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

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

Study Overview

• Status: Completed
• Conditions: Professional Stress
• Intervention / 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; Other: Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team)

• Study Type: Observational
• Enrollment (Actual): 198

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • AP-HM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Urielle DESALBRES, AP-HM

Publications and helpful links

General Publications

• El Khamali R, Mouaci A, Valera S, Cano-Chervel M, Pinglis C, Sanz C, Allal A, Attard V, Malardier J, Delfino M, D'Anna F, Rostini P, Aguilard S, Berthias K, Cresta B, Iride F, Reynaud V, Suard J, Syja W, Vankiersbilck C, Chevalier N, Inthavong K, Forel JM, Baumstarck K, Papazian L; SISTRESSREA Study Group. Effects of a Multimodal Program Including Simulation on Job Strain Among Nurses Working in Intensive Care Units: A Randomized Clinical Trial. JAMA. 2018 Nov 20;320(19):1988-1997. doi: 10.1001/jama.2018.14284.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Occupational Stress
• Other Study ID Numbers: 2015-04; RCAPHM15_0036 (Other Identifier: APHM)