Condition category
Mental and Behavioural Disorders
Date applied
28/10/2019
Date assigned
02/12/2019
Last edited
02/12/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Coercive measures in psychiatry are discussed controversially. On the one hand, they are a violation of the human rights of people with mental health problems. On the other hand, they are often used as measures of the last resort to restore safety for patients and staff on psychiatric wards. This study aims to find out whether the use of coercive measures on psychiatric wards can be reduced by implementing the German Clinical Practice Guidelines "Avoidance of Coercion-Prevention and Treatment of Aggressive Behavior in Adults" (2018).

Who can participate?
52 psychiatric wards (26 from Southern Germany and 26 from Berlin) selected by the ward’s staff according to their needs and possibilities, supported by an implementation consultant (nurse, psychologist).

What does the study involve?
The participating wards are randomly allocated to either an intervention group or a control group. The intervention group receive the intervention (implementation of clinical practice guidelines) straight away for 12 months. The control group also receive the intervention after 12 months. The level of implementation, number of coercive measures, and the duration of coercive measures are recorded before and after the intervention and are compared between the intervention and control wards.

What are the possible benefits and risks of participating?
Staff on the wards might worry that aggressive incidents become more frequent when restrictive measures are reduced and that they might become victims of assaults. Therefore, the number and severity of aggressive incidents is also measured.

Where is the study run from?
1. Ulm University (Germany)
2. Vivantes Klinikum Am Urban, Clinic for Psychiatry, Psychotherapie und Psychosomatic Charite Berlin (Germany)
3. St. Hedwig Hospital, Psychiatric University Clinic, Charité Berlin (Germany)

When is the study starting and how long is it expected to run for?
January 2019 to January 2023

Who is funding the study?
Innovationsausschuss beim Gemeinsamen Bundesausschuss

Who is the main contact?
Dr Sophie Hirsch
sophie.hirsch@zfp-zentrum.de

Trial website

Contact information

Type

Public

Primary contact

Dr Sophie Hirsch

ORCID ID

http://orcid.org/0000-0002-1012-0853

Contact details

Weingartshofer Strasse 2
Ravensburg-Weissenau
88214
Germany
+49 (0)17684366426
sophie.hirsch@zfp-zentrum.de

Type

Scientific

Additional contact

Dr Sophie Hirsch

ORCID ID

http://orcid.org/0000-0002-1012-0853

Contact details

Weingartshofer Strasse 2
Ravensburg
88214
Germany
+49 (0)17684366426
sophie.hirsch@zfp-zentrum.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IVZ S3

Study information

Scientific title

Implementation of clinical practice guidelines on prevention of coercion in adult's psychiatry in Germany [Implementierung der S3 Leitlinie Verhinderung von Zwang]

Acronym

IVZ S3

Study hypothesis

H1: The number of coercive measures per bed and year can be reduced by the intervention.
H2: The cumulative duration of seclusion and restraint per bed and year can be reduced by the intervention.
H3: Wards with high fidelity to the clinical practice guidelines have less coercive measures and less aggressive incidents.
H4: There is a correlation between the level of implementation in the intervention phase and the reduction of coercive measures.
H5: Various successful strategies can be identified due to the variety of interventions applied on the different participating wards.

Ethics approval

Approved 04/09/2019, ethics committee of Ulm University (Ulm HelmholtzstraBe 20 (Oberer Eselsberg) 89081 Ulm, Germany; Tel: +49 (0)731 500 22050/22052; Email: ethik-kommission@uni-ulm.de), ref: 55/19

Study design

Mixed methods multicentre interventional cluster-randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Psychiatric wards treating patients with severe mental illness, including the option of involuntary treatment

Intervention

Participating wards choose 2-3 interventions from the following list:
1. Implementation of standardised recording of coercive measures and aggressive incidents allowing analysis on a ward level
2. Implementation of internal standards in accordance with the Clinical Practice Guidelines concerning indication, conduct, review, documentation and debriefing of coercive measures or review existing standards.
3. Establish monthly team meetings were the data on coercive measures are discussed together with the ward manager and the head of the department
4. Establish a schedule for staff training in de-escalation techniques and aggression management and make sure that every employee who has contact with patients is trained at least once every two years
5. Ensure that patients who are secluded or restrained receive continuous personal 1:1 support by trained staff
6. Guarantee that after coercive measures debriefings with involved patients are done regularly and that these debriefings are documented properly
7. Employ peers on the wards
8. Install a plan of action to enhance the physical environment to avoid aggression and coercion on the ward and review this plan annually
9. Implementation of risk assessment tools e.g. the Brøset Violence Checklist (BVC) or another instrument in all patients at risk. Ensure that patients with high scorings will get appropriate interventions, e. g. talking down a patient by two staff members
10. Advise the patients who experienced coercive measures to prepare a patient advance directive or offer to develop joint crisis plans together with their treating physicians
11. Realize pharmacotherapy in accordance with current clinical guidelines, evaluate the quality of the pharmacotherapy in regular intervals, e. g. once a month
12. Implementation of Safewards or another complex intervention consisting of different modules (e. g. Weddinger Modell, Six Core Strategies)

52 psychiatric wards (26 from Southern Germany and 26 from Berlin) are recruited to implement some of these interventions, selected by the ward’s staff according to their needs and possibilities, supported by an implementation consultant (nurse, psychologist). The wards are randomised to an intervention and a control group. The control group will also get the intervention after 12 months.

The level of implementation, number of coercive measures, the duration of coercive measures and the number and severity of aggressive incidents are recorded before and after the intervention and are compared between intervention and control wards. In T0 the intervention wards will have their baseline assessment and their 1-day kick-off workshop. The intervention period will last 12 months. The wards will have 2 further half-day-workshops and telephone and email support by experts during this year. In T1 (after 12 months) follow-up assessment will be performed on the intervention wards and baseline assessment will be performed on the waiting list wards. Then the waiting list wards will have the intervention. In T2 (after 24 months) the waiting list wards will have their follow-up measurement. The study contains also a qualitative part. The interviews will start in month 2 on the intervention wards and in month 14 on the waiting list wards.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Number of coercive measures, measured per bed and year in the year before the intervention and in the intervention year. These are routine data available in all the clinics as prescribed by law. Coercive measures are forced medication, physical and mechanical restraint and seclusion.

Secondary outcome measures

1. Level of implementation of the Clinical Practice Guidelines measured using a Likert scale graduated in ten steps (0-9) with standard examples covering the 12 interventions (derived from the guidelines recommendations) that can be implemented by the wards. Change will be measured by a pre-post-comparison calculating the difference between post- and pre-scoring (baseline and after 12 months)
2. Cumulative duration of coercive measures (physical and mechanical restraint and seclusion), measured using routine data in the year before the intervention and in the intervention year
3. Number of aggressive incidents measured using the SOAS-R scale during the year of the intervention. Events with >= 10 points on the SOAS-R scale will be counted as assaults

Overall trial start date

30/01/2019

Overall trial end date

31/01/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Psychiatric wards with the option to realize involuntary treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

52 wards

Participant exclusion criteria

1. Forensic wards
2. Wards for children and adolescents
3. Wards where mainly people with dementia are treated

Recruitment start date

01/02/2020

Recruitment end date

30/04/2020

Locations

Countries of recruitment

Germany

Trial participating centre

Ulm University
ZfP Suedwuerttemberg, CLinic for Psychiatry and Psychotherapie I Weingartshofer Strasse 2
Ravensburg-Weissenau
88214
Germany

Trial participating centre

Vivantes Klinikum Am Urban, Clinic for Psychiatry, Psychotherapie und Psychosomatic Charite Berlin,
Dieffenbachstraße 1
Berlin
10967
Germany

Trial participating centre

St. Hedwig Hospital, Psychiatric University Clinic, Charité Berlin
Große Hamburger Str. 5-11
Berlin
10115
Germany

Sponsor information

Organisation

Ulm University

Sponsor details

ZfP Suedwuerttemberg
Clinic of Psychiatry and Psychotherapy I
Weingartshofer Strasse 2
Ravensburg-Weissenau
88214
Germany
+49 (0)75176012378
tilman.steinert@zfp-zentrum.de

Sponsor type

Hospital/treatment centre

Website

https://www.zfp-web.de

Funders

Funder type

Government

Funder name

Innovationsausschuss beim Gemeinsamen Bundesausschuss

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study design will be published at the end of 2019. In 2023 the quantitative and qualitative analysis will be published.

IPD sharing statement:
The data will be available on request from Dr Sophie Hirsch, sophie.hirsch@zfp-zentrum.de.

Intention to publish date

31/07/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/11/2019: Trial's existence confirmed by ethics committee.