Experiences of Visitors to a Regional Major Trauma Intensive Care Unit (VISIT_ICU)

October 8, 2018 updated by: Stefan Tino Kulnik, Kingston University

Since 2011, people who have had a serious accident in England are no longer looked after at the hospital nearest to them. Instead, they are cared for at a specialist hospital called the regional major trauma centre. This is so that they can get the best possible care from specialist professionals.

St George's is the regional major trauma centre for the 2.6 million people living in South West London and Surrey County. This area stretches about 40 miles across.

About one fifth of major trauma patients who come to St George's live more than one hour's journey away. Their visitors often travel a similar distance or even further. Family members and friends play an important part during the patient's stay. It is important to support visitors.

The aim of this study is to describe the experiences of visitors whose family member or friend has been admitted to the major trauma intensive care unit at St George's. In particular, the aim is to describe the experiences of visitors who travel from far.

First, ten visitors will be interviewed to find out more about their experiences. From these data, a survey questionnaire will then be developed and approximately 150 visitors who have been to St George's in recent months will be surveyed. This will give in-depth insights to understanding peoples' experiences of visiting at St George's, and what people thought was going well and things that could be better. The study will end with a service improvement workshop with representatives from the team at St George's and visitors. Study findings will be discussed and decisions on what should be improved will be made.

This study is being funded by St George's Hospital Charity. The study runs from August 2017 to October 2018.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW17 0QT
        • St George's University Hosptials NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Visitors (i.e. designated next of kin and/or other family member or friend with a close relationship and significant involvement in the patient's circumstances and care) of a patient who has been admitted to ICUs at St George's University Hospitals NHS Foundation Trust under the major trauma care pathway

Description

Inclusion Criteria:

  • Visitors (i.e. designated next of kin and/or other family member or friend with a close relationship and significant involvement in the patient's circumstances and care) of a patient who has been admitted to intensive care at St George's University Hospitals NHS Foundation Trust under the major trauma care pathway
  • Ordinary residence further away than one hour's drive from St George's Hospital (estimated driving time in mid-week mid-morning traffic according to Google Maps, equating to a distance of approximately 30 miles)
  • Adults (18 years and over)
  • Written informed consent (for semi-structured qualitative interviews)

Exclusion Criteria:

  • Ordinary residence within one hour's drive from St George's Hospital (estimated driving time in mid-week mid-morning traffic according to Google Maps, equating to a distance of within approximately 30 miles)
  • Limited English (for semi-structured qualitative interviews)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Visitors
Qualitative interviews and questionnaire survey
Other: Qualitative interviews and questionnaire survey
Qualitative interviews and questionnaire survey

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visitors' experiences
Time Frame: 15 months

This study uses mixed-methods in a two-staged approach, to provide both depth and breadth in capturing data on visitors' experiences.

In the first stage, a series of semi-structured qualitative interviews will capture in-depth data on visitors' experiences. Participants will be asked questions such as "Can you talk a bit about visiting your relative/friend here at St George's" and "How has your daily life been since you started visiting here at St George's". These in-depth qualitative data will inform the content and structure for a bespoke visitor experience questionnaire, which will be newly developed as part of the study and copyrighted.

In the second stage, the newly developed, bespoke visitor experience questionnaire will be used to survey a larger number of visitors, gathering both quantitative and qualitative data to describe the experiences of visitors, areas of good practice and needs and opportunities for service improvement at the study site.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kingston University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan T Kulnik, PhD, Kingston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 233327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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