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

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ClinicalTrials.gov Identifier: NCT04344145
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Julien Tiete, Université Libre de Bruxelles

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. Analysis of variance (ANOVA) will be performed for the PFI, the DASS-21 and the ISI (group effect). Age, gender, profession, sector of activity, job status and job experience will be entered as covariate. Effect sizes will be reported with the eta-squared (η²) given by the ANOVA. All tests are two-tailed and alpha is set at .05. All analyzes will be performed using IBM SPSS®, version 26.


Condition or disease
COVID-19

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 consisted first in a comparative analysis of participants' characteristics using parametric and nonparametric tests as appropriate (Student's t test, Mann-Withney U test or Chi-squared test). Second, means and standard deviation will be calculated for the PFI, the DASS-21, the ISI and the NDI. Third, Analysis of Variance (ANOVA) will be performed for the PFI, the DASS-21 and the ISI (group effect). Age, gender, profession, sector of activity, job status and job experience will be entered as covariate. Effect sizes will be report with the eta-squared (η²) given by the ANOVA. All tests are two-tailed and alpha is set at .05. All analyzes will be performed using IBM SPSS®, version 26.

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Study Type : Observational
Actual Enrollment : 693 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Burnout, Emotional Distress and Needs in Frontline COVID-19 Healthcare Workers: Cross-sectional Study in a Belgian Population
Actual Study Start Date : April 16, 2020
Actual Primary Completion Date : May 25, 2020
Actual Study Completion Date : May 29, 2020

Group/Cohort
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.
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.



Primary Outcome Measures :
  1. Burnout [ Time Frame: 1 assessment time, at inclusion ]
    Measured with the Professional Fulfillment Index (PFI). This is a 16-item scale, divided into 2 sub-scales: professional fulfillment (6 items) and burnout, including professional exhaustion (4 items) and interpersonal disengagement (6 items). Subscales scores are given by the mean of all sub-scale items (professional fulfillment, 0-4; burnout, 0-4). Cut-off scores are set for the fulfillment sub-scale at > 3, significant professional fulfillment and for the burnout sub-scale at > 1.33, significant burnout.

  2. Emotional Distress [ Time Frame: 1 assessment time, at inclusion ]
    Measured with the Depression, Anxiety and Stress Scale-Short Form (DASS-21). This a 21-item scale divided into 3 7-item sub-scales: depression, anxiety and stress. Sub-scales scores are given by the sum of all sub-scale items. The DASS has a 4-point Likert scale. Responses options range from " Never " to " Almost always " (0-3 score range). Only cut-off scores are provided for the original version of the DASS. Sub-scales scores must therefore be multiplied by 2. Cut-off scores for depression are Normal, 0-9; Mild, 10-13; Moderate, 14-20; Severe, 21-27; Extremely severe, 28+. Cut-off scores for anxiety are Normal, 0-7; Mild, 8-9; Moderate, 10-14; Severe, 15-19; Extremely severe, 20+. Cut-off scores for stress are Normal, 0-14; Mild, 15-18; Moderate, 19-25; Severe, 26-33; Extremely severe, 34+.

  3. Insomnia [ Time Frame: 1 assessment time, at inclusion ]
    Measured with the Insomnia Severity Index (ISI). This is a 7-item scale. The ISI has a 5-point Likert scale (0-4 score range). Responses options range from " None " to " Very severe " for items 1a., 1b. and 1c., from " Very satisfied " to " Very dissatisfied " for item 2 and from " None " to " Very much " for items 3,4 and 5. The ISI provides a total score by summing all items scores. Cut-off scores are set for no clinically significant insomnia (0-7), subthreshold insomnia (8-14), moderate clinical insomnia (15-21) and severe clinical insomnia (22-28).


Secondary Outcome Measures :
  1. Needs and difficulties in work situations [ Time Frame: 1 assessment time, at inclusion ]
    Measured with the Needs and Difficulties Inventory (developed for the study). This scale has been set up for this study. This is a 17-item scale, divided into 5 sub-scales: information/communication (3 items), practical (4 items), physical (4 items), emotional (4 items) and ethical (2 items). The NDI has a 4-point Likert scale. Responses options range from " Not at all agree " to " Totally agree " (0-3 score range). The NDI provides 5 sub-scales scores by summing all sub-scales items: information/communication, 0-9; practical, 0-12; physical, 0-12; emotional, 0-12 and ethical, 0-6. As a no-validated scale, scores and their treatment will be taken into account with caution. In order to compare sub-scales with each other, each sub-scale score must be divided by its maximum value, providing a coefficient (0-1).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study targets healthcare workers in Belgian hospital. It targets any physician, nurse or physiotherapist in emergency, non-intensive Covid-19 and intensive Covid-19 care unit (target group) and in usual medical care unit (control group). There is no sampling method. Participation is on voluntary basis.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344145


Locations
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Belgium
Hôpital de Warquignies
Boussu, Hainaut, Belgium, 7300
Hôpital de Jolimont
Haine-Saint-Paul, Hainaut, Belgium, 7100
Hôpital de Lobbes
Lobbes, Hainaut, Belgium, 6540
Hôpital de Mons
Mons, Hainaut, Belgium, 7000
Erasme Hospital CUB
Brussels, Belgium, 1070
Sponsors and Collaborators
Université Libre de Bruxelles
Investigators
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Principal Investigator: Julien Tiete, PhD Université Libre de Bruxelles
Publications of Results:
Antony, MM, Bieling, PJ, Cox, BJ, Enns, MW, Swinson, RP. (1998). Psychometric properties of the 42-item and 21-item versions of the depression anxiety stress scales in clinical groups and a community sample. Psychological Assessment 10, 176-81.
Lovibond, SH, Lovibond, PF. (1995). Manual for the Depression Anxiety & Stress Scales (2nd Ed.) Sydney: Psychology Foundation.
Morin, CM. (1993). Insomnia: Psychological assessment and management. New York: Guilford Press

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Responsible Party: Dr Julien Tiete, Dr, Université Libre de Bruxelles
ClinicalTrials.gov Identifier: NCT04344145    
Other Study ID Numbers: PSY-ENCOVID19
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Local Ethics Committee has not yet approved the study. No plan has therefore been done for the IPD sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Julien Tiete, Université Libre de Bruxelles:
COVID-19
Healthcare workers burn out
Healthcare workers emotional distress
Healthcare workers needs