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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

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.
Estimated Study Start Date : September 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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03984682


Contacts
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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

Locations
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France
CHU Saint-Etienne Not yet 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
Investigators
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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
ClinicalTrials.gov Identifier: NCT03984682     History of Changes
Other Study ID Numbers: 18PH221
ANSM ( Other Identifier: 2019-A00062-55 )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
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)
Isolation
physical restraint
Psychiatry

Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders