Clinical trial NCT02672072: Simulation-based Education for Managing Stress in ICU Nurses
Official title: Simulation-based Education for Managing Stress in ICU Nurses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Professional Stress
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

Brief 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


Eligibility 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

Primary outcomes:
measure: Presence of job stain evaluated by the French version of the Karasek scale
timeFrame: 6 months
Secondary outcomes:
measure: Stress evaluated by the Karasek scale
timeFrame: enrollment and 1 year
measure: Psychosocial risks (Copenhagen Psychosocial Questionnaire)
timeFrame: enrollment, 6 months and one year
measure: Burnout (Maslach Burnout Inventory)
timeFrame: enrollment, 6 months and one year
measure: Intent-to-leave (Number of enrolled nurses who leave the actual ICU)
timeFrame: enrollment, 6 months and one year
measure: Quality of life (visual analogic scale)
timeFrame: enrollment, 6 months and one year
Other outcomes:
Locations:
city: Marseille
country: France
facility: AP-HM
Study officials:
affiliation: AP-HM
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
citation: 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.