Trial document




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  DRKS00009723

Trial Description

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Title

evaluation of a deescalation management named OUTCOME to reduce aggression and violence in psychiatry

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Trial Acronym

OUTCOME

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URL of the Trial

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Brief Summary in Lay Language

Patient aggression and violence can be frequently observed in psychiatry. The negative impact is distinctly noticable for all groups involved like staff, patients, institution and health insurance. Coercion measures are frequently used to reduce violence and aggression, sometimes against the explicit approval of patients. Recently the use of coersion is widely criticised by the UN-Disability-Rights-Convention. The encouragment of patient autonomy is strongly required. In compliance with the enforcement of patient-rights by means of legal decisions and judicial judgements a process of rethinking in psychiatry is necessary. Currently, coercion is to be reduced as far as possible and the use of medication needs judicial approval. At first all mild measures should be used to reduce patient aggression. One of the aforementioned mild measures are deescalation trainings. Against this background the care managers of the Central Institute of Mental Health and the Centre of Psychiatry Weinsberg developed a multimodal deescalation managements program with focus on the patients needs.
This deescalation management should be introduced in all protective stations of two psychiatric hospitals. The evaluation of the deescalation management focusses on the amount of severe escalations and the duration of each coersion measure. In addition, the staff is asked to name the impact of patient aggression, the sense of security in dealing with aggressive patients and the attitude towards coersion.
There will be an intervention and a control group. Both groups will be measured twice: at first before the intervention starts and at second after 12 months. Both groups receive the same basic deescalataion training programm which is a full-day training on two days. In addition, the intervention group receives refresher trainings three times a full-day training every three months.

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Brief Summary in Scientific Language

BACKGROUND Patient aggression and violence can be frequently observed in psychiatry. The negative impact is distinctly noticable for all groups involved like staff, patients, institution and health insurance. Coercion measures are frequently used to reduce violence and aggression, sometimes against the explicit approval of patients. Recently the use of coersion is widely criticised by the UN-Disability-Rights-Convention. The encouragment of patient autonomy is strongly required. In compliance with the enforcement of patient-rights by means of legal decisions and judicial judgements a process of rethinking in psychiatry is necessary. Currently, coercion is to be reduced as far as possible and the use of medication needs judicial approval. At first all mild measures should be used to reduce patient aggression. One of the aforementioned mild measures are deescalation trainings. Against this background the care managers of the Central Institute of Mental Health and the Centre of Psychiatry Weinsberg developed a multimodal deescalation managements program with focus on the patients needs.
AIM This deescalation management should be introduced in all protective stations of two psychiatric hospitals. The evaluation of the deescalation management focusses on the amount of severe escalations and the duration of each coersion measure. In addition, the staff is asked to name the impact of patient aggression, the sense of security in dealing with aggressive patients and the attitude towards coersion.
DESIGN The study is a prospective cohort-study (longitudinal observation). There will be an intervention and a control group. Both groups will be measured twice: at first before the intervention starts and at second after 12 months. Both groups receive the same basic deescalataion training programm which is a full-day training on two days. In addition, the intervention group receives refresher trainings three times a full-day training every three months.
METHODS The are two primary endpoints. Both are measured twice (first measurement: reference date before the basic training starts, i.e. 01.01.2016; second measurement 12 months after the basic training, i.e. 01.02.2017). The primary endpoints are clinical parameters who will be refered to 90 days prior to the reference date: a.) amount of severe escalations - each escalation event with a point vaule of greater/equal 9 on der SOAS-R (Nijman et al 1999) will be counted; b.) cumulated time per coersion measure (in hours).
There are three secondary endpoints with regard to the staff level. The secondary endpoints will be measured three times: first measurement before he basic training, second measurement 1 month after the basic training, third measurement 12 months aftre the basic training. Three different insruments will be used a.) the IMPACS (IMpact of Patient Aggression on Carers Scale (Needham et al., 2005)), b.) the SACS (Staff Attitude to Coercion Scale (Husum, Finset, & Ruud, 2008)) and c.) the CCAI (Confidence in Coping with Aggression Instrument (Thackrey, 1987)).

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Organizational Data

  •   DRKS00009723
  •   2015/11/30
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  •   yes
  •   Approved
  •   2015-614N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   U1111-1177-0045 
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Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   F30 -  Manic episode
  •   F31 -  Bipolar affective disorder
  •   F60 -  Specific personality disorders
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Interventions/Observational Groups

  •   Interventiongroup: basic training of deescalation measures and additional refresher trainings (3 times)

    The basic deescalataion training programm OUTCOME is a full-day training on two days. And three times a full-day refresher training every three months.
  •   Controlgroup: basic training of deescalation measures

    The basic deescalataion training programm OUTCOME is a full-day training on two days.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Station level:
The primary end points will be measured twice: at first prior to the basic training intervention and secondly 12 months after the basic training intervention. The observed measurement period is refered to 90 days prior to each reference date. The first reference date will be the 01.01.2016 and the second reference date will be the 01.02.2017. The clinical outcomes are:
a.) the amount of severe escalations - mesasured as the incidence of escalations with a point value of greater/equal 9 on the SOAS-R (Nijman et al., 1999). To take into account the differences between the stations which take part in the study, the operationalisation according to Bowers is used: X = (N cases of severe escalations/ N amount of hospitalisation days) x 100 hospitalisation days (Bowers, 2000)
b.) cumulated time per coersion measure (in hours) - operationalised according to Janssen and collegues: Y = (N hours per coersion measure/ N amount of hospitalisation hours) x 1.000 hospitalisation hours (Janssen et al., 2011).

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Secondary Outcome

Staff level: The secondary end points will be measured three times: at first prior to the basic training, secondly 1 month after the basic training and thirdly 12 months after the basic training.
The following well established instruments will be used:
a.) CCAI - Confidence in Coping with Aggression Instrument (Thackrey, 1987)
b.) IMPACS - IMpact of Patient Aggression on Carers Scale (Needhan et al., 2005)
c.) SACS - Staff Attitude to Coersion Scale (Husum, Finset & Ruud, 2008).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2016/01/07
  •   130
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   67   Years
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Additional Inclusion Criteria

staff of protective stations

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Exclusion Criteria

pregnant staff

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Addresses

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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Andreas  Hoell 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr.  Mathias  Zink 
    • J5
    • 68159  Mannheim
    • Germany
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    • ZfP Weinsberg
    • Ms.  Dr. med.  Jutta  Kammerer-Ciernioch 
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Claus  Staudter 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr.  Stefan  schwarz 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische GesundheitAG Versorgungsforschung
    • Mr.  Andreas  Hoell 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische GesundheitAG Versorgungsforschung
    • Mr.  Andreas  Hoell 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Koordinierungsstelle Versorgungsforschung Baden WürttembergAbteilung Allgemeinmedizin & Versorgungsforschung
    • Mr.  Prof. Dr.  Joachim  Szecsenyi 
    • Voßstraße 2
    • 69115  Heidelberg
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr.  Andreas  Meyer-Lindenberg 
    • J5
    • 68159  Mannheim
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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