Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff

NCT ID: NCT04538469

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-12-31

Brief Summary

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.

Detailed Description

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:

1. Is there a negative impact on the clinical outcomes due to the COVID-19 visitation restrictions?

2. Is there an increase in the incidence and duration of delirium in patients who do not receive visitors?

3. What experiences do patients recall during their ICU admission through the COVID-19 pandemic visitation restrictions?

4. What experiences do relatives recall from their loved-ones during an ICU admission during the COVID-19 pandemic visitation restrictions?

5. What impact, if any, do the changes to visiting have on staff?

In order to answer these research questions the investigators will carry out a single centre mixed method observational study. This study will consist of two arms.

The first arm of this study will utilise retrospective data that is routinely collected in normal clinical practice in this single centre. This will be used to compare to patient outcomes prior to COVID-19 with outcomes following the implementation of COVID-19 visiting restrictions.

The second arm of this study involves semi-structured interviews with patients, relatives and staff that allow deeper exploration of the issues around current visiting policy.

Conditions

Cardiovascular Diseases; Delirium; Critical Illness; Intensive Care Unit Delirium; Thoracic Diseases; Respiratory Failure; Cardiac Disease; Cardiac Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 1

Admitted prior to COVID visitation restrictions introduced

No interventions assigned to this group

Group 2

Admitted following the introductions of visitation restrictions due to COVID 19 pandemic

COVID visitation restrictions

Intervention Type: OTHER

Visitation to patients in hospitals in Scotland was ceased due to the COVID 19 pandemic. Slow reintroduction of visitors has been introduced, however not to the pre COVID 19 levels. This study will examine the effects of these restrictions on patients in the cardiothoracic critical care unit that do not suffer from COVID 19.

Interventions

COVID visitation restrictions

Visitation to patients in hospitals in Scotland was ceased due to the COVID 19 pandemic. Slow reintroduction of visitors has been introduced, however not to the pre COVID 19 levels. This study will examine the effects of these restrictions on patients in the cardiothoracic critical care unit that do not suffer from COVID 19.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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

For Staff:

• Age > 18
• Clinical responsibility within the critical care department

Exclusion:

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:

• Prisoner
• 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

For Staff:

• Age < 18yrs

Exclusion Criteria

• 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

Arm 2

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role: collaborator

University of Glasgow

OTHER

Sponsor Role: lead

Responsible Party

Dr Ben Shelley

Chief Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ben Shelley

Role: STUDY_CHAIR

National Waiting Times Centre Board

Leah Hughes

Role: PRINCIPAL_INVESTIGATOR

National Waiting Times Centre Board

Central Contacts

Leah Hughes

Role: CONTACT

leah.hughes@gjnh.scot.nhs.uk

0141 951 5305

Ben Shelley

Role: CONTACT

benjamin.shelley@glasgow.ac.uk

0141 951 5000

Other Identifiers

20/ANAES/02

Identifier Type: -

Identifier Source: org_study_id