Simulation-based Education for Managing Stress in ICU Nurses (SISTRESSREA)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Professional Stress

Treatments: 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 12 months; Other: questionnaire to define the presence of job strain at 6 months

Study type: Observational

Funder types: Other

Identifiers

NCT02672072

RCAPHM15_0036 (Other Identifier)

2015-04

Details and patient eligibility

About

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

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

198 participants in 2 patient groups

Control group

Description:

5-day specific training with dedicated scenario done by an ICU expert simulation team after the period of the study

Treatment:

Other: questionnaire to define the presence of job strain at 6 months

Other: questionnaire to define the presence of job strain at 12 months

Simulation group

Description:

5-day specific training with dedicated scenario done by an ICU expert simulation team

Treatment:

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