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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Delirium; Critical Illness; Respiratory Failure; Thoracic Diseases; Cardiac Disease; Cardiac Failure; Intensive Care Unit Delirium
• Intervention / Treatment: Other: COVID visitation restrictions

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Leah Hughes; Phone Number: 0141 951 5305; Email: leah.hughes@gjnh.scot.nhs.uk
• Study Contact Backup: Name: Ben Shelley; Phone Number: 0141 951 5000; Email: Benjamin.Shelley@glasgow.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patient population of this unit comprises of adults undergoing cardiac or thoracic surgical procedures, the majority of which are elective operations. Other patients who receive care on this unit routinely are patients requiring level 3 care following out of hospital cardiac arrest or requiring therapies for advanced heart failure.

Description

Arm 1

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

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

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Admitted prior to COVID visitation restrictions introduced
Group 2; Admitted following the introductions of visitation restrictions due to COVID 19 pandemic	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of delirium	Number of days patient found to have delirium using the Confusion Assessment Method for the ICU (CAM-ICU)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		6 months
Incidence of delirium	CAM-ICU	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	Days	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	Days	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	Days	From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploring the experiences of patients, relatives and staff of the visitation restrictions during the COVID-19 pandemic	Semi structured interviews	18 months

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: Golden Jubilee National Hospital
• Investigators: Study Chair: Ben Shelley, National Waiting Times Centre Board; Principal Investigator: Leah Hughes, National Waiting Times Centre Board

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease Attributes; Heart Failure; Heart Diseases; Delirium; Cardiovascular Diseases; Respiratory Insufficiency; Critical Illness; Thoracic Diseases
• Other Study ID Numbers: 20/ANAES/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results to be published in a peer reviewed journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No