Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04538469
Study type Observational
Source University of Glasgow
Contact Leah Hughes
Phone 0141 951 5305
Email leah.hughes@gjnh.scot.nhs.uk
Status Not yet recruiting
Phase
Start date September 2020
Completion date December 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Recruiting NCT04417387 - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04514445 - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Completed NCT04083846 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed) Phase 1
Completed NCT04083872 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting) Phase 1
Completed NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Completed NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT05132998 - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04098172 - Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR N/A