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Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: the COVID-NURSE cluster randomized controlled trial.

Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: the COVID-NURSE cluster randomized controlled trial.
Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: the COVID-NURSE cluster randomized controlled trial.
Aim: to evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health-related quality of life and cost-effectiveness.

Design: parallel two-arm, cluster-level randomized controlled trial.

Methods: between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses.

Results: we randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570–572 (98.1%–98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the ‘other’ ethnicity subgroup.

Conclusion: we did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients' experience of care.

Implications for the Profession and/or Patient Care: we cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required.

Impact: fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients' experience of care.

Reporting Method: CONSORT and CONSERVE.

Patient or Public Contribution: patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.
COVID-19, SARS-COV-2, cluster randomized controlled trial, fundamental nursing care, patient experience
0309-2402
Richards, David A.
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Bollen, Jess
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Jones, Ben
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Melendez-Torres, G.J.
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Hulme, Claire
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Cockcroft, Emma
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Cook, Heather
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Cooper, Joanne
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Creator, Siobhan
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Cruikshank, Susanne
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Dawe, Phoebe
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Dorris, Faye
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Iles-Smith, Heather
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Kent, Merry
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Logan, Pip
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O'Connell, Abby
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Onysk, Jakub
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Owens, Rosie
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Quinn, Lynne
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Rafferty, Anne Marie
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Romanczuk, Lidia
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Russell, Anne Marie
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Shepherd, Maggie
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Singh, Sally J.
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Sugg, Holly V.R.
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Thompson Coon, Jo
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Tooze, Susannah
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Warren, Fiona C.
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Whale, Bethany
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Wootton, Stephen
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Richards, David A.
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Bollen, Jess
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Jones, Ben
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Melendez-Torres, G.J.
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Hulme, Claire
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Cockcroft, Emma
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Cook, Heather
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Cooper, Joanne
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Creator, Siobhan
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Cruikshank, Susanne
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Dawe, Phoebe
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Dorris, Faye
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Iles-Smith, Heather
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Kent, Merry
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Logan, Pip
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O'Connell, Abby
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Onysk, Jakub
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Owens, Rosie
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Quinn, Lynne
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Rafferty, Anne Marie
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Romanczuk, Lidia
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Russell, Anne Marie
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Shepherd, Maggie
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Singh, Sally J.
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Sugg, Holly V.R.
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Thompson Coon, Jo
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Tooze, Susannah
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Warren, Fiona C.
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Whale, Bethany
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Wootton, Stephen
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Richards, David A., Bollen, Jess, Jones, Ben, Melendez-Torres, G.J., Hulme, Claire, Cockcroft, Emma, Cook, Heather, Cooper, Joanne, Creator, Siobhan, Cruikshank, Susanne, Dawe, Phoebe, Dorris, Faye, Iles-Smith, Heather, Kent, Merry, Logan, Pip, O'Connell, Abby, Onysk, Jakub, Owens, Rosie, Quinn, Lynne, Rafferty, Anne Marie, Romanczuk, Lidia, Russell, Anne Marie, Shepherd, Maggie, Singh, Sally J., Sugg, Holly V.R., Thompson Coon, Jo, Tooze, Susannah, Warren, Fiona C., Whale, Bethany and Wootton, Stephen (2023) Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: the COVID-NURSE cluster randomized controlled trial. Journal of Advanced Nursing. (doi:10.1111/jan.15959).

Record type: Article

Abstract

Aim: to evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health-related quality of life and cost-effectiveness.

Design: parallel two-arm, cluster-level randomized controlled trial.

Methods: between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses.

Results: we randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570–572 (98.1%–98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the ‘other’ ethnicity subgroup.

Conclusion: we did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients' experience of care.

Implications for the Profession and/or Patient Care: we cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required.

Impact: fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients' experience of care.

Reporting Method: CONSORT and CONSERVE.

Patient or Public Contribution: patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.

Text
Richards et al 2023 COVID NURSE JAN online first - Version of Record
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More information

Accepted/In Press date: 1 November 2023
Published date: 20 November 2023
Additional Information: Funding Information: This article is a report of independent research funded by the UKRI/NIHR and managed by the Medical Research Council, award number MR/V02776X/1. The work is also supported by the NIHR Applied Research Collaboration South West Peninsula. The views expressed in this publication are those of the authors and not necessarily those of the NIHR or the UK Department of Health and Social Care. We would like to thank all patient participants, nurses and healthcare workers involved in the study and acknowledge the contribution of the Exeter Clinical Trials Unit, the local Principal Investigators and research data collectors in the clusters' NHS Clinical Research Networks, our patient involvement group, and the members of our independent trial steering committee. Funding Information: We developed our guideline in partnership with a patient advisory group (seven patients with experience of hospitalization with COVID‐19). A patient representative (FD) was involved in trial decisions as a member of the core management team. Both she and the wider patient advisory group were involved in the writing of the guideline, the interpretation of trial findings and its implications. The involvement of patients was supported by a patient involvement facilitator (EC). Publisher Copyright: © 2023 The Authors. Journal of Advanced Nursing published by John Wiley & Sons Ltd.
Keywords: COVID-19, SARS-COV-2, cluster randomized controlled trial, fundamental nursing care, patient experience

Identifiers

Local EPrints ID: 484805
URI: http://eprints.soton.ac.uk/id/eprint/484805
ISSN: 0309-2402
PURE UUID: b2982af0-b455-42fc-9a90-477a6a688c95

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Date deposited: 22 Nov 2023 17:32
Last modified: 05 Jun 2024 18:33

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Contributors

Author: David A. Richards
Author: Jess Bollen
Author: Ben Jones
Author: G.J. Melendez-Torres
Author: Claire Hulme
Author: Emma Cockcroft
Author: Heather Cook
Author: Joanne Cooper
Author: Siobhan Creator
Author: Susanne Cruikshank
Author: Phoebe Dawe
Author: Faye Dorris
Author: Heather Iles-Smith
Author: Merry Kent
Author: Pip Logan
Author: Abby O'Connell
Author: Jakub Onysk
Author: Rosie Owens
Author: Lynne Quinn
Author: Anne Marie Rafferty
Author: Lidia Romanczuk
Author: Anne Marie Russell
Author: Maggie Shepherd
Author: Sally J. Singh
Author: Holly V.R. Sugg
Author: Jo Thompson Coon
Author: Susannah Tooze
Author: Fiona C. Warren
Author: Bethany Whale
Author: Stephen Wootton

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