<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/NCT02258737</url>
  </required_header>
  <id_info>
    <org_study_id>CMT</org_study_id>
    <nct_id>NCT02258737</nct_id>
  </id_info>
  <brief_title>Efficacy of Transitional Case Management Following Psychiatric Hospital Discharge</brief_title>
  <official_title>Efficacy of Transitional Case Management Following Psychiatric Hospital Discharge: a Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss National Science Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Lausanne Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficacy of transitional case management following psychiatric hospital discharge: a&#xD;
      randomized trial&#xD;
&#xD;
      Background The movement of deinstitutionalisation in Western societies has modified the role&#xD;
      of psychiatric hospital, which has lost its asylum function to become a place for acute care.&#xD;
&#xD;
      Psychiatric stays are now shorter and close interactions with the outpatient care network is&#xD;
      therefore more critical than before. The first weeks following discharge from psychiatric&#xD;
      hospital represent a period of high risk for relapse, readmission or even suicide. Case&#xD;
      management has a proven efficacy in facilitating patients' deinstitutionalisation after very&#xD;
      long hospitalisations and in stabilizing high users of psychiatric care. In contrast, studies&#xD;
      exploring the impact of time limited case management following discharge from short stays&#xD;
      (transitional case management) in earlier phases of psychiatric disorders in connection with&#xD;
      primary care are lacking.&#xD;
&#xD;
      Working Hypotheses The investigators hypothesize that transitional case management following&#xD;
      hospital discharge decreases risk of readmission, improves adherence to outpatient care,&#xD;
      facilitates recovery and improves patients' satisfaction with treatment as compared to&#xD;
      routine care.&#xD;
&#xD;
      Specific Aims In this study, the investigators will compare the impact of both intervention&#xD;
      on number of contact and level of adherence to outpatient care. The investigators will also&#xD;
      compare both groups on number of readmission, risk of early aggravation of the disorders,&#xD;
      level of functioning and satisfaction with care.&#xD;
&#xD;
      Methods This is a randomized single-blind study comparing transitional case management after&#xD;
      discharge with routine post-hospitalization care for subjects living independently without&#xD;
      institutional psychiatric follow-up. Demographic and clinical data will be gathered during&#xD;
      hospitalization, and 1, 3, 6 and 12 months after discharge. Quantitative assessment of&#xD;
      outcomes using validated instruments will be: contact and level of adherence to outpatient&#xD;
      care (primary outcomes), as well as number of hospitalization days, number of readmissions,&#xD;
      severity of illness and satisfaction with care (secondary outcomes).&#xD;
&#xD;
      Expected Value of the Proposed Project This study should improve psychiatric patients&#xD;
      follow-up in collaboration with the different levels of care in the global context of&#xD;
      deinstitutionalization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2007</start_date>
  <completion_date type="Actual">April 2009</completion_date>
  <primary_completion_date type="Actual">April 2009</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to outpatient care</measure>
    <time_frame>one year</time_frame>
    <description>Information on admission, diagnoses, notes on problems of compliance, preparation for hospital discharge and links with outpatient care using the Boyer Scale (Boyer, McAlpine, Pottick et al. 2000)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working alliance</measure>
    <time_frame>one year</time_frame>
    <description>Assessment of the relationship between patient and care provider uning the Working Alliance Inventory, short version (WAI-SRp) (Horvath, 1984; Hatcherr &amp; Gillaspy, 2006; translation : Baillargeon &amp; Leduc, 2000; de Roten, 2006)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of readmissions</measure>
    <time_frame>one year</time_frame>
    <description>Socio-demographic assessment of service receipt (use of services, length of hospitalization and number of readmissions) and medication profile using the Client Socio-Demographic and Service Receipt Inventory (CSSRI - EU) (Chisholm et al., 2000)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Degree of psychiatric symptoms</measure>
    <time_frame>one year</time_frame>
    <description>Assessment of psychiatric symptoms (global severity, diversity of symptoms and degree of discomfort) using the Symptom check-list (SCL-90 R) (Derogatis, 1977; French translation: Guelfi et Dreyfus,1984)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hopelessness</measure>
    <time_frame>one year</time_frame>
    <description>Assessment of the risks of suicide attempts or of suicide. Assessment of pessimism using the Hopelessness Scale - Questionnaire H (Hopelessness scale) (Beck, 1974; translation Cottraux, 1985)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Substance use</measure>
    <time_frame>one year</time_frame>
    <description>Assessment of alcohol and drug consumption (prevalence and frequency) using an extract from &quot; Cannabis and Substance Use Assessment Scale &quot; (CASUAS) (Edwards et al., 2003)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Improvement</measure>
    <time_frame>one year</time_frame>
    <description>Assessment of the patient's perception of clinical improvement using the Perceived Improvement questionnaire (Perreault, 2003)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of mental health problems</measure>
    <time_frame>one year</time_frame>
    <description>Assessment of the severity of mental health problems (behavior, handicap, symptoms, social) using the Health of Nation Outcome Scale (HoNOS) (Wing &amp; Curtis, 1996; Lauzon et al. 2001)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global Assessment of Functioning</measure>
    <time_frame>one year</time_frame>
    <description>Assessment of the patient's level of global functioning on a scale of 0 to 100 using the Global Assessment of Functioning (GAF), (Endicott, Spitzer et al 1976; translation Guelfi, Boyer, 1989)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social and Occupational Functioning</measure>
    <time_frame>one year</time_frame>
    <description>Assessment of the levels of social and professional functioning on a scale of 0 to 100 using the Social and Occupational Functioning Assessment Scale (SOFAS) (Goldman, Skodol et Lave, 1992)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social support</measure>
    <time_frame>one year</time_frame>
    <description>Assessment of the network's and of the patient's perception regarding availability using the &quot; Social Support &quot; questionnaire (Community Mental Health Evaluation Initiative, CMHEI, 2001)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Empowerment</measure>
    <time_frame>one year</time_frame>
    <description>Measure of empowerment using the &quot;Empowerment&quot; questionnaire (Community Mental Health Evaluation Initiative, CMHEI, 2001)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction</measure>
    <time_frame>one year</time_frame>
    <description>Assessment of the degree of satisfaction of users of psychiatric services using the Client's Satisfaction Questionnaire (CSQ- 8) (Larsen, 1979; translation Chambon, 1992)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Mental Disorders</condition>
  <arm_group>
    <arm_group_label>transitional case management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>standard care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Transitional Case Management</intervention_name>
    <description>The case management activity deals with organizational and clinical aspects. The objective is to focus on network's expectations during hospitalization and at discharge, and ensure contacts between hospital and patient' social network. The aim is to support patient during the transition phase following discharge</description>
    <arm_group_label>transitional case management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Routine hospitalization care is broadly defined as the usual level of care in the context of the adult department of psychiatry of the CHUV (Centre Hospitalier Universitaire Vaudois).</description>
    <arm_group_label>standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are 18-65 years of age&#xD;
&#xD;
          -  No immediate institutional follow up after discharge&#xD;
&#xD;
          -  Independent living condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Organic brain disease&#xD;
&#xD;
          -  Clinically significant concurrent illnesses&#xD;
&#xD;
          -  Poor understanding of French&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Bonsack, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lausanne University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Social Psychiatry Section, Lausanne University Hospital</name>
      <address>
        <city>Prilly</city>
        <state>VD</state>
        <zip>1008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>Charles Bonsack</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Case management</keyword>
  <keyword>psychiatric hospitalization</keyword>
  <keyword>discharge</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental 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/NCT02258737
org study id: CMT
nct id: NCT02258737
lead sponsor: 
collaborator: 
has dmc: No
Efficacy of transitional case management following psychiatric hospital discharge: a
      randomized trial

      Background The movement of deinstitutionalisation in Western societies has modified the role
      of psychiatric hospital, which has lost its asylum function to become a place for acute care.

      Psychiatric stays are now shorter and close interactions with the outpatient care network is
      therefore more critical than before. The first weeks following discharge from psychiatric
      hospital represent a period of high risk for relapse, readmission or even suicide. Case
      management has a proven efficacy in facilitating patients' deinstitutionalisation after very
      long hospitalisations and in stabilizing high users of psychiatric care. In contrast, studies
      exploring the impact of time limited case management following discharge from short stays
      (transitional case management) in earlier phases of psychiatric disorders in connection with
      primary care are lacking.

      Working Hypotheses The investigators hypothesize that transitional case management following
      hospital discharge decreases risk of readmission, improves adherence to outpatient care,
      facilitates recovery and improves patients' satisfaction with treatment as compared to
      routine care.

      Specific Aims In this study, the investigators will compare the impact of both intervention
      on number of contact and level of adherence to outpatient care. The investigators will also
      compare both groups on number of readmission, risk of early aggravation of the disorders,
      level of functioning and satisfaction with care.

      Methods This is a randomized single-blind study comparing transitional case management after
      discharge with routine post-hospitalization care for subjects living independently without
      institutional psychiatric follow-up. Demographic and clinical data will be gathered during
      hospitalization, and 1, 3, 6 and 12 months after discharge. Quantitative assessment of
      outcomes using validated instruments will be: contact and level of adherence to outpatient
      care (primary outcomes), as well as number of hospitalization days, number of readmissions,
      severity of illness and satisfaction with care (secondary outcomes).

      Expected Value of the Proposed Project This study should improve psychiatric patients
      follow-up in collaboration with the different levels of care in the global context of
      deinstitutionalization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Adherence to outpatient care
time frame: one year
description: Information on admission, diagnoses, notes on problems of compliance, preparation for hospital discharge and links with outpatient care using the Boyer Scale (Boyer, McAlpine, Pottick et al. 2000)
measure: Working alliance
time frame: one year
description: Assessment of the relationship between patient and care provider uning the Working Alliance Inventory, short version (WAI-SRp) (Horvath, 1984; Hatcherr & Gillaspy, 2006; translation : Baillargeon & Leduc, 2000; de Roten, 2006)
measure: Number of readmissions
time frame: one year
description: Socio-demographic assessment of service receipt (use of services, length of hospitalization and number of readmissions) and medication profile using the Client Socio-Demographic and Service Receipt Inventory (CSSRI - EU) (Chisholm et al., 2000)
measure: Degree of psychiatric symptoms
time frame: one year
description: Assessment of psychiatric symptoms (global severity, diversity of symptoms and degree of discomfort) using the Symptom check-list (SCL-90 R) (Derogatis, 1977; French translation: Guelfi et Dreyfus,1984)
measure: Hopelessness
time frame: one year
description: Assessment of the risks of suicide attempts or of suicide. Assessment of pessimism using the Hopelessness Scale - Questionnaire H (Hopelessness scale) (Beck, 1974; translation Cottraux, 1985)
measure: Substance use
time frame: one year
description: Assessment of alcohol and drug consumption (prevalence and frequency) using an extract from " Cannabis and Substance Use Assessment Scale " (CASUAS) (Edwards et al., 2003)
measure: Perceived Improvement
time frame: one year
description: Assessment of the patient's perception of clinical improvement using the Perceived Improvement questionnaire (Perreault, 2003)
measure: Severity of mental health problems
time frame: one year
description: Assessment of the severity of mental health problems (behavior, handicap, symptoms, social) using the Health of Nation Outcome Scale (HoNOS) (Wing & Curtis, 1996; Lauzon et al. 2001)
measure: Global Assessment of Functioning
time frame: one year
description: Assessment of the patient's level of global functioning on a scale of 0 to 100 using the Global Assessment of Functioning (GAF), (Endicott, Spitzer et al 1976; translation Guelfi, Boyer, 1989)
measure: Social and Occupational Functioning
time frame: one year
description: Assessment of the levels of social and professional functioning on a scale of 0 to 100 using the Social and Occupational Functioning Assessment Scale (SOFAS) (Goldman, Skodol et Lave, 1992)
measure: Social support
time frame: one year
description: Assessment of the network's and of the patient's perception regarding availability using the " Social Support " questionnaire (Community Mental Health Evaluation Initiative, CMHEI, 2001)
measure: Empowerment
time frame: one year
description: Measure of empowerment using the "Empowerment" questionnaire (Community Mental Health Evaluation Initiative, CMHEI, 2001)
measure: Satisfaction
time frame: one year
description: Assessment of the degree of satisfaction of users of psychiatric services using the Client's Satisfaction Questionnaire (CSQ- 8) (Larsen, 1979; translation Chambon, 1992)
arm group label: transitional case management
arm group type: Experimental
arm group label: standard care
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Transitional Case Management
description: The case management activity deals with organizational and clinical aspects. The objective is to focus on network's expectations during hospitalization and at discharge, and ensure contacts between hospital and patient' social network. The aim is to support patient during the transition phase following discharge
arm group label: transitional case management
intervention type: Behavioral
intervention name: Standard Care
description: Routine hospitalization care is broadly defined as the usual level of care in the context of the adult department of psychiatry of the CHUV (Centre Hospitalier Universitaire Vaudois).
arm group label: standard care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Charles Bonsack, MD
role: Principal Investigator
affiliation: Lausanne University Hospital
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: Charles Bonsack
investigator title: Professor
mesh term: Mental Disorders