NCT04344145

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
693

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

April 16, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

April 9, 2020

Last Update Submit

September 6, 2020

Conditions

Keywords

COVID-19Healthcare workers burn outHealthcare workers emotional distressHealthcare workers needs

Outcome Measures

Primary Outcomes (3)

  • Burnout

    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.

    1 assessment time, at inclusion

  • Emotional Distress

    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+.

    1 assessment time, at inclusion

  • Insomnia

    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).

    1 assessment time, at inclusion

Secondary Outcomes (1)

  • Needs and difficulties in work situations

    1 assessment time, at inclusion

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital de Warquignies

Boussu, Hainaut, 7300, Belgium

Location

Hôpital de Jolimont

Haine-Saint-Paul, Hainaut, 7100, Belgium

Location

Hôpital de Lobbes

Lobbes, Hainaut, 6540, Belgium

Location

Hôpital de Mons

Mons, Hainaut, 7000, Belgium

Location

Erasme Hospital CUB

Brussels, 1070, Belgium

Location

Related Publications (20)

  • Vandenbroeck S, Van Gerven E, De Witte H, Vanhaecht K, Godderis L. Burnout in Belgian physicians and nurses. Occup Med (Lond). 2017 Oct 1;67(7):546-554. doi: 10.1093/occmed/kqx126.

  • Shanafelt TD, Boone S, Tan L, Dyrbye LN, Sotile W, Satele D, West CP, Sloan J, Oreskovich MR. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012 Oct 8;172(18):1377-85. doi: 10.1001/archinternmed.2012.3199.

  • Wurm W, Vogel K, Holl A, Ebner C, Bayer D, Morkl S, Szilagyi IS, Hotter E, Kapfhammer HP, Hofmann P. Depression-Burnout Overlap in Physicians. PLoS One. 2016 Mar 1;11(3):e0149913. doi: 10.1371/journal.pone.0149913. eCollection 2016.

  • Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA. 2002 Oct 23-30;288(16):1987-93. doi: 10.1001/jama.288.16.1987.

  • Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc. 2015 Dec;90(12):1600-13. doi: 10.1016/j.mayocp.2015.08.023.

  • van der Heijden F, Dillingh G, Bakker A, Prins J. Suicidal thoughts among medical residents with burnout. Arch Suicide Res. 2008;12(4):344-6. doi: 10.1080/13811110802325349.

  • Shanafelt TD, Mungo M, Schmitgen J, Storz KA, Reeves D, Hayes SN, Sloan JA, Swensen SJ, Buskirk SJ. Longitudinal Study Evaluating the Association Between Physician Burnout and Changes in Professional Work Effort. Mayo Clin Proc. 2016 Apr;91(4):422-31. doi: 10.1016/j.mayocp.2016.02.001.

  • West CP, Huschka MM, Novotny PJ, Sloan JA, Kolars JC, Habermann TM, Shanafelt TD. Association of perceived medical errors with resident distress and empathy: a prospective longitudinal study. JAMA. 2006 Sep 6;296(9):1071-8. doi: 10.1001/jama.296.9.1071.

  • West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009 Sep 23;302(12):1294-300. doi: 10.1001/jama.2009.1389.

  • Fahrenkopf AM, Sectish TC, Barger LK, Sharek PJ, Lewin D, Chiang VW, Edwards S, Wiedermann BL, Landrigan CP. Rates of medication errors among depressed and burnt out residents: prospective cohort study. BMJ. 2008 Mar 1;336(7642):488-91. doi: 10.1136/bmj.39469.763218.BE. Epub 2008 Feb 7.

  • Linzer M, Visser MR, Oort FJ, Smets EM, McMurray JE, de Haes HC; Society of General Internal Medicine (SGIM) Career Satisfaction Study Group (CSSG). Predicting and preventing physician burnout: results from the United States and the Netherlands. Am J Med. 2001 Aug;111(2):170-5. doi: 10.1016/s0002-9343(01)00814-2. No abstract available.

  • Meo SA, Alhowikan AM, Al-Khlaiwi T, Meo IM, Halepoto DM, Iqbal M, Usmani AM, Hajjar W, Ahmed N. Novel coronavirus 2019-nCoV: prevalence, biological and clinical characteristics comparison with SARS-CoV and MERS-CoV. Eur Rev Med Pharmacol Sci. 2020 Feb;24(4):2012-2019. doi: 10.26355/eurrev_202002_20379.

  • Cook TM, El-Boghdadly K, McGuire B, McNarry AF, Patel A, Higgs A. Consensus guidelines for managing the airway in patients with COVID-19: Guidelines from the Difficult Airway Society, the Association of Anaesthetists the Intensive Care Society, the Faculty of Intensive Care Medicine and the Royal College of Anaesthetists. Anaesthesia. 2020 Jun;75(6):785-799. doi: 10.1111/anae.15054. Epub 2020 Apr 1.

  • Wu YC, Chen CS, Chan YJ. The outbreak of COVID-19: An overview. J Chin Med Assoc. 2020 Mar;83(3):217-220. doi: 10.1097/JCMA.0000000000000270.

  • Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.

  • Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.

  • 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.

    RESULT
  • Lovibond, SH, Lovibond, PF. (1995). Manual for the Depression Anxiety & Stress Scales (2nd Ed.) Sydney: Psychology Foundation.

    RESULT
  • Morin, CM. (1993). Insomnia: Psychological assessment and management. New York: Guilford Press

    RESULT
  • Tiete J, Guatteri M, Lachaux A, Matossian A, Hougardy JM, Loas G, Rotsaert M. Mental Health Outcomes in Healthcare Workers in COVID-19 and Non-COVID-19 Care Units: A Cross-Sectional Survey in Belgium. Front Psychol. 2021 Jan 5;11:612241. doi: 10.3389/fpsyg.2020.612241. eCollection 2020.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Julien Tiete, PhD

    Université Libre de Bruxelles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 14, 2020

Study Start

April 16, 2020

Primary Completion

May 25, 2020

Study Completion

May 29, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations