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Impact of Joint Crisis Plan (PLANCO-ISO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03984682
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : January 9, 2020
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment Phase
Mental Disorders Procedure: Joint Crisis Plan Not Applicable

Detailed Description:
The primary objective of this study is to evaluate efficacy of the Joint Crisis Plan.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Joint Crisis Plan on the Duration of Isolation Measures in Psychiatry.
Actual Study Start Date : November 21, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Experimental: Experimental group
Patients will benefit from regular care + Joint Crisis Plan
Procedure: Joint Crisis Plan
A Joint Crisis Plan will be drafted with the patient and a nurse

No Intervention: Control group
Patients will benefit from regular care

Primary Outcome Measures :
  1. Duration of isolation [ Time Frame: Months: 12 ]
    Measured in hours.

Secondary Outcome Measures :
  1. 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.

  2. Number of hospitalizations [ Time Frame: Months: 12 ]
  3. Number of isolation [ Time Frame: Months: 12 ]
  4. Number of physical restraints [ Time Frame: Months: 12 ]
  5. Duration of physical restraint [ Time Frame: Months: 12 ]
    Measured in hours

  6. 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.

  7. Number of violent events [ Time Frame: Months: 12 ]
  8. Number of emergency room visits for psychiatric opinion [ Time Frame: Months: 12 ]
  9. Adhesion and feeling of nurses in relation to Joint Crisis Plan [ Time Frame: Months: 12 ]
    Measured by focus-groups and individual interviews of nurses

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03984682

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Contact: Yvonne QUENUM, Coordinating nurse (0)477127968 ext +33
Contact: Amandine BAUDOT, CRA (0)477829450 ext +33

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CHU Saint-Etienne Recruiting
Saint-Étienne, France
Principal Investigator: Yvonne QUENUM, Coordinating nurse         
Sub-Investigator: Eric FAKRA, MD PhD         
Sub-Investigator: Maël PULCINI, MD         
Sub-Investigator: Aurélie CHABALIER, Coordinating nurse         
Sub-Investigator: Emilie LECA, Coordinating nurse         
Sub-Investigator: Eric BENDEL, Coordinating nurse         
Sub-Investigator: Fouad BELMOUNES, Coordinating nurse         
Sub-Investigator: Henri ODDE, Coordinating nurse         
Sub-Investigator: Morgane SHEYKHI, Coordinating nurse         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
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Principal Investigator: Yvonne QUENUM, Coordinating nurse CHU Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne Identifier: NCT03984682    
Other Study ID Numbers: 18PH221
ANSM ( Other Identifier: 2019-A00062-55 )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Joint Crisis Plan
Internalized Stigma of Mental Illness (ISMI)
physical restraint
Additional relevant MeSH terms:
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Mental Disorders