The Trial

Aim

In the COVID-NURSE trial, our objective is to undertake a rapid cycle cluster randomised controlled superiority trial to evaluate an evidence-based nursing protocol for patients with the SARS-CoV-2 virus, compared to care as usual, in terms of patients’ reported experience of transactional and relational nursing care, care quality, treatment  outcomes and costs.

Funder: NIHR/UKRI/MRC
Study Grant Ref: MR/V02776X/1
Trial Registration: ISRCTN13177364

The trial is being administered by a team from the UKCRC-registered University of Exeter Clinical Trials Unit

Abstract:

Introduction; Patient experience of nursing care is correlated with safety, clinical effectiveness, care quality, treatment outcomes and service use. Effective nursing care includes nurse-patient relationships and transactional behaviours to meet patients’ fundamental care needs. The high risk of transmission of the SARS-CoV-2 virus compromises nurses’ relational and transactional care. No evidence-based nursing guidelines exist for patients with SARS-CoV-2, leading to potential variations in patient experience, outcomes, quality and costs.

Methods and analysis; we aim to recruit 1080 in-patient participants treated for the SARS-CoV-2 virus from 18 UK hospitals, to a three wave, rapid-cycle cluster randomised controlled trial, with embedded process and economic evaluations, of a fundamental nursing care protocol co-designed by nurses and patients, using data from a systematic review and survey of nursing innovations, 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 (UK NHS Ward to Board dashboard); 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). We will estimate mean differences or risk ratios comparing intervention and control hospitals using paired-tests on cluster-level summaries weighted by the number of observations in each cluster, also estimating intervention effectiveness in an exploratory unpaired analysis using generalised linear mixed-effects models to model time trends, including time from implementation. We will undertake a planned sub-group analysis to compare the impact of ethnicity on outcomes.

Ethics and dissemination; research governance and ethical approvals are from the UK National Health Service Health Research Authority and 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.

A full protocol is being published and will be available shortly.

Progress

Thank you to everyone, who has participated in the Covid-Nurse survey. We will be using the survey results alongside our systematic review findings to co-develop a fundamental nursing care protocol for patients with Covid-19 with patients, nurses, and other health care professionals.

In the meantime, if you or your organisation wishes to take part on the trial please use the contact details below for  more information or expressions of interest:

Trial Research Associates:
Leila Morgan – ,
Naomi Morley – .

Study Administrator:
Merryn Kent – .