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

Sponsor
Universidad Miguel Hernandez de Elche (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04486404
Collaborator
Universidad Catolica Santiago de Guayaquil (Other), Universidad de Santander (Other), University of Sao Paulo (Other), Pontificia Universidad Catolica de Chile (Other)
2,500
Enrollment
5
Locations
21
Anticipated Duration (Months)
500
Patients Per Site
23.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Online survey

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
2500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Personal Protective Equipmente Needs, Perceptions and Acute Stress Among Healthcare Workers Caring for COVID-19 Patients in South America
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

ArmIntervention/Treatment
Group 1

Online survery to healtcare personnel and other professionals in the front-line from Col, Bra and Ec.

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

Group 2

Online survery to healtcare personnel and other professionals in the front-line from Col, Bra, Ch and Ec.

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

Outcome Measures

Primary Outcome Measures

  1. Prevalence of Acute Stress [15 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthcare professionals, other professionals working in the front-line of COVID-19.
Exclusion Criteria:

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Institute for Clinical Effectiveness and Health PolicyBuenos AiresArgentina
2Pontificia Universidad Católica de ChileSantiagoChile
3Universidad de SantanderBucaramangaSantanderColombia
4Universidad Católica de Santiago de GuayaquilGuayaquilGuayasEcuador
5Universidad Miguel Hernández de ElcheElcheAlicanteSpain03202

Sponsors and Collaborators

  • Universidad Miguel Hernandez de Elche
  • Universidad Catolica Santiago de Guayaquil
  • Universidad de Santander
  • University of Sao Paulo
  • Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Jose J Mira, PhD, Universidad Miguel Hernández de Elche

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
José Joaquín Mira, PhD, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier:
NCT04486404
Other Study ID Numbers:
  • 08/04/2020
First Posted:
Jul 24, 2020
Last Update Posted:
Sep 30, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by José Joaquín Mira, PhD, Universidad Miguel Hernandez de Elche
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2021