Cardiovascular DiseasesVINCINCT04538469
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
An observational study of Cardiovascular Diseases and Delirium, run by University of Glasgow.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Delirium, Critical Illness
- What is being tested?
- COVID visitation restrictions
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 22Show fewer
- 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
Who cannot join
- 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
Show all 35Show fewer
- Patients admitted following out of hospital cardiac arrest
- Patients admitted for COVID-19 pneumonia
- Arm 2
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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:
- 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?
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
- Being tested
- COVID visitation restrictions
- Medical subject headings
- Cardiovascular Diseases, Delirium, Critical Illness, Thoracic Diseases, Respiratory Insufficiency, Heart Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID visitation restrictionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Admitted prior to COVID visitation restrictions introduced | |
| Group 2 | Admitted following the introductions of visitation restrictions due to COVID 19 pandemic Receives: Other: COVID visitation restrictions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of delirium
Number of days patient found to have delirium using the Confusion Assessment Method for the ICU (CAM-ICU)
Measured: 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 outcomes (6)
Incidence of delirium
CAM-ICU
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.
Mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Golden Jubilee National Hospital
- Responsible party
- Principal investigator, Dr Ben Shelley, University of Glasgow
- Investigators
- Ben Shelley, Study chair, National Waiting Times Centre BoardLeah Hughes, Principal investigator, National Waiting Times Centre Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538469
- Sponsor's protocol ID
- 20/ANAES/02
- Acronym
- VINCI
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results to be published in a peer reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
- ClinicalTrials.gov ID
- NCT04538469
- Acronym / sponsor ID
- VINCI / 20/ANAES/02
- Conditions
- Cardiovascular Diseases, Delirium, Critical Illness, Intensive Care Unit Delirium, Thoracic Diseases, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Golden Jubilee National Hospital
- Study start
- Sep 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Admitted prior to COVID visitation restrictions introduced |
| Group 2 | – | Other: COVID visitation restrictionsAdmitted following the introductions of visitation restrictions due to COVID 19 pandemic |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (22 listed)
- Length of stay within critical care > 4 days
- Age > 18 years
- Patients who have been admitted:
- Length of stay within critical care > 4 days
- Age > 18 years
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID visitation restrictionsVisitation 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. | Other | Group 2 |
Primary outcome
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)
6 secondary outcomes
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.
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.
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.
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.
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.
Mortality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: Yes. Results to be published in a peer reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Shelley study chair
National Waiting Times Centre Board
Leah Hughes principal investigator
National Waiting Times Centre Board
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Delirium, run by University of Glasgow.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leah Hughes (0141 951 5305, leah.hughes@gjnh.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.