TY - JOUR
T1 - COVID-NURSE
T2 - Evaluation of a fundamental nursing care protocol compared with care as usual on experience of care for noninvasively ventilated patients in hospital with the SARS-CoV-2 virus-Protocol for a cluster randomised controlled trial
AU - Richards, David A.
AU - Sugg, Holly V.R.
AU - Cockcroft, Emma
AU - Cooper, Joanne
AU - Cruickshank, Susanne
AU - Doris, Faye
AU - Hulme, Claire
AU - Logan, Phillipa
AU - Iles-Smith, Heather
AU - Melendez-Torres, G. J.
AU - Rafferty, Anne Marie
AU - Reed, Nigel
AU - Russell, Anne Marie
AU - Shepherd, Maggie
AU - Singh, Sally J.
AU - Thompson Coon, Jo
AU - Tooze, Susannah
AU - Wootton, Stephen
AU - Abbott, Rebecca
AU - Bethel, Alison
AU - Creanor, Siobhan
AU - Quinn, Lynne
AU - Tripp, Harry
AU - Warren, Fiona C.
AU - Whear, Rebecca
AU - Bollen, Jessica
AU - Hunt, Harriet A.
AU - Kent, Merryn
AU - Morgan, Leila
AU - Morley, Naomi
AU - Romanczuk, Lidia
N1 - Funding Information:
This work is supported by National Institute for Health Research and UK Research and Innovation, administered by the MRC: grant number MR/V02776X/1. The trial sponsor is the University of Exeter, ref: 1920/Research Ethics and Governance Office, Lafrowda House, St Germans Road, Exeter, Devon, EX4 6TL.
Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.
PY - 2021/5/26
Y1 - 2021/5/26
N2 - Introduction: Patient experience of nursing care is correlated with safety, clinical effectiveness, care quality, treatment outcomes and service use. Effective nursing care includes actions to develop nurse-patient relationships and deliver physical and psychosocial care to patients. The high risk of transmission of the SARS-CoV-2 virus compromises nursing care. No evidence-based nursing guidelines exist for patients infected with SARS-CoV-2, leading to potential variations in patient experience, outcomes, quality and costs. Methods and analysis: we aim to recruit 840 in-patient participants treated for infection with the SARS-CoV-2 virus from 14 UK hospitals, to a cluster randomised controlled trial, with embedded process and economic evaluations, of care as usual and a fundamental nursing care protocol addressing specific areas of physical, relational and psychosocial nursing care where potential variation may occur, compared with care as usual. Our coprimary outcomes are patient-reported experience (Quality from the Patients' Perspective; Relational Aspects of Care Questionnaire); secondary outcomes include care quality (pressure injuries, falls, medication errors); functional ability (Barthell Index); treatment outcomes (WHO Clinical Progression Scale); depression Patient Health Questionnaire-2 (PHQ-2), anxiety General Anxiety Disorder-2 (GAD-2), health utility (EQ5D) and nurse-reported outcomes (Measure of Moral Distress for Health Care Professionals). For our primary analysis, we will use a standard generalised linear mixed-effect model adjusting for ethnicity of the patient sample and research intensity at cluster level. We will also undertake a planned subgroup analysis to compare the impact of patient-level ethnicity on our primary and secondary outcomes and will undertake process and economic evaluations. Ethics and dissemination: Research governance and ethical approvals are from the UK National Health Service Health Research Authority Research Ethics Service. Dissemination will be open access through peer-reviewed scientific journals, study website, press and online media, including free online training materials on the Open University's FutureLearn web platform. Trial registration number: ISRCTN13177364; Pre-results.
AB - Introduction: Patient experience of nursing care is correlated with safety, clinical effectiveness, care quality, treatment outcomes and service use. Effective nursing care includes actions to develop nurse-patient relationships and deliver physical and psychosocial care to patients. The high risk of transmission of the SARS-CoV-2 virus compromises nursing care. No evidence-based nursing guidelines exist for patients infected with SARS-CoV-2, leading to potential variations in patient experience, outcomes, quality and costs. Methods and analysis: we aim to recruit 840 in-patient participants treated for infection with the SARS-CoV-2 virus from 14 UK hospitals, to a cluster randomised controlled trial, with embedded process and economic evaluations, of care as usual and a fundamental nursing care protocol addressing specific areas of physical, relational and psychosocial nursing care where potential variation may occur, compared with care as usual. Our coprimary outcomes are patient-reported experience (Quality from the Patients' Perspective; Relational Aspects of Care Questionnaire); secondary outcomes include care quality (pressure injuries, falls, medication errors); functional ability (Barthell Index); treatment outcomes (WHO Clinical Progression Scale); depression Patient Health Questionnaire-2 (PHQ-2), anxiety General Anxiety Disorder-2 (GAD-2), health utility (EQ5D) and nurse-reported outcomes (Measure of Moral Distress for Health Care Professionals). For our primary analysis, we will use a standard generalised linear mixed-effect model adjusting for ethnicity of the patient sample and research intensity at cluster level. We will also undertake a planned subgroup analysis to compare the impact of patient-level ethnicity on our primary and secondary outcomes and will undertake process and economic evaluations. Ethics and dissemination: Research governance and ethical approvals are from the UK National Health Service Health Research Authority Research Ethics Service. Dissemination will be open access through peer-reviewed scientific journals, study website, press and online media, including free online training materials on the Open University's FutureLearn web platform. Trial registration number: ISRCTN13177364; Pre-results.
KW - clinical trials
KW - COVID-19
KW - infectious diseases
KW - protocols & guidelines
UR - http://www.scopus.com/inward/record.url?scp=85106918999&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-046436
DO - 10.1136/bmjopen-2020-046436
M3 - Article
C2 - 34039574
AN - SCOPUS:85106918999
SN - 2044-6055
VL - 11
JO - BMJ open
JF - BMJ open
IS - 5
M1 - e046436
ER -
