Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RCAPHM15_0036 | Other Identifier | APHM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | 5-day specific training with dedicated scenario done by an ICU expert simulation team after the period of the study |
| |
| Simulation group | 5-day specific training with dedicated scenario done by an ICU expert simulation team |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team) | Other |
| ||
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Non inclusion Criteria:
Exclusion Criteria :
Not provided
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Urielle DESALBRES | AP-HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HM | Marseille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30357264 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| questionnaire to define the presence of job strain at 6 months |
| Other |
|
| questionnaire to define the presence of job strain at 12 months | Other |
|
| 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 |
| ID | Term |
|---|---|
| D000073397 | Occupational Stress |
| ID | Term |
|---|---|
| D009784 | Occupational Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided