Condition category
Infections and Infestations
Date applied
10/08/2020
Date assigned
09/09/2020
Last edited
09/09/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Patient experience of care is correlated 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, leading 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 website

http://blogs.exeter.ac.uk/covid-nurse/

Contact information

Type

Scientific

Primary contact

Prof David Richards

ORCID ID

http://orcid.org/0000-0002-8821-5027

Contact details

University of Exeter
St Luke's Campus
Heavitree Road
Exeter
EX1 2LU
United Kingdom
+44 (0)1392 724615
d.a.richards@exeter.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

MR/V02776X/1, IRAS 287288, CPMS 46874

Study information

Scientific title

COVID-NURSE. The development and evaluation of a fundamental nursing care protocol for hospitalised patients with the SARS-CoV-2 virus not invasively ventilated on patients’ experience of care: a cluster randomized controlled trial

Acronym

COVID-NURSE

Study hypothesis

To undertake a rapid cycle (Johnson et al., 2015) 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.

Ethics approval

Approved 31/07/2020, University of Exeter Medical School (Knowledge Spa, Royal Cornwall Hospital, Truro, Cornwall, TR1 3HD, UK; +44 (0)1872 256460; c.barkle@exeter.ac.uk), ref: 20/07/256

Study design

Three-wave rapid-cycle cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

COVID-19 (SARS-CoV-2 infection)

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.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

Measured after a minimum of 72 hours after protocol exposure:
1. Care quality by the United Kingdom National Health Service Ward to Board dashboard
2. Functional ability by the Barthell Index
3. Treatment outcomes by the WHO Clinical Progression Scale
4. Nurse outcomes by the Measure of Moral Distress for Health Care Professionals
5. Health utility measured using the EQ5D

Overall trial start date

20/07/2020

Overall trial end date

19/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1080

Participant exclusion criteria

1. Patients who are invasively ventilated
2. Participants unable to give informed consent

Recruitment start date

01/11/2020

Recruitment end date

08/03/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon and Exeter NHS Foundation Trust
Royal Devon and Exeter Hospital Barrack Road
Exeter
EX2 5DW
United Kingdom

Sponsor information

Organisation

University of Exeter

Sponsor details

Lafrowda House
St Germans Road
Exeter
EX4 6TL
United Kingdom
+44 (0)1392 723588
p.r.baxter2@exeter.ac.uk

Sponsor type

University/education

Website

http://www.exeter.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. The study protocol is being submitted for publication.
2. Publication planned in high-quality peer-reviewed academic journals and professional journals.
3. Guidelines, education materials and strategies accessible via Health Education England, the Open University’s FutureLearn web platform, and through experienced NHS sites acting as training and dissemination hubs for other health Trusts, environments such as care homes, and global health systems.

IPD sharing statement
Participants will be identified by a unique study ID. Personal identifiable data including date of birth and NHS number may be collected but will be stored separately to research data and will be destroyed as per applicable regulations when the project is concluded. Data will be managed by the UKCRC registered Exeter Clinical Trials Unit (ExeCTU) following GDPR and data protection guidelines and all relevant Clinical Trial Regulations. All data will be anonymised prior to publication. Data will be collected and stored electronically in accordance with the Data Protection Act 2018 and ICH GCP E6 R2. ExeCTU will use Redcap Cloud Electronic Data Capture System to collect all case report data. This system is validated to ISO27001 standards, backed up and maintained in Europe. This system is fully compliant to GDPR regulations and managed by ExeCTU. Any additional study data will be stored and backed up on the secure ExeCTU servers, maintained by ExeCTU. Data will be cleaned and validated appropriately and a full Data Protection Impact Assessment (DPIA) will be undertaken along with the development of a comprehensive Data Management Plan (DMP) before the first participant is recruited.
Where data are disseminated (e.g. via report, presentation or publication), they will be anonymised. The researchers will align all confidentiality and data handling with the Caldicott Principles. Anonymised data will be stored indefinitely on a research data storage system provided by the University of Exeter called Open access Research Exeter (ORE) for archiving (http://www.exeter.ac.uk/research/openresearch/policies/ore/).

Intention to publish date

01/05/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/08/2020: Trial's existence confirmed by NHS Health Research Authority.