Please select the eligibility criteria that correspond to the clinical trial below.
Title: Simulation-based Education for Managing Stress in ICU Nurses
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


Options:
A: 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
B: Inclusion Criteria:

1. Location: newborn center, i.e. the NICU or a step down unit
2. Provider:

   1. Primary work place is the Newborn Center
   2. Full time equivalent of \>=40%
   3. Date of hire more than 4 weeks prior to start of the intervention
3. Provider groups:

   1. Attendings that identify your newborn center as their primary site of work (not physicians from satellite NICUs)
   2. NICU fellows
   3. Nurse practitioners
   4. Physician Assistants
   5. Nurses, including nurse leadership (managers, educators)
   6. Nurse Assistant
   7. Respiratory care providers
   8. Transport specialists if primarily neonatal transport team
   9. Newborn Center Social workers
   10. Newborn Center Clerks
   11. Newborn Center Pharmacists
   12. Newborn Center Physical, Occupational, Speech, and Developmental Therapists
   13. Newborn Center Nutritionists
   14. Newborn Center Lactation Consultants

Exclusion Criteria:

1. Location: Labor and delivery or the newborn nursery
2. Provider: Work is delivered mostly outside the newborn center (this may affect providers who delivery services across the hospital such as residents, surgeons, anesthesia, consultants, nutritionists, PT/OT (these are included if they are mostly dedicated to the newborn center)
3. Float personnel
4. Does not speak english
5. Cannot operate computer or smart phone
C: Inclusion Criteria:

* Employed as a healthcare provider, practicing primarily in a hospital setting for at least 20 hours per week.
* Positive symptoms of burnout measured via the Maslach Burnout Inventory (MBI):

  * emotional exhaustion score of \>17, or
  * depersonalization score of \>7, or
  * personal accomplishment score of \< 31.

Exclusion Criteria:

• Unwillingness to participate in any of the four creative arts interventions.
D: Inclusion Criteria: All members of the intern class (e.g. post-graduate year 1) of pediatric residency programs who enrolled in this study will be eligible to participate in this study.

Exclusion Criteria: None.

Answer: A