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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. [ABSTRACT FROM AUTHOR]

Background: Randomised trials play a vital role in underpinning evidence-based care. However, trials involving adults with impaired capacity to consent raise a number of ethical and methodological challenges, leading to the frequent exclusion of this group from trials. This includes challenges around involving family members as alternative 'proxy' decision-makers. Family members are often given little information about their role as a consultee or legal representative. Some family members find making a decision about trial participation difficult and may experience an emotional and decisional burden as a result. Families have reported a need for greater support and guidance when making such decisions, leading to the development of a decision aid ('Making decisions about research for others') for family members acting as consultee/legal representative. The decision aid now requires evaluation to determine its effectiveness in supporting families to make more informed decisions.Methods: This protocol describes a prospective, multi-centre, randomised-controlled Study Within a Trial (SWAT) to evaluate the effectiveness of the decision aid. The SWAT will initially be embedded in approximately five host trials. SWAT participants will be randomised in a 1:1 ratio to either the intervention (decision aid alongside standard information about the host trial provided to consultees/legal representatives) or control (standard information alone). The primary outcome is the quality of proxy consent decision, assessed by the Combined Scale for Proxy Informed Consent Decisions (CONCORD). The SWAT design is informed by previous qualitative research. Initial feasibility will be explored in one host trial, followed by the main SWAT. An embedded process evaluation and economic evaluation will enable the SWAT findings to be contextualised and identify factors likely to affect implementation.Discussion: This SWAT will generate the first evidence for recruitment interventions for trials involving adults lacking capacity to consent and add to knowledge about the use of decision support interventions in trial participation decisions. The SWAT will be embedded in a range of trials, and the heterogenous nature of the host trials, settings and populations involved will enable the intervention to be evaluated in a wide range of contexts. However, a pragmatic and flexible approach to conducting the SWAT is needed.Trial Registration: The SWAT is registered as SWAT #159 with the Northern Ireland Hub for Trials Methodology Research SWAT repository (registered 09.08.2020). Each host trial will be registered on a clinical trials registry. [ABSTRACT FROM AUTHOR]