Effects of a Standardized Post-coercion Review Session.

Effects of a Standardized Post-coercion Review Session on Objective and Perceived Coercion

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.

Study Overview

• Status: Completed
• Conditions: Coercive Measures
• Intervention / Treatment: Other: Standardized debriefing session of coercive measures

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.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12351
    • Vivantes Klinikum Neukölln
  • Berlin, Germany, 10967
    • Vivantes Klinikum Am Urban
  • Berlin, Germany, 12099
    • Vivantes Wenckebach-Klinikum
  • Berlin, Germany, 12526
    • Alexianer Krankenhaus Hedwigshöhe
  • Berlin, Germany, 13088
    • St. Joseph Krankenhaus Weißensee
  • Berlin
    • Berlin-Mitte, Berlin, Germany, 10115
      • Psychiatrische Universitätsklink der Charité - SHK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized post-coercion review; 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; Debriefing session following the developed guidelines including setting and themes.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective experience of coercion (1)	Subjective experience coercion assessed by the German version of the Perceived Coercion Subscale (PCS) of the MacArthur Admission Experience Survey (AES). The AES comprises 16 dichotomous items (yes-no answers) divided in 4 subscales. The PCS comprises 5 items. A higher score (range 0-5) indicates a high level of perceived coercion.	At the time of discharge from the hospital by every included patient, up to 6 months
Subjective experience of coercion (2)	Subjective experience coercion assessed by the Coercion Ladder (CL). The CL is an analog scale ranging from 1 to 10 and assessing the level pf perceived coercion. Higher values indicate a higher level of perceived coercion.	At the time of discharge from the hospital by every included patient, up to 6 months
Subjective experience of coercion (3)	Subjective experience coercion assessed by the German version of the Coercion Experience Scale (CES). The CES is a scale used to measure the impact of coercive measures. It comprises 29 items related to perceived stressors during a coercive intervention with a 5-point Likert-scale. A total score is used with higher values indicating higher perceived coercion.	At the time of discharge from the hospital by every included patient, up to 6 months
Quality of the therapeutic relationship	Evaluation of the quality of the therapeutic relationship assessed by the German version of the Work Alliance Inventory-Short Form (WAI-SR). The WAI comprises 12 items divided into 3 subclass (goal, task, bond). each subscale comprises 4 items with a 5-point Likert-scale. The score range for each subscale ranges from 5 to 20. Higher scores indicate a better therapeutic alliance.	At the time of discharge from the hospital by every included patient, up to 6 months
Post-traumatic symptoms (1)	Development of post-traumatic symptoms assessed by the German version of the Peri-Traumatic Distress Inventory (PDI). The PDI assesses the reactions during the traumatic event. It comprises 13 items with a 0-4 Likert-scale. Scores of all items are summed up and so the total score ranges from 0 to 52. A score higher than 26 indicates a high risk of developing a post traumatic stress disorder.	At the time of discharge from the hospital by every included patient, up to 6 months
Post-traumatic symptoms (2)	Development of post-traumatic symptoms assessed by the German version of the Impact of Events Scale Revised (IES-R). The IES-R comprises 22 items with a Likert-scale ranging from 0 to 5. Items are divided into 3 sub scales (Intrusion (7 items), Avoidance (8 items), and Hyperarousal (7 items)). Scores for each sub scales are built by adding the answers to each item. Higher scores indicate a higher level of symptoms. The probability of post traumatic stress disorder (PTSD) is assessed using a formula developed by the German translators: X = (-0,02 x intrusion) + (0,07 x avoidance) + (0,15 x hyperarousal) - 4,36. Scores >0 indicate the probable presence of PTSD.	At the time of discharge from the hospital by every included patient, up to 6 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Federal Ministry of Health, Germany
• Investigators: Study Chair: PD Dr. med. Montag, Charité; Study Chair: Dr. med. Mahler, Charité; Principal Investigator: Dr. med. Wullschleger, Charité

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Mental health; Mechanical restraint; Coercion; Post-coercion review; Seclusion
• Other Study ID Numbers: NBZM_MZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No