Covid19PEOpLe-C19NCT04910243
The Practice of Providing Palliative Care in the Situation of the COVID-19 (Coronavirus Disease 2019) Pandemic in Czech Republic
An observational study of Covid19 and Distress, Emotional, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Pandemic of coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus 2) causing the disease COVID-19 (Coronavirus Disease 2019) overwhelmed healthcare and brought new challenges and stressful situations. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Covid19, Distress, Emotional
- What is being tested?
- Questionnaire Survey
- How many people
- 307 participants
- Where
- 1 siteCzechia
- Study dates
- 21 Jun 2021to 14 Oct 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthcare providers (physicians and nurses) providing care to patients with COVID-19 admitted at ICU in period of COVID-19 pandemic.
Who may be able to join
- Healthcare providers (physicians and nurses) providing care to patients with COVID-19 admitted at ICU in period of COVID-19 pandemic.
Who cannot join
- Healthcare professionals who did not managed COVID-19 patients admitted at the ICU in situation of COVID-19 pandemic in the period 2020/2021.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Practice of Providing Palliative Care in the Situation of the COVID-19 (Coronavirus Disease 2019) Pandemic in the Perspective of Physicians and Nurses - Survey Study
Pandemic of coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus 2) causing the disease COVID-19 (Coronavirus Disease 2019) overwhelmed healthcare and brought new challenges and stressful situations.
Read the detailed description
In a short time, the capacities of intensive care units (ICU) were filled in many countries and regions. Due to the need for an excessive number of patients requiring intensive care, physicians and nurses who do not routinely provide care to critically ill patients or do not have the appropriate training (non-ICU clinician) were involved in the care of COVID-19 (Coronavirus Disease 2019) patients. In this context, ICU directly dedicated to the care of patients with COVID-19 ARDS (Acute Respiratory Distress Syndrome) were also opened. Non-ICU clinicians were more or less involved together with the standard ICU staff in palliative care, including End-of-Life decision (EOLD) making, even in a situation of limited scarce resources (equipment or personnel). New workplace and scope of work, which did not correspond to the standard activity or education, most likely led to an increased stress load. EOLD can also be one of the factors leading to increased stress levels. The aim of the project is to describe the practice of palliative care for patients with COVID-19 in a situation of pandemic COVID-19 and to identify factors leading to possible moral distress related with EOLD.
- Conditions
- Covid19, Distress, Emotional
- Being tested
- Questionnaire Survey
- Keywords
- Palliative Care, Compassionate Care, End-of-life decisions, Moral distress
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire SurveyOther
Physicians providing care to patients with COVID-19 admitted at ICU in period of COVID-19 pandemic will be questioned by electronic web-based survey within Masaryk University information system.
| Study group | Role | What they receive |
|---|---|---|
| Physicians | Physicians managing patients with COVID-19 admitted at ICU during period of COVID-19 pandemic. Receives: Other: Questionnaire Survey | |
| Nurses | Nurses providing care to patients with COVID-19 admitted at ICU during period of COVID-19 pandemic. Receives: Other: Questionnaire Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of practice of providing palliative care at ICU in COVID-19 pandemic
Change of practice of providing palliative care including EOLD practice in patients with COVID-19 admitted at ICU during pandemic.
Measured: Through study completion, an average of 1 month
Secondary outcomes (1)
Risk factors for moral distress
Identify factors leading to moral distress during COVID-19 pandemic and describe possible different risk factors by profession
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start21 Jun 2021
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Jan Malaska, Brno University Hospital
- Investigators
- Tereza Prokopová, M.D., Principal investigator, Masaryk University Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910243
- Sponsor's protocol ID
- PEOpLe-C19 study
- Acronym
- PEOpLe-C19
- Status last verified
- Oct 2021
- First submitted
- 28 May 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prokopova T, Hudec J, Vrbica K, Stasek J, Pokorna A, Stourac P, Rusinova K, Kerpnerova P, Stepanova R, Svobodnik A, Malaska J; RIPE-ICU study group. Palliative care practice and moral distress during COVID-19 pandemic (PEOpLE-C19 study): a national, cross-sectional study in intensive care units in the Czech Republic. Crit Care. 2022 Jul 19;26(1):221. doi: 10.1186/s13054-022-04066-1.
PubMed 35854318
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Practice of Providing Palliative Care in the Situation of the COVID-19 (Coronavirus Disease 2019) Pandemic in the Perspective of Physicians and Nurses - Survey Study
- ClinicalTrials.gov ID
- NCT04910243
- Acronym / sponsor ID
- PEOpLe-C19 / PEOpLe-C19 study
- Conditions
- Covid19, Distress, Emotional
- Keywords
- Palliative Care, Compassionate Care, End-of-life decisions, Moral distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 2 Jun 2021 (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.
Pandemic of coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus 2) causing the disease COVID-19 (Coronavirus Disease 2019) overwhelmed healthcare and brought new challenges and stressful situations.
Detailed description
In a short time, the capacities of intensive care units (ICU) were filled in many countries and regions. Due to the need for an excessive number of patients requiring intensive care, physicians and nurses who do not routinely provide care to critically ill patients or do not have the appropriate training (non-ICU clinician) were involved in the care of COVID-19 (Coronavirus Disease 2019) patients. In this context, ICU directly dedicated to the care of patients with COVID-19 ARDS (Acute Respiratory Distress Syndrome) were also opened. Non-ICU clinicians were more or less involved together with the standard ICU staff in palliative care, including End-of-Life decision (EOLD) making, even in a situation of limited scarce resources (equipment or personnel). New workplace and scope of work, which did not correspond to the standard activity or education, most likely led to an increased stress load. EOLD can also be one of the factors leading to increased stress levels. The aim of the project is to describe the practice of palliative care for patients with COVID-19 in a situation of pandemic COVID-19 and to identify factors leading to possible moral distress related with EOLD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: Questionnaire SurveyPhysicians managing patients with COVID-19 admitted at ICU during period of COVID-19 pandemic. |
| Nurses | – | Other: Questionnaire SurveyNurses providing care to patients with COVID-19 admitted at ICU during period of COVID-19 pandemic. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare providers (physicians and nurses) providing care to patients with COVID-19 admitted at ICU in period of COVID-19 pandemic.
Key inclusion criteria (1 listed)
- Healthcare providers (physicians and nurses) providing care to patients with COVID-19 admitted at ICU in period of COVID-19 pandemic.
Key exclusion criteria (1 listed)
- Healthcare professionals who did not managed COVID-19 patients admitted at the ICU in situation of COVID-19 pandemic in the period 2020/2021.
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 |
|---|---|---|
| Questionnaire SurveyPhysicians providing care to patients with COVID-19 admitted at ICU in period of COVID-19 pandemic will be questioned by electronic web-based survey within Masaryk University information system. | Other | Nurses, Physicians |
Primary outcome
Change of practice of providing palliative care at ICU in COVID-19 pandemic
Time frame: Through study completion, an average of 1 month
Change of practice of providing palliative care including EOLD practice in patients with COVID-19 admitted at ICU during pandemic.
1 secondary outcome
Risk factors for moral distress
Time frame: Through study completion, an average of 1 month
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 Oct 2021.
- Derived from this study: PubMed 35854318Prokopova T, Hudec J, Vrbica K, Stasek J, Pokorna A, Stourac P, Rusinova K, Kerpnerova P, Stepanova R, Svobodnik A, Malaska J; RIPE-ICU study group. Palliative care practice and moral distress during COVID-19 pandemic (PEOpLE-C19 study): a national, cross-sectional study in intensive care units in the Czech Republic. Crit Care. 2022 Jul 19;26(1):221. doi: 10.1186/s13054-022-04066-1.
- Individual participant dataSharing planned: No
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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.
Tereza Prokopová, M.D. principal investigator
Masaryk University Brno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Distress, Emotional, run by Brno University Hospital at 1 site in Czechia.
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 1 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 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
Change of practice of providing palliative care at ICU in COVID-19 pandemic (time frame: Through study completion, an average of 1 month). 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 NCT04910243, which also lists 1 linked publication.
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 Oct 2021.