Exhaustion and Needs in Frontline COVID-19 Healthcare Workers: Cross-sectional Study in a Belgian Population

NCT ID: NCT04344145

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 693 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-16
• Study Completion Date: 2020-05-29

Brief Summary

Background: In the Covid-19 pandemic context, all healthcare teams face clinical, organizational and technical challenges given the contagion, severity and mortality characteristics of the disease. A study reported the negative psychological impact on healthcare workers of this new situation, in terms of depression, anxiety and distress. Working in frontline constitutes an independent risk factor for worse mental health outcomes.

Methods: This is a cross-sectional study aiming to compare levels of burnout, emotional distress and needs between frontline Covid-19 and non-Covid-19 healthcare workers. Any physician, nurse and physiotherapist will be recruited from emergency care units and Covid-19 care units (target group) and from non-Covid-19 care units (control group) from different hospitals in Belgium. The participation will occur on a voluntary basis. Participants will be recruited from April 15th 2020 to May 15th 2020. Participants will complete self-reported questionnaires and scales. A mixed-mode data collection will be carried out, either in paper or web-based form. This mixed-mode survey will ensure the highest range of participants, considering the hygiene and organizational requirements for target care units. Assessment will provide socio-demographic characteristics and professional information. It will also measure professional fulfillment and burnout with the Stanford Professional Fulfillment Index (PFI), emotional distress with the Depression, Anxiety and Distress Scale-Short Form (DASS-21), sleep disturbance with the Insomnia Severity Index (ISI) and needs with the Needs and Difficulties Inventory (developed for the study).

Hypothesis: This study is based on the hypothesis that higher levels of burnout, depression, anxiety and stress will be found in frontline Covid-19 healthcare workers than in non-Covid-19 healthcare workers. Considering the unprecedented challenges for healthcare workers and organizations, and considering the exploratory nature of the study, no hypothesis is made for the needs of the healthcare workers.

Statistical Analysis: Means and standard deviation will be calculated for the PFI, the DASS-21, the ISI and the NDI. Multivariate Analysis of Variance (MANOVA) will be performed including the PFI, the DASS-21 and the ISI scores to test the effect of group (work position), occupation and the two-way group × occupation interaction effect. Age, gender, profession, sector of activity, job status and job experience will be entered as covariate. Odds ratio will be also provided. All tests are two-tailed and alpha is set at .05. All analyzes will be performed using IBM SPSS®, version 26.

Detailed Description

This is a cross-sectional comparative study based on self-reported questionnaires and scales (validated for the most part) assessing the levels of burnout, emotional distress, sleep disturbance and needs in frontline Covid-19 healthcare workers vs non-Covid-19 healthcare workers. The enrollment and the course of the study will be carried out on site. Participants are volunteers and are informed about the objectives and methods of the study.

Any physician, nurse or physiotherapist (referred as "healthcare worker") actively working in a medical care unit from different medical facilities will be informed of the study. An email containing information regarding the study and its implications will be sent. If required by the care unit they work in, potential participants will also be invited to a one-time information session. Potential participants will also be given an information form during this oral information session. Participants will be recruited from April 15th to May 15th 2020.

The assessment will be proposed by paper or web-based self-reported questionnaires and scales. This mixed-mode survey will not be randomized and will ensure the highest range of participants, considering the hygiene and organizational requirements in the target units. The assessment time will be proposed at the participant's inclusion. Because of the mixed-mode survey and anonymity of data, the completion of questionnaires and scales will be considered as informed consent as stated in the information form received by the participants.

The questionnaires and scales include sociodemographic characteristics, professional information, the Professional Fulfillment Index (PFI), the Depression, Anxiety and Stress Scale-Short Form (DASS-21), the Insomnia Severity Index (ISI) and the Needs and Difficulties Inventory (NDI, developed for the study).

Healthcare workers from emergency units, non-intensive Covid-19 and intensive Covid-19 units will be in the target group. Healthcare workers from non-Covid-19 units will be in the control group. In terms of enrollment, 200 participants (100 in each group) are expected. The objectives of the study will be reached by statistical comparison of these groups.

In terms of data collection, the data manager collects data from paper version and electronic version. For the paper version, participants will be able to deposit their assessment in specific drop boxes available in the concerned care units. Then, data manager's assistant will be in charge of producing a digital copy. The data from the paper version will undergo double encoding (by two assistants, not linked to the principal investigator) in order to reduce encoding errors. The electronic data will be stored on a secure platform, linked to the Free University of Brussels. The paper version will be stored in a secure location within Erasme Hospital (Brussels, Belgium), accessible only by the principal investigator and the data manager. Evaluations, whether paper or electronic, will be destroyed 1 month after study completion date.

Statistical analysis will consist firstly in a comparative analysis of participants' sociodemographic and professional characteristics using Chi-squared (or Student t test, Mann-Whitney U test when applicable for continuous variable) test for each categorical variable. Secondly, descriptive analyses will be performed on severity categories for professional fulfillment, burnout, insomnia, depression, anxiety and stress. Differences between groups regarding severity levels will be tested using X2. A two-way MANOVA will be used to test main effects of working position (group effect), occupation type (occupation effect) and to test a group × occupation interaction effect on fulfillment, burnout, insomnia and mental health scores. The two-way MANOVA will be adjusted for age, gender, marital status, workload and job status. Multivariable logistic regression analyses will be performed to estimate risk factors for burnout, clinically significant insomnia and severe to extremely severe depression, anxiety and stress. These will be presented as odds ratios, with 95% confidence intervals, adjusting for confounders. All tests will be two-tailed and alpha was set at .05. All analyses will be performed using IBM SPSS® v26.

Conditions

COVID-19

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Target Group

This group includes frontline healthcare workers who are actively involved in the management of the Covid-19 outbreak: from emergency units, non-intensive Covid-19 and intensive Covid-19 units. They will fill self-reported questionnaires and scales upon their inclusion.

No interventions assigned to this group

Control group

This group includes healthcare workers who are actively involved in usual medical care units, referred in this study as non-Covid-19 units. They will fill same self-reported questionnaires and scales than those filled in the Target group, also upon their inclusion.This group will be the comparator of the Target Group to assess the "frontline Covid-19" condition.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Ability to read, speak and write in French;
• Being professionally active (doctor, nurse or physiotherapist) within a medical care unit;

Exclusion Criteria

• Having been off work (for medical, professional or personal reasons) for ≥ 3 weeks before first assessment time.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Libre de Bruxelles

OTHER

Sponsor Role: lead

Responsible Party

Dr Julien Tiete

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julien Tiete, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Libre de Bruxelles

Locations

Hôpital de Warquignies

Boussu, Hainaut, Belgium

Hôpital de Jolimont

Haine-Saint-Paul, Hainaut, Belgium

Hôpital de Lobbes

Lobbes, Hainaut, Belgium

Hôpital de Mons

Mons, Hainaut, Belgium

Erasme Hospital CUB

Brussels, , Belgium

Countries

Belgium

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Other Identifiers

PSY-ENCOVID19

Identifier Type: -

Identifier Source: org_study_id