- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05198414
SER+ Against COVID-19 - Interventions to Strengthen the Resilience of HCWs in Ecuador
SER+ Against COVID-19 - Interventions to Strengthen the Resilience of Organizations and Professionals of the Public Health System in Ecuador.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The COVID-19 pandemic has been one of the health emergencies with the most significant impact on the world's population as a whole since records have been kept. The number of infected people (more than 234 million cases as of October 5, 2021) and deaths from this cause (4.8 million as of October 5, 2021) had exceeded any initial forecast when the WHO declared a public health emergency of international concern on January 30, 2020, and subsequently reported the COVID-19 outbreak a pandemic on March 11, 2020. In Ecuador, the situation has been equally alarming, with excess mortality of 46,470 people, which proportionally represents an increase of 57.72% compared to 2019 during 2020. As of December 6, 526,000 cases and 33,000 deaths have been confirmed.
Health organizations in Ecuador have faced this health crisis by implementing organizational and structural reforms (for example, increasing the number of beds in critical care units to the limit of possibilities and setting up convention centers for the care of COVID patients). No specific measures have been put in place to alleviate pressure and help professionals cope with compassion fatigue or acute stress experienced during the most critical moments of the pandemic. This situation was exacerbated by the scarcity of personal protective equipment, fear, and distress of health professionals as they put their lives and their family members at risk.
This study aims to draw lessons learned from these responses that have contributed to dealing with the health emergency, both at the institutional and individual level of health personnel, identifying those actions that have had a positive impact. These lessons can be used in the future in other crises and emergencies to develop measures for the protection and organization of the work of health personnel and to achieve a better response for the benefit of patients.
This perspective-shifting approach focuses on the positive things that have helped health professionals cope with the pandemic that has not been sufficiently researched previously. Most studies focus on the negatives and what has gone wrong, but it is time to look back and compile the things that have helped us have valuable tools for future public health emergencies.
Methods Mixed study that combines a first phase of qualitative research with a second phase of field study to, through a survey, capture information relevant to the objectives of the study and, finally, to develop a series of recommendations to support Ecuador's health system in the post-pandemic of COVID-19 and increase the resilience of personnel in future health emergencies.
First phase
The Focus Group technique will be used to capture experiences, experiences and measures taken to cope with the emotional consequences of the pandemic among the staff of the different health centers. We will seek to include primary care and hospital professionals from the city of Guayaquil. Group sessions will be conducted, each with between 8 and 11 participants, and the dynamics will be maintained until information saturation is reached. Recruitment will be carried out using the snowball technique among health professionals (physicians, nurses, support staff, among others). These group sessions will be complemented with a minimum of 5 and a maximum of 10 semi-structured interviews with middle managers of the organization and managers of at the level of the Integral Public Health Network (RSPI), such as the Ecuadorian Institute of Social Security, a health care referent and the North General Hospital of Guayaquil. The latter became a sentinel hospital for the care of most of the cases during this pandemic. For this reason, it has been considered ideal for conducting focus groups and surveys. The discourse will be analyzed and the ideas will be classified into categories. The information obtained will be triangulated and its consistency will be determined.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Guayas
-
Guayaquil, Guayas, Ecuador
- Universidad Católica de Santiago de Guayaquil
-
Guayaquil, Guayas, Ecuador
- Hospital General Norte "Los Ceibos"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthcare workers of primary care providng care to COVID-19 patients.
- Healthcare workers of hospitals providng care to COVID-19 patients.
- Medical directors (high management) of COVID-19 hospitals.
- Administrative personnel of COVID-19 hospitals.
Exclusion criteria:
- Healthcare workers, medical directors and administrative personnel not involved in COVID19 care.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthcare workers
Healthcare workers at the first line and healthcare directives.
|
Qualitative research methodology with healthcare workers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recommendations to support and increase the resilience of healthcare workers
Time Frame: 31/05/2022
|
Recommendations to support Ecuador's health system in the COVID-19 pandemic and increase the resilience of personnel in future health emergencies.
|
31/05/2022
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Categories of analysis
Time Frame: 01/02/2022
|
Capture experiences, feelings and measures taken to cope with the emotional consequences of the pandemic among healthcare workers
|
01/02/2022
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jose J Mira Solves, PhD, Universidad Miguel Hernández
Publications and helpful links
General Publications
- Mira JJ, Carrillo I, Guilabert M, Mula A, Martin-Delgado J, Perez-Jover MV, Vicente MA, Fernandez C; SARS-CoV-2 Second Victim Study Group. Acute stress of the healthcare workforce during the COVID-19 pandemic evolution: a cross-sectional study in Spain. BMJ Open. 2020 Nov 6;10(11):e042555. doi: 10.1136/bmjopen-2020-042555.
- Martin-Delgado J, Viteri E, Mula A, Serpa P, Pacheco G, Prada D, Campos de Andrade Lourencao D, Campos Pavan Baptista P, Ramirez G, Mira JJ. Availability of personal protective equipment and diagnostic and treatment facilities for healthcare workers involved in COVID-19 care: A cross-sectional study in Brazil, Colombia, and Ecuador. PLoS One. 2020 Nov 11;15(11):e0242185. doi: 10.1371/journal.pone.0242185. eCollection 2020.
- Mira JJ, Vicente MA, Lopez-Pineda A, Carrillo I, Guilabert M, Fernandez C, Perez-Jover V, Martin Delgado J, Perez-Perez P, Cobos Vargas A, Astier-Pena MP, Martinez-Garcia OB, Marco-Gomez B, Abad Bouzan C. Preventing and Addressing the Stress Reactions of Health Care Workers Caring for Patients With COVID-19: Development of a Digital Platform (Be + Against COVID). JMIR Mhealth Uhealth. 2020 Oct 5;8(10):e21692. doi: 10.2196/21692.
- Mira JJ, Cobos-Vargas A, Astier-Pena MP, Perez-Perez P, Carrillo I, Guilabert M, Perez-Jover V, Fernandez-Peris C, Vicente-Ripoll MA, Silvestre-Busto C, Lorenzo-Martinez S, Martin-Delgado J, Aibar C, Aranaz J. Addressing Acute Stress among Professionals Caring for COVID-19 Patients: Lessons Learned during the First Outbreak in Spain (March-April 2020). Int J Environ Res Public Health. 2021 Nov 16;18(22):12010. doi: 10.3390/ijerph182212010.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Stress, Psychological
- Occupational Diseases
- COVID-19
- Occupational Stress
Other Study ID Numbers
- UMHODS22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.