- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05306717
Impact of the Preventive Emotions Management Questionnaire on the Rates of Isolation and Mechanical Restraint Measures in the Psychiatric Admission Unit (PACT)
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
Enrollment (Actual)
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
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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
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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
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up to 1 year
|
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Rate of mechanical restraint measures (%)
Time Frame: up to 1 year
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up to 1 year
|
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Duration of mechanical restraint measures (hours)
Time Frame: up to 1 year
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up to 1 year
|
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User satisfaction score at the end of hospitalization
Time Frame: up to 1 year
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up to 1 year
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Collaborators and Investigators
Investigators
- Study Director: Vincent BILLE, Advanced Practice Nurse
Publications and helpful links
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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