Simulation-based Education for Managing Stress in ICU Nurses

Study Overview
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Brief Summary
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I. Main outcome Decrease of the stress evaluated 6 months after training. Stress is defined as the presence of job strain as defined by Karasek. II. Main secondary outcomes ICU nurses stress at one year Burnout Intent-to-leave the ICU Quality of life III. Design Prospective, randomized, open study comparing 2 groups of ICU nurses: Simulation group and Control group Nurses from 9 different adult ICUs will be included. Stratification by ICU will be done (to take into account differences between the ICUs regarding organization, activity, patients…). This study is observational because nurses can participate to this training when they want. The fact that nurses are in control group delays their participation to this training but does not forbid them to particpate. The nurses from control group will participate to training at the end of study. IV. Specific measures Control group: none Simulation group: 5-day specific training with dedicated scenario done by an ICU expert simulation team V. Study duration 48 months VI. Ethical aspects - Reglementary concerns Study accepted by the Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé (CCTIRS) and by the Commission Nationale de l'Informatique et des Libertés (CNIL) Information to the participants prior inclusion VII. Study population Job strain evaluated in a French study was 59% . The same rate was observed in a survey done in our institution (Assistance Publique Hôpitaux de Marseille). We therefore hypothesized that the intervention (simulation) should be able to reduce the job strain from 59% to 45% of the participants. With a power of 80% and a risk a of 5%, this study needs to include 185 patients per arm. To take into account few participants who will not complete the study, we aimed to include a total of 400 ICU nurses. VIII Results An interim analysis will be performed after 200 inclusions

Official Title
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Simulation-based Education for Managing Stress in ICU Nurses

Conditions
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Professional Stress

Intervention / Treatment
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* Other: Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team)
* Other: questionnaire to define the presence of job strain at 6 months
* Other: questionnaire to define the presence of job strain at 12 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU nurses from adult ICUs with a professional experience in the actual ICU of at least 6 months and no decision to leave the ICU at the time of enrollment Non inclusion Criteria: Less than 6 months of professional activity in the actual ICU at the time of enrollment Intent-to-leave in the next 6-month period Previous experience of this simulation program Pregnant women Exclusion Criteria : ICU nurses who leave their city during the study period Pregnant women who miss their job during at least 4 weeks during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>5-day specific training with dedicated scenario done by an ICU expert simulation team after the period of the study | Other: questionnaire to define the presence of job strain at 6 months<br> <br> Other: questionnaire to define the presence of job strain at 12 months<br> <br> |
| Simulation group<br>5-day specific training with dedicated scenario done by an ICU expert simulation team | Other: Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team)<br> <br> Other: questionnaire to define the presence of job strain at 6 months<br> <br> Other: questionnaire to define the presence of job strain at 12 months<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of job stain evaluated by the French version of the Karasek scale | Presence of job strain: psychological demand of work > 21 and decision latitude < 72 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress evaluated by the Karasek scale | Karasek questionnaire | enrollment and 1 year | 
| Psychosocial risks (Copenhagen Psychosocial Questionnaire) | French version of the COPSOQ (Copenhagen Psychosocial Questionnaire) | enrollment, 6 months and one year | 
| Burnout (Maslach Burnout Inventory) | French version of the Maslach Burnout Inventory | enrollment, 6 months and one year | 
| Intent-to-leave (Number of enrolled nurses who leave the actual ICU) | Number of enrolled nurses who leave the actual ICU | enrollment, 6 months and one year | 
| Quality of life (visual analogic scale) | visual analogic scale from 0 to 10 | enrollment, 6 months and one year |