Evaluation of a COVID‐19 fundamental nursing care guideline versus usual care: The COVID‐NURSE cluster randomized controlled trial
Authors: Richards David A. , Bollen Jess , Jones Ben , Melendez‐Torres G. J. , Hulme Claire , Cockcroft Emma , Cook Heather , Cooper Joanne , Creanor Siobhan , Cruickshank Susanne , Dawe Phoebe , Doris Faye , Iles‐Smith Heather , Kent Merryn , 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. , Coon Jo Thompson , Tooze Susannah , Warren Fiona C. , Whale Bethany , Wootton Stephen 
Published: November 2023

AbstractAimTo 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.DesignParallel two‐arm, cluster‐level randomized controlled trial.MethodsBetween 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.ResultsWe 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.ConclusionWe 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 CareWe cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required.ImpactFundamental 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 MethodCONSORT and CONSERVE.Patient or Public ContributionPatients with experience of hospitalization with COVID‐19 were involved in guideline development and writing, trial management and interpretation of findings.