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.
| Original language | English |
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| Journal | Journal of Advanced Nursing |
| Early online date | 20 Nov 2023 |
| DOIs | |
| Publication status | E-pub ahead of print - 20 Nov 2023 |
Bibliographical note
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.
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
- cluster randomized controlled trial
- COVID-19
- fundamental nursing care
- patient experience
- SARS-COV-2
ASJC Scopus subject areas
- General Nursing