COVID-NURSE: RCT for nursing protocol intervention
Research type
Research Study
Full title
COVID-NURSE: evaluation of the effects of a COVID-specific fundamental nursing care protocol compared to care as usual on experience of care for non-invasively ventilated patients in hospital with the SARS-CoV-2 virus: a randomised controlled trial.
IRAS ID
288479
Contact name
David A. Richards
Contact email
Sponsor organisation
University of Exeter
ISRCTN Number
ISRCTN13177364
Clinicaltrials.gov Identifier
46874, CPMS
Duration of Study in the UK
0 years, 5 months, 6 days
Research summary
Summary of Research
Nursing care is hugely important to people in hospital. Nursing includes helping people with those essential and intimate tasks of life that we normally take for granted – washing, eating, cleaning, going to the toilet, etc. Nursing care makes a significant difference to the way people experience being in hospital and to their recovery. This is certainly true for people with COVID-19. However, the nature of the COVID-19 illness and the protective clothing worn by nurses has meant that nurses have had to change their day to day work.In this study, we are testing a set of specific procedures that nurses can use to care for patients with COVID-19. We call this a nursing protocol – a type of blueprint for nursing patients with COVID-19. Our protocol is based on what nurses themselves have done to adapt the way they care for people. We have also had a lot of input from patients who have been nursed through their COVID-19 illness.
We are now conducting a type of scientific study called a randomised controlled trial. This will allow us to test these procedures to determine their effect on patient experience, care quality, patients’ ability to manage day to day activities, treatment outcomes and costs. Because we don’t know if they are any better than the procedures nurses normally use, half the patients and hospitals in the study will implement the new way of working, half will continue to deliver nursing care as usual.
At the end of the study we will know how well these procedures meet the needs of patients in hospital with COVID-19. If the study is successful, we will be able to use the protocol across the NHS and even for hospitals in other countries.
Summary of Results
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.
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.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0253
Date of REC Opinion
30 Oct 2020
REC opinion
Favourable Opinion