NCT04441476

Brief Summary

The intensive care unit occupies a particular place in our health care system. The urgency of the clinical situations, the proportion of deaths encountered, and the daily workload is likely to generate suffering among staff. The health crisis linked to SARS-COV-2 is unprecedented and has leads to the unprecedented mobilisation of care providers, particularly in the ICU. Faced with the massive and growing influx of patients, human, therapeutic and material resources are overwhelmed and the teams are faced with an unusually heavy workload in a context of extreme tension. These professionals are thus exposed to a risk of over-investment, in a context of acute and repetitive stress, over an indeterminate period of time combining workload, emotional intensity with specific ethical issues, simultaneously affecting the professional sphere but also the personal and family sphere (confinement, risk of contamination). Now more than ever, the mental health of caregivers is an important concern, as highlighted by the CCNE. Mental health is understood in the way in which the individual responds specifically to work-related suffering by developing individual and collective defensive strategies. Thus, the issue of mental health in the ICU cannot be considered without taking into account the strategies that professionals put in place to combat stress and to contribute or not to the construction and stabilization of the work collective (collaboration, support). Ethical and/or psychological support systems have been set up in most of the establishments involved in the care of Covid-19 patients. However, the adequacy of these systems relative to the needs of professionals during and after the crisis is not yet known. We hypothesize that the psychological and social repercussions of this pandemic as well as the individual and collective strategies deployed by ICU care providers to deal with it will evolve in view of the progression of the crisis but also of the various types of support, particularly psychological and/or ethical, available to them.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,080

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

March 30, 2021

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

June 17, 2020

Last Update Submit

March 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • PS-ICU Scale Score

    This scale integrates generic stressors as well as factors specific to intensive care and crises.

    Through study completion, an average of 6 months after the epidemic peak

Study Arms (1)

ICU staff

Other: QuestionnairesOther: psychological and sociological interviews

Interventions

An online questionnaire (Limesurvey platform) will be made available at 4 different times (M0, M1, M2 and M6). * The first questionnaires (M0 and M1) will include a component for professional characterization. Generic and specific stress factors related to ICU and the current pandemic and collective and individual defensive strategies will also be collected in M0 and M1. * At M2 and M6, the traumatic impact of the crisis, burnout, signs of depression and recourse to internal or external support in the department (occupational medicine, support unit) will be collected.

ICU staff

conducting semi-directive psychological interviews (40 interviews in M2, 40 interviews in M6). sociological interviews: 40 (20 in M1-M2 then 20 in M6) in order to understand the consequences of the epidemic on daily life, both intra-family and micro-social.

ICU staff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

nursing staff in French hospitals

You may qualify if:

  • The study population is the entire ICU staff of the participating centres, whether they are permanently or transiently assigned to these units and/or the institution, whether they are students or not.
  • Professionals involved in psychological and ethical support structures may also be interviewed to provide the information necessary to describe and evaluate the organisations and their evolution.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 22, 2020

Study Start

April 21, 2020

Primary Completion

December 21, 2020

Study Completion

December 21, 2020

Last Updated

March 30, 2021

Record last verified: 2020-06

Locations