Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 主要终点
- Duration of delirium
研究概览
简要总结
Patients are part of a family network. When any person in a family becomes critically unwell and requires the assistance of an Intensive Care Unit (ICU), this has an impact on all members of that family.
COVID-19 changed visiting for all patients in hospitals across Scotland. It is not known what effect these restrictions will have on patients' recovery, nor do we understand the impact it may have on their relatives or staff caring for them. This study will look at the implications of the visiting restrictions as a consequence of the COVID-19 pandemic upon patients without COVID-19 who are in the cardiothoracic ICU. It will also explore the impact of these restrictions on them, their relatives and staff.
This study will be carried out within a single specialised intensive care unit in Scotland using mixed methods.
The first arm of this study will use retrospective data that is routinely collected in normal clinical practice. The investigators will compare patient outcomes prior to COVID-19 with outcomes following the implementation of COVID-19 visiting restrictions. The aim is to establish if the restrictions on visiting has an impact on the duration of delirium. Delirium is an acute mental confusion and is associated with longer hospital stays and worse outcomes in this patient group.
The second arm of this study involves semi-structured interviews with patients, relatives and staff that will allow deeper exploration of the issues around current visiting policy. The interviews will last approximately 1 hour and will address these issues. They will then be transcribed word for word and analysed using grounded theory, meaning the theories will develop from the data as it is analysed.
详细描述
This study will look at the implications of visiting restrictions on patients without COVID-19 who are in the intensive care unit. It will also explore the impact of these restrictions on them, their relatives and staff.
The investigators hypothesise that the restriction of visiting has a negative impact on recovery of patients, families of patients and staff caring for patients without COVID-19 in the cardiothoracic ICU.
In order to answer this hypothesis, the wider implications of COVID-19 will be explored, not only with patients, but also relatives and staff involved in the care of these patients.
The research questions this study aims to answer are:
- Is there a negative impact on the clinical outcomes due to the COVID-19 visitation restrictions?
- Is there an increase in the incidence and duration of delirium in patients who do not receive visitors?
- What experiences do patients recall during their ICU admission through the COVID-19 pandemic visitation restrictions?
- What experiences do relatives recall from their loved-ones during an ICU admission during the COVID-19 pandemic visitation restrictions?
- What impact, if any, do the changes to visiting have on staff?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Length of stay within critical care > 4 days
- •Age > 18 years
- •Patients who have been admitted:
- •Following cardiac or thoracic surgery or,
- •For treatment of advanced heart failure
排除标准
- •Pregnancy
- •Diagnosed learning disability
- •Pre-admission evidence of cognitive impairment
- •Patients admitted to the ICU following ear nose and throat (ENT) procedures
- •Patients admitted to the ICU following orthopaedics procedure
- •Patients admitted to the ICU following general surgical procedures
- •Patients admitted following out of hospital cardiac arrest
- •Patients admitted for COVID-19 pneumonia
- •Inclusion Criteria:
- •For Patients:
- •Length of stay within critical care > 4 days
- •Age > 18 years
- •Reason for admission
- •Post-operative patients following cardiac or thoracic surgery or,
- •Following admission for advanced heart failure therapies
- •Provision of informed consent
- •For relatives:
- •Age > 18 years
- •Relative of a patient that has been in critical care > 4 days
- •Relative of a patient who has been admitted:
- •Following cardiac or thoracic surgery or,
- •Treatment of advanced heart failure
- •Relative of a patient admitted for > 4days
- •Age > 18
- •Clinical responsibility within the critical care department
- •For patients:
- •Prisoners
- •Age < 18yrs
- •No family or social support
- •Non-English speaker
- •Pre-admission evidence of cognitive impairment
- •Pre-admission diagnosis of learning disability
- •Imminent death
- •Brain injury
- •Lacks capacity (using Montreal Cognitive Assessment tool (MoCA))
- •Patients admitted after out of hospital cardiac arrest
- •Patients admitted to the ICU following ENT procedures
- •Patients admitted to the ICU following orthopaedics procedure
- •Patients admitted to the ICU following general surgical procedures
- •Patients admitted with COVID-19 pneumonia
- •For relatives:
- •Age < 18yrs
- •Non-English speaker
- •Relative of a patient who is close to death
- •Relative of a patient admitted after out of hospital cardiac arrest
- •Relative of a patient admitted for ENT procedure
- •Relative of a patient admitted for orthopaedic procedure
- •Relative of a patient admitted following general surgical procedure
- •Age < 18yrs
结局指标
主要结局
Duration of delirium
时间窗: From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.
Number of days patient found to have delirium using the Confusion Assessment Method for the ICU (CAM-ICU)
次要结局
- Mortality(6 months)
- Incidence of delirium(From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.)
- Length of critical care stay(From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.)
- Length of hospital stay(From the date of admission to the hospital until discharge from the hospital or death, whichever came first, up to 12 months.)
- Doses of specified drugs during ICU admission(From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.)
- Length of time ventilated(From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.)
研究者
Dr Ben Shelley
Chief Investigator
University of Glasgow