Psychiatric DisorderPACTNCT05306717
Impact of the Preventive Emotions Management Questionnaire on the Rates of Isolation and Mechanical Restraint Measures in the Psychiatric Admission Unit
An observational study of Psychiatric Disorder, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- Questionnaire
- How many people
- 416 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with psychiatric disorders and hospitalized in a sectoral admission unit receiving patients in care without consent
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Psychiatric Disorder
- Being tested
- Questionnaire
- Keywords
- Psychiatric Disorder, Prevention, Mechanical restraint, Isolation
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 year
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
Measured: up to 1 year
Secondary outcomes (5)
Rate of isolation measures not associated with an episode of mechanical restraint (%)
Measured: up to 1 year
Duration of isolation measures not associated with an episode of mechanical restraint. (hours)
Measured: up to 1 year
Rate of mechanical restraint measures (%)
Measured: up to 1 year
Duration of mechanical restraint measures (hours)
Measured: up to 1 year
User satisfaction score at the end of hospitalization
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vincent BILLE, Study director, Advanced Practice Nurse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306717
- Sponsor's protocol ID
- 2021-A03039-32
- Acronym
- PACT
- Status last verified
- Jun 2024
- First submitted
- 14 Mar 2022
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23438697Riahi 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.
PubMed 26809740Bowers 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.
PubMed 17333953Bowers 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.
PubMed 24460906
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Preventive Emotions Management Questionnaire on the Rates of Isolation and Mechanical Restraint Measures in the Psychiatric Admission Unit
- ClinicalTrials.gov ID
- NCT05306717
- Acronym / sponsor ID
- PACT / 2021-A03039-32
- Conditions
- Psychiatric Disorder
- Keywords
- Psychiatric Disorder, Prevention, Mechanical restraint, Isolation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidemiology | – | Other: QuestionnaireThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with psychiatric disorders and hospitalized in a sectoral admission unit receiving patients in care without consent
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe 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. | Other | Epidemiology |
Primary outcome
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
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
5 secondary outcomes
Rate of isolation measures not associated with an episode of mechanical restraint (%)
Time frame: up to 1 year
Duration of isolation measures not associated with an episode of mechanical restraint. (hours)
Time frame: up to 1 year
Rate of mechanical restraint measures (%)
Time frame: up to 1 year
Duration of mechanical restraint measures (hours)
Time frame: up to 1 year
User satisfaction score at the end of hospitalization
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Results publication: PubMed 23438697Beghi 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.
- Results publication: PubMed 26809740Riahi 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.
- Results publication: PubMed 17333953Bowers 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.
- Results publication: PubMed 24460906Bowers 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.
- Individual participant dataSharing planned: No
Related trials for Psychiatric Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent BILLE study director
Advanced Practice Nurse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of isolation measures.(%) (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306717, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.