Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic (IMPACCT COVID-19): a Prospective, Multicentre, Mixed-methods Cohort Study
Conditions: Covid19, Critical Care, Postintensive Care Syndrome
Sponsor: Universidad del Desarrollo

 
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Title: Impact on Mental, Physical, And, Cognitive functioning of Critical care Time 
due to COVID-19 (IMPACCT-COVID19): protocol for a multicentre, prospective 
cohort study 
Clinical Trials registration number: NCT04979897 
Abbreviated title: IMPACCT-COVID19 study protocol 
Date: 18th of May 2021 
Ana Castro-Ávila, Catalina Merino-Osorio, Felipe González-Seguel, Agustín 
Camus-Molina, Jaime Leppe, on behalf of the IMPACCT study group 
 
Ana Castro-Ávila, PT, MSc, PhD, Department of Health Sciences, University of 
York, Heslington, United Kingdom. Docente, Carrera de Kinesiología, Facultad de 
Medicina Clínica Alemana Universidad del Desarrollo, Av. Plaza 680, Las Condes, 
Santiago, Chile. https://orcid.org/0000-0003-4475-4325 
 
Catalina Merino-Osorio, PT, MSc, Carrera de Kinesiología, Facultad de Medicina 
Clínica Alemana Universidad del Desarrollo, Av. Plaza 680, Las Condes, Santiago, 
Chile. https://orcid.org/0000-0002-6836-5466 
 
Felipe González-Seguel, PT, MSc, Servicio de Medicina Física y Rehabilitación, 
Departamento de Medicina Interna, Facultad de Medicina Clínica Alemana 
Universidad del Desarrollo, Av. Vitacura 5951, Santiago, Chile. 
https://orcid.org/0000-0001-9099-2389 
Address all correspondence at: feligonzalezs@udd.cl +(56) 9 89540683. 
 

 
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Agustín Camus-Molina, PT, MSc, Servicio de Medicina Física y Rehabilitación, 
Departamento de Medicina Interna, Facultad de Medicina Clínica Alemana 
Universidad del Desarrollo, Av. Vitacura 5951, Santiago, Chile. 
https://orcid.org/0000-0001-7378-9565 
 
Jaime Leppe, PT, MSc, Carrera de Kinesiología, Facultad de Medicina Clínica 
Alemana Universidad del Desarrollo, Av. Plaza 680, Las Condes, Santiago, Chile. 
https://orcid.org/0000-0002-8663-1182 
 
Conflict of interest: The authors declare no conflicts of interest. 
 
Number of figures: 1 
Reference Style: BMJ Open 
Word count (excluding title page, abstract, references, figures, tables and 
strengths and limitations): 3540/4000 
 

 
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ABSTRACT (290/300) 
Introduction: Intensive care unit (ICU) survivors and their families present a 
variety of mental, cognitive and physical impairments lasting years. The ongoing 
pandemic could affect the duration, variety, and severity of these impairments. Our 
aim is to determine the impact of the COVID-19 pandemic on the physical, mental, 
and cognitive health of survivors, their families and their treating healthcare 
professionals in the long-term. 
Methods and analysis: Prospective cohort in seven Chilean ICUs with a 
qualitative component. Sample: 450 adults, able to walk independently, in ICU and 
mechanical ventilation >48 hours with and without COVID-19. Assessments: Only 
at ICU discharge, Clinical Frailty Scale, Charlson comorbidity index, mobility (FSS-
ICU) and muscle strength (MRC-SS). Cognitive functioning (MOCA-blind), anxiety 
and depression (HADS), post-traumatic stress (IES-R) symptoms, disability 
(WHODAS 2.0), quality of life (EQ-5D-3L), employment, and survival will be 
assessed at ICU discharge, 3 and 6 months. Physical activity (GPAQ and 
actigraphy) will be measured in a sample at 6 months after ICU discharge. The 
perceptions of family members regarding the ICU stay and the later recovery will 
be explored 3 months after discharge. Health care professionals will be invited to 
discuss the challenges faced during the pandemic using semi-structured 
interviews. 
Ethics and dissemination: The “Impact on Mental, Physical, And, Cognitive 
functioning of Critical care Time due to COVID-19” (IMPACCT-COVID19) study 
was approved by the local Research and Clinical Trials Unit, the local Ethics 
Committee (2020-78) and each participating site. All eligible patients will receive 

 
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verbal and written information about the study before signing an informed consent 
form. A leaflet containing information about post-intensive care syndrome and 
rehabilitation alternatives will be provided to all participants. Study findings will be 
published in peer-reviewed journals following standard guidelines and 
disseminated through social media and conference meetings. 
 
Keywords: COVID-19, critical care, postintensive care syndrome, rehabilitation, 
follow-up studies 
 
Strengths and limitations of this study: 
▪ 
The mental, physical and cognitive consequences related to the post-
intensive care syndrome could be greater in periods of high occupancy 
during the pandemic and even more in patients infected with COVID-19. 
▪ 
This is the first Chilean multicentre follow-up study assessing functional 
outcomes of mechanically ventilated patients discharged from intensive care 
unit (ICU). 
▪ 
This study will also explore the views and experiences of family members/ 
next of kin and health care professionals working during the pandemic. 
 
INTRODUCTION 
Post-intensive care syndrome (PICS) is a common consequence of an intensive 
care unit (ICU) stay and can last up to 5 years.[1–3] The family members are often 
affected, reporting diminished quality of life and mental health related quality of 
life.[4] About 80% of family members become informal carers and 33% of families 

 
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see a significant reduction of income the first 6 months after discharge.[5] The 
extent to which these problems will be modified by the pandemic and coronavirus 
disease 2019 (COVID-19) remains unknown. 
If under normal circumstances, an ICU stay has detrimental effects, the pandemic 
added two extra factors. Firstly, a rapid and exponential increase in acute care bed 
capacity might have affected the quality of care delivered by spreading too thin 
highly skilled healthcare staff. Secondly, COVID-19 involves a new disease with 
great uncertainties regarding treatment, prognosis and long-term effects. Early 
reports suggest that 64% of patients who were discharged from ICU after severe 
COVID-19 have at least one symptom of PICS at 6 months after discharge[6] and 
32% had anxiety or depression symptoms,[7] which suggests these patients will 
have similar impairments to what has been reported for other ICU survivors 
previously.[8,9] Additionally, infection control protocols meant that healthcare staff 
had to wear personal protective equipment and family visiting was restricted.[10] 
These factors add another layer of potential negative effects due to challenges in 
communication with patients and their family members. Therefore, we hypothesize 
that the prevalence and severity of mental, physical, and cognitive impairments will 
be higher in patients treated in periods of higher bed occupancy and those who 
had severe COVID-19. In the case of family members, we expect that the 
experience of having a next of kin in the ICU during pandemic would be stressful 
and traumatic, but those with social support will cope better. In the case of staff 
members, their experiences will vary greatly depending on their profession and 
workplace, but we expect places with a more open/ less hierarchical structure to 
have coped better with the increase in demand. 

 
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The primary objective of this study is to compare the trajectory of mental, physical 
and cognitive impairments at ICU discharge, 3 and 6 months of mechanically 
ventilated adult patients who survived an ICU stay due to severe COVID-19 or 
other causes, during the pandemic. Secondary objectives are: 
● To compare the disability, quality of life and survival rate at ICU discharge, 3 
and 6 months of patients who were admitted to ICU due to severe COVID-
19 or other causes during high and low bed occupancy in the pandemic; 
● To describe the sedentary behaviour and physical activity levels in a sample 
of ICU survivors during the COVID-19 pandemic using a one-week 
actigraphy protocol; 
● To explore the psychological and emotional experiences reported by family 
members/next of kin of patients admitted to the ICU during the COVID-19 
pandemic; 
● To explore the emotional, intellectual, physical and administrative 
challenges faced by the participating ICU staff during the COVID-19 
pandemic; 
● To evaluate the feasibility of the follow-up from ICU discharge to 3 and 6 
months during the pandemic. 
 
METHODS 
Study design and setting 
The “Impact on Mental, Physical, And, Cognitive functioning of Critical care Time 
due to COVID-19” (IMPACCT-COVID19) is a prospective, multicentre, cohort study 
in seven Chilean academic medical-surgical ICUs. This study also involves a 

 
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qualitative component including semi-structured interviews with family 
members/next of kin of ICU survivors and with ICU staff from the participating 
centres. Participating sites are four public and three private hospitals comprising a 
pooled bed capacity of about 200 ICU beds for both COVID-19 patients and 
patients admitted for other causes. The IMPACCT-COVID19 study started in 
October 2020. Data collection is planned until November 2021 to achieve 
completion of the study in February 2022. 
 
Study population and eligibility criteria 
Adult patients (≥18 years old) who are mechanically ventilated for at least 48 hours 
in one of the participating ICUs and do not meet any of the exclusion criteria (Table 
1) will be invited to participate. 

 
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Table 1. Exclusion and stopping follow-up criteria 
Exclusion criteria 
Rationale 
Unable to walk independently 2 weeks prior to ICU admission (with or without a gait aid) 
Potential confounding factor 
S5q < 5 or CAM-ICU positive within 72 hours after ICU discharge 
Unable to evaluate 
Patient who do not understand or speak Spanish 
Unable to evaluate 
Patient unable to communicate verbally 
Incomplete assessment data 
Burn or severe trauma as admission diagnosis 
Incomplete assessment data 
Any neurological disorder (i.e. spinal cord injury, stroke and brain tumours) as admission diagnosis 
Potential confounding factor 
Transferred to a non-participating study centre before ICU discharge assessment 
Unable to evaluate 
Recent prolonged hospital stay (extended by more than 3 months) 
Potential confounding factor 
Criteria to stop follow-up 
 
Re-admission after being ICU discharged 
Potential confounding factor 
Withdrawal of consent 
Incomplete assessment data 
Death before 3 or 6 months from ICU discharge 
Incomplete assessment data 
ICU, intensive care unit; s5q, simple 5 questions scale; CAM-ICU, Confusion Assessment Method for the Intensive Care Unit 

 
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Procedure 
The planned flow of participants throughout the study is presented in Figure 1. 
Daily, patients will be screened to identify those who could potentially be 
discharged from the ICU. Each site coordinator, which is a clinician physiotherapist 
responsible for the site, will check that the patient is delirium-free (CAM-ICU 
negative) and cooperative (i.e. using 5 standardised questions: open [close] your 
eyes; look at me; open your mouth and stick out your tongue; nod your head; raise 
your eyebrows when I have counted up to five[11]) within 72 hours from ICU 
discharge. Every patient deemed eligible will be invited to participate and will 
receive verbal and written information about the study. Patients will be assessed at 
ICU discharge (T1, defined by the point between medical decision of discharge 
until 72 hours after), 3 months (T2) and 6 months after ICU discharge (T3). 
Fifty-eight physiotherapists were trained for the assessments at ICU discharge, 
which included in-person measurements and self-administered questionnaires. 
Physiotherapists had to be working in one of the participating ICUs at the time of 
the training. Training for standardising T1 assessments was delivered by 
experienced physiotherapists and researchers (ACM, CMO and FGS). For the 
follow-up assessments (T2 and T3), patients will be contacted via email or 
telephone to schedule a phone call evaluation performed by trained interviewers. 
 
Baseline data collection 
After the patient agreed to participate and signed the informed consent form, the 
following baseline data will be collected from the patient clinical records: age, 
gender, body mass index (BMI), highest educational level achieved (no formal 

 
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education, primary school, secondary school, undergraduate or postgraduate), 
admission diagnosis, Charlson Comorbidity Index, duration of mechanical 
ventilation, length of hospital stay before ICU admission, ICU length of stay, 
number of intubations and the maximum level of organ system support 
received.[12] 
 
Measurement Outcomes 
The assessment points and measurement instruments are presented in Table 2. 
Measurement instruments were selected according to the recommended Core 
Outcome Measurement Set for critical illness survivors.[13,14] 
 
Table 2. Schedule of enrolment and follow-up of the IMPACCT-COVID19 study 
 
Study period 
 
Enrolment  
Follow-up 
 
ICU 
discharge 
 3 months from 
enrolment 
6 months from 
enrolment 
Eligibility screening 
Inclusion and exclusion 
X 
 
 
 
Invitation to participate 
Informed consent 
X 
 
 
 
Patient characteristics 
Age, gender, BMI 
X 
 
 
 
Data related to hospitalisation 
Diagnosis, MV days, ICU LOS 
X 
 
 
 
Maximum level of organ system support 
X 
 
 
 
Pre-admission health and functioning 
Charlson Comorbidity Index 
X 
 
 
 
Educational level 
X 
 
 
 
Employment status 
X 
 
X 
X 
Clinical Frailty Scale 
X 
 
X 
X 
Physical functioning 
MRC Sum Score 
X 
 
 
 
FSS-ICU 
X 
 
 
 
Cognitive functioning 
MoCA blind 
X 
 
X 
X 

 
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Mental functioning 
IES-R 
X 
 
X 
X 
HADS 
X 
 
X 
X 
Disability and quality of life 
WHODAS 2.0 
X 
 
X 
X 
EQ-5D-3L 
 
 
X 
X 
Sedentary behaviour and physical activity 
 
 
 
 
Actigraphy 
 
 
 
X 
GPAQ 
 
 
 
X 
Survival rate 
X 
 
X 
X 
ICU, intensive care unit; BMI, body mass index; MV, mechanical ventilation; LOS, length of stay; 
FSS-ICU, Functional Status Score for the Intensive Care Unit; MRC, Medical Research Council; 
MoCA, Montreal Cognitive Assessment; IES-R, Impact of Event Scale Revised; HADS, Hospital 
Anxiety and Depression Scale; WHODAS, World Health Organization Disability Assessment 
Schedule; EQ-5D-3L, European Quality of Life Health Questionnaire 5 domains; GPAQ, Global 
Physical Activity Questionnaire 
 
When available, we used the Chilean version of each instrument, otherwise, the 
validated version in Spanish. Trained physiotherapists will take an estimated 
maximum time of 70 minutes to perform the assessment at ICU discharge (T1). A 
trained interviewer will take an estimated maximum time of 20 minutes to apply the 
questionnaires by telephone at 3 (T2) and 6 months (T3) after ICU discharge. 
 
The primary outcome measure is disability assessed at 6 months after ICU 
discharge using the World Health Organization Disability Assessment Schedule 2.0 
(WHODAS 2.0) which is recommended for critical illness survivors.[8] The 
WHODAS 2.0 is a self-reported disability questionnaire based on the International 
Classification of Functioning, Disability, and Health (ICF). It includes 36 questions, 
organised under six domains (cognition, mobility, self-care, getting along, life 
activities and participation). Each question must be answered based on the 
perceived difficulty for performing activities using a 5-point scale (none, mild, 
moderate, severe and extreme).[15] We will use the Spanish version freely 

 
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available at https://apps.who.int/iris/handle/10665/170500.[16] The estimated 
response time ranges from 5 to 10 minutes when evaluated in-person at ICU 
discharge and 10 to 20 minutes when evaluated by telephone at 3 and 6 months 
after ICU discharge. 
 
Secondary outcomes measures 
Clinical Frailty Scale 
The Clinical Frailty Scale (CFS) is a clinical judgment based tool developed for the 
Canadian Study of Health and Aging to evaluate the degree of frailty in elderly 
patients.[17] Currently, it is also used for critically ill patients.[18] The CFS 
evaluates specific domains including physical functioning, activities of daily living 
(ADL), instrumental ADL, assistance for personal care, comorbidities, and 
cognition to generate a frailty score using a 9-point scale ranging from 1 (very fit) to 
9 (terminally ill). A score greater than 4 is considered fragile.[17] We will use the 
Spanish version and recommended training material by the developers at the 
Dalhousie University.[17,19]) The estimated scoring time ranges from 1 to 5 
minutes evaluated in-person at ICU discharge considering the status 2 weeks 
before the onset of symptoms. 
 
Medical Research Council Sum Score (MRC-SS) 
Limb muscle strength will be assessed using the MRC-SS, which consists in a 
standardised examination of six muscle groups bilaterally (i.e. shoulder abduction, 
elbow flexion, wrist extension, hip flexion, knee extension and dorsiflexion).[20] All 
muscle groups are scored using a 6-point scale between 0 and 5 (0 = no visible / 

 
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palpable contraction; 1 = visible / palpable contraction or no limb movement; 2 = 
limb movement, but not against gravity; 3 = movement against the gravity over 
nearly the entire range of motion; 4 = motion against gravity and resistance, 
subjectively adjusted for gender and age; 5 = normal force). This scale requires an 
estimated assessment time of 5 to 10 minutes and will be evaluated only at ICU 
discharge following the method described by Hermans et al.[21] 
 
Functional Status Score for the Intensive Care Unit (FSS-ICU) 
The FSS-ICU is a mobility instrument to score the level of physical assistance 
required when performing five functional activities: rolling, transfer from supine to 
sit, sitting at the edge of the bed, transfer from sitting to stand, and walking.[22] 
Each activity is scored using a 7-point scale ranging from 0 (not able to perform) to 
7 (complete independence). The resulting overall score ranges from 0 to 35 points. 
Each evaluation requires between 10 and 30 minutes. It will be assessed at ICU 
discharge using the available and validated Chilean version.[23,24] Due to the 
limitations during the pandemic, walking will be evaluated inside the room, forcing 
the patient to walk with more laps than usual. 
 
Montreal Cognitive Assessment–Blind (MoCA blind) 
The MoCA blind is a cognitive screening tool designed to detect cognitive 
dysfunction in five areas: memory, attention, language, abstraction and orientation. 
It requires 5 minutes to be completed.[25] Each domain is scored separately for a 
total score ranging from 0 to 22 points. A score equal to or greater than 18 points is 
considered normal cognition. To minimize memory bias, the MoCA blind will be 

 
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assessed using version 7.1 at ICU discharge (in-person), version 7.2 at 3 months 
(by telephone) and version 7.3 at 6 months (by telephone),[26,27] following the 
standardised procedure recommended at https://www.mocatest.org. 
  
Hospital Anxiety and Depression Scale (HADS) 
The HADS is an interviewer or self-administered questionnaire designed to identify 
anxiety and depressive symptoms in a wide variety of in-hospital patients, which 
requires between 2 and 5 minutes to be completed.[28] The HADS has fourteen 
questions, seven for anxiety and seven for depressive symptoms. Each question is 
rated with a 4-point scale ranging from 0 ("absence") to 3 ("extreme presence"), 
resulting in a sum score of 21 points per subscale. HADS will be evaluated at ICU 
discharge and by telephone at 3 and 6 months using the Chilean version.[29] 
 
Impact of Events Scale–Revised (IES-R) 
The IES-R is an interviewer or self-administered questionnaire designed to 
measure the subjective distress caused by traumatic events that has been 
validated for critical illness survivors.[30] It comprises 22 questions divided in three 
subscales: intrusion, avoidance, and hyperarousal. Questions are rated in a 5-point 
scale ranging from 0 ("not at all") to 4 ("extremely"). The estimated response time 
is 6 minutes. It will be evaluated at ICU discharge and by telephone at 3 and 6 
months using the available Chilean version.[31] 
 

 
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European Quality of Life Health Questionnaire (EQ-5D-3L)  
The EQ-5D-3L is an interviewer or self-administered questionnaire of health status 
or health-related quality of life, including five domains: mobility, self-care, usual 
activities, pain/discomfort, anxiety/depression and global health state.[32,33] Each 
domain is scored based on 3 levels of severity: no problems, some problems, and 
extreme problems. Additionally, EQ-5D-3L includes a Visual Analog Scale ranging 
from “best imaginable health state” (100) to “worst imaginable health state” (0). 
Both parts of the questionnaire take an estimated response time of 2 minutes. It 
will be evaluated by telephone at 3 and 6 months using the Chilean version.[34] 
 
Employment status 
The employment status will be evaluated at ICU discharge, 3 and 6 months using 
tailored questions regarding current occupation, working hours, and any changes 
to their employment situation as it has been used elsewhere.[35,36] 
 
Survival 
The survival rate will be measured by the percentage of patients still alive at ICU 
discharge, 3 months, and 6 months after ICU discharge. Information on deaths will 
be obtained from death certificates from the Chilean National Civil Registry. 
 
Sedentary Behaviour and Physical Activity 
Sedentary behaviour and physical activity will be measured using a standardized 
one-week actigraphy protocol according to the Chilean National Health Survey 
[37,38] using the ActiGraph GT3X (ActiGraph, Pensacola, FL, USA) accelerometer 

 
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and the Global Physical Activity Questionnaire (GPAQ) in a selected sample of 
survivors at 6 months after ICU discharge. 
 
Family or next of kin interviews 
During the 3-month follow-up call, patients will be asked if a family member or next 
of kin will be willing to participate in the interview study. Once monthly, we will 
purposely select a sample of family members to be contacted. The selection will be 
performed to ensure maximum variation in terms of age, educational level, length 
of ICU stay, treatment centre and COVID-19 status of the patient that went through 
ICU. Information about the interview study will be provided over the phone 
following a script approved by the ethics committee. Once the family members 
verbally consent, the interview will be scheduled. Interviews will be semi-structured 
and be recorded for later transcription verbatim. The interviewer is a clinical 
psychologist with experience conducting interviews and training on providing 
emotional support for people under distress. We will aim to conduct 18 interviews 
or more until data saturation is achieved. Interviews will cover four main topic 
areas: ICU admission, communication during the ICU stay, experience of returning 
home, and the experience of having a loved one in the ICU. Each transcription will 
be anonymised, and the recording will be securely deleted. 
 
Critical care staff interviews 
Once the bed occupancy in ICU returns to usual levels, recruitment will start. An 
open call to participate will be made through WhatsApp and Facebook groups of 
the clinicians working in the participating centres. Additionally, posters will be put in 

 
17 
the rest areas to capture a wider population. We will recruit medics, nurses, 
healthcare assistants and physiotherapists that normally work in an ICU and have 
patient-facing clinical duties for more than 96 hours during the pandemic. The 
invitation to participate will lead to a google form containing information about the 
study and a short script that constitutes the informed consent. From the list of 
volunteers, we will purposely sample three professionals per clinical group aiming 
to maximise variation regarding years of experience and centre where they work. 
We expect a minimum of 40 interviews, but we will continue recruitment until data 
saturation is achieved. Interviews will be conducted online or over the phone. 
Participants will be asked for verbal consent before starting the interview, which will 
be recorded for later transcription verbatim. Interviews will be semi-structured 
covering five main topic areas: preparation before the pandemic; intellectual, 
physical and emotional challenges during the pandemic; and learning for future 
events. 
  
Follow-up feasibility 
The consent rate will be collected, calculating the number of patients who agreed 
to participate divided by the number of patients who meet selection criteria, 
expecting a consent rate of > 70%.[39] The feasibility over-time during the follow-
up will be measured as cohort retention rate, considering the number of patients 
who can be contacted and evaluated at 3 and 6 months. [40,41] The reasons for 
the lack of assessments will be recorded individually. 
 

 
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Sample size calculation 
All patients meeting the eligibility criteria discharged from ICU between October 
2020 and April 2021 (due to funding constraints) will be invited to participate. 
Based on bed capacity and patient flow from previous years, we estimated that 20 
to 30 mechanically ventilated adult patients are discharged monthly from each 
centre. This means the sampling universe ranges from 840 to 1260 patients. 
Hodgson et al (2017) found that a quarter of ICU survivors had severe or moderate 
disability at 6 months after discharge, and half of them had mild disability.[8] There 
is no information to estimate how much the prevalence of disability increases 
during a pandemic; however, the prevalence of mental health issues could be used 
as a proxy of the expected impact on physical health. Hodgson et al (2017) found 
that 22% of patients had anxiety or depressive symptoms at 6 months after 
discharge. Lee et al (2007) found that among survivors of the SARS outbreak, 40% 
had at least moderate anxiety one year after.[42] This is equivalent to a relative risk 
of 1.81. Considering that measurement time points are different, we have 
estimated our sample size assuming a relative risk (RR) of 1.5 or 1.6, which is 
more conservative than the estimation based on the literature. The different 
scenarios used for the sample size calculation appear in Table 3.  
 
Table 3. Different plausible scenarios for sample size calculation 
Outcome 
Risk in non-
pandemic situation 
Risk during the pandemic 
Type 1 
error 
Power 
Sample 
size 
WHODAS 2.0 
25% severe or 
moderate disability 
40% severe or moderate 
disability (RR=1.6) 
0.05 
0.8 
343 

 
19 
WHODAS 2.0 
40% some degree 
of disability 
64% some degree of 
disability (RR=1.6) 
0.05 
0.8 
288 
WHODAS 2.0 
50% mild disability 
75% mild disability 
(RR=1.5) 
0.05 
0.8 
388 
HADS 
22% anxiety or 
depressive 
symptoms 
40% moderate anxiety 
(RR=1.8) 
0.05 
0.8 
226 
HADS, Hospital Anxiety and Depression Scale; WHODAS, World Health Organization Disability 
Assessment Schedule; RR, relative risk 
 
The most plausible scenario is that 40% of ICU survivors discharged in a low 
demand period will have some degree of disability and this will increase to 64% for 
those discharged during high-demand periods. Considering loss to follow-up, we 
estimate 550 patients need to be recruited at ICU discharge; so 413 patients are 
assessed at 3 months after discharge (25% loss to follow-up) and 289 patients at 6 
months (30% lost to follow-up). 
 
Quantitative analysis 
Categorical variables will be presented as absolute and relative frequencies for 
each subgroup (i.e. admission diagnosis and treatment centre) and time point (i.e. 
ICU discharge, 3 and 6 months follow-up). In the case of normally distributed 
continuous variables, these will be summarised using the mean and standard 
deviation, while for those non-normally distributed, the median and interquartile 
range will be used instead. 
The trajectory for each outcome measure will be estimated using longitudinal 
multilevel regression with robust standard errors to account for data coming from 

 
20 
seven treatment centres. If data have a normal distribution, a linear regression 
model will be chosen. In the case of right skewed data, a Poisson regression will 
be used. For HADS, IES-R and WHODAS 2.0, data will be analysed as total 
scores and categories given by each questionnaire. 
Survival will be analysed using Kaplan-Meier curves. If the assumption of 
proportional hazards is met, survival will be compared between patients admitted 
due to COVID-19 vs. other causes using Cox regression. All analyses will be 
performed in Stata 16.0 SE. 
Qualitative analysis 
Data from the interviews with family members and critical care staff will be 
analysed using framework analysis.[43] Transcription will be aided by the software 
Scrintal and analysis by Nvivo 12.0. Two coders will listen and read in-full all 
interviews before meeting to explore potential common topics that were discussed 
during the interviews. These topics will form the initial coding framework. Through 
an iterative process these codes will be refined into overarching themes capturing 
differences and similarities across subgroups. A more advanced coding framework 
will be reviewed with members of the research team until agreement regarding the 
final framework is reached. 
Themes will be used to explain the experience of family members during the 
pandemic and, potentially, identify areas where improvements could be made in 
the future. In the case of critical care staff, the aim is to explore to what extent the 
approach to the pandemic of each centre influenced the experience of the different 
clinical groups, and what can be learned for future outbreaks. 

 
21 
Findings will be shared with our participants and with other family members/ critical 
care staff that did not participate in the interviews to ensure our interpretation 
reflects their experiences. 
 
Patient and public involvement 
Patients or the public were not involved in the design, conduct, reporting, or 
dissemination plans of this study. 
 
ETHICS AND DISSEMINATION 
Ethical considerations 
The IMPACCT-COVID19 study is conducted in accordance with the Declaration of 
Helsinki. Due to the observational nature of this study, patients will not be exposed 
to any intervention, just observing the evolution of outcomes from ICU discharge to 
6 months after. This study was reviewed and approved by the Clínica Alemana 
Research and Clinical Trials Unit and the Facultad de Medicina Clínica Alemana 
Universidad del Desarrollo Ethics Committee (registration number 2020-78). The 
protocol was also reviewed and approved by each participating site ethics 
committee. All recruited patients will be informed on the study obtaining their 
written informed consent before the first evaluation. Patients will receive verbal and 
written information related to post-intensive care syndrome at the ICU discharge 
evaluation. At the 3- or 6-month evaluation patients with moderate or severe 
disability (according to the WHODAS 2.0 results) will receive information on 
rehabilitation alternatives at their nearest hospital. 
 

 
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Dissemination 
We will disseminate results to key stakeholders including critical care clinicians, 
patients, families, rehabilitation staff, research funders and the public. 
The knowledge translation of the IMPACCT-COVID-19 study will follow the three 
end-of-grant knowledge translation strategy categories: diffusion (let it happen), 
dissemination (help it happen) and application (make it happen).[44] Diffusion will 
be carried out using social media such as Twitter and ResearchGate. 
Dissemination will be carried out through presentation of findings in conference 
meetings and peer-review journal publications following the Strengthening the 
Reporting of Observational studies in Epidemiology (STROBE) guidelines. 
Additionally, the progress, preliminary findings and final results will be 
disseminated on the study’s tailored website (https://medicina.udd.cl/kinesiologia-
santiago/impacct). Application will include workshops, academic meetings and 
development of useful tool for the follow-up of ICU survivors for both clinicians and 
researchers. 
 

 
23 
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29 
Collaborators: The IMPACCT-COVID19 study group includes the following main 
collaborators (organized alphabetically): Ana Castro-Ávila, Agustín Camus-Molina, 
Catalina Merino-Osorio, Felipe González-Seguel and Jaime Leppe; and the 
following additional collaborators: Camilo Cáceres Parra, Eduardo González Tapia, 
Felipe Muñoz-Muñoz, Fernanda Baus Auil, Javiera Aguilera Scarpati, Joaquín 
Olave, Macarena Leiva-Corvalán, Pilar Castro and Yerko Villagra Jofré. 
 
Acknowledgements: We want to acknowledge the Universidad del Desarrollo for 
funding this research and each participating site for allowing us to use part of their 
infrastructure. 
 
Contributors: ACA, CMO, FGS and ACM contributed to the conception. ACA, 
CMO, and FGS drafted the first version of the protocol manuscript. All authors 
contributed to the study design, contributed to drafting the protocol, revised the 
manuscript for important intellectual content and gave final approval of the version 
to be published. 
 
Funding statement: IMPACCT-COVID19 study is funded by Universidad del 
Desarrollo (Grant number 2020-78) and sponsored by the Chilean National Agency 
for Research and Development (ANID-0772). The funders had no role in the 
design, collection, analysis of the study, and writing of this manuscript. 
 
Competing interest statement: None declare 
 

 
30 
Figure caption 
 
Figure 1. IMPACCT-COVID19 study flowchart. 
ICU, intensive care unit; COVID-19, coronavirus disease 2019