BPS)) by a research group in Bern. This scale helps to identify illness symptoms of three relevant communication domains (affectivity, language and motor behavior). With this information, professionals can focus their communication on the healthy domain. The idea is to avoid misunderstandings potentially leading to aggressions and violence. However, the effectiveness of this communication approach at reducing aggression and coercion has not been investigated before. Moreover it is unclear whether the Safewards interventions are effective in Swiss psychiatric wards. The aim of this study is to test the Safewards intervention in Swiss psychiatric wards and for the first time, communications training based on the mentioned Bern psychopathology scale.

Who can participate?
Staff and patients in acute psychiatric wards

What does the study involve?
Participating wards are randomly allocated either to the Safewards intervention group or the control group (treatment as usual). Both interventions focus on the training of the professionals. Patients are not actively involved, but they receive potentially better care due to better trained staff. The Safewards intervention includes the training and support of the staff during the implementation of the ten Safewards interventions. These include simple behaviour recommendations and training for the employees on the subject of conflict management, and measures for improving the relationships among patients as well as among the professionals in the normal daily life and when problems arise. All interventions and support measures are described comprehensively on the website www.safewards.com. The scale-based communication training includes training the employees how to assess patients with the BPS Scale as well as assistance and support in the training of communication strategies. The staff of the two control wards receive brief oral and written information on aggression and coercion. The intervention phase lasts 4 to 12 months. The number of aggression events and the use of coercive measures are recorded. Group interviews with patients and staff take place on the intervention wards at the end of the training or intervention in order to gain a better understanding of their experiences.

What are the possible benefits and risks of participating?
Because the interventions are staff-related and the intervention focuses on minimising the risks of aggression incidents and coercive measures, no direct risks are expected. In case of ineffective interventions the usual risks of a psychiatric in-patient treatment can be expected, which are unrelated to the interventions. It is possible that individual patients consider individual interventions like a mutual help meeting (an example of a safewards intervention) as not helpful or that they reject them, as is usual in mental health practice.

Where is the study run from?
University Hospital of Psychiatry and Psychotherapy Berne (Switzerland)

When is the study starting and how long is it expected to run for?
May 2016 to January 2019

Who is funding the study?
University Hospital of Psychiatry and Psychotherapy Berne (Switzerland)

Who is the main contact?
Christian Burr

Contact information

Mr Christian Burr
Public

UPD Bern
Bolligenstrasse 111
Berne 60
3000
Switzerland

Phone +41 (0)31 930 97 12
Email christian.burr@upd.ch
Prof Sebastian Walther
Scientific

UPD Bern
Murtenstrasse 21
Berne 60
CH-3000
Switzerland

Study information

Study designSingle-centre three-armed cluster-controlled intervention study
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA project to deal with and reduce coercion and aggression on acute psychiatric wards
Study acronymACR-Study
Study objectivesOn acute psychiatric wards, where the Safewards intervention or BPS intervention are implemented, the frequency of coercion and aggression events will decrease during and after the implementation phase in comparison to the control group
Ethics approval(s)Ethics Board of the canton of Berne (Switzerland, swissethics), 16/09/2016, Quantitative Part of the Study: Reg-2016-00513; Qualitative Part of the Study: Reg-2017-00846
Health condition(s) or problem(s) studiedCoercion and aggression on acute psychiatric wards
InterventionStratified cluster randomisation was used. The six recruited wards were divided up in two as equal as possible groups regarding the length of average stay, frequency of involuntary admissions and number of seclusion rooms. Then from each group there was a concealed allocation to the following three groups:

1st Intervention: Training and supporting the staff to implement the 10 Safewards interventions. These include simple behavioural tips and training for staff on the topic of de-escalation and conflict management, activities to improve the relationship between patients and staff in everyday life and in problem situations like: weekly support conferences, systematic supportive conversations before or after negative events, as well as hopeful actions regarding the current, but also future situation of the patients, for example with the hopeful discharge messages from patients leaving the ward. All interventions are comprehensively described on the website www.safewards.com.

2nd Intervention: Training and supporting of staff implementing of the communication strategies based and focused on the domains of the Bern Psychopathology Scale (BPS). The BPS is a clinical rating scale developed to group psychotic symptoms in the domains of language, affectivity and motor behavior. These domains are of particular interest for understanding the fundamental communication breakdown during psychotic disorders, since they can be linked to known, higher order brain systems, i.e. the language, the limbic and the motor system. The intervention gives a training to recognize the well-functioning domain and to focus the communications skills on this domain.

Control: Short verbal and written information on the topic of coercion and aggression as well as attaching pictures to aims and intervention of the project at the corresponding wards.

Follow-up measures are planned for all arms 6 months after finishing the implementation of the interventions.
Intervention typeBehavioural
Primary outcome measureFreedom restrictive interventions, measured using the electronic patient record at baseline (15/12/2016-15/04/2017), T1 (01/09/2017-30/12/2017), T2 (01/04/2018-30/07/2018), follow-up (01/01/2019-30/04/2019)
Secondary outcome measures1. Aggressive events, measured using the EVA Form (part of the electronic patient record) at baseline (15/12/2016-15/04/2017), T1 (01/09/2017-30/12/2017), T2 (01/04/2018-30/07/2018), follow-up (01/01/2019-30/04/2019)
2. The percentage of hours/days during which the doors of the wards were open, at baseline (15/12/2016-15/04/2017), T1 (01/09/2017-30/12/2017), T2 (01/04/2018-30/07/2018), follow-up (01/01/2019-30/04/2019)
3. Perspectives of staff and patients related to the experience on the intervention wards, evaluated in focus group interviews at the end of the intervention phase (01/06/2018-01/08/2018)
Overall study start date01/05/2016
Completion date01/01/2019

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participants6 wards with approximately 120 staff and 2200 patients
Key inclusion criteria1. Acute psychiatric ward with admission obligation
2. The positions of the senior physician and the nursing ward manager are filled
3. Adequate data quality from the outcome parameters to be collected during the last 6 months
Key exclusion criteria1. Wards with specialized therapeutic regimen where patients are admitted only with special indication
2. Day clinics
Date of first enrolment01/11/2016
Date of final enrolment30/11/2016

Locations

Countries of recruitment

  • Switzerland

Study participating centre

University Hospital for Psychiatry and Psychotherapy
Bolligenstrasse 111
Berne 60
CH-3000
Switzerland

Sponsor information

University Berne Psychiatric Services Inc
Hospital/treatment centre

University Hospital of Psychiatry and Psychotherapy
Bolligenstrasse 111
Berne
CH-3000
Switzerland

Phone +41 (0)31 930 91 11
Email info@upd.ch
Website www.upd.ch
ROR logo "ROR" https://ror.org/02k7v4d05

Funders

Funder type

Hospital/treatment centre

University Berne Psychiatric Services Inc. University Hospital of Psychiatry and Psychotherapy

No information available

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planAll documents and study information can be requested from Christian Burr. Planned publication in a high-impact peer reviewed journal around end of 2019.
IPD sharing planBecause the trialists have data from the medical record, they are not allowed to make the original data available. The anonymized data can be provided as an Excel or SPSS file. For this please contact Christian Burr. The data is stored securely in the Unit for R&D in Nursing of the University Hospital for Psychiatry and Psychotherapy in Berne (CH).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 22/08/2022 No No

Additional files

ISRCTN17993261_PROTOCOL.pdf

Editorial Notes

22/08/2022: Protocol file uploaded.