Major TraumaVISIT_ICUNCT03259776
Experiences of Visitors to a Regional Major Trauma Intensive Care Unit
An observational study of Major Trauma, run by Kingston University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Trauma
- What is being tested?
- Qualitative interviews and questionnaire survey
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Nov 2017to 31 Aug 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's University Hosptials NHS Foundation Trust
London, SW17 0QT
About this study
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.
Read more
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.
- Conditions
- Major Trauma
- Being tested
- Qualitative interviews and questionnaire survey
- Keywords
- Intensive Care, Patient- and Family-Centred Care, Patient and Public Involvement, South West London Major Trauma Network, Service Improvement, Survey Questionnaire, Visitor Experiences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviews and questionnaire surveyOther
Qualitative interviews and questionnaire survey
| Study group | Role | What they receive |
|---|---|---|
| Visitors | Qualitative interviews and questionnaire survey Receives: Other: Qualitative interviews and questionnaire survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visitors' experiences
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start16 Nov 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major TraumaStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kingston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Tino Kulnik, Kingston University
- Investigators
- Stefan T Kulnik, PhD, Principal investigator, Kingston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259776
- Sponsor's protocol ID
- 233327
- Acronym
- VISIT_ICU
- Status last verified
- Oct 2018
- First submitted
- 17 Aug 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences of Visitors to a Regional Major Trauma Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03259776
- Acronym / sponsor ID
- VISIT_ICU / 233327
- Conditions
- Major Trauma
- Keywords
- Intensive Care, Patient- and Family-Centred Care, Patient and Public Involvement, South West London Major Trauma Network, Service Improvement, Survey Questionnaire, Visitor Experiences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Kingston UniversityUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 24 Aug 2017 (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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visitors | – | Other: Qualitative interviews and questionnaire surveyQualitative interviews and questionnaire survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| Qualitative interviews and questionnaire surveyQualitative interviews and questionnaire survey | Other | Visitors |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Stefan T Kulnik, PhD principal investigator
Kingston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Trauma, run by Kingston University at 1 site in United Kingdom.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visitors' experiences (time frame: 15 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 9 Oct 2018.