Needs, Perceptions and Acute Stress of Healtcare Workers Caring for COVID-19 Patients in South America

Acute Stress Disorder Clinical Trial

Official title:

Personal Protective Equipmente Needs, Perceptions and Acute Stress Among Healthcare Workers Caring for COVID-19 Patients in South America

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486404
• Other study ID #: 08/04/2020
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2022
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The pressure on care and the demand for critical decision-making generated by the current SARS-CoV-2 (COVID-19) pandemic, together with the situation of extreme social alarm and the adverse conditions in which care work must be promoted at this time, draw an extreme scenario in which action is urgently needed to alleviate emotional overload, acute stress reactions and other affective pathologies or psychosomatic reactions that may eventually lead to post-traumatic stress situations. This eventuality is being observed massively among professionals from different groups and levels of responsibility.

In the case of healthcare personnel, it should be added that the care of non-COVID19 patients (of all pathologies and conditions) is clearly compromised and it is up to the professionals as a whole to make critical decisions and exercise a professional practice that is radically different from what has usually been done, which may require the application of undesirable triage criteria that are difficult for everyone to assume.

Healthcare professionals and other essential personnel for healthcare and social-healthcare work (including personnel from external companies) are being subjected to emotional tensions and extraordinary, high-intensity work demands. Without professionals who feel supported and with moral strength, care will be even more compromised.

The current scenario makes us think of many critical situations that are occurring as a result of the overload experienced. It is essential to act in order to counteract the devastating effect of this health crisis on health professionals and those who support them in their care work.

Description:

Coronavirus 2019 disease - of recent appearance - has become a global public health problem due to its rapid spread, since 11 March declared by WHO as a pandemic. It represents a real challenge for health systems, which at first lack information to organize the response to this situation, effective treatments to combat this lethal infection and with health personnel lacking the necessary security in their daily work to minimize the risk of contagion. The COVID-19 pandemic has caused, up to July 21, more than 609,000 deaths worldwide, 28,422 in Spain. The number of professionals suffering from COVID-19 is high. In Spain it accounts for more than 20% of the total number of people infected.

In this way, health professionals have been taking on a notable role without hardly any intention of doing so. Situations of constant uncertainty and emotional distress have posed a risk to patients and to the quality of care, making health professionals the second most affected by SARS-CoV-2 (COVID-19), which also requires special biosecurity and protection measures.

In a global survey, 52% of the 2711 health workers included reported that at least 1 standard PPE piece was out of stock. For example, in the United States, the Food and Drug Administration and the Centers for Disease Control and Prevention have taken several steps to optimize the use of PPE due to its scarcity. Although professionals in Germany consider that they have been well prepared for the pandemic, there are substantial differences in the availability of PPE depending on the health professional and the setting (outpatient or acute care hospitals). In Spain, 54% of primary health care workers reported that they were not adequately trained to use PPE. No similar studies we found in the local context of South American countries.

Although the incidence of the pandemic has expanded differently in different geographical areas of each country, most hospitals and health centres around the world have had to reorganise themselves to prioritise the care of COVID-19 patients, breaking with their usual work dynamics. To this cause of work stress must be added the uncertainty in which decisions have had to be made and the lack of resources both to treat patients adequately and to protect against possible contagion. Reactions of compassionate fatigue, post-traumatic stress, and moral damage have been observed among health professionals, which has depended on the expansion of the pandemic, available means, and individual differences in stress response.

These types of responses and reactions to this crisis are natural and affect all staff and all professional levels, including care support staff (IT, supplies, cleaning, etc.). The opposite would be difficult to explain. However, the key question is not the number of professionals who have been emotionally affected as a result of their care work, a circumstance that is aggravated in this crisis but is inherent to the work they do, but rather how many are unable to recover, how their resilience is evolving or to what extent they are able to cope with a possible new outbreak.

Most studies have analysed the emotional responses in a short period of time (approximately one week) coinciding with a specific stage of the crisis. However, studies on community coping with catastrophic situations have described that the psychological response evolves over time resulting in: impact phase, heroic (intensification of efforts), honeymoon (optimism), disillusionment (fatigue) and restoration (recovery pre-crisis levels). Therefore, it is expected that the effects of the pandemic on the psychological and emotional well-being of health professionals will vary as the pandemic evolves.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthcare professionals, other professionals working in the front-line of COVID-19.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Acute Stress Disorder
• COVID-19
• Stress Disorders, Traumatic, Acute

Intervention

Other:
• Online survey
Online survey including questions related to PPE availability, perceptions, emotions and EASE scale (Acute Stress Scale).

Locations

Country	Name	City	State
Argentina	Institute for Clinical Effectiveness and Health Policy	Buenos Aires
Chile	Pontificia Universidad Católica de Chile	Santiago
Colombia	Universidad de Santander	Bucaramanga	Santander
Ecuador	Universidad Católica de Santiago de Guayaquil	Guayaquil	Guayas
Spain	Universidad Miguel Hernández de Elche	Elche	Alicante

Sponsors (5)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Pontificia Universidad Catolica de Chile, Universidad Catolica Santiago de Guayaquil, Universidad de Santander, University of Sao Paulo

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Ecuador,  Spain, 

References & Publications (12)

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Li W, Yang Y, Liu ZH, Zhao YJ, Zhang Q, Zhang L, Cheung T, Xiang YT. Progression of Mental Health Services during the COVID-19 Outbreak in China. Int J Biol Sci. 2020 Mar 15;16(10):1732-1738. doi: 10.7150/ijbs.45120. eCollection 2020. Review. — View Citation

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Wu P, Fang Y, Guan Z, Fan B, Kong J, Yao Z, Liu X, Fuller CJ, Susser E, Lu J, Hoven CW. The psychological impact of the SARS epidemic on hospital employees in China: exposure, risk perception, and altruistic acceptance of risk. Can J Psychiatry. 2009 May;54(5):302-11. — View Citation

Xiang YT, Yang Y, Li W, Zhang L, Zhang Q, Cheung T, Ng CH. Timely mental health care for the 2019 novel coronavirus outbreak is urgently needed. Lancet Psychiatry. 2020 Mar;7(3):228-229. doi: 10.1016/S2215-0366(20)30046-8. Epub 2020 Feb 4. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Acute Stress	Prevalence of acute stress using the Acute Stress Scale (EASE Scale) among healthcare personnel in the front-line caring for COVID-19 patients.; Score values range from 0 to 30. 0-9 points, good emotional adjustment; 10-14 points, emotional distress; 15-24 points, medium-high emotional overload; > 25 points, extreme acute stress.	15 days

External Links

•   Be+ Against COVID Second Victims working group website
•   EASE Scale pre-print