<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03240380</url>
  </required_header>
  <id_info>
    <org_study_id>0748-111</org_study_id>
    <nct_id>NCT03240380</nct_id>
  </id_info>
  <brief_title>Joint Crisis Plans or Crisis Cards for People With Severe Mental Disorders to Reduce Coercion in Psychiatric Care.</brief_title>
  <acronym>JCPUKE</acronym>
  <official_title>A Randomized Controlled Trial Comparing Joint Crisis Plans With Crisis Cards for People With Bipolar Disorders, Schizophrenia and Other Psychotic Disorders to Reduce Involuntary Admission and Coercive Measures.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal Ministry of Health, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bundesarbeitsgemeinschaft Gemeindepsychiatrischer Verbünde e. V.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aktion Psychisch Kranke e. V.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial compares the influence of joint crisis plans (JCP) or crisis&#xD;
      cards to reduce psychiatric coercion for people with severe and often recurring mental&#xD;
      illnesses like schizophrenia, bipolar disorder or schizoaffective disorder. Both&#xD;
      interventions will be carried out as an integrated part of otherwise standard psychiatric&#xD;
      in-patient and out-patient care in psychiatric units specializing in the acute or non-acute&#xD;
      treatment of mentioned mental illnesses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single open-label randomised clinical trial with parallel control groups.&#xD;
&#xD;
      The intervention group &quot;joint crisis plan&quot; benefits from a joint crisis plan in addition to&#xD;
      the usual in-patient care. The active control group &quot;crisis card&quot; benefits from the crisis&#xD;
      card in addition to the usual in-patient or out-patient care.&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
      The study aims at evaluating the effectiveness of a joint crisis plan compared with crisis&#xD;
      cards regarding the reduction of coercive measure in the following hospital admission.&#xD;
&#xD;
      PROCEDURES:&#xD;
&#xD;
      A weekly screening of all service users regarding eligibility will be carried out. Each&#xD;
      eligible person will be approached by a trained staff member of the unit and invited to&#xD;
      participate in the study, but not before the patient is capable of consenting to treatment.&#xD;
      After informed consent has been obtained, a staff member conducts a baseline assessment using&#xD;
      the Global Assessment of Functioning (GAF), the Clinical Global Impression (CGI) and the&#xD;
      Brief Psychiatric Rating Scale (BPRS). Then participants will be randomly allocated to either&#xD;
      intervention or control group and specific intervention will be carried out. Joint crisis&#xD;
      plan: Due to the duration of the process, the facilitated preparations for the negotiation&#xD;
      session should start immediately. For those treated as in-patients, intervention should be&#xD;
      finish before their release from the hospital. Crisis card: The in-patient and the attending&#xD;
      physician fill out a crisis card together when the patient is to be released from the clinic.&#xD;
      Out-patient prepare a crisis card together with their clinic physician during a routine visit&#xD;
      to the clinic doctor's office. After the 12-month-follow-up-period participants will be&#xD;
      assessed again regarding received psychiatric in-patient care and experienced coercive&#xD;
      measures in any clinic during this period. Additionally, the patient's case files are&#xD;
      examined for documented coercive measures.&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
      The primary hypothesis to be tested is whether JCPs significantly reduce the average of&#xD;
      involuntarily spent days of hospitalization during the 12 month follow-up period, compared&#xD;
      with the control group receiving crisis cards.&#xD;
&#xD;
      Secondary hypotheses will be to determine whether compared with the control condition, JCP&#xD;
      use will result in improvements regarding other common coercive incidents: involuntary&#xD;
      medication, isolation, and physical restraint.&#xD;
&#xD;
      SAMPLE SIZE CALCULATION:&#xD;
&#xD;
      The necessary sample size regarding the primary outcome criterion &quot;days in accommodation&quot; was&#xD;
      calculated utilizing routine data of a random sample (N = 20) of in-patients. The following&#xD;
      inclusion criteria were used for the population of patients:&#xD;
&#xD;
        -  relevant period: 1st of January to 31st of December 2016&#xD;
&#xD;
        -  at least one acute psychiatric inpatient hospital stay with admission and discharge in&#xD;
           2016 (UKE: station PEAG)&#xD;
&#xD;
        -  minimum length of in-patient treatment 3 days&#xD;
&#xD;
        -  documented ICD-10 diagnosis: F2*/F3*&#xD;
&#xD;
      A zero-inflated negative binomial regression was calculated to obtain the estimator for the&#xD;
      average number of days in accommodation (15.69) and the estimator for the overdispersion&#xD;
      (0.49). The sample size calculation was carried out with a type I error of 5% (two-tailed)&#xD;
      and a power of 80%.&#xD;
&#xD;
      The calculation was carried out with PASS 2008 (NCSS, LLC Kaysville, Utah). It led to a&#xD;
      sample size of 151 patients per group (a total of 302 patients). Taking withdrawal and&#xD;
      follow-up loss of combined approx. 20% into account an initial sample size of 374 patients&#xD;
      (187 per group) will be necessary.&#xD;
&#xD;
      STATISTICAL ANALYSIS:&#xD;
&#xD;
      In order to address primary and secondary objectives, an intention-to-treat analysis (ITT)&#xD;
      will be calculated as a zero-inflated negative binomial regression. The group variable (JCP&#xD;
      vs. crisis card) is included as a fixed effect into the model. Additionally, a per-protocol&#xD;
      analysis (PP) will be performed to examine the actual interventional effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cumulative time in days of involuntary psychiatric hospitalization</measure>
    <time_frame>12 month</time_frame>
    <description>involuntarily spent psychiatric hospital days during follow-up period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cumulative frequency of forced medication</measure>
    <time_frame>12 month</time_frame>
    <description>cumulative occurrences of the coercive measure &quot;forced medication&quot; during the follow-up period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative duration of mechanical restraint</measure>
    <time_frame>12 month</time_frame>
    <description>cumulative duration of the coercive measure &quot;mechanical restraint&quot; in minutes during the follow-up period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative duration of isolation</measure>
    <time_frame>12 month</time_frame>
    <description>cumulative duration of the coercive measure &quot;isolation&quot; in minutes during the follow-up period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">374</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Bipolar Disorder</condition>
  <condition>Schizoaffective Disorder</condition>
  <arm_group>
    <arm_group_label>joint crisis plan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects benefit from a joint crisis plan and the process of its negotiation in addition to the usual in-patient or out-patient care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>crisis card</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects benefit from a crisis card in addition to the usual in-patient or out-patient care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>joint crisis plan</intervention_name>
    <description>Joint crisis plans are consensual written patient-clinic-agreements for future crisis intervention, especially for people with recurring severe mental illnesses. In case of relapse, they provide the hospital with contact information and detailed patient's preferences regarding medical, psychological and psychosocial measures. Thus JCPs aim to implement patient self-determination rights, prevent psychiatric coercion and foster self-management and recovery.&#xD;
Between the patient and the clinic represented by the attending physician a joint crisis plan is to be negotiated and agreed upon on individual basis as part of inpatient care. If possible this is to be facilitated by peer counselors or another third party. If for an in-patient the process is not completed until the end of the hospital stay it becomes part of regular outpatient aftercare.</description>
    <arm_group_label>joint crisis plan</arm_group_label>
    <other_name>Behandlungsvereinbarungen (German)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>crisis card</intervention_name>
    <description>Crisis cards are credit card-sized booklets to be kept preferably always at hand. They can contain important information: persons to contact, current medication, basic treatment preferences and hints to advance directives or other existing legal documents. They may be of use in the event of a mental health crisis and help to quickly receive appropriate support.&#xD;
When the in-patient is to be released from the clinic, the attending physician and the patient together fill out a crisis card. Out-patients get their crisis cards during the next routine visit to their clinic doctor's office.</description>
    <arm_group_label>crisis card</arm_group_label>
    <other_name>Krisenpass (German)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mental capacity to consent the participation in the study&#xD;
&#xD;
          -  principal diagnosis according to criteria in ICD-10 main groups F20-F29 or F30-F39&#xD;
&#xD;
          -  patient is residing in the care area of the clinic OR currently at least 2nd inpatient&#xD;
             hospital stay in this clinic OR currently treated in a psychiatric outpatients&#xD;
             department of the participating clinic&#xD;
&#xD;
          -  at least one psychiatric hospital stay within the last 24 months in any clinic&#xD;
             including the current stay OR patient has a history of coercion (involuntary&#xD;
             hospitalization, mechanical restraint, isolation, forced medication) in any clinic&#xD;
             including the current stay&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinical impression of insufficient cognitive capacity&#xD;
&#xD;
          -  insufficient understanding of the German language&#xD;
&#xD;
          -  planned transfer to involuntary long-term inpatient care or forensic facilities&#xD;
&#xD;
          -  serious somatic or organic brain disorder (dementia e.g.) or more than slight mental&#xD;
             retardation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Bock, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Candelaria I. Mahlke, Dr. phil.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Candelaria I. Mahlke, Dr. phil.</last_name>
    <phone>+49 (0)40 7410 58933</phone>
    <email>c.mahlke@uke.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>René Uhlig, M.Sc. psych.</last_name>
    <phone>+49 (0)40 7410 58933</phone>
    <email>re.uhlig@uke.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Candelaria I. Mahlke, Dr. phil.</last_name>
      <phone>+49 (0)40 7410 58933</phone>
      <email>c.mahlke@uke.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.bag-gpv.de/projekte/projekt-vermeidung-von-zwangsmassnahmen-im-psychiatrischen-hilfesystem/</url>
    <description>main site of the overarching project</description>
  </link>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03240380
org study id: 0748-111
nct id: NCT03240380
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized clinical trial compares the influence of joint crisis plans (JCP) or crisis
      cards to reduce psychiatric coercion for people with severe and often recurring mental
      illnesses like schizophrenia, bipolar disorder or schizoaffective disorder. Both
      interventions will be carried out as an integrated part of otherwise standard psychiatric
      in-patient and out-patient care in psychiatric units specializing in the acute or non-acute
      treatment of mentioned mental illnesses.
Single open-label randomised clinical trial with parallel control groups.

      The intervention group "joint crisis plan" benefits from a joint crisis plan in addition to
      the usual in-patient care. The active control group "crisis card" benefits from the crisis
      card in addition to the usual in-patient or out-patient care.

      OBJECTIVES:

      The study aims at evaluating the effectiveness of a joint crisis plan compared with crisis
      cards regarding the reduction of coercive measure in the following hospital admission.

      PROCEDURES:

      A weekly screening of all service users regarding eligibility will be carried out. Each
      eligible person will be approached by a trained staff member of the unit and invited to
      participate in the study, but not before the patient is capable of consenting to treatment.
      After informed consent has been obtained, a staff member conducts a baseline assessment using
      the Global Assessment of Functioning (GAF), the Clinical Global Impression (CGI) and the
      Brief Psychiatric Rating Scale (BPRS). Then participants will be randomly allocated to either
      intervention or control group and specific intervention will be carried out. Joint crisis
      plan: Due to the duration of the process, the facilitated preparations for the negotiation
      session should start immediately. For those treated as in-patients, intervention should be
      finish before their release from the hospital. Crisis card: The in-patient and the attending
      physician fill out a crisis card together when the patient is to be released from the clinic.
      Out-patient prepare a crisis card together with their clinic physician during a routine visit
      to the clinic doctor's office. After the 12-month-follow-up-period participants will be
      assessed again regarding received psychiatric in-patient care and experienced coercive
      measures in any clinic during this period. Additionally, the patient's case files are
      examined for documented coercive measures.

      HYPOTHESES:

      The primary hypothesis to be tested is whether JCPs significantly reduce the average of
      involuntarily spent days of hospitalization during the 12 month follow-up period, compared
      with the control group receiving crisis cards.

      Secondary hypotheses will be to determine whether compared with the control condition, JCP
      use will result in improvements regarding other common coercive incidents: involuntary
      medication, isolation, and physical restraint.

      SAMPLE SIZE CALCULATION:

      The necessary sample size regarding the primary outcome criterion "days in accommodation" was
      calculated utilizing routine data of a random sample (N = 20) of in-patients. The following
      inclusion criteria were used for the population of patients:

        -  relevant period: 1st of January to 31st of December 2016

        -  at least one acute psychiatric inpatient hospital stay with admission and discharge in
           2016 (UKE: station PEAG)

        -  minimum length of in-patient treatment 3 days

        -  documented ICD-10 diagnosis: F2*/F3*

      A zero-inflated negative binomial regression was calculated to obtain the estimator for the
      average number of days in accommodation (15.69) and the estimator for the overdispersion
      (0.49). The sample size calculation was carried out with a type I error of 5% (two-tailed)
      and a power of 80%.

      The calculation was carried out with PASS 2008 (NCSS, LLC Kaysville, Utah). It led to a
      sample size of 151 patients per group (a total of 302 patients). Taking withdrawal and
      follow-up loss of combined approx. 20% into account an initial sample size of 374 patients
      (187 per group) will be necessary.

      STATISTICAL ANALYSIS:

      In order to address primary and secondary objectives, an intention-to-treat analysis (ITT)
      will be calculated as a zero-inflated negative binomial regression. The group variable (JCP
      vs. crisis card) is included as a fixed effect into the model. Additionally, a per-protocol
      analysis (PP) will be performed to examine the actual interventional effect.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: cumulative time in days of involuntary psychiatric hospitalization
time frame: 12 month
description: involuntarily spent psychiatric hospital days during follow-up period
measure: cumulative frequency of forced medication
time frame: 12 month
description: cumulative occurrences of the coercive measure "forced medication" during the follow-up period
measure: cumulative duration of mechanical restraint
time frame: 12 month
description: cumulative duration of the coercive measure "mechanical restraint" in minutes during the follow-up period
measure: cumulative duration of isolation
time frame: 12 month
description: cumulative duration of the coercive measure "isolation" in minutes during the follow-up period
arm group label: joint crisis plan
arm group type: Experimental
description: Subjects benefit from a joint crisis plan and the process of its negotiation in addition to the usual in-patient or out-patient care.
arm group label: crisis card
arm group type: Active Comparator
description: Subjects benefit from a crisis card in addition to the usual in-patient or out-patient care.
intervention type: Behavioral
intervention name: joint crisis plan
description: Joint crisis plans are consensual written patient-clinic-agreements for future crisis intervention, especially for people with recurring severe mental illnesses. In case of relapse, they provide the hospital with contact information and detailed patient's preferences regarding medical, psychological and psychosocial measures. Thus JCPs aim to implement patient self-determination rights, prevent psychiatric coercion and foster self-management and recovery.
Between the patient and the clinic represented by the attending physician a joint crisis plan is to be negotiated and agreed upon on individual basis as part of inpatient care. If possible this is to be facilitated by peer counselors or another third party. If for an in-patient the process is not completed until the end of the hospital stay it becomes part of regular outpatient aftercare.
arm group label: joint crisis plan
other name: Behandlungsvereinbarungen (German)
intervention type: Behavioral
intervention name: crisis card
description: Crisis cards are credit card-sized booklets to be kept preferably always at hand. They can contain important information: persons to contact, current medication, basic treatment preferences and hints to advance directives or other existing legal documents. They may be of use in the event of a mental health crisis and help to quickly receive appropriate support.
When the in-patient is to be released from the clinic, the attending physician and the patient together fill out a crisis card. Out-patients get their crisis cards during the next routine visit to their clinic doctor's office.
arm group label: crisis card
other name: Krisenpass (German)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Bock, Prof. Dr.
role: Principal Investigator
affiliation: Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf
last name: Candelaria I. Mahlke, Dr. phil.
role: Principal Investigator
affiliation: Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf
last name: Candelaria I. Mahlke, Dr. phil.
phone: +49 (0)40 7410 58933
email: c.mahlke@uke.de
last name: René Uhlig, M.Sc. psych.
phone: +49 (0)40 7410 58933
email: re.uhlig@uke.de
facility: 
status: Recruiting
contact: 
country: Germany
url: http://www.bag-gpv.de/projekte/projekt-vermeidung-von-zwangsmassnahmen-im-psychiatrischen-hilfesystem/
description: main site of the overarching project
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Bipolar Disorder
mesh term: Psychotic Disorders