Clinical trial NCT05348720: Impact of a COVID-19 Related ICU Stay on Mental Health for Patients and Their Relatives
Official title: Impact of a COVID-19 Related ICU Stay on Mental Health for Patients and Their Relatives. An Exploratory 18-month Follow-up Study for COVID-19 ICU Survivors and Their Relatives.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Intensive Care Syndrome
PICS
COVID-19
Critically Ill
Mental Health
Keywords: COVID-19
ICU survivor
PICS
PICS-F
neurocognitive sequels
Follow-up
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All COVID-19 patients admitted to the ICU between 1/3/2020 and 31/5/2021, who survived the ICU and index hospitalisation, requiring High Flow Oxygen Therapy (HFOT), non-invasive ventilation (NIV) or mechanical ventilation (MV) due to respiratory failure primarily related to COVID-19, will be eligible.

Covid-19 diagnosis will be based on RNA detection of SARS-COV-2 using RT-PCR of a nasopharyngeal swab or through respiratory specimen obtained by bronchoscopy.

All eligible patients, still alive 18 months after ICU discharge, will be contacted by telephone for participation in this study. Simultaneously, these patients will be asked if their family member is keen to participate in the study as well. We aim to enroll the family member the most involved in the patient's ICU stay.

Brief summary: As ICU mortality has been significantly decreased over the last two decades, the focus has been shifting from short term (such as ICU and hospital mortality) to long-term outcome. This evolution has led to a new entity that has been established in 2012 at a stakeholder conference: the Post-Intensive Care Syndrome (PICS). It is defined as impairments in physical, cognitive and mental health status arising after critical illness and persisting beyond acute care hospitalisation. As family members of ICU patients may also be affected by mental health impairment, the PICS-F (F for Family) has been introduced simultaneously.

It is expected that the COVID-19 pandemic will result in a significant increase of the proportion of patients and relatives suffering PICS and PICS-F, as there is during the COVID-19 related ICU-stay exposure to a high number of risk factors for developing these entities.

This Post Intensive Care Syndrome in COVID-19 survivors (PICOVIDS) study is an observational, single-center exploratory follow-up cohort study that aims to get insight into the mental impact of a COVID-19 related ICU stay for COVID-19 ICU survivors and their family members, 18 months after ICU discharge.

Specific research questions are:

1. What is the prevalence of symptoms of depression, anxiety and Post Traumatic Stress Disorder (PTSD) and what is the prevalence of these specific disorders in COVID-19 ICU-survivors and their relatives 18 months after ICU-discharge?
2. What are important risk factors for these symptoms and disorders?
3. What is the satisfaction level of patient and caregiver about the ICU care: How did they experience ICU stay?

Detailed description: Design:

The Post Intensive Care Syndrome in COVID-19 survivors (PICOVIDS) study is an observational, single-center exploratory follow-up cohort study in a non-university hospital with 31 ICU beds.

Objective:

The study aims to get insight into the mental impact of a COVID-19 related ICU stay for COVID-19 ICU survivors and their family members, 18 months after ICU discharge.

Specific research questions are:

1. What is the prevalence of symptoms of depression, anxiety and Post Traumatic Stress Disorder (PTSD) and what is the prevalence of these specific disorders in COVID-19 ICU-survivors and their relatives 18 months after ICU-discharge?
2. What are important risk factors for these symptoms and these disorders?
3. What is the satisfaction level of patient and caregiver about the ICU care: How did they experience ICU stay?

Patients' recruitment (See section 'inclusion and exclusion criteria' for further details):

Patients admitted to the ICU between 1 March 2020 and 31 May 2021, with respiratory failure primarily due to COVID-19, who survived ICU stay and hospitalisation are eligible and will be contacted by telephone 16 to 18 months after ICU discharge by the research team. Patients will receive information regarding the aim, content and relevance of the study and asked for participation to this study. They will be asked as well whether his or her caregiver the most involved during the ICU stay would participate to the study.

Methods:

Once oral informed consent by telephone will be given, a bundle will be sent to patient and involved relative by post. This bundle contains informed consent, information brochure and several questionnaires.

Questionnaires for patients are:

* Hospital and Depression Scale (HADS anxiety and depression)
* Patient Checklist for DSM-5 (PCL-5) for COVID
* Cognitive Failure Questionnaire (CFQ)
* Short Form 36 Health Survey Questionnaire (SF-36)
* Questionnaire for persistent physical complaints
* Rockwood Clinical Frailty Scale
* Patient Continuity of Care Questionnaire adjusted (PCCQ): subscales relationship in hospital, information transfer)
* Socio-demographic questionnaire

Caregivers will receive the same questionnaires except for the SF-36, the questionnaire assessing persistent physical complaints and the Rockwood Clinical Frailty Scale as these one are not applicable to them, while a Caregiver Reaction Assessment (CRA) scale questionnaire will be added for this cohort.

Consequently psychological, cognitive and physical symptoms, clinical frailty, satisfaction level about care and socio-demographic factors will be assessed.

There are Dutch, French and English versions of this bundle available, as preferred by patient and relative.

Patient and caregiver will be contacted a second time by telephone 10 to 14 days after the first call for verifying whether there are remaining questions after receiving the bundle. A second bundle will be sent by post in case of the first one would have been lost or patient and/or caregiver couldn't be reached.

Questionnaires will be analysed by two members of the research team. Patients and caregivers scoring more than 7 on the HADS-Anxiety, more than 8 on the HADS-Depression or more than 32 on the PCL-5 COVID questionnaire will be considered as having symptoms of respectively anxiety, depression and PTSD. Subsequently, they will be invited for a clinical and structured interview, using the Mini-International Neuropsychiatric Interview (MINI), the Clinician-Administered PTSD scale (CAPS) and the Montreal cognitive Assessment (MoCa). A psychiatrist and clinical psychologist will conduct this interview. Consequently, diagnosis of Generalised Anxiety Disorder (GAD), Depression and PTSD according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as well as cognitive impairment could be established.

Data Collection:

On the one hand, anonymised patient data with respect to the ICU hospitalisation will be collected from patient records (electronic patient records, Patient Data Management System (PDMS), Klinisch Werkstation (KWS), Cyberlab). This data collecting process will be facilitated by LynxCare® company, an Artificial Intelligence (AI) and Natural Language Processing (NLP) based big data platform. This medical data will include: demographics, pre-existing co-morbidities (including Clinical Frailty score (CFS) and Charlson Comorbidity Index, severity of illness scores (APACHE-II score, Simplified Acute Physiology Score (SAPS), Sequential Organ Failure Assessment (SOFA)), specific COVID-treatment, method of respiratory support during ICU stay (High Flow Oxygen, Non-Invasive Ventilation, Mechanical Ventilation, prone ventilation, Extracorporeal Membrane Oxygenation (ECMO), duration of mechanical ventilation, duration of ECMO run, diagnosis of ICU-Acquired Weakness (ICU-AW) or Critical Illness Polyneuropathy (CIP) and Myopathy (CIM, presentation of Acute Kidney Injury (AKI) grade 3 of need for dialysis, ICU-Length of stay (LOS), Hospital-LOS Additionally, specific interest will go to data regarding potential risk factors for long-term neurocognitive sequels such as: age, social context, pre-existing psychiatric and/or cognitive symptoms, neurological events during ICU hospitalisation (e.g. delirium, ICU-AW, CIP and CIM, stroke (ischemic or hemorrhagic)), need for mechanical ventilation, need for ECMO, need for multiple sedative agents, AKI with or without need for dialysis, ICU-LOS, hospital-LOS, persisting symptoms after discharge, duration of work-related problems (duration of sick leave), increased dependence after discharge, inability to return to original home situation, loss of other family members during follow-up period.

On the other hand, data about long-term outcome will be collected from questionnaires and a possibly clinical interview (for details with regards to this data: see section 'methods').

Data analysis Data will be merged ad patient level. Descriptive statistics will be used to describe baseline characteristics, inpatient course during index hospitalisation and findings (prevalence of the various long-term outcome) obtained from the questionnaires for patient and relatives. Regression analysis will be used to determine associations between patient characteristics, inpatient course and long-term outcomes.

Software Package for the Social Sciences (SPSS) will be used for data analysis.

Data management and ethical considerations Both data extracted from medical records and from the questionnaires will be anonymised before analysis and will be merged at patient level. Data management will be performed by the team of Lynxcare® and by the research team (study nurses and investigators).

Importantly, LynxCare® will only have access to the encrypted data, only the research team will have the key for decoding. This all will be strictly conform the most recent European Union's General Data Protection Regulation (GDPR). Hence patient's privacy will be guaranteed maximally throughout the whole process.

Patients will be asked for oral informed consent during the first phone call, followed by obtaining a written informed consent for both patient and relative, a form that will be included in the bundle sent by post. This written (signed) informed consent is a strict condition prior to enrollment, data collection and analysis.

Ethical approval was given by the Medical Ethical Committee AZ Groeninge (B3962021000047), all patients will give their informed consent prior to data collection and analysis.

Eligibility criteria: Inclusion Criteria:

* COVID-19 patient admitted to the ICU between 1st of March 2020 and 31st of May 2021
* Surviving ICU and index hospitalisation
* Respiratory failure due to COVID-19 with need for High Flow Oxygen Therapy (HFOT), non-invasive ventilation (NIV) or mechanical ventilation (MV)
* Family member (caregiver) of eligible COVID-19
* Written informed consent obtained from patient and family member

Exclusion Criteria:

* ICU length of stay (ICU-LOS) \</= 72h
* Decease of the COVID-19 patient during 18-month follow-up period
* Respiratory failure and admission to ICU was not primary related to COVID-19
* Poor or moderate knowledge of Dutch, French or English language
* Mentally not able to complete questionnaires or to give informed consent, due to a neurocognitive deficit

Primary outcomes:
measure: Composite outcome: Prevalence of psychiatric symptoms in COVID-19 ICU survivors
timeFrame: 18 months after ICU discharge
measure: Composite outcome: Prevalence of psychiatric symptoms among relatives of COVID-19 ICU survivors
timeFrame: 18 months after ICU discharge
Secondary outcomes:
measure: Composite outcome: Prevalence of psychiatric disorders among relatives of COVID ICU survivors.
timeFrame: 18 months after ICU discharge
measure: Composite outcome: Prevalence of psychiatric disorders among COVID ICU survivors.
timeFrame: 18 months after ICU discharge
measure: Prevalence of cognitive impairment in COVID-19 ICU survivors and their relatives
timeFrame: 18 months after ICU discharge
measure: Impact of caring for COVID-19 ICU survivor after hospital discharge on the relative
timeFrame: 18 months after ICU discharge
measure: Patient and relatives' satisfaction level about continuity of care after hospital discharge
timeFrame: 18 months after ICU discharge
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: AZ Groeninge Kortrijk
Study officials:
affiliation: General Hospital Groeninge
name: Stoffel Lamote, MD
role: PRINCIPAL_INVESTIGATOR
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