Occupational StressNCT05198414
SER+ Against COVID-19 - Interventions to Strengthen the Resilience of HCWs in Ecuador
An observational study of Occupational Stress and Stress, Physiological, run by Universidad Miguel Hernandez de Elche at 2 sites in Ecuador.
Trial summary
The SARS-CoV-2 pandemic has particularly impacted Ecuador. By May 31, 2021, 426,000 cases (10% of health professionals) and 20,572 deaths. Care procedures, organization and priorities have been altered, if not broken. The quality and safety of COVID19 and non-COVID19 patients have been compromised. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress, Stress, Physiological
- What is being tested?
- Focus group
- How many people
- 44 participants
- Where
- 2 sitesEcuador
- Study dates
- 1 Sep 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health professionals of primary care, hospital, medical directors and administrative personnel of the city of Guayaquil who have been working directly with COVID patients or in facilities destined to the care of COVID patients.
Who may be able to join
- 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.
Who cannot join
- Healthcare workers, medical directors and administrative personnel not involved in COVID19 care.
Trial locations and contacts
2 sites in 1 country.
Ecuador2 sites
Hospital General Norte "Los Ceibos"
Guayaquil, Guayas
Universidad Católica de Santiago de Guayaquil
Guayaquil, Guayas
About this study
Official title: SER+ Against COVID-19 - Interventions to Strengthen the Resilience of Organizations and Professionals of the Public Health System in Ecuador.
The SARS-CoV-2 pandemic has particularly impacted Ecuador. By May 31, 2021, 426,000 cases (10% of health professionals) and 20,572 deaths. Care procedures, organization and priorities have been altered, if not broken. The quality and safety of COVID19 and non-COVID19 patients have been compromised. Compassion fatigue, post-traumatic stress and moral damage reactions have been observed among healthcare professionals, considered second victims of SARS-CoV-2. Without professionals who feel supported and morally strong, care will be compromised, leading to greater uncertainty and insecurity in the care of COVID19 and non-COVID19 patients. In coordination with local authorities, this project seeks to strengthen the resilience of public institutions and healthcare professionals to implement. In coordination with local authorities, this project seeks to strengthen the resilience of public institutions and health professionals to implement proven interventions and scale them up to the whole health system to strengthen it after the impact of the COVID19 pandemic. This proposal is aligned with Sustainable Development Goal 3, which includes different targets to ensure healthy lives and promote well-being for all ages. Health emergencies, such as the one resulting from COVID-19, pose a global risk and have shown that preparedness is vital. Improving the Quality of the National Health Services and strengthening the health system in preparedness and response to health emergencies are the main priority lines of action in this project, thus aligning with SDG target 3.8 concerning strengthening health professional morale since to save lives, countries' public health systems must be strengthened. Previous work with the local partner supports the good performance and development of this proposal, which arose from a need based on the need to This proposal arose from a need based on the lessons learned in Spain.
Read the 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.
- Conditions
- Occupational Stress, Stress, Physiological
- Being tested
- Focus group
- Keywords
- Healthcare workers, Qualitative study, COVID-19, Quality of care, Occupational Stress, Stress, Physiological
- Medical subject headings
- Occupational Stress, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupOther
Qualitative research methodology with healthcare workers
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers | Healthcare workers at the first line and healthcare directives. Receives: Other: Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommendations to support and increase the resilience of healthcare workers
Recommendations to support Ecuador's health system in the COVID-19 pandemic and increase the resilience of personnel in future health emergencies.
Measured: 31/05/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Sep 2021
- Primary completion1 Feb 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Occupational StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Catolica Santiago de Guayaquil, Hospital General del Norte de Guayaquil IESS Los Ceibos
- Responsible party
- Principal investigator, José Joaquín Mira, Universidad Miguel Hernandez de Elche
- Investigators
- Jose J Mira Solves, PhD, Principal investigator, Universidad Miguel Hernandez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198414
- Sponsor's protocol ID
- UMHODS22
- Status last verified
- Sep 2022
- First submitted
- 17 Jan 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a qualitative study, participants' data, verbatims, and transcription of recorded focus groups can not be disclosed.
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.
PubMed 33158839Martin-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.
PubMed 33175877Mira 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.
PubMed 32936769Mira 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.
PubMed 34831767
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SER+ Against COVID-19 - Interventions to Strengthen the Resilience of Organizations and Professionals of the Public Health System in Ecuador.
- ClinicalTrials.gov ID
- NCT05198414
- Acronym / sponsor ID
- UMHODS22
- Conditions
- Occupational Stress, Stress, Physiological
- Keywords
- Healthcare workers, Qualitative study, COVID-19, Quality of care, Occupational Stress, Stress, Physiological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Universidad Catolica Santiago de Guayaquil, Hospital General del Norte de Guayaquil IESS Los Ceibos
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SARS-CoV-2 pandemic has particularly impacted Ecuador. By May 31, 2021, 426,000 cases (10% of health professionals) and 20,572 deaths. Care procedures, organization and priorities have been altered, if not broken. The quality and safety of COVID19 and non-COVID19 patients have been compromised. Compassion fatigue, post-traumatic stress and moral damage reactions have been observed among healthcare professionals, considered second victims of SARS-CoV-2. Without professionals who feel supported and morally strong, care will be compromised, leading to greater uncertainty and insecurity in the care of COVID19 and non-COVID19 patients. In coordination with local authorities, this project seeks to strengthen the resilience of public institutions and healthcare professionals to implement. In coordination with local authorities, this project seeks to strengthen the resilience of public institutions and health professionals to implement proven interventions and scale them up to the whole health system to strengthen it after the impact of the COVID19 pandemic. This proposal is aligned with Sustainable Development Goal 3, which includes different targets to ensure healthy lives and promote well-being for all ages. Health emergencies, such as the one resulting from COVID-19, pose a global risk and have shown that preparedness is vital. Improving the Quality of the National Health Services and strengthening the health system in preparedness and response to health emergencies are the main priority lines of action in this project, thus aligning with SDG target 3.8 concerning strengthening health professional morale since to save lives, countries' public health systems must be strengthened. Previous work with the local partner supports the good performance and development of this proposal, which arose from a need based on the need to This proposal arose from a need based on the lessons learned in Spain.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers | – | Other: Focus groupHealthcare workers at the first line and healthcare directives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health professionals of primary care, hospital, medical directors and administrative personnel of the city of Guayaquil who have been working directly with COVID patients or in facilities destined to the care of COVID patients.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Healthcare workers, medical directors and administrative personnel not involved in COVID19 care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupQualitative research methodology with healthcare workers | Other | Healthcare workers |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Background: PubMed 33158839Mira 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.
- Background: PubMed 33175877Martin-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.
- Results publication: PubMed 32936769Mira 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.
- Results publication: PubMed 34831767Mira 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.
- Social Observatory of Ecuador. Deceased personsLink provided by the sponsor.
- World Health Organization (WHO). WHO Coronavirus Disease (COVID-19) DashboardLink provided by the sponsor.
- Individual participant dataSharing planned: No. As this is a qualitative study, participants' data, verbatims, and transcription of recorded focus groups can not be disclosed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose J Mira Solves, PhD principal investigator
Universidad Miguel Hernandez
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Stress and Stress, Physiological, run by Universidad Miguel Hernandez de Elche at 2 sites in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommendations to support and increase the resilience of healthcare workers (time frame: 31/05/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05198414, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.