Simulation-based Education for Managing Stress in ICU Nurses

Professional Stress Clinical Trial

— SISTRESSREA  

Official title:

Simulation-based Education for Managing Stress in ICU Nurses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672072
• Other study ID #: 2015-04
• Secondary ID: RCAPHM15_0036
• Status: Completed
• Start date: January 2016
• Est. completion date: May 2018

Study information

• Verified date: March 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: May 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Professional Stress

Intervention

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

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

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

Locations

Country	Name	City	State
France	AP-HM	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stress evaluated by the Karasek scale	Karasek questionnaire	enrollment and 1 year
Secondary	Psychosocial risks (Copenhagen Psychosocial Questionnaire)	French version of the COPSOQ (Copenhagen Psychosocial Questionnaire)	enrollment, 6 months and one year
Secondary	Burnout (Maslach Burnout Inventory)	French version of the Maslach Burnout Inventory	enrollment, 6 months and one year
Secondary	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
Secondary	Quality of life (visual analogic scale)	visual analogic scale from 0 to 10	enrollment, 6 months and one year