Clinical trial NCT04344145: Exhaustion and Needs in Frontline COVID-19 Healthcare Workers: Cross-sectional Study in a Belgian Population
Official title: Burnout, Emotional Distress and Needs in Frontline COVID-19 Healthcare Workers: Cross-sectional Study in a Belgian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Healthcare workers burn out
Healthcare workers emotional distress
Healthcare workers needs
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Burnout
timeFrame: 1 assessment time, at inclusion
measure: Emotional Distress
timeFrame: 1 assessment time, at inclusion
measure: Insomnia
timeFrame: 1 assessment time, at inclusion
Secondary outcomes:
measure: Needs and difficulties in work situations
timeFrame: 1 assessment time, at inclusion
Other outcomes:
Locations:
city: Boussu
country: Belgium
facility: Hôpital de Warquignies
state: Hainaut
city: Haine-Saint-Paul
country: Belgium
facility: Hôpital de Jolimont
state: Hainaut
city: Lobbes
country: Belgium
facility: Hôpital de Lobbes
state: Hainaut
city: Mons
country: Belgium
facility: Hôpital de Mons
state: Hainaut
city: Brussels
country: Belgium
facility: Erasme Hospital CUB
Study officials:
affiliation: Université Libre de Bruxelles
name: Julien Tiete, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Lovibond, SH, Lovibond, PF. (1995). Manual for the Depression Anxiety & Stress Scales (2nd Ed.) Sydney: Psychology Foundation.
citation: Morin, CM. (1993). Insomnia: Psychological assessment and management. New York: Guilford Press
citation: 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.