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OpenTrials
Completed

NCT Number: NCT03984682

Impact of Joint Crisis Plan

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Joint Crisis Plan

Procedure

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

Primary outcomes

  1. Duration of isolation

    Time frame: Months: 12

    Measured in hours.

Secondary outcomes

  1. 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.

  2. Number of hospitalizations

    Time frame: Months: 12

  3. Number of isolation

    Time frame: Months: 12

  4. Number of physical restraints

    Time frame: Months: 12

  5. Duration of physical restraint

    Time frame: Months: 12

    Measured in hours

  6. 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.

  7. Number of violent events

    Time frame: Months: 12

  8. Number of emergency room visits for psychiatric opinion

    Time frame: Months: 12

  9. Adhesion and feeling of nurses in relation to Joint Crisis Plan

    Time frame: Months: 12

    Measured by focus-groups and individual interviews of nurses

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: PLANCO-ISO

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Jun 13, 2019
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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