Impact on Mental, Physical and Cognitive functioning of a Critical care sTay during the COVID-19 pandemic (IMPACCT COVID-19): protocol for a prospective, multicentre, mixed-methods cohort study
Journal
BMJ Open
ISSN
2044-6055
2044-6055
Date Issued
2021
Author(s)
Catalina Merino-Osorio
Felipe González-Seguel
Type
Resource Types::text::journal::journal article
URL Institutional Repository
Abstract
<jats:sec><jats:title>Introduction</jats:title><jats:p>The ongoing pandemic could affect the duration, variety and severity of the mental, physical, and cognitive impairments intensive care unit (ICU) survivors and their families frequently present. We aim to determine the impact of the COVID-19 pandemic on the mental, physical, and cognitive health of survivors, the experience of their families and their treating healthcare professionals.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>Prospective, multicentre, mixed-methods cohort study in seven Chilean ICUs. Sample: 450 adults, able to walk independently prior to admission, in ICU and mechanical ventilation >48 hours with and without COVID-19. Clinical Frailty Scale, Charlson comorbidity index, mobility (Functional Status Score for the Status Score for the Intensive Care Unit) and muscle strength (Medical Research Council Sum Score) will be assessed at ICU discharge. Cognitive functioning (Montreal Cognitive Assessment–blind), anxiety and depression (Hospital Anxiety and Depression Scale), post-traumatic stress (Impact of Event Scale-Revised) symptoms, disability (WHO Disability Assessment Schedule 2.0), quality of life (European Quality of Life Health Questionnaire), employment and survival will be assessed at ICU discharge, 3 months and 6 months. A sample will be assessed using actigraphy and the Global Physical Activity Questionnaire at 6 months after ICU discharge. Trajectories of mental, physical, and cognitive impairments will be estimated using multilevel longitudinal modelling. A sensitivity analysis using multiple imputations will be performed to account for missing data and loss-to-follow-up. Survival will be analysed using Kaplan-Meier curves. The perceptions of family members regarding the ICU stay and the later recovery will be explored 3 months after discharge. Healthcare professionals will be invited to discuss the challenges faced during the pandemic using semistructured interviews. Interviews will be thematically analysed by two independent coders to identify the main themes of the experience of family members and healthcare professionals.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The study was approved by the Clinica Alemana Universidad del Desarrollo Ethics Committee (2020–78) and each participating site. Study findings will be published in peer-reviewed journals and disseminated through social media and conference meetings.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results" xlink:href="NCT04979897">NCT04979897</jats:ext-link>.</jats:p></jats:sec>
Subjects
respiratory-failure survivors
;
intensive-care
;
clinical-research
;
hospital anxiety
;
depression scale
;
critical illness
;
stress
;
unit
;
disability
;
distress
;
adult
;
cognition
;
cohort studies
;
covid-19
;
critical care
;
humans
;
intensive care units
;
multicenter studies as topic
;
pandemics
;
prospective studies
;
quality of life
;
sars-cov-2
;
actimetry
;
adult
;
article
;
artificial ventilation
;
charlson comorbidity index
;
clinical frailty scale
;
clinical protocol
;
cognition
;
cognitive defect
;
cohort analysis
;
coronavirus disease 2019
;
employment
;
european quality of life 5 dimensions 3 level questionnaire
;
female
;
follow up
;
functional status
;
health care personnel
;
hospital admission
;
hospital anxiety and depression scale
;
human
;
impact of events scale
;
intensive care unit
;
kaplan meier method
;
major clinical study
;
male
;
mental health
;
montreal cognitive assessment
;
multicenter study
;
muscle strength
;
pandemic
;
physical activity
;
post-covid-19 functional status scale
;
posttraumatic stress disorder
;
prospective study
;
quality of life
;
semi structured interview
;
social media
;
survivor
;
cognition
;
intensive care
;
multicenter study (topic)