Impact of Joint Crisis Plan

Mental Disorders Clinical Trial

— PLANCO-ISO  

Official title:

Impact of Joint Crisis Plan on the Duration of Isolation Measures in Psychiatry.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03984682
• Other study ID #: 18PH221
• Secondary ID: ANSM
• Status: Completed
• Phase: N/A
• Start date: November 21, 2019
• Est. completion date: April 4, 2024

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 4, 2024
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders

Intervention

Procedure:
• Joint Crisis Plan
A Joint Crisis Plan will be drafted with the patient and a nurse

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of isolation	Measured in hours.	Months: 12
Secondary	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.	Months: 12
Secondary	Number of hospitalizations		Months: 12
Secondary	Number of isolation		Months: 12
Secondary	Number of physical restraints		Months: 12
Secondary	Duration of physical restraint	Measured in hours	Months: 12
Secondary	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.	Months: 12
Secondary	Number of violent events		Months: 12
Secondary	Number of emergency room visits for psychiatric opinion		Months: 12
Secondary	Adhesion and feeling of nurses in relation to Joint Crisis Plan	Measured by focus-groups and individual interviews of nurses	Months: 12