Reducing force in mental health care with the help of guidelines
| ISRCTN | ISRCTN71467851 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71467851 |
| Secondary identifying numbers | IVZ S3 |
- Submission date
- 28/10/2019
- Registration date
- 02/12/2019
- Last edited
- 17/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Public
Weingartshofer Strasse 2
Ravensburg-Weissenau
88214
Germany
 ORCID ID |
0000-0002-1012-0853 |
|---|---|
| Phone | +49 (0)17684366426 |
| sophie.hirsch@zfp-zentrum.de |
Scientific
Weingartshofer Strasse 2
Ravensburg
88214
Germany
| ORCID ID |
0000-0002-1012-0853 |
|---|---|
| Phone | +49 (0)17684366426 |
| sophie.hirsch@zfp-zentrum.de |
Study information
| Study design | Multicenter randomized matched-pair waiting list control trial (RCT) with complementary qualitative interviews |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | 37367 PIS 1 page 31Aug2019.pdf |
| Scientific title | Implementation of the German Clinical Practice Guidelines on Prevention of Coercion and Violence (PreVCo) in psychiatry: a 2-year multicenter randomized matched-pair waiting list control trial (RCT) with complementary qualitative interviews |
| Study acronym | PreVCo |
| Study objectives | Current study hypothesis as of 06/04/2023: H1: The number of coercive measures per bed and year can be reduced by the intervention. H1a: The guideline adherence can be enhanced 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. Previous 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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. Added 06/04/2023: Due to the COVID-19 pandemic some wards were closed for several months and could not provide data at 12 months. Therefore the researchers decided to analyse the last 3 months provided by every ward. The intention to analyse all months (9-12 months were available) was also followed and used as a sensitive analysis. |
| Secondary outcome measures | Current secondary outcome measures as of 17/01/2023: 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 patient records during the year of the intervention _____ Previous 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 study start date | 30/01/2019 |
| Completion date | 31/01/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 52 wards |
| Total final enrolment | 55 |
| Key inclusion criteria | Psychiatric wards with the option to realize involuntary treatment |
| Key exclusion criteria | 1. Forensic wards 2. Wards for children and adolescents 3. Wards where mainly people with dementia are treated |
| Date of first enrolment | 01/02/2020 |
| Date of final enrolment | 29/07/2020 |
Locations
Countries of recruitment
- Germany
Study participating centres
Weingartshofer Strasse 2
Ravensburg-Weissenau
88214
Germany
Berlin
10967
Germany
Berlin
10115
Germany
Sponsor information
Hospital/treatment centre
ZfP Suedwuerttemberg, Clinic of Psychiatry and Psychotherapy I
Weingartshofer Strasse 2
Ravensburg-Weissenau
88214
Germany
| Phone | +49 (0)75176012378 |
|---|---|
| tilman.steinert@zfp-zentrum.de | |
| Website | https://www.zfp-web.de |
"ROR" |
https://ror.org/032000t02 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Current publication and dissemination plan as of 17/01/2023: The study design was published in 2020, the pilot study was published in 2022. In 2023 the quantitative and qualitative analysis will be published. Previous 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 plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/09/2020 | 27/10/2020 | Yes | No |
| Interim results article | Pilot study results | 01/05/2022 | 17/01/2023 | Yes | No |
| Participant information sheet | Brief PIS. In German. | 31/08/2019 | 17/01/2023 | No | Yes |
| Participant information sheet | In German | 17/01/2023 | No | Yes | |
| Interim results article | baseline survey data | 11/05/2023 | 31/05/2023 | Yes | No |
| Dataset | 22/11/2023 | 16/01/2024 | No | No | |
| Results article | 01/12/2023 | 16/01/2024 | Yes | No | |
| Other publications | Barriers and facilitators | 14/02/2025 | 17/02/2025 | Yes | No |
Additional files
- 37367 PIS.pdf
- In German
- 37367 PIS 1 page 31Aug2019.pdf
- Brief PIS. In German.
Editorial Notes
17/02/2025: Publication reference added.
16/01/2024: The following changes were made to the trial record:
1. Publication reference added.
2. A link to the dataset was added.
3. The participant level data sharing statement was added.
31/05/2023: Publication reference added.
06/04/2023: The study hypothesis and primary outcome measure were updated.
21/03/2023: The study design was changed from 'Mixed methods multicentre interventional cluster-randomised trial' to 'Multicenter randomized matched-pair waiting list control trial (RCT) with complementary qualitative interviews'.
17/01/2023: The following changes were made to the trial record:
1. The participant information sheets were uploaded as additional files.
2. Publication reference added.
3. The trial website was added.
4. The total final enrolment was added.
5. The recruitment end date was changed from 30/04/2020 to 29/07/2020.
6. The publication and dissemination plan was changed.
7. The secondary outcome measures were changed.
27/10/2020: Publication reference added.
27/04/2020: The following changes have been made:
1. The scientific title has been changed from "Implementation of clinical practice guidelines on prevention of coercion in adult's psychiatry in Germany [Implementierung der S3 Leitlinie Verhinderung von Zwang]" to "Implementation of the German Clinical Practice Guidelines on Prevention of Coercion and Violence (PreVCo) in psychiatry: a 2-year multicenter randomized matched-pair waiting list control trial (RCT) with complementary qualitative interviews".
2. The acronym has been changed from "IVZ S3" to "PreVCo".
3. The secondary study design from "Cluster randomised trial" to "Randomised controlled trial".
4. The participant type has been changed from "Patient" to "Other".
12/11/2019: Trial's existence confirmed by ethics committee.
