Clinical trial NCT05306717: Impact of the Preventive Emotions Management Questionnaire on the Rates of Isolation and Mechanical Restraint Measures in the Psychiatric Admission Unit
Official title: Impact of the Preventive Emotions Management Questionnaire on the Rates of Isolation and Mechanical Restraint Measures in the Psychiatric Admission Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Disorder
Keywords: Psychiatric Disorder
Prevention
Mechanical restraint
Isolation
Lead sponsor: Centre Hospitalier Charles Perrens, Bordeaux
Sponsor class: OTHER_GOV
First posted: 2022-04-01
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with psychiatric disorders and hospitalized in a sectoral admission unit receiving patients in care without consent

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of isolation measures.(%)
timeFrame: up to 1 year
measure: Rate of restraint measures.(%)
timeFrame: up to 1 year
Secondary outcomes:
measure: Rate of isolation measures not associated with an episode of mechanical restraint (%)
timeFrame: up to 1 year
measure: Duration of isolation measures not associated with an episode of mechanical restraint. (hours)
timeFrame: up to 1 year
measure: Rate of mechanical restraint measures (%)
timeFrame: up to 1 year
measure: Duration of mechanical restraint measures (hours)
timeFrame: up to 1 year
measure: User satisfaction score at the end of hospitalization
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Charles Perrens
state: Gironde
Study officials:
affiliation: Advanced Practice Nurse
name: Vincent BILLE
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.