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.|
|ClinicalTrials.gov Identifier: NCT03984682|
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : January 9, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Duration of isolation [ Time Frame: Months: 12 ]Measured in hours.
- 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
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
|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|
|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|
|Principal Investigator:||Yvonne QUENUM, Coordinating nurse||CHU Saint-Etienne|