Simulation-based Education for Managing Stress in ICU Nurses

NCT02672072 | Completed

• 2 other identifiers: 2015-04RCAPHM15_0036
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

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

Conditions

Professional Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Stress evaluated by the Karasek scale

  enrollment and 1 year

• Psychosocial risks (Copenhagen Psychosocial Questionnaire)

  enrollment, 6 months and one year

• Burnout (Maslach Burnout Inventory)

  enrollment, 6 months and one year

• Intent-to-leave (Number of enrolled nurses who leave the actual ICU)

  enrollment, 6 months and one year

• Quality of life (visual analogic scale)

  enrollment, 6 months and one year

Study Arms (2)

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: 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

Interventions

Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team) OTHER

Simulation group

questionnaire to define the presence of job strain at 6 months OTHER

Control group; Simulation group

questionnaire to define the presence of job strain at 12 months OTHER

Control group; Simulation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

AP-HM

Marseille, France

Location

Related Publications (1)

• 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.

  PMID: 30357264 DERIVED

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Urielle DESALBRES

  AP-HM

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 3, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-03

Locations

FR (1)