Effects of a Standardized Post-coercion Review Session.

NCT03512925 | Completed

• 1 other identifier: NBZM_MZ
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 6

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.

Conditions

Coercive Measures

Keywords

Coercion; Post-coercion review; Mental health; Seclusion; Mechanical restraint

Outcome Measures

Primary Outcomes (1)

• Objective coercive measures

  Number of coercive measures (seclusion, restraint, forced medication)

  At the time of discharge from the hospital by every included patient, up to 6 months

Secondary Outcomes (6)

• Subjective experience of coercion (1)

  At the time of discharge from the hospital by every included patient, up to 6 months

• Subjective experience of coercion (2)

  At the time of discharge from the hospital by every included patient, up to 6 months

• Subjective experience of coercion (3)

  At the time of discharge from the hospital by every included patient, up to 6 months

• Quality of the therapeutic relationship

  At the time of discharge from the hospital by every included patient, up to 6 months

• Post-traumatic symptoms (1)

  At the time of discharge from the hospital by every included patient, up to 6 months

Study Arms (2)

Standardized post-coercion review

EXPERIMENTAL

Intervention: Standardized post-coercion review session. Patients allocated to this arm receive a standardized post-coercion review of the coercive measure they experienced using the developed guidelines.

Other: Standardized debriefing session of coercive measures

Control group

NO INTERVENTION

Patients allocated to this arm are treated following usual standards and routine. This might include some form of post-coercion review that doesn't follow the developed standardized guidelines.

Interventions

Standardized debriefing session of coercive measures OTHER

Debriefing session following the developed guidelines including setting and themes.

Standardized post-coercion review

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Federal Ministry of Health, Germany: collaborator

Study Sites (6)

Psychiatrische Universitätsklink der Charité - SHK

Mitte, State of Berlin, 10115, Germany

Location

Vivantes Klinikum am Urban

Berlin, 10967, Germany

Location

Vivantes Wenckebach-Klinikum

Berlin, 12099, Germany

Location

Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

Alexianer Krankenhaus Hedwigshöhe

Berlin, 12526, Germany

Location

St. Joseph Krankenhaus Weißensee

Berlin, 13088, Germany

Location

Related Publications (1)

• 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.

  PMID: 33231771 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• PD Dr. med. Montag

  Charité

  STUDY CHAIR

• Dr. med. Mahler

  Charité

  STUDY CHAIR

• Dr. med. Wullschleger

  Charité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eligible participants are randomly assigned either to the intervention arm (standardized post-coercion review session session) or to the Treatment-as-usual (TAU) arm.

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: May 1, 2018
• Study Start: November 1, 2017
• Primary Completion: May 31, 2019
• Study Completion: June 30, 2019
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

DE (6)