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

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ClinicalTrials.gov Identifier: NCT02672072
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date January 22, 2016
First Posted Date February 3, 2016
Last Update Posted Date May 30, 2018
Actual Study Start Date January 2016
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2018)
Presence of job stain evaluated by the French version of the Karasek scale [ Time Frame: 6 months ]
Presence of job strain: psychological demand of work > 21 and decision latitude < 72
Original Primary Outcome Measures
 (submitted: January 29, 2016)
Presence of job stain evaluated by the French version of the Karasek scale [ Time Frame: 6 months ]
Presence of job strain: psychological demand of work > 20 and decision latitude < 71
Change History
Current Secondary Outcome Measures
 (submitted: January 29, 2016)
  • Stress evaluated by the Karasek scale [ Time Frame: enrollment and 1 year ]
    Karasek questionnaire
  • Psychosocial risks (Copenhagen Psychosocial Questionnaire) [ Time Frame: enrollment, 6 months and one year ]
    French version of the COPSOQ (Copenhagen Psychosocial Questionnaire)
  • Burnout (Maslach Burnout Inventory) [ Time Frame: enrollment, 6 months and one year ]
    French version of the Maslach Burnout Inventory
  • Intent-to-leave (Number of enrolled nurses who leave the actual ICU) [ Time Frame: enrollment, 6 months and one year ]
    Number of enrolled nurses who leave the actual ICU
  • Quality of life (visual analogic scale) [ Time Frame: enrollment, 6 months and one year ]
    visual analogic scale from 0 to 10
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Simulation-based Education for Managing Stress in ICU Nurses
Official 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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Professional Stress
Intervention
  • 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
Study Groups/Cohorts
  • Control group
    5-day specific training with dedicated scenario done by an ICU expert simulation team after the period of the study
    Interventions:
    • 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
    Interventions:
    • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 25, 2018)
198
Original Estimated Enrollment
 (submitted: January 29, 2016)
400
Actual Study Completion Date May 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02672072
Other Study ID Numbers 2015-04
RCAPHM15_0036 ( Other Identifier: APHM )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor Assistance Publique Hopitaux De Marseille
Collaborators Not Provided
Investigators
Study Director: Urielle DESALBRES AP-HM
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date March 2018