PIM-COVID study: protocol for a multicentre, longitudinal study measuring the psychological impact of surviving an intensive care admission due to COVID-19 on patients in the UK

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Abstract

Introduction

Psychological distress is common in intensive care unit (ICU) survivors and is anticipated in those who were treated for severe COVID-19 infection. This trainee-led, multicentre, observational, longitudinal study aims to assess the psychological outcomes of ICU survivors treated for COVID-19 infection in the UK at 3, 6 and/or 12 months after ICU discharge and explore whether there are demographic, psychosocial and clinical risk factors for psychological distress.

Methods and analysis

Questionnaires will be provided to study participants 3, 6 and/or 12 months after discharge from intensive care, assessing for anxiety, depression, post-traumatic stress symptoms, health-related quality of life and physical symptoms. Demographic, psychosocial and clinical data will also be collected to explore risk factors for psychological distress using latent growth curve modelling. Study participants will be eligible to complete questionnaires at any of the three time points online, by telephone or by post.

Ethics and dissemination

The PIM-COVID study was approved by the Health Research Authority (East Midlands - Derby Research and Ethics Committee, reference: 20/EM/0247).

Trial registration number

NCT05092529.

Related collections

Most cited references 32

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Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

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The REDCap consortium: Building an international community of software platform partners

Paul Harris, Robert Taylor, Brenda Minor … (2019)

The Research Electronic Data Capture (REDCap) data management platform was developed in 2004 to address an institutional need at Vanderbilt University, then shared with a limited number of adopting sites beginning in 2006. Given bi-directional benefit in early sharing experiments, we created a broader consortium sharing and support model for any academic, non-profit, or government partner wishing to adopt the software. Our sharing framework and consortium-based support model have evolved over time along with the size of the consortium (currently more than 3200 REDCap partners across 128 countries). While the "REDCap Consortium" model represents only one example of how to build and disseminate a software platform, lessons learned from our approach may assist other research institutions seeking to build and disseminate innovative technologies.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2023

Publication date (Electronic): 27 September 2023

Publication date PMC-release: 27 September 2023

Volume: 13

Issue: 9

Electronic Location Identifier: e071730

Affiliations

[1 ]departmentIntensive Care Unit , Ringgold_159020Royal Liverpool University Hospital , Liverpool, UK

[2 ]departmentInstitute of Life Course and Medical Sciences , Ringgold_4591University of Liverpool , Liverpool, UK

[3 ]departmentRegional Intensive Care Unit , Ringgold_156555Royal Victoria Hospital , Belfast, UK

[4 ]departmentDepartment of Primary Care and Mental Health, Institute of Population Health , Ringgold_4591University of Liverpool , Liverpool, UK

[5 ]departmentSchool of Psychology , Ringgold_1319University of New England , Armidale, New South Wales, Australia

[6 ]ICUsteps , London, UK

Author notes

[Correspondence to ] Dr Alicia A C Waite; Alicia.Waite@ 123456liverpool.ac.uk

Author information

Alicia A C Waite http://orcid.org/0000-0001-8734-994X

Ingeborg D Welters http://orcid.org/0000-0002-3408-8798

Article

Publisher ID: bmjopen-2023-071730

DOI: 10.1136/bmjopen-2023-071730

PMC ID: 10537987

PubMed ID: 37758678

SO-VID: f5fc35c0-552d-461e-990f-5e8b962e2b1f

License:

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 17 January 2023

Date accepted : 15 August 2023

Funding

Funded by: Mersey School of Anaesthesia;

Award ID: N/A

Funded by: FundRef http://dx.doi.org/10.13039/501100000846, Intensive Care Society;

Award ID: N/A

Custom metadata

special-feature unlocked

access-type free

ScienceOpen disciplines: Medicine

Keywords: anxiety disorders,depression & mood disorders,covid-19,quality of life,adult intensive & critical care

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ScienceOpen disciplines: Medicine

Keywords: anxiety disorders, depression & mood disorders, covid-19, quality of life, adult intensive & critical care

PIM-COVID study: protocol for a multicentre, longitudinal study measuring the psychological impact of surviving an intensive care admission due to COVID-19 on patients in the UK

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Related collections

Novel Coronavirus Disease COVID-19

Most cited references 32

Cutoff criteria for fit indexes in covariance structure analysis: Conventional criteria versus new alternatives

Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

The REDCap consortium: Building an international community of software platform partners

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Affiliations

Author notes

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History

Funding

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