NCT02672072

Simulation-based Education for Managing Stress in ICU Nurses

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 198 (actual)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Professional Stress

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-02-01
• Completion: 2018-05-01
• First posted: 2016-02-03
• Last updated: 2018-05-30

Locations

1 site across 1 country: France