COVID-NURSE. The development, testing and evaluation of a COVID-19 fundamental nursing care protocol: a randomised controlled trial

Lead Research Organisation: University of Exeter
Department Name: Institute of Health Research


Nursing care is hugely important to people in hospital. Nurses help people with eating, drinking, going to the toilet, skin care, moving, keeping clean, breathing, communication and mental wellbeing. Nursing care makes a significant difference to the way people experience being in hospital and to their recovery. For people with COVID-19, their symptoms and the infectiousness of the virus poses unique challenges for nurses in delivering this care.

In this study we will examine the literature from previous viral outbreaks and undertake a survey of innovations from NHS clinical teams. We will work with patients, nurses, other health care workers and doctors to design specific nursing procedures for these patients. We will then undertake a type of randomised controlled trial called a 'rapid-cycle' trial, which will allow us to quickly test these procedures across an initial 18 NHS sites to determine their impact on patient experience, care quality, patients' ability to manage day to day activities, treatment outcomes and costs.

We will ensure our nursing procedures are acceptable and realistic for rapid NHS implementation, with guidance and education materials. We will ensure they could be adapted for care homes, patients with other conditions requiring isolation and to global health systems.

Technical Summary

Background: nursing care is a key determinant of patient experience and correlated with safety, clinical effectiveness, care quality, treatment outcomes and reduced overall service use. No evidence-based nursing protocols exist to address the unique challenges of nursing hospitalised patients with the SARS-CoV-2 virus.

Aim: to co-create and evaluate the impact on patient experience, care quality, functional ability, treatment outcomes and costs of a nursing care protocol specifically addressing the fundamental care requirements of hospitalised patients with the SARS-CoV-2 virus not invasively ventilated.
Methods: 2-stage mixed-methods programme, following revised 2020 complex interventions guidance, of: 1) rapid-review, survey, co-creation consensus development of a nursing protocol; 2) rapid-cycle cluster randomised controlled trial with embedded process and economic evaluations.

1.Fundamental nursing care protocol for hospitalised patients with the SARS-CoV-2 virus not invasively ventilated, with proven effectiveness on patient experience, care quality, functional ability and treatment outcomes within 9 months of project inception.

2.Feasible, acceptable and 'implementation-optimised' protocol for widespread implementation, through co-creation and changes implemented during rapid cycle trial waves.

3.Adaptable protocol designed to be generalisable for environments such as care homes, patients with other conditions requiring isolation and to global health systems via knowledge gained in a process analysis of intervention fidelity, mechanisms, contextual factors and implementation.

4.Guidelines, education materials and strategies accessible via Health Education England, the Open University's FutureLearn web platform, and experienced NHS sites acting as training hubs for other health Trusts/care homes/global health systems.
Description Nurses faced severe pressures during the COVID-19 pandemic. Hospital based nurses had to overcome barriers when communicating with patients. They had to reorganise their practice to cope with high volumes of very severely ill patients. However, there were no guidelines or research evidence to help them. This was a significant issue since nursing care is associated with patient satisfaction and clinical outcomes.

We developed and tested a guideline for nurses to deliver fundamental nursing care to patients in hospital with COVID-19. We defined fundamental care as actions on the part of the nurse to meet people's essential physical and psychosocial needs, such as oral care, toileting, nutrition, mobility, emotional and psychological wellbeing. The guideline included strategies on communication, organising care, meeting patients' values, specific interventions, and mental health and wellbeing. We also included a section for managers on supporting their teams.

We tested the guideline in a cluster randomised controlled trial. We introduced the guideline into a number of English National Health Service hospitals and evaluated its effects in these hospitals compared to others where the guideline was not used. We included patients admitted to hospital for at least three days or nights and being treated for the SARS-COV-2 virus that causes COVID-19 illness. We collected data from patients directly on their experience of being nursed, their functional ability, their clinical status, depression, anxiety and collected measures of patient safety and quality of care (pressure injuries, falls, medication errors) from routine hospital data. We also asked nurses how they felt about nursing these patients and undertook a health economic analysis.

We recruited 15 hospitals, 581 patients and 418 nurses. One hospital site dropped out before any patient or nurse data was collected. We found no overall differences on any of our measures between the two groups of hospitals, patients or nurses. However, we found that over time, patients in the guideline hospitals reported better experience of care because patients in non-guideline hospitals reported worse experience over time. We also found that people from non-white British backgrounds reported better experience of care on one of our main outcome measure sub-scales.
Exploitation Route In conclusion, despite the lack of overall differences between groups, the guideline helped to maintain high levels of positive patient experience compared to hospitals where the guideline was not in place. We suggest that the guideline may be useful in maintaining or improving nursing practice quality and positive patient experience. It may also be helpful for patients who are not white British.

We have developed and published a massive open online course (MOOC) to enable global nursing organisations learn about fundamental nursing care:
Sectors Healthcare

Description Chief Nurse for England
Geographic Reach National 
Policy Influence Type Participation in a guidance/advisory committee
Description COVID-NURSE. The development, testing and evaluation of a COVID-19 fundamental nursing care protocol: a randomised controlled trial
Amount £433,956 (GBP)
Funding ID MR/V02776X/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 07/2020 
End 04/2021
Description Norway 
Organisation Bergen University College
Country Norway 
Sector Academic/University 
PI Contribution Publications
Collaborator Contribution Rsearch design
Impact Publication
Start Year 2018