Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic (IMPACCT)

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

Intensive care unit (ICU) survivors and their families frequently present 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, the experience of their families and their treating healthcare professionals in the long-term.

This is a prospective, multicentre, mixed-methods cohort study in seven Chilean ICUs. 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.

Study Overview

• Status: Completed
• Conditions: Covid19; Critical Care; Postintensive Care Syndrome
• Intervention / Treatment: Other: Intensive care unit stay during the COVID-19 pandemic

• Study Type: Observational
• Enrollment (Actual): 252

Contacts and Locations

Study Locations

• Chile
  • Antofagasta, Chile
    • Hospital Regional Dr. Leonardo Guzmán de Antofagasta
  • Coquimbo, Chile
    • Hospital San Pablo de Coquimbo
  • Santiago, Chile
    • Clínica Alemana de Santiago
  • Santiago, Chile
    • Hospital del Salvador
  • Santiago, Chile
    • Clínica BUPA
  • Santiago, Chile
    • Clinica Indisa
  • Santiago, Chile
    • Hospital Metropolitano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults who were mechanically ventilated in the ICU, either with the diagnosis of COVID-19 or other causes

Description

Inclusion Criteria:

• Adult patients (≥18 years old)
• Mechanically ventilated for at least 48 hours

Exclusion Criteria:

• Unable to walk independently 2 weeks prior to ICU admission (with or without a gait aid)
• S5q < 5 or CAM-ICU positive within 72 hours after ICU discharge
• Patient who do not understand or speak Spanish
• Patient unable to communicate verbally
• Burn or severe trauma as admission diagnosis
• Any neurological disorder (i.e. spinal cord injury, stroke and brain tumours) as admission diagnosis
• Transferred to a non-participating study centre before ICU discharge assessment
• Recent prolonged hospital stay (extended by more than 3 months)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intensive care unit stay during high bed occupancy in the COVID-19 pandemic; Adult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a high bed occupancy in the pandemic	Other: Intensive care unit stay during the COVID-19 pandemic; Patients will be screened daily for a potential ICU discharge. 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) within 72 hours from ICU discharge. Every patient deemed eligible will be invited to participate through a face-to-face visit by the assigned evaluator, receiving verbal and written information about the study
Intensive care unit stay during low bed occupancy in the COVID-19 pandemic; Adult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a low bed occupancy in the pandemic	Other: Intensive care unit stay during the COVID-19 pandemic; Patients will be screened daily for a potential ICU discharge. 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) within 72 hours from ICU discharge. Every patient deemed eligible will be invited to participate through a face-to-face visit by the assigned evaluator, receiving verbal and written information about the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	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). The overall score of each domain, it is transformed into a score between 0 and 100, where 0 means no disability and 100 is complete disability	6 months after the ICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Frailty Scale	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	Within 72 hours from ICU discharge
Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength	the MRC-SS consists of a standardised examination of six muscle groups bilaterally (i.e. shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension and dorsiflexion). All muscle groups are scored using a 6-point scale between 0 and 5 (0 = no visible /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). The score goes from 0 (no strength) to a maximum score of 60 points, indicating normal peripheral strength.	Within 72 hours from ICU discharge
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. 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, where a higher scores indicates better performance.	Within 72 hours from ICU discharge
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. 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.	6 months after the ICU discharge
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. 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. For each subscale, a score >8 indicates suspected anxiety or depression, while a score >11 indicates clinical symptoms of anxiety or depression.	6 months after the ICU discharge
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. It comprises 22 questions in three subscales: intrusion, avoidance, and hyperarousal. Questions are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The score goes from 0 to 88 points. Scores above 33 are indicative of post-traumatic stress symptoms.	6 months after the ICU discharge
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. Each domain is scored based on 3 levels of severity: no problems, some problems, and extreme problems. Each combination of answers can be translated into a utility score, where 0 is similar to being dead and 1 represents the best possible quality of life. The utility scores were obtained using the Chilean Social valuation of EQ-5D health states (DOI: http://dx.doi.org/10.1016/j.jval.2011.09.002)	6 months after the ICU discharge
Employment Status	The employment status was evaluated using the following questions: What is your current employment status? What working hours do you have? and has your employment situation changed after your ICU stay?	6 months after the ICU discharge
Survival	Number of patients who survived	6 months after the ICU discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort Retention Rate	Number of patients who can be contacted and evaluated	Every month during one year

Collaborators and Investigators

• Sponsor: Universidad del Desarrollo
• Collaborators: Clinica Alemana de Santiago; Clinica Indisa; Clínica BUPA; Hospital del Salvador; Hospital Regional Dr. Leonardo Guzmán de Antofagasta; Hospital San Pablo de Coquimbo; Hospital Metropolitano
• Investigators: Principal Investigator: Ana Castro-Ávila, PhD, Universidad del Desarrollo

Publications and helpful links

General Publications

• Castro-Avila AC, Merino-Osorio C, Gonzalez-Seguel F, Camus-Molina A, Leppe J; IMPACCT COVID-19 study group. 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. BMJ Open. 2021 Sep 8;11(9):e053610. doi: 10.1136/bmjopen-2021-053610.

Helpful Links

• Custom-made study web site

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: July 24, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Covid19; Critical care; Follow-up; Postintensive Care Syndrome
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-78

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No