Mental DisordersPLANCO-ISONCT03984682
Impact of Joint Crisis Plan
A study testing Joint Crisis Plan in people with Mental Disorders, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Joint Crisis Plan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2019to 4 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient having already had a Joint Crisis Plan for less than 6 months.
- Patient does not speak French
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The primary objective of this study is to evaluate efficacy of the Joint Crisis Plan.
- Conditions
- Mental Disorders
- Being tested
- Joint Crisis Plan
- Keywords
- Joint Crisis Plan, Internalized Stigma of Mental Illness (ISMI), Isolation, physical restraint, Psychiatry
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint Crisis PlanProcedure or surgery
A Joint Crisis Plan will be drafted with the patient and a nurse
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients will benefit from regular care + Joint Crisis Plan Receives: Procedure: Joint Crisis Plan |
| Control group | No intervention | Patients will benefit from regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of isolation
Measured in hours.
Measured: Months: 12
Secondary outcomes (9)
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.
Measured: Months: 12
Number of hospitalizations
Measured: Months: 12
Number of isolation
Measured: Months: 12
Number of physical restraints
Measured: Months: 12
Duration of physical restraint
Measured in hours
Measured: 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.
Measured: Months: 12
Number of violent events
Measured: Months: 12
Number of emergency room visits for psychiatric opinion
Measured: Months: 12
Adhesion and feeling of nurses in relation to Joint Crisis Plan
Measured by focus-groups and individual interviews of nurses
Measured: Months: 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start21 Nov 2019
- Primary completion28 Mar 2023
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Yvonne QUENUM, Coordinating nurse, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984682
- Sponsor's protocol ID
- 18PH221
- Other IDs
- ANSM
- Acronym
- PLANCO-ISO
- Status last verified
- Apr 2024
- First submitted
- 11 Jun 2019
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Joint Crisis Plan on the Duration of Isolation Measures in Psychiatry.
- ClinicalTrials.gov ID
- NCT03984682
- Acronym / sponsor ID
- PLANCO-ISO / 18PH221
- Conditions
- Mental Disorders
- Keywords
- Joint Crisis Plan, Internalized Stigma of Mental Illness (ISMI), Isolation, physical restraint, Psychiatry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Joint Crisis PlanPatients will benefit from regular care + Joint Crisis Plan |
| Control group | No intervention | –Patients will benefit from regular care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patient having already had a Joint Crisis Plan for less than 6 months.
- Patient does not speak French
- Pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint Crisis PlanA Joint Crisis Plan will be drafted with the patient and a nurse | Procedure or surgery | Experimental group |
Primary outcome
Duration of isolation
Time frame: Months: 12
Measured in hours.
9 secondary outcomes
Perception of constraint
Time frame: Months: 12
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
Experience of discrimination and stigmatization
Time frame: Months: 12
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne QUENUM, Coordinating nurse principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Crisis Plan in people with Mental Disorders, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of isolation (time frame: Months: 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.