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

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

416

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Centre Hospitalier Charles Perrens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People with psychiatric disorders and hospitalized in a sectoral admission unit receiving patients in care without consent

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Epidemiology
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 year
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
up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of isolation measures not associated with an episode of mechanical restraint (%)
Time Frame: up to 1 year
up to 1 year
Duration of isolation measures not associated with an episode of mechanical restraint. (hours)
Time Frame: up to 1 year
up to 1 year
Rate of mechanical restraint measures (%)
Time Frame: up to 1 year
up to 1 year
Duration of mechanical restraint measures (hours)
Time Frame: up to 1 year
up to 1 year
User satisfaction score at the end of hospitalization
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Vincent BILLE, Advanced Practice Nurse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A03039-32

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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