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Impact of Joint Crisis Plan (PLANCO-ISO)

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ClinicalTrials.gov Identifier: NCT03984682
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date June 28, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
Duration of isolation [ Time Frame: Months: 12 ]
Measured in hours.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03984682 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Perception of constraint [ Time Frame: Months: 12 ]
    Measured by the MacArthur Coercion Scale. Each "True" = 0, and each "False" = 1, perceived cohesion scale score is between 0 and 5, Negative pressures scale score is between 0 and 6, Voice scale score is between 0 and 3, Affective Reactions to Hospitalization score is between 0 and 6.
  • Number of hospitalizations [ Time Frame: Months: 12 ]
  • Number of isolation [ Time Frame: Months: 12 ]
  • Number of physical restraints [ Time Frame: Months: 12 ]
  • Duration of physical restraint [ Time Frame: Months: 12 ]
    Measured in hours
  • Experience of discrimination and stigmatization [ Time Frame: Months: 12 ]
    Measured by the Internalized Stigma of Mental Illness. This scale is a 29 items scale with stigma graded on a 4 point scale (Strongly disagree-1, Disagree-2, Agree-3 and strongly agree-4) which are divided into fivecomponents/domains (alienation, stereotype endorsement, perceived discrimination, social withdrawal and stigma resistance). Higher scores indicate higher level of self stigma.
  • Number of violent events [ Time Frame: Months: 12 ]
  • Number of emergency room visits for psychiatric opinion [ Time Frame: Months: 12 ]
  • Adhesion and feeling of nurses in relation to Joint Crisis Plan [ Time Frame: Months: 12 ]
    Measured by focus-groups and individual interviews of nurses
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Perception of constraint [ Time Frame: Months: 12 ]
    Measured by the MacArthur Coercion Scale
  • Number of hospitalizations [ Time Frame: Months: 12 ]
  • Modalities of hospitalizations [ Time Frame: Months: 12 ]
    Free hospitalization, psychiatric care at the request of a third party, psychiatric care at the request of a state representative
  • Number of isolation [ Time Frame: Months: 12 ]
  • Number of physical restraints [ Time Frame: Months: 12 ]
  • Duration of physical restraint [ Time Frame: Months: 12 ]
    Measured in hours
  • Experience of discrimination and stigmatization [ Time Frame: Months: 12 ]
    Measured by the Internalized Stigma of Mental Illness (ISMI).
  • Number of violent events [ Time Frame: Months: 12 ]
  • Number of emergency room visits for psychiatric opinion [ Time Frame: Months: 12 ]
  • Adhesion and feeling of nurses in relation to Joint Crisis Plan [ Time Frame: Months: 12 ]
    Measured by focus-groups and individual interviews of nurses
  • Patients satisfaction Joint Crisis Plan [ Time Frame: Months: 12 ]
    Measured by a satisfaction questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Joint Crisis Plan
Official Title  ICMJE Impact of Joint Crisis Plan on the Duration of Isolation Measures in Psychiatry.
Brief Summary

For some patients in department psychiatric, isolation measures are put in place. But the measures is not pleasant for the patient or for the care team.

That's why care team are trying to find ways to improve patient care, including asking them how they would like to be treated.

One of the solutions is called the Joint Crisis Plan. A Joint Crisis Plan is a personalized procedure for a patient. It describes the attitude, the care, the measures in case of crisis with the patient and his family. Patients indicate their wishes regarding their care. However, there is no real scientific proof of the effectiveness of this Joint Crisis Plan, especially to reduce isolation measures.

Detailed Description The primary objective of this study is to evaluate efficacy of the Joint Crisis Plan.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Mental Disorders
Intervention  ICMJE Procedure: Joint Crisis Plan
A Joint Crisis Plan will be drafted with the patient and a nurse
Study Arms  ICMJE
  • Experimental: Experimental group
    Patients will benefit from regular care + Joint Crisis Plan
    Intervention: Procedure: Joint Crisis Plan
  • No Intervention: Control group
    Patients will benefit from regular care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients >18 years
  • Patients having had at least one isolation, restraint or forced hospitalization measure in the 24 months before inclusion
  • Followed by nurses of a mobile team of psychiatry sector Saint Etienne
  • Social security affiliation
  • Signed informed consent

Exclusion Criteria:

  • Patient having already had a Joint Crisis Plan for less than 6 months.
  • Patient does not speak French
  • Pregnant and lactating women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yvonne QUENUM, Coordinating nurse (0)477127968 ext +33 Yvonne.Quenum@chu-st-etienne.fr
Contact: Amandine BAUDOT, CRA (0)477829450 ext +33 Amandine.Baudot@chu-st-etienne.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984682
Other Study ID Numbers  ICMJE 18PH221
ANSM ( Other Identifier: 2019-A00062-55 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Yvonne QUENUM, Coordinating nurse CHU Saint-Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP