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

Psychiatric Disorder Clinical Trial

— PACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05306717
• Other study ID #: 2021-A03039-32
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Charles Perrens, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Other:
• Questionnaire
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Charles Perrens	Bordeaux	Gironde

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Charles Perrens, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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; — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of isolation measures.(%)	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
Primary	Rate of restraint measures.(%)	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	Rate of isolation measures not associated with an episode of mechanical restraint (%)		up to 1 year
Secondary	Duration of isolation measures not associated with an episode of mechanical restraint. (hours)		up to 1 year
Secondary	Rate of mechanical restraint measures (%)		up to 1 year
Secondary	Duration of mechanical restraint measures (hours)		up to 1 year
Secondary	User satisfaction score at the end of hospitalization		up to 1 year