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

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ClinicalTrials.gov Identifier: NCT04538469
Recruitment Status : Not yet recruiting
First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Collaborator:
Golden Jubilee National Hospital
Information provided by (Responsible Party):
Dr Ben Shelley, University of Glasgow

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.


Condition or disease Intervention/treatment
Cardiovascular Diseases Delirium Critical Illness Intensive Care Unit Delirium Thoracic Diseases Respiratory Failure Cardiac Disease Cardiac Failure 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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.




Primary Outcome Measures :
  1. Duration of delirium [ Time Frame: 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)


Secondary Outcome Measures :
  1. Incidence of delirium [ Time Frame: 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. ]
    CAM-ICU

  2. Length of critical care stay [ Time Frame: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months. ]
    Days

  3. Length of hospital stay [ Time Frame: From the date of admission to the hospital until discharge from the hospital or death, whichever came first, up to 12 months. ]
    Days

  4. Doses of specified drugs during ICU admission [ Time Frame: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months. ]
  5. Length of time ventilated [ Time Frame: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months. ]
    Days

  6. Mortality [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Exploring the experiences of patients, relatives and staff of the visitation restrictions during the COVID-19 pandemic [ Time Frame: 18 months ]
    Semi structured interviews



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes 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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04538469


Contacts
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Contact: Leah Hughes 0141 951 5305 leah.hughes@gjnh.scot.nhs.uk
Contact: Ben Shelley 0141 951 5000 benjamin.shelley@glasgow.ac.uk

Sponsors and Collaborators
University of Glasgow
Golden Jubilee National Hospital
Investigators
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Study Chair: Ben Shelley National Waiting Times Centre Board
Principal Investigator: Leah Hughes National Waiting Times Centre Board
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Responsible Party: Dr Ben Shelley, Chief Investigator, University of Glasgow
ClinicalTrials.gov Identifier: NCT04538469    
Other Study ID Numbers: 20/ANAES/02
First Posted: September 4, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results to be published in a peer reviewed journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Thoracic Diseases
Delirium
Cardiovascular Diseases
Heart Diseases
Heart Failure
Critical Illness
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes