Impact of the Preventive Emotions Management Questionnaire on the Rates of Isolation and Mechanical Restraint Measures in the Psychiatric Admission Unit (PACT)
June 17, 2024 updated by: Centre Hospitalier Charles Perrens, Bordeaux
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
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
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Gironde
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Bordeaux, Gironde, France, 33000
- Centre Hospitalier Charles Perrens
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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 |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of isolation measures.(%)
Time Frame: up to 1 year
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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
|
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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
|
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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
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up to 1 year
|
|
Duration of mechanical restraint measures (hours)
Time Frame: up to 1 year
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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.
General Publications
- Bowers L, Alexander J, Bilgin H, Botha M, Dack C, James K, Jarrett M, Jeffery D, Nijman H, Owiti JA, Papadopoulos C, Ross J, Wright S, Stewart D. Safewards: the empirical basis of the model and a critical appraisal. J Psychiatr Ment Health Nurs. 2014 May;21(4):354-64. doi: 10.1111/jpm.12085. Epub 2014 Jan 24.
- Beghi M, Peroni F, Gabola P, Rossetti A, Cornaggia CM. Prevalence and risk factors for the use of restraint in psychiatry: a systematic review. Riv Psichiatr. 2013 Jan-Feb;48(1):10-22. doi: 10.1708/1228.13611.
- Riahi S, Thomson G, Duxbury J. An integrative review exploring decision-making factors influencing mental health nurses in the use of restraint. J Psychiatr Ment Health Nurs. 2016 Mar;23(2):116-28. doi: 10.1111/jpm.12285. Epub 2016 Jan 26.
- Bowers L, Allan T, Simpson A, Nijman H, Warren J. Adverse incidents, patient flow and nursing workforce variables on acute psychiatric wards: the Tompkins Acute Ward Study. Int J Soc Psychiatry. 2007 Jan;53(1):75-84. doi: 10.1177/0020764007075011.
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
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