The development, testing and evaluation of a COVID-19 fundamental nursing care protocol

INTERVENTION: To ensure allocation concealment, the researchers will undertake randomisation through the use of an externally administered, password‐protected randomisation website independently developed and maintained by the UKCRC‐registered University of Exeter Clinical Trials Unit. They will pair the 18 sites according to admission case rates, hospital type and patient ethnic diversity and, for each of the nine pairs, randomly allocate one site to the intervention group and one site to the control group. Allocation will be conducted over three cycles of six sites (three pairs) each. Experimental intervention: care as usual plus the clinical protocol developed in stage 1. After each wave of implementation and drawing on process evaluation findings, the researchers will modify their clinical protocol accordingly and embed the new version of the protocol in each subsequent experimental intervention cycle site. They will embed the protocol in intervention sites before each cycle via staff education, reminders and leadership‐directed strategies successfully used in a previous cluster randomised controlled trial to significantly increase handwashing by nurses and care staff. They will monitor protocol adherence and fidelity as part of the process evaluation, amending their educational and leadership strategies accordingly before each subsequent rapid cycle wave. Control: care as usual only The intervention duration will be a minimum of 72 hours. Follow up will be also after a minimum of 72 hours, ensuring that patient‐participants are able to report their experience of being nursed using the nursing protocol for a minimum of 72 hours. CONDITION: COVID‐19 (SARS‐CoV‐2 infection) ; Infections and Infestations PRIMARY OUTCOME: Patient experience measured using the Quality from the Patient’s Perspective, and the Relational Aspects of Care Questionnaires at a minimum of 72 hours after exposure to the nursing care protocol INCLUSION CRITERIA: 1. Patients who are not invasively ventilated 2. Aged =18 years 3. Currently hospitalised and treated for infection with the SARS‐CoV‐2 virus 4. Received nursing care for a minimum of 72 hours during their current admission SECONDARY OUTCOME: ; Current secondary outcome measures as of 19/10/2020:; Measured after a minimum of 72 hours after protocol exposure:; 1. Care quality (prevalence of level 3 and 4 pressure sores, frequency of patient falls, frequency of medication errors) measured using the United Kingdom National Health Service Ward to Board dashboard; 2. Functional ability measured using the Barthell Index; 3. Treatment outcomes measured using the WHO Clinical Progression Scale; 4. Depression measured using the PHQ‐2; 5. Anxiety measured using the GAD‐2; 6. Health utility measured using the EQ5D; 7. Nurse outcomes measured using the Measure of Moral Distress for Health Care Professionals; ; Previous secondary outcome measures:; Measured after a minimum of 72 hours after protocol exposure:; 1. Care quality measured using the United Kingdom National Health Service Ward to Board dashboard; 2. Functional ability measured using the Barthell Index; 3. Treatment outcomes measured using the WHO Clinical Progression Scale; 4. Nurse outcomes measured using the Measure of Moral Distress for Health Care Professionals; 5. Health utility measured using the EQ5D;