Impact of Joint Crisis Plan (PLANCO-ISO)

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders
• Intervention / Treatment: Procedure: Joint Crisis Plan

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of isolation	Measured in hours.	Months: 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Yvonne QUENUM, Coordinating nurse, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2019
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Psychiatry; Isolation; Joint Crisis Plan; Internalized Stigma of Mental Illness (ISMI); physical restraint
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 18PH221; ANSM (Other Identifier: 2025-A01697-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No