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
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