Clinical trial NCT03512925: Effects of a Standardized Post-coercion Review Session.
Official title: Effects of a Standardized Post-coercion Review Session on Objective and Perceived Coercion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coercive Measures
Keywords: Coercion
Post-coercion review
Mental health
Seclusion
Mechanical restraint
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Health, Germany
First posted: 2018-05-01
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants are randomly assigned either to the intervention arm (standardized post-coercion review session session) or to the Treatment-as-usual (TAU) arm.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The present study aims at exploring the impact of a standardized post-coercion review session of coercive measures that took place in the psychiatric inpatient setting in reducing the use of coercive measures and the subjective perception of coercion. It is well known that coercive measures have a major negative impact on the health, well-being and the course of treatment of patients suffering from mental health issues. Many interventions have been implemented in the last years to reduce the use of coercion and limit its consequences.

The investigators developed a standardized post-coercion review intervention. This session takes place as soon as possible after the concerned coercive measure and is moderated by a member of staff who has not been involved in the use of coercion. Other persons involved are the patient, a staff member who took the decision leading to the use of the coercive measure, and a one of the patient's relatives.

Hypothesis is that the use of this standardized intervention can reduce the use of subsequent coercive measures and level of perceived coercion, prevent the development of post-traumatic symptoms, help preserving a trustful therapeutic relationship and positively change the attitude of staff regarding the use of coercion. This intervention has been proven to be well accepted by patients and staff members in a previous pilot study.

The present study is designed as a randomised-controlled study investigating the effect of post-coercion review.

Detailed description: The present study aims at exploring the impact of a standardized post-coercion review session of coercive measures that took place in the psychiatric inpatient setting in reducing the use of coercive measures and the subjective perception of coercion. It is well known that coercive measures have a major negative impact on the health, well-being and the course of treatment of patients suffering from mental health issues. Many interventions have been implemented in the last years to reduce the use of coercion and limit its consequences.

The investigators developed a standardized post-coercion review intervention. This session takes place as soon as possible after the concerned coercive measure and is moderated by a member of staff who has not been involved in the use of coercion. Other persons involved are the patient, a staff member who took the decision leading to the use of the coercive measure, and a one of the patient's relatives. The guidelines define important themes and questions that should be addressed during the review session. These guidelines have been developed with the help of psychiatrists, nurses and a peer worker.

Hypothesis is that the use of this standardized intervention can reduce the use of subsequent coercive measures and level of perceived coercion, prevent the development of post-traumatic symptoms, help preserving a trustful therapeutic relationship and positively change the attitude of staff regarding the use of coercion. This intervention has been proven to be well accepted by patients and staff members in a previous pilot study. The methods combine quantitative and qualitative evaluations.

The present study is designed as a randomised-controlled study investigating the effect of post-coercion review.

Eligibility criteria: Inclusion Criteria:

* Inpatient
* Subject to coercive measure (seclusion, restraint, forced medication)
* Diagnosis of a psychotic disorder (ICD-10: F1x.5, F2x, F31.x).
* Written and informed consent.

Exclusion Criteria:

* Inability to provide informed consent
* Hospital stay \< 24h

Primary outcomes:
measure: Objective coercive measures
timeFrame: At the time of discharge from the hospital by every included patient, up to 6 months
Secondary outcomes:
measure: Subjective experience of coercion (1)
timeFrame: At the time of discharge from the hospital by every included patient, up to 6 months
measure: Subjective experience of coercion (2)
timeFrame: At the time of discharge from the hospital by every included patient, up to 6 months
measure: Subjective experience of coercion (3)
timeFrame: At the time of discharge from the hospital by every included patient, up to 6 months
measure: Quality of the therapeutic relationship
timeFrame: At the time of discharge from the hospital by every included patient, up to 6 months
measure: Post-traumatic symptoms (1)
timeFrame: At the time of discharge from the hospital by every included patient, up to 6 months
measure: Post-traumatic symptoms (2)
timeFrame: At the time of discharge from the hospital by every included patient, up to 6 months
Other outcomes:
Locations:
city: Berlin-Mitte
country: Germany
facility: Psychiatrische Universitätsklink der Charité - SHK
state: Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban
city: Berlin
country: Germany
facility: Vivantes Wenckebach-Klinikum
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Berlin
country: Germany
facility: Alexianer Krankenhaus Hedwigshöhe
city: Berlin
country: Germany
facility: St. Joseph Krankenhaus Weißensee
Study officials:
affiliation: Charité
name: PD Dr. med. Montag
role: STUDY_CHAIR
affiliation: Charité
name: Dr. med. Mahler
role: STUDY_CHAIR
affiliation: Charité
name: Dr. med. Wullschleger
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wullschleger A, Vandamme A, Mielau J, Renner L, Bermpohl F, Heinz A, Montag C, Mahler L. Effect of standardized post-coercion review session on symptoms of PTSD: results from a randomized controlled trial. Eur Arch Psychiatry Clin Neurosci. 2021 Sep;271(6):1077-1087. doi: 10.1007/s00406-020-01215-x. Epub 2020 Nov 24.