Effect of in Situ Simulation on Quality of Work Life and Multiprofessional Team Effectiveness in the Intensive Care Unit (EFFIQUASS)

The lack of specific, personalized training for intensive care workers can lead to a deterioration in quality of life at work, and can result in burnout, absenteeism or wanting to leave the service. The aim of this study is to assess the impact of in situ simulation on quality of work life and the effectiveness of multi-professional teamwork in intensive care.

Study Overview

• Status: Completed
• Conditions: Simulation; Quality of Work Life; Burn-out
• Intervention / Treatment: Procedure: In-situ simulation; Other: Role-playing using a simulation scenario; Other: Questionnaires

Detailed Description

Paramedics in intensive care are particularly exposed to the risk of burnout, which is multifactorial (psychologically and physically challenging environment, life-threatening emergency context, etc.). Personal assistance professions require a high level of compassion, leading to a positive feeling of compassionate satisfaction, i.e. the satisfaction of helping others. Compassion fatigue leads to a reduction in job satisfaction, culminating in burnout. Factors negatively influencing compassion satisfaction are the absence of specific and adapted training, or the lack of support from the hierarchy. Among the pedagogical tools available, in situ simulation could be used to respond to a specific and personalized training request from a care department. The study will be carried out in the cardio-thoracic intensive care unit at Montpellier University Hospital, comparing 2 groups to assess the effect of simulation on paramedics. Paramedics will be randomized into 2 groups, with stratification on diploma (nursing assistant or nurse): group A benefiting from a simulation program, and group B not benefiting from it during the study.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • University Hospital of Montpellier
  • Occitanie
    • Montpellier, Occitanie, France, 34090
      • Departement of anesthesia cardio-thoracic and vascular resuscitation Arnaud de Vinelleuve Hospital CHU of Montpellier.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Paramedical staff (nurse and nursing assistant) in the cardiothoracic intensive care unit at Montpellier University Hospital.
• Acceptance of being filmed for direct video transcription during the intervention

Exclusion Criteria:

• Refusal of consent or inability to give consent (guardianship, curatorship)
• Paramedics intending to leave the department before the end of the study.
• Not affiliated to a French social security scheme or not a beneficiary of such a scheme

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control	Other: Role-playing using a simulation scenario; Team performance in critical situations, assessed during a simulation scenario for all participants. The assessment will be carried out blind by 1 examiner, trained in CRM (Crisis Resource Management) analysis in simulation and debriefing.; Other: Questionnaires; Quality of lige questionnaire Pro-QOL, Karasek questionnaire, Satisfaction questionnaire at work : WRQoL, Work Life Balance scale, Mayo Hight Team Performance scale will be completed at baseline and at 6 months
Experimental: In-situ stimulation	Procedure: In-situ simulation; Each simulation session takes place over one day, with 4 scenarios recreating life-threatening emergency situations (cardiorespiratory arrest, hemorrhagic shock, etc.). Each scenario is designed to meet specific pedagogical objectives, which will be debriefed by simulation trainers: crisis resource management (communication, alerting, etc.) or organization of multi-professional teamwork; Other: Role-playing using a simulation scenario; Team performance in critical situations, assessed during a simulation scenario for all participants. The assessment will be carried out blind by 1 examiner, trained in CRM (Crisis Resource Management) analysis in simulation and debriefing.; Other: Questionnaires; Quality of lige questionnaire Pro-QOL, Karasek questionnaire, Satisfaction questionnaire at work : WRQoL, Work Life Balance scale, Mayo Hight Team Performance scale will be completed at baseline and at 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subscale of compassion satisfaction of ProQOL-5 (Professional Quality of Life Scale version 5	The ProQOL is composed of 30 questions with 3 subscales : compassion satisfaction, burnout and vicarious trauma. Each response are scored from 1 to 5 . The subscale Compassion Satisfaction is composed of 10 questions. A score ≤ 22 indicates a deterioration in compassion satisfaction.	From baseline to the end of the follow up at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Burnout subscale of ProQOL-5	The ProQOL is composed of 30 questions with 3 subscales : compassion satisfaction, burnout and vicarious trauma. Each response are scored from 1 to 5 . The subscale Burnout is composed of 10 questions. A score ≥42 indicates a hight burnout level	From baseline to the end of the follow up at 6 months
Vicarious trauma subscale of ProQOL	The ProQOL is composed of 30 questions with 3 subscales : compassion satisfaction, burnout and vicarious trauma. Each response are scored from 1 to 5 . The subscale " Vicarious Trauma " is composed of 10 questions. A score ≥42 indicates a hight vicarious trauma level	From baseline to the end of the follow up at 6 months
Karasek	The Karasek self-questionnaire assess the "job strain ". It is composed of 3 susbscales : the psychological demand, the Decision latitude and the Social support at work. A decision-making latitude score < 72 and a Psychological Demand score ≥ 21 is associated with a Job Strain	From baseline to the end of the follow up at 6 months
WRQoL (QwOL)	The Work-related Quality of Life is composed of 23 questions. It evaluates 6 dimensions: the feeling of being involved in decisions (3 assertions), appreciation of work organization and general satisfaction (7), help with external demands (3), satisfaction with working conditions (3), satisfaction with the ability to do one's job (6) and stress at work (2). A higher score is associated to a highter quality of life at work.	From baseline to the end of the follow up at 6 months
Work-Life Balance scale questionnaire	The Work-Life Balance scale assess the impact of work on personal quality of life. It is composed of 3 subscales about : Work interferes with personal life (WIPL), Personal interferes with work (PLIW), Satisfaction with quality of personal and work life (WPLE). A high score is associated with significant interference of work with private life	From baseline to the end of the follow up at 6 months
Mayo High Performance Team Scale	The Mayo High Performance Team Scale is a standardized evaluation scale, designed to meet non-technical teaching objectives named CRM (Crisis Resource Management). This scale assess the effectiveness and performance of teams of emergency care workers	From baseline to the end of the follow up at 6 months
Adverse event	Occurrence of adverse events or errors linked to a lack of interprofessional communication	From baseline to the end of the follow up at 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Actual): April 17, 2026
• Study Completion (Actual): April 17, 2026

Study Registration Dates

• First Submitted: April 18, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Stress; Performance; Caregivers; Intensive care; Quality of care; Teamwork; In-situ simulation; Quality of working life
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Burnout, Psychological; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: RECHMPL24_0497

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
• product manufactured in and exported from the U.S.: No