Trial document




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  DRKS00010168

Trial Description

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Title

Randomized clinical Trail on effects of negotiating a Joint Crisis Plans (JSP) on illness perception and trust in hospital physicians in inpatients with severe mental illnesses and observation of patients' satisfaction and admission experience and use of coercion in a subsequent hospitalization.

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Trial Acronym

JCPUKE

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URL of the Trial

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Brief Summary in Lay Language

This study examines effects of Joint Crisis Plans in routine psychiatric hospital care at the Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf (UKE), Germany.
JCP is a well known, but rarely used consensual agreement on future treatment options, patients' preferences and actions to be taken in case of future hospital admission between patients and authorized hospital personnel.

Patients of the participating wards (PAEG, PA 2) with severe mental conditions, like Schizophrenia or Bipolar Disorder, who decide to make use of JCP, are surveyed prior newly established negotiation procedure (commencing during their routine hospital stay) and 4 weeks later. We examine whether patients' personal control of their medical condition and it's control by professional treatment, their illness comprehension and their trust in hospital physicians improves while comparing a treatment group with a waiting-list control. Control group participants pass the same procedure in an out-patient facility of the hospital (SPA, Sozialpsychiatrische Spezialambulanz für Psychosen und Bipolare Störungen) after postwaitinglist measurement and hospital discharge.

In case of a subsequent hospital stay within a 3-year period after discharge patients holding a Joint Crisis Plans are surveyed again to find possible improvements in terms of admission situation, patient satisfaction and regarding the reduced use of coercion and restraint by comparing patients' hospitalization with and without a JCP.

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Brief Summary in Scientific Language


This RCT (n=40) uses a pre-post-follow-up design with a treatment group and a waiting-list control. It examines in field conditions immediate effects of a newly introduced routinely offered negotiation procedure for arranging Joint Crisis Plans. This measure targets especially repeatedly hospitalized patients with severe mental conditions like Schizophrenia or Bipolar Disorder with higher risk of experiencing psychiatric coercive and restrain measures.

Self report measures regarding illness perception (IPQ-R sub-scales personal control, treatment control, coherence) and trust in physicians (TIP) are applied to voluntary participants prior the negotiation procedure (pretreatment measurement), again 4 weeks later (posttreatment/postwaillist measurement, negotiation procedure in treatment group has finished) and as follow-up measurement 26 weeks after post-treatment measurement and within the treatment group only.

In case of a subsequent hospital stay within a 3-year period patients with Joint Crisis Plan are surveyed again to examine improvements in subjective quality of admission (FEA-P) and of psychiatric hospital care in general (ZUF-8) and regarding the reduced use of coercive measures (CI) compared with the index hospital stay. Used Baseline data is part of the RCT pretreatment measurement.


Course of measurements:
1. pretreatment measurement at study entry
2. treatment or waiting-list control
3. posttreatment-/postwaitlist measurement 4 weeks after pretreatment measurement
4. follow-up measurement: 26 weeks after posttreatment measurement, with treatment group only
5. measurement with returning patients during subsequent hospital stay starting max. 3 years after index stay.

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Organizational Data

  •   DRKS00010168
  •   2016/05/06
  •   [---]*
  •   yes
  •   Approved
  •   PV5253, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   F20-F29 -  Schizophrenia, schizotypal and delusional disorders
  •   F30-F39 -  Mood [affective] disorders
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Interventions/Observational Groups

  •   Treatment group: participants are offered a negotiation procedure to create a Joint Crisis Plan about two weeks before the predicted end of their current psychiatric hospital stay besides the usual treatment.
  •   Waiting-list control group: participants receive routine treatment until discharge. After postwaitlist measurement und discharge the JCP negotiation procedure is carried out similarly by an outpatient facility.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

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IPQ-R Personal control
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What: personal control as part of the Illness Perception Model
When: pre, post, fup (fup with treatment group only)
How: Illness Perception Questionnaire – Revised, Subscale "Personal control", German Version (IPQ-R; Gaab, Bunschoten, Sprott, & Ehlert, 2004, 2008; Moss-Morris et al., 2002), self-report questionnaire

Course of measurements:
1. pretreatment measurement at study entry
2. treatment or waiting-list control
3. posttreatment-/postwaitlist measurement 4 weeks after pretreatment measurement
4. follow-up measurement: 26 weeks after posttreatment measurement, with treatment group only
5. measurement with returning patients during subsequent hospital stay starting max. 3 years after index stay.

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Secondary Outcome

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IPQ-R Treatment control
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What: Treatment control as part of the Illness Perception Model
When: pre, post, fup (fup with treatment group only)
How: Illness Perception Questionnaire – Revised, Subscale "Treatment control", German Version (IPQ-R; Gaab, Bunschoten, Sprott, & Ehlert, 2004, 2008; Moss-Morris et al., 2002), self-report questionnaire
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IPQ-R Coherence
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What: illness coherence as part of the Illness Perception Model
When: pre, post, fup (fup with treatment group only)
How: Illness Perception Questionnaire – Revised, Subscale "Illness coherence", German Version (IPQ-R; Gaab, Bunschoten, Sprott, & Ehlert, 2004, 2008; Moss-Morris et al., 2002), self-report questionnaire
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VIA
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What: trust in hospital physician
When: pre, post, fup (fup with treatment group only)
How: "Trust in Physician scale" (TPS; german Version, Anderson & Dedrick, 1990; Glattacker, Gülich, Farin, & Jäckel, 2007), self-report questionnaire
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ZUF-8
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What: questionnaire on patient satisfaction with in-patient hospital care
When: pre, return (end of a subsequent hospital stay)
How: "Fragebogen zur Patientenzufriedenheit" (Schmidt, Lamprecht, & Wittmann, 1989; Schmidt, Nübling, Lamprecht, & Wittmann, 1994), self-report questionnaire
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FEA-P
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What: Evaluation of admission to a psychiatric hospital by patients
When: pre, return (end of a subsequent hospital stay)
How: "Fragebogen zum Erleben der Aufnahme in einer Klinik für Psychiatrie und Psychotherapie" (FEA-P, Driessen et al., 2013; Wertz et al., 2013), self-report questionnaire
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CI
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What: subjective an objective coercive incidents during a hospitalization
When: pre, return (end of a subsequent hospital stay)
How: "CI Coercive Incidents"(Høyer et al., 2002; Iversen, Høyer, Sexton, & Grønli, 2002; Kjellin & Wallsten, 2010) combined instrument; self-report questionnaire and patient record study

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/05/20
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. capacity to consent regarding participation in the study and related activities (negotiation and completion of a Joint Crisis Plan)
2. over 18 years of age
3. sufficient understanding of the German language
4. principal diagnosis in ICD-10 main groups F20-F29 or F30-F39
5. count and duration of psychiatric hospitalizations: 2 and more stays with at least 14 days in total until study entry
Note: Criterion 5 is not required for UKE sector patients and involuntarily admitted patients.
6. minimum of 14 days left until an expectable discharge by clinical judgement

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Exclusion Criteria

1. lack of written informed consent
2. serious somatic or organic brain disorder

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf (UKE), Klinik und Poliklinik für Psychiatrie und Psychotherapie - Spezialambulanz für Psychosen und Bipolare Störungen,
    • Mr.  Prof. Dr. phil. Dipl.-Psych.  Thomas  Bock 
    • Martinistraße 52, Haus W37, Erdgeschoss
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf (UKE), Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Mr.  cand. M.Sc. psych.  René  Uhlig 
    • Rappstr. 10
    • 20146  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf (UKE), Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Mr.  cand. M.Sc. psych.  René  Uhlig 
    • Rappstr. 10
    • 20146  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Hamburg-Eppendorf (UKE)Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr. phil. Dipl.-Psych.  Thomas  Bock 
    • Martinistraße 52, Haus W37
    • 20246  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.