Trial document




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  DRKS00013985

Trial Description

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Title

Use of joint crisis plans for psychiatric patients suffering from psychotic disorders in the context of integrated treatment planning to reduce coercive and measures

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Trial Acronym

CRIPREC

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URL of the Trial

http://evkb.de/ueber-das-evkb/kliniken-institute-zentren/nervensystem/psychiatrie-und-psychotherapie/forschung/projekte/projekte/studie-zur-krisenvorsorge.html

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Brief Summary in Lay Language

Schizophrenia and schizoaffective disorders are diseases, which are often associated with recurrent disease phases. During inpatient treatment, in some cases measures are applied which are perceived as negative by those affected, because these forms of treatment do not correspond to their wishes.
In order to make provision and to prospectively prepare further possible crises situations or crisis treatments, different measures have been established: e.g. the crisis card and the joint crisis plan. In cooperation with several treatment centers, a study will be conducted in order to examine the effects of these measures.
For this, the study participants are randomly assigned to a group and receive either a crisis card or a joint crisis plan. In advance and about 18 months later, the participants are interviewed in detail. Based on interviews, questionnaires and further information it will be examined whether the measures have an effect e.g. on coercive measures or on the duration of treatment.

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Brief Summary in Scientific Language

A multi-center RCT to evaluate the effectiveness of interventions for crisis provision (joint crisis plans versus crisis cards) in patients with schizophrenia and schizoaffective disorders.
Main hypothesis (sample relevant): Compared to crisis cards, joint crisis plans lead to lower cumulative duration of inpatient treatment (= primary outcome parameter 1) as well as to less coercive measures (sections, fixation, forced medication) (= primary outcome parameter 2).
Subordinate hypothesis (eplorative):
Compared to crisis cards, joint crisis plans are also superior in terms of additional parameters: number of hospital admissions, trust in the treatment team, adherence, drug attitude, psychopathology, psychosocial functioning level including ICF skills, locus of control.

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Organizational Data

  •   DRKS00013985
  •   2018/02/09
  •   [---]*
  •   yes
  •   Approved
  •   17-6059, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   F25 -  Schizoaffective disorders
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Interventions/Observational Groups

  •   Joint crisis plan: the joint crisis plan will be made on the basis of a predetermined date (on the day of discharge or at the latest within 28 days after discharge) in the presence of the patient, her / his personal psychiatrist or psychologist, her / his social worker, the responsible PMHN and, if required, her / his close confidant. A previously determined and trained member of the treatment team will moderate the session. The course of the conversation is standardized. First, the background and general conditions of a joint crisis plan will be explained. After a discussion, the detailed arrangements on following areas for future treatments will be made:
    - contacts
    - admission and treatment
    - medication
    - judicial accommodation (for example PsychKG)
    - coercive measures
    - social situation
    - others.
    The concluded agreements will be documented in a standardized form (joint crisis plan) and signed by all involved parties. The joint crisis plan will be handed out to the patient and another copy will be archived in the clinic in such a way that it is always accessible to the treatment team, but also to the doctors on duty.
  •   Crisis card (control group): The standardized crisis card contains the most important addresses and telephone numbers of the patient´s personal psychiatrist / psychologist, of close confidants and the clinic, necessary and particularly effective drugs and side effects. These issues will be discussed with the patient within 15-20 minutes and will be documented by the responsible psychiatrist, psychologist or PMHN prior to discharge. Afterwards, the completed crisis card is handed out to the patient who is advised to always carry the crisis card with her / him when being out.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

cumulative duration of inpatient treatment (measured in days, measure time: T2, i.e. 18 month after study enrollment / first data collection (T1))

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Secondary Outcome

coercive measures (sections under Mental Health Act / unvoluntary treatment measured in days, physical restraints and seclusions measured in minutes, forced medication measured in frequency; measure time: T2, i.e. 18 month after study enrollment / first data collection (T1))

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/01/23
  •   260
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Diseases: F 20 or F 25 (ICD-10); age: between18 - 55 years; treatment history: at least two inpatient treatments; further requirements: permanent residence in the supply area

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Exclusion Criteria

Diseases/impairments: Congenital and acquired moderate and severe mental retardation; other severe cognitive impairments that limit the ability to participate: severe physical diseases; acute substance dependence (alcohol, drugs)

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Addresses

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Sources of Monetary or Material Support

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    • Bezirksregierung Detmold
    • Leopoldstraße 15
    • 32756  Detmold
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.