Reducing force in mental health care with the help of guidelines

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71467851

Enrollment

Registered

2019-12-02

Start date

2020-02-01

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychiatric wards treating patients with severe mental illness, including the option of involuntary treatment Mental and Behavioural Disorders

Interventions

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. Imp

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Psychiatric wards with the option to realize involuntary treatment

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactSophie Hirsch

sophie.hirsch@zfp-zentrum.de+49 (0)17684366426

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026