Impact of Joint Crisis Plan (PLANCO-ISO)
Primary Purpose
Mental Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Joint Crisis Plan
Sponsored by
About this trial
This is an interventional other trial for Mental Disorders focused on measuring Joint Crisis Plan, Internalized Stigma of Mental Illness (ISMI), Isolation, physical restraint, Psychiatry
Eligibility 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
Sites / Locations
- CHU Saint-EtienneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Patients will benefit from regular care + Joint Crisis Plan
Patients will benefit from regular care
Outcomes
Primary Outcome Measures
Duration of isolation
Measured in hours.
Secondary Outcome Measures
Perception of constraint
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
Number of isolation
Number of physical restraints
Duration of physical restraint
Measured in hours
Experience of discrimination and stigmatization
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
Number of emergency room visits for psychiatric opinion
Adhesion and feeling of nurses in relation to Joint Crisis Plan
Measured by focus-groups and individual interviews of nurses
Full Information
NCT ID
NCT03984682
First Posted
June 11, 2019
Last Updated
June 16, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT03984682
Brief Title
Impact of Joint Crisis Plan
Acronym
PLANCO-ISO
Official Title
Impact of Joint Crisis Plan on the Duration of Isolation Measures in Psychiatry.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Joint Crisis Plan, Internalized Stigma of Mental Illness (ISMI), Isolation, physical restraint, Psychiatry
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients will benefit from regular care + Joint Crisis Plan
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will benefit from regular care
Intervention Type
Procedure
Intervention Name(s)
Joint Crisis Plan
Intervention Description
A Joint Crisis Plan will be drafted with the patient and a nurse
Primary Outcome Measure Information:
Title
Duration of isolation
Description
Measured in hours.
Time Frame
Months: 12
Secondary Outcome Measure Information:
Title
Perception of constraint
Description
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.
Time Frame
Months: 12
Title
Number of hospitalizations
Time Frame
Months: 12
Title
Number of isolation
Time Frame
Months: 12
Title
Number of physical restraints
Time Frame
Months: 12
Title
Duration of physical restraint
Description
Measured in hours
Time Frame
Months: 12
Title
Experience of discrimination and stigmatization
Description
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.
Time Frame
Months: 12
Title
Number of violent events
Time Frame
Months: 12
Title
Number of emergency room visits for psychiatric opinion
Time Frame
Months: 12
Title
Adhesion and feeling of nurses in relation to Joint Crisis Plan
Description
Measured by focus-groups and individual interviews of nurses
Time Frame
Months: 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne QUENUM, Coordinating nurse
Phone
(0)477127968
Ext
+33
Email
Yvonne.Quenum@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Amandine BAUDOT, CRA
Phone
(0)477829450
Ext
+33
Email
Amandine.Baudot@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne QUENUM, Coordinating nurse
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne QUENUM, Coordinating nurse
First Name & Middle Initial & Last Name & Degree
Eric FAKRA, MD PhD
First Name & Middle Initial & Last Name & Degree
Maël PULCINI, MD
First Name & Middle Initial & Last Name & Degree
Aurélie CHABALIER, Coordinating nurse
First Name & Middle Initial & Last Name & Degree
Emilie LECA, Coordinating nurse
First Name & Middle Initial & Last Name & Degree
Eric BENDEL, Coordinating nurse
First Name & Middle Initial & Last Name & Degree
Fouad BELMOUNES, Coordinating nurse
First Name & Middle Initial & Last Name & Degree
Henri ODDE, Coordinating nurse
First Name & Middle Initial & Last Name & Degree
Morgane SHEYKHI, Coordinating nurse
First Name & Middle Initial & Last Name & Degree
Fanny PONCET, Coordinating nurse
First Name & Middle Initial & Last Name & Degree
Séverine COURRIER, Coordinating nurse
12. IPD Sharing Statement
Plan to Share IPD
No
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