Clinical trial NCT04372056: The COVID-ICU Healthcare Professional Study
Official title: A Norwegian Study on Views and Experiences of Health Care Professionals Working in Intensive Care Units During the COVID-19 Pandemic.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Critical Care
Intensive Care Units
Health Personnel
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 484
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The longitudinal cohort study will collect data from all consenting health care professionals in COVID-ICUs in Norway during the pandemic with 3- and 12-months follow-up on a combined electronic consent form and questionnaire that the informants will fill in using a computer and an electronic identification.

A few of the informants (medical doctors, nurses, leaders) participating in the cohort study will randomly (computerized) be asked to participate in focus groups during the 12-months study follow-up. Leaders at the randomized hospitals will be asked to participate in individualized interviews.

Brief summary: The project is a longitudinal cohort study based on an electronic questionnaire on views and experiences of COVID-ICU Health care professionals during the pandemic. In addition, a few of the informants participating in the cohort study will be asked to participate in focus groups to get a deeper understanding of the experiences of Health care professionals. Leaders at the randomized hospitals will be asked to participate in individualized interviews.

Detailed description: Health Care professionals in intensive care units (ICU) are working front-line with coronavirus disease (COVID-19) patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in need of intensive care treatment.

Data collected will identify the health care professionals' (nurses, medical doctors, leaders) views and experiences from the planning period of COVID-19 ICU units until a follow-up at 12 months.Themes to be covered in the survey are organization, information, communication across disciplines, education, practical implementation, use of personal protective equipment, daily working conditions and psychosocial aspects. The Oslo University Hospital/University of Oslo, GDPR (General Data Protection Regulation) compliant "TSD"-Services for Sensitive data web-based solution "Nettskjema" will be used combined for consent form and data collection from the survey. It is within the scope of the study to perform sub analysis on background variables as profession related to daily working experiences on COVID-ICU and psychosocial aspects.

A few of the informants (medical doctors, nurses, leaders) participating in the cohort study will randomly (computerized) be asked to participate in focus groups to get a deeper understanding of the experiences of the health care professionals during the pandemic and after the pandemic when they are back to a normal working condition. Leaders at the randomized hospitals will be asked to participate in individualized interviews. Data from the focus group interviews and individual interviews will be taped on a recorder approved by data protection officer at Oslo University Hospital and then stored at a secured computerized research place at Oslo University Hospital.

The gained knowledge from both the survey, the focus group interviews and individual interviews in this study may guide hospital directors and the government in follow up of health care professionals and to prepare for a later pandemic.

Eligibility criteria: Inclusion Criteria:

All health care professionals (nurses, medical doctors, leaders) working in all COVID-ICUs in Norway will be invited to participate in this project.

Exclusion Criteria:

No exclusion criteria

Primary outcomes:
measure: Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university hospital
Study officials:
affiliation: Oslo University Hospital
name: Irene Lie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lie I, Stafseth S, Skogstad L, Hovland IS, Hovde H, Ekeberg O, Raeder J. Healthcare professionals in COVID-19-intensive care units in Norway: preparedness and working conditions: a cohort study. BMJ Open. 2021 Oct 11;11(10):e049135. doi: 10.1136/bmjopen-2021-049135.