Plain English Summary of the Trial Protocol

Background and study aims

Patient experience of care is connected with safety, clinical effectiveness, care quality, treatment outcomes and reduced overall service use. Currently, no international evidence-based guidelines exist for nursing hospitalised patients with SARS-CoV-2 who are not invasively ventilated. This can lead to potential variations in patient experience, treatment outcomes, care quality and costs.

The aim of this study is 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.

Who can participate?

UK hospital trusts providing care for patients with COVID-19, patients who are not invasively ventilated admitted for care by these Trusts, and the nurses caring for these patients

What does the study involve?

Trusts will be allocated at random to one of two groups, one to implement the protocol and the other to continue to deliver nursing care as usual. In Trusts allocated to the COVID-NURSE protocol group, nurses and care assistants caring for patients with COVID-19 will need to undertake a three-hour online education programme about the protocol. Senior managers and nurse leaders will be required to support nursing teams to use the protocol. The researchers will provide support to managers and leaders together with materials supporting the protocol.

The research team and clinical research nurses will collect data in both groups from non-invasively ventilated patients with COVID-19 on their experiences of care. They will also collect routine health outcomes data and questionnaires from nurses delivering care.

What are the possible benefits and risks of participating?

The study is comparing a COVID-specific nursing protocol with usual care. Participants in the experimental group of the study may benefit from receiving this protocol and no existing treatment will be withheld from any participants in either group of the study. Therefore, the researchers do not believe that participation in the study is a risk to participants. Participants may withdraw from the study at any time without prejudicing their treatment, care or employment.

Where is the study run from?

University of Exeter (UK)

When is the study starting and how long is it expected to run for?

July 2020 to April 2021

Who is funding the study?

National Institute for Health Research (NIHR) (UK)

Who is the main contact?

Prof. David Richards
D.a.richards@exeter.ac.uk

Trial Registration

ISRCTN number 13177364