Psychological Impact of COVID-19 on Intensive Care Survivors (PIM-COVID)

Royal Liverpool University Hospital

Status: Completed

Conditions: COVID-19; Post-traumatic Stress Disorder; Post Intensive Care Syndrome; Depression; Anxiety; Psychological Distress

Study type: Observational

Funder types: Other

Identifiers

NCT05092529

SP0316

IRAS 282400 (Registry Identifier)

NIHR CPMS 47545 (Registry Identifier)

Details and patient eligibility

About

Psychological distress is commonly experienced by survivors of an intensive care admission, including patients treated during previous pandemics. Whilst data emerges about the short-term impact of COVID-19 on patients and healthcare systems, the long term impact remains unclear.

The purpose of this trainee-led, multi-centre longitudinal study is to assess the short- and long-term psychological impact on patients who have survived an admission to intensive care due to COVID-19, and identify possible predictors of anxiety, depression and trauma symptoms in this patient group.

Full description

The primary objective is to identify the proportion of patients surviving an admission to intensive care due to COVID-19 who experience anxiety, depression and/or trauma symptoms in the 6 months post discharge.

Whilst the secondary objectives are to identify demographic, clinical, physical and/or psychosocial predictors of depression, anxiety and/or trauma symptoms at 3-, 6- and 12-months post discharge from ICU. And to assess the feasibility of using a self-reported online questionnaire to assess anxiety, depression and/or trauma symptoms in patients following ICU admission.

An amendment was approved by the East Midlands - Derby Research Ethics Committee on 17 March 2022, to conduct three sub-studies:

1. Semi-structured interviews - to explore the experiences of critical care survivors following COVID-19 infection during their recovery phase, including perceptions about the care received and support available to them.
2. Survey of follow-up services offered to ICU survivors - to assess geographical differences in the availability and structure of follow-up services offered to patients with critical COVID-19 after hospital discharge.
3. Survey of study team members - to gain feedback from the study team members on their involvement in the study.

Enrollment: 1,620 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients ≥18 years
• Survival to intensive care / high dependency unit discharge following an admission of ≥24 hours
• Treated for COVID-19

Exclusion criteria

• Unable to complete questionnaires
• Unable or unwilling to consent
• Unable to speak, understand or communicate in English
• Patients with diagnosed, pre-existing cognitive impairment (at the time of ICU admission)
• Patients without a fixed abode, at which postal questionnaires might be received, and who have no access to a personal email address.

Trial design