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COVID-NURSE: evaluation of a fundamental nursing care protocol compared to care as usual on experience of care for non-invasively ventilated patients in hospital with the SARS-CoV-2 virus: protocol for a cluster randomised controlled trial

COVID-NURSE: evaluation of a fundamental nursing care protocol compared to care as usual on experience of care for non-invasively ventilated patients in hospital with the SARS-CoV-2 virus: protocol for a cluster randomised controlled trial
COVID-NURSE: evaluation of a fundamental nursing care protocol compared to care as usual on experience of care for non-invasively ventilated patients in hospital with the SARS-CoV-2 virus: protocol for a cluster randomised controlled trial
Introduction; Patient experience of nursing care is correlated with safety, clinical effectiveness, care quality, treatment outcomes and service use. Effective nursing care includes actions to develop nurse-patient relationships and deliver physical and psychosocial care to patients. The high risk of transmission of the SARS-CoV-2 virus compromises nursing care. No evidence-based nursing guidelines exist for patients infected with SARS-CoV-2, leading to potential variations in patient experience, outcomes, quality and costs.
Methods and analysis; we aim to recruit 840 in-patient participants treated for infection with the SARS-CoV-2 virus from 14 UK hospitals, to a cluster randomised controlled trial, with embedded process and economic evaluations, of care as usual plus a fundamental nursing care protocol addressing specific areas of physical, relational and psychosocial nursing care where potential variation may occur, compared to care as usual. Our co-primary outcomes are patient-reported experience (Quality from the Patients’ Perspective; Relational Aspects of Care Questionnaire); secondary outcomes include care quality (pressure injuries, falls, medication errors); functional ability (Barthell Index); treatment outcomes (WHO Clinical Progression Scale); depression (PHQ-2), anxiety (GAD-2), health utility (EQ5D), and nurse-reported outcomes (Measure of Moral Distress for Health Care Professionals). For our primary analysis we will use a standard generalised linear mixed-effect model adjusting for ethnicity of the patient sample and research intensity at cluster level. We will also undertake a planned sub-group analysis to compare the impact of patient-level ethnicity on our primary and secondary outcomes and will undertake process and economic evaluations.
Ethics and dissemination; research governance and ethical approvals are from the UK National Health Service Health Research Authority Research Ethics Service. Dissemination will be open access through peer reviewed scientific journals, study website, press and online media, including free online training materials on the Open University’s FutureLearn web platform.
COVID-19, clinical trials, infectious diseases, protocols & guidelines
2044-6055
Richards, David
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Sugg, Holly V.R.
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Cockcroft, Emma
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Cooper, Joanne H.
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Cruickshank, Susanne
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Doris, Faye
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Hulme, Claire
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Logan, Phillipa
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Iles-Smith, Heather
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Melendez-Torres, G.J.
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Rafferty, Anne Marie
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Reed, Nigel
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Russell, Anne-Marie
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Shepherd, Maggie
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Singh, Sally J.
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Thompson Coon, Jo
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Tooze, Susannah
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Wootton, Stephen
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Abbott, Rebecca
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Bethel, Alison
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Creanor, Siobhan
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Quinn, Lynne
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Tripp, Harry
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Warren, Fiona C.
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Whear, Rebecca
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Bollen, Jessica
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Hunt, Harriet A.
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Kent, Merryn
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Morgan, Leila
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Morley, Naomi
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Romanczuk, Lidia
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Richards, David
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Sugg, Holly V.R.
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Cockcroft, Emma
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Cooper, Joanne H.
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Cruickshank, Susanne
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Doris, Faye
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Hulme, Claire
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Logan, Phillipa
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Iles-Smith, Heather
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Melendez-Torres, G.J.
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Rafferty, Anne Marie
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Reed, Nigel
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Russell, Anne-Marie
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Shepherd, Maggie
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Singh, Sally J.
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Thompson Coon, Jo
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Tooze, Susannah
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Wootton, Stephen
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Abbott, Rebecca
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Bethel, Alison
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Creanor, Siobhan
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Quinn, Lynne
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Tripp, Harry
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Warren, Fiona C.
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Whear, Rebecca
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Bollen, Jessica
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Hunt, Harriet A.
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Kent, Merryn
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Morgan, Leila
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Morley, Naomi
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Romanczuk, Lidia
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Richards, David, Sugg, Holly V.R., Cockcroft, Emma, Cooper, Joanne H., Cruickshank, Susanne, Doris, Faye, Hulme, Claire, Logan, Phillipa, Iles-Smith, Heather, Melendez-Torres, G.J., Rafferty, Anne Marie, Reed, Nigel, Russell, Anne-Marie, Shepherd, Maggie, Singh, Sally J., Thompson Coon, Jo, Tooze, Susannah, Wootton, Stephen, Abbott, Rebecca, Bethel, Alison, Creanor, Siobhan, Quinn, Lynne, Tripp, Harry, Warren, Fiona C., Whear, Rebecca, Bollen, Jessica, Hunt, Harriet A., Kent, Merryn, Morgan, Leila, Morley, Naomi and Romanczuk, Lidia (2021) COVID-NURSE: evaluation of a fundamental nursing care protocol compared to care as usual on experience of care for non-invasively ventilated patients in hospital with the SARS-CoV-2 virus: protocol for a cluster randomised controlled trial. BMJ Open, 11 (5), [e046436]. (doi:10.1136/bmjopen-2020-046436).

Record type: Article

Abstract

Introduction; Patient experience of nursing care is correlated with safety, clinical effectiveness, care quality, treatment outcomes and service use. Effective nursing care includes actions to develop nurse-patient relationships and deliver physical and psychosocial care to patients. The high risk of transmission of the SARS-CoV-2 virus compromises nursing care. No evidence-based nursing guidelines exist for patients infected with SARS-CoV-2, leading to potential variations in patient experience, outcomes, quality and costs.
Methods and analysis; we aim to recruit 840 in-patient participants treated for infection with the SARS-CoV-2 virus from 14 UK hospitals, to a cluster randomised controlled trial, with embedded process and economic evaluations, of care as usual plus a fundamental nursing care protocol addressing specific areas of physical, relational and psychosocial nursing care where potential variation may occur, compared to care as usual. Our co-primary outcomes are patient-reported experience (Quality from the Patients’ Perspective; Relational Aspects of Care Questionnaire); secondary outcomes include care quality (pressure injuries, falls, medication errors); functional ability (Barthell Index); treatment outcomes (WHO Clinical Progression Scale); depression (PHQ-2), anxiety (GAD-2), health utility (EQ5D), and nurse-reported outcomes (Measure of Moral Distress for Health Care Professionals). For our primary analysis we will use a standard generalised linear mixed-effect model adjusting for ethnicity of the patient sample and research intensity at cluster level. We will also undertake a planned sub-group analysis to compare the impact of patient-level ethnicity on our primary and secondary outcomes and will undertake process and economic evaluations.
Ethics and dissemination; research governance and ethical approvals are from the UK National Health Service Health Research Authority Research Ethics Service. Dissemination will be open access through peer reviewed scientific journals, study website, press and online media, including free online training materials on the Open University’s FutureLearn web platform.

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BMJ COVID-NURSE Protocol R2 14_04_21 CLEAN COPY - Accepted Manuscript
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Accepted/In Press date: 21 April 2021
Published date: 26 May 2021
Additional Information: Funding Information: This work is supported by National Institute for Health Research and UK Research and Innovation, administered by the MRC: grant number MR/V02776X/1. The trial sponsor is the University of Exeter, ref: 1920/Research Ethics and Governance Office, Lafrowda House, St Germans Road, Exeter, Devon, EX4 6TL. Funding Information: Funding This work is supported by National Institute for Health Research and UK Research and Innovation, administered by the MRC: grant number MR/V02776X/1. The trial sponsor is the University of Exeter, ref: 1920/Research Ethics and Governance Office, Lafrowda House, St Germans Road, Exeter, Devon, EX4 6TL. Publisher Copyright: © 2021 BMJ Publishing Group. All rights reserved. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
Keywords: COVID-19, clinical trials, infectious diseases, protocols & guidelines

Identifiers

Local EPrints ID: 449764
URI: http://eprints.soton.ac.uk/id/eprint/449764
ISSN: 2044-6055
PURE UUID: b1a9f572-811a-4f71-9752-f7abc1102d18

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Date deposited: 16 Jun 2021 16:30
Last modified: 05 Jun 2024 18:09

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Contributors

Author: David Richards
Author: Holly V.R. Sugg
Author: Emma Cockcroft
Author: Joanne H. Cooper
Author: Susanne Cruickshank
Author: Faye Doris
Author: Claire Hulme
Author: Phillipa Logan
Author: Heather Iles-Smith
Author: G.J. Melendez-Torres
Author: Anne Marie Rafferty
Author: Nigel Reed
Author: Anne-Marie Russell
Author: Maggie Shepherd
Author: Sally J. Singh
Author: Jo Thompson Coon
Author: Susannah Tooze
Author: Stephen Wootton
Author: Rebecca Abbott
Author: Alison Bethel
Author: Siobhan Creanor
Author: Lynne Quinn
Author: Harry Tripp
Author: Fiona C. Warren
Author: Rebecca Whear
Author: Jessica Bollen
Author: Harriet A. Hunt
Author: Merryn Kent
Author: Leila Morgan
Author: Naomi Morley
Author: Lidia Romanczuk

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