<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03259776</url>
  </required_header>
  <id_info>
    <org_study_id>233327</org_study_id>
    <nct_id>NCT03259776</nct_id>
  </id_info>
  <brief_title>Experiences of Visitors to a Regional Major Trauma Intensive Care Unit</brief_title>
  <acronym>VISIT_ICU</acronym>
  <official_title>Experiences of Visitors to a Regional Major Trauma Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kingston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kingston University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since 2011, people who have had a serious accident in England are no longer looked after at&#xD;
      the hospital nearest to them. Instead, they are cared for at a specialist hospital called the&#xD;
      regional major trauma centre. This is so that they can get the best possible care from&#xD;
      specialist professionals.&#xD;
&#xD;
      St George's is the regional major trauma centre for the 2.6 million people living in South&#xD;
      West London and Surrey County. This area stretches about 40 miles across.&#xD;
&#xD;
      About one fifth of major trauma patients who come to St George's live more than one hour's&#xD;
      journey away. Their visitors often travel a similar distance or even further. Family members&#xD;
      and friends play an important part during the patient's stay. It is important to support&#xD;
      visitors.&#xD;
&#xD;
      The aim of this study is to describe the experiences of visitors whose family member or&#xD;
      friend has been admitted to the major trauma intensive care unit at St George's. In&#xD;
      particular, the aim is to describe the experiences of visitors who travel from far.&#xD;
&#xD;
      First, ten visitors will be interviewed to find out more about their experiences. From these&#xD;
      data, a survey questionnaire will then be developed and approximately 150 visitors who have&#xD;
      been to St George's in recent months will be surveyed. This will give in-depth insights to&#xD;
      understanding peoples' experiences of visiting at St George's, and what people thought was&#xD;
      going well and things that could be better. The study will end with a service improvement&#xD;
      workshop with representatives from the team at St George's and visitors. Study findings will&#xD;
      be discussed and decisions on what should be improved will be made.&#xD;
&#xD;
      This study is being funded by St George's Hospital Charity. The study runs from August 2017&#xD;
      to October 2018.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visitors' experiences</measure>
    <time_frame>15 months</time_frame>
    <description>This study uses mixed-methods in a two-staged approach, to provide both depth and breadth in capturing data on visitors' experiences.&#xD;
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 &quot;Can you talk a bit about visiting your relative/friend here at St George's&quot; and &quot;How has your daily life been since you started visiting here at St George's&quot;. 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.&#xD;
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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">57</enrollment>
  <condition>Major Trauma</condition>
  <arm_group>
    <arm_group_label>Visitors</arm_group_label>
    <description>Qualitative interviews and questionnaire survey</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Qualitative interviews and questionnaire survey</intervention_name>
    <description>Qualitative interviews and questionnaire survey</description>
    <arm_group_label>Visitors</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Visitors (i.e. designated next of kin and/or other family member or friend with a close&#xD;
        relationship and significant involvement in the patient's circumstances and care) of a&#xD;
        patient who has been admitted to ICUs at St George's University Hospitals NHS Foundation&#xD;
        Trust under the major trauma care pathway&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Visitors (i.e. designated next of kin and/or other family member or friend with a&#xD;
             close relationship and significant involvement in the patient's circumstances and&#xD;
             care) of a patient who has been admitted to intensive care at St George's University&#xD;
             Hospitals NHS Foundation Trust under the major trauma care pathway&#xD;
&#xD;
          -  Ordinary residence further away than one hour's drive from St George's Hospital&#xD;
             (estimated driving time in mid-week mid-morning traffic according to Google Maps,&#xD;
             equating to a distance of approximately 30 miles)&#xD;
&#xD;
          -  Adults (18 years and over)&#xD;
&#xD;
          -  Written informed consent (for semi-structured qualitative interviews)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ordinary residence within one hour's drive from St George's Hospital (estimated&#xD;
             driving time in mid-week mid-morning traffic according to Google Maps, equating to a&#xD;
             distance of within approximately 30 miles)&#xD;
&#xD;
          -  Limited English (for semi-structured qualitative interviews)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan T Kulnik, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kingston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St George's University Hosptials NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>October 8, 2018</last_update_submitted>
  <last_update_submitted_qc>October 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kingston University</investigator_affiliation>
    <investigator_full_name>Stefan Tino Kulnik</investigator_full_name>
    <investigator_title>Postdoctoral Researcher</investigator_title>
  </responsible_party>
  <keyword>Intensive Care</keyword>
  <keyword>Patient- and Family-Centred Care</keyword>
  <keyword>Patient and Public Involvement</keyword>
  <keyword>South West London Major Trauma Network</keyword>
  <keyword>Service Improvement</keyword>
  <keyword>Survey Questionnaire</keyword>
  <keyword>Visitor Experiences</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03259776
org study id: 233327
nct id: NCT03259776
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Other
measure: Visitors' experiences
time frame: 15 months
description: 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.
arm group label: Visitors
description: Qualitative interviews and questionnaire survey
intervention type: Other
intervention name: Qualitative interviews and questionnaire survey
description: Qualitative interviews and questionnaire survey
arm group label: Visitors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stefan T Kulnik, PhD
role: Principal Investigator
affiliation: Kingston University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Kingston University
investigator full name: Stefan Tino Kulnik
investigator title: Postdoctoral Researcher
mesh term: Wounds and Injuries
sharing ipd: No