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Completed

NCT Number: NCT05306717

Impact of the Preventive Emotions Management Questionnaire on the Rates of Isolation and Mechanical Restraint Measures in the Psychiatric Admission Unit

This observational study assesses whether the use of the QPGE has an impact on the rates of isolation and mechanical restraint in adult psychiatric admission units. It is supplemented by a qualitative survey that will collect the experience of caregivers using the QPGE.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Charles Perrens

Bordeaux, Gironde, 33000, France

About this study

The use of isolation and mechanical restraint in psychiatry has deleterious consequences for the patient. Caregivers also testify to their dissatisfaction with using these methods. The Coping Agreement Questionnaire (CAQ) is a form presented to the patient admitted to a psychiatric unit in the United States that has shown a significant effect on the reduction of coercive measures. It has been translated into French under the name Questionnaire Préventif de la Gestion des Emotions (QPGE). In France, the Haute Autorité de Santé has been recommending this type of tool since 2016 in the form of shared prevention plans to better prevent moments of violence.

The main objective is to assess whether the use of a shared prevention plan based on the Preventive Emotions Management Questionnaire (QPGE) can reduce the rates of isolation measures and mechanical restraint in hospitalized people. in a sectoral admission unit receiving patients in care without consent.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have been hospitalized in psychiatric admission unit with an entry date between January 1, 2020 and December 31, 2020
  • Be at least 18 years old at the time of hospitalization
  • Master the French language in order to have benefited from the QPGE and the satisfaction questionnaire

Exclusion criteria

  • Being the subject of an isolation and/or restraint measure, decided in another unit before, during the transfer to the study places
  • To have objected to the use of data collected during hospitalization following the information in the welcome booklet

Treatment and study plan

Questionnaire

Other

The study will compare the rates of isolation and restraint of the two sectoral admission units welcoming people in care without consent for a period of one year. The impact of the QPGE on the satisfaction scores will be systematically evaluated by a self-questionnaire for patients at the end of hospitalization. The QPGE is administered by a nurse during the reception interview of the patient in the unit.

Primary outcomes

  1. Rate of isolation measures.(%)

    Time frame: up to 1 year

    Isolation and/or restraint notified in the registers dedicated to the monitoring of measures restricting liberty in the admission units during the study period

  2. Rate of restraint measures.(%)

    Time frame: up to 1 year

    Isolation and/or restraint notified in the registers dedicated to the monitoring of measures restricting liberty in the admission units during the study period

Secondary outcomes

  1. Rate of isolation measures not associated with an episode of mechanical restraint (%)

    Time frame: up to 1 year

  2. Duration of isolation measures not associated with an episode of mechanical restraint. (hours)

    Time frame: up to 1 year

  3. Rate of mechanical restraint measures (%)

    Time frame: up to 1 year

  4. Duration of mechanical restraint measures (hours)

    Time frame: up to 1 year

  5. User satisfaction score at the end of hospitalization

    Time frame: up to 1 year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Charles Perrens, Bordeaux

Other Gov

Registry information

Acronym: PACT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2022
Registry last updated
Jun 18, 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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