Abstract：
OBJECTIVE: To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses\' moral distress, patient health-related quality of life and cost-effectiveness.
METHODS: Parallel two-arm, cluster-level randomized controlled trial.
METHODS: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses.
RESULTS: We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570-572 (98.1%-98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the \'other\' ethnicity subgroup.
CONCLUSIONS: We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients\' experience of care.
UNASSIGNED: We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required.
CONCLUSIONS: Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients\' experience of care.
UNASSIGNED: CONSORT and CONSERVE.
UNASSIGNED: Patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.
METHODS: Parallel two-arm, cluster-level randomized controlled trial.
METHODS: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses.
RESULTS: We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570-572 (98.1%-98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the \'other\' ethnicity subgroup.
CONCLUSIONS: We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients\' experience of care.
UNASSIGNED: We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required.
CONCLUSIONS: Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients\' experience of care.
UNASSIGNED: CONSORT and CONSERVE.
UNASSIGNED: Patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.
摘要：
目的：评估常规护理加基本护理指南与仅对COVID-19住院患者的常规护理相比对患者体验的影响，护理质量，功能能力，治疗结果，护士道德困扰，患者健康相关的生活质量和成本效益。
方法：平行双臂，整群随机对照试验。
方法：在2021年1月18日至12月20日之间，我们招募了（i）18岁及以上患有COVID-19的成年人，不包括侵入性通风者，在英国医院信托基金住院至少三天或三个晚上；（ii）照顾他们的护士。我们随机分配医院使用基本护理指南和常规护理或仅常规护理。我们的患者报告的共同主要结果是护理问卷的关系方面和来自患者观点问卷的质量的四个量表。我们进行了意向治疗分析。
结果：我们随机分为15组，招募了581名患者和418名护士参与者。主要结果数据可用于14个集群中的570-572名（98.1％-98.5％）患者参与者。我们没有发现任何患者的组间差异的证据，护士或经济结果。随着时间的推移，我们发现了组间的差异，赞成干预，对于我们五个共同主要结果中的三个，和一个主要患者的种族结局的显着相互作用(英国白人与其他)并分配组支持对“其他”种族亚组的干预。
结论：与常规护理相比，我们没有发现基本护理指南的患者体验总体差异。我们有迹象表明，随着时间的推移，该指南可能有助于维持良好的实践，并对非白人英国患者的护理体验产生了更积极的影响。
■我们不建议在常规护理实践中全面实施我们的指南。进一步的干预发展，可行性,需要进行试点和评估研究。
结论：基础护理驱动患者体验，但在大流行中受到严重影响。我们的指导方针并不优于常规护理，尽管它可以维持良好的实践，并对非白人英国患者的护理体验产生积极影响。
■CONSORTandCONSERVE.
■有COVID-19住院经历的患者参与了指南的制定和编写，试验管理和结果解释。
方法：平行双臂，整群随机对照试验。
方法：在2021年1月18日至12月20日之间，我们招募了（i）18岁及以上患有COVID-19的成年人，不包括侵入性通风者，在英国医院信托基金住院至少三天或三个晚上；（ii）照顾他们的护士。我们随机分配医院使用基本护理指南和常规护理或仅常规护理。我们的患者报告的共同主要结果是护理问卷的关系方面和来自患者观点问卷的质量的四个量表。我们进行了意向治疗分析。
结果：我们随机分为15组，招募了581名患者和418名护士参与者。主要结果数据可用于14个集群中的570-572名（98.1％-98.5％）患者参与者。我们没有发现任何患者的组间差异的证据，护士或经济结果。随着时间的推移，我们发现了组间的差异，赞成干预，对于我们五个共同主要结果中的三个，和一个主要患者的种族结局的显着相互作用(英国白人与其他)并分配组支持对“其他”种族亚组的干预。
结论：与常规护理相比，我们没有发现基本护理指南的患者体验总体差异。我们有迹象表明，随着时间的推移，该指南可能有助于维持良好的实践，并对非白人英国患者的护理体验产生了更积极的影响。
■我们不建议在常规护理实践中全面实施我们的指南。进一步的干预发展，可行性,需要进行试点和评估研究。
结论：基础护理驱动患者体验，但在大流行中受到严重影响。我们的指导方针并不优于常规护理，尽管它可以维持良好的实践，并对非白人英国患者的护理体验产生积极影响。
■CONSORTandCONSERVE.
■有COVID-19住院经历的患者参与了指南的制定和编写，试验管理和结果解释。
