xml: <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/NCT05996640</url>
    </required_header>
    <id_info>
      <org_study_id>319498</org_study_id>
      <nct_id>NCT05996640</nct_id>
    </id_info>
    <brief_title>Patient Preferences and Experiences of Waiting for Heart Surgery</brief_title>
    <official_title>Investigating Patient Preferences and Experiences of Waiting for Elective Heart Surgery: a Cross-sectional Online Survey</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King's College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>King's College London</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Waiting for heart surgery could be difficult and anxiety-provoking for some patients.&#xD;
        Research suggests that some specific factors (e.g., individual coping strategies,&#xD;
        communication with the clinical team, having a more active role in care decision-making)&#xD;
        could reduce the stress associated with waiting. However, most of this research has looked at&#xD;
        patients waiting for other types of surgery (e.g., cancer surgery). Therefore, more research&#xD;
        focusing on patients waiting for heart surgery is needed.&#xD;
  &#xD;
        This project aims to investigate patients' experiences, perceptions and preferences about&#xD;
        waiting for elective (non-emergency) heart surgery across four London-based National Health&#xD;
        Service (NHS) hospitals that belong to King's Health Partners (KHP): Royal Brompton,&#xD;
        Harefield, St Thomas', and King's College hospitals. The project is led by the research team&#xD;
        at King's Improvement Science, (King's College London), in collaboration with clinicians and&#xD;
        patients with lived experience of waiting for heart surgery.&#xD;
  &#xD;
        This project will look at:&#xD;
  &#xD;
          -  how patients feel their heart condition affects their day-to-day life;&#xD;
  &#xD;
          -  how patients experience being on a waiting list;&#xD;
  &#xD;
          -  what factors patients consider as most important for their upcoming surgery (e.g. to&#xD;
             have their surgery as soon as possible, at their nearest hospital, or carried out by a&#xD;
             specific surgeon);&#xD;
  &#xD;
          -  patients' opinions about how the heart surgery waiting list process could be improved.&#xD;
  &#xD;
        Adult patients (&gt;18 years old) waiting for elective heart surgery at the four hospitals&#xD;
        listed above will be invited, via a text message and a letter, to complete an online survey&#xD;
        (i.e. a list of questions). Completing reading study information and completing the survey&#xD;
        will likely take approximately 30 minutes. The survey will be open for 8 weeks in total.&#xD;
  &#xD;
        Findings from this project, together with other work looking at clinical processes and&#xD;
        outcomes across heart surgery services at the four KHP hospitals, will inform a wider quality&#xD;
        improvement project.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 14, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2023</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Patient experience</measure>
      <time_frame>8 weeks</time_frame>
      <description>ratings on impact of heart condition on life</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient preferences</measure>
      <time_frame>8 weeks</time_frame>
      <description>qualitative description of preferences about service improvement</description>
    </primary_outcome>
    <enrollment type="Anticipated">268</enrollment>
    <condition>Cardiac Disease</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>This is study does not use an intervention</intervention_name>
      <description>This is study does not use an intervention. A survey will be used to collected data on patients' experiences and preferences about waiting list for heart surgery.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Based on the NHS guide for surgical prioritisation, waiting lists for elective surgery are&#xD;
          grouped into four priority categories: P1 includes emergency patients (requiring surgery&#xD;
          within 24 hours, therefore they are not on elective cardiac surgery waiting lists); P2&#xD;
          includes patients who require surgery within 4 weeks; P3 and P4 are patients who require&#xD;
          surgery within 3 months, and between 3-6 months, respectively.&#xD;
  &#xD;
          The population of interest in this study is composed by patients in the P2, P3 and P4&#xD;
          categories whose most common diagnoses are coronary heart disease, aortic stenosis, mitral&#xD;
          regurgitation, and aortic aneurysm. Accordingly, the most commonly performed surgeries&#xD;
          within the above categories are coronary artery bypass grafts (CABGs), aortic valve&#xD;
          replacement, mitral valve repair or replacement and aortic aneurysm repair.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  being on a waiting list for elective cardiac surgery under any of the following&#xD;
               surgical prioritisation categories P2, P3, and P4;&#xD;
  &#xD;
            -  being at least 18 years old;&#xD;
  &#xD;
            -  being on a waiting list for cardiac surgery across any of the four KHP participating&#xD;
               sites: RBH, HH, STH, and KCH.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  being on a waiting list for cardiac surgery at sites other than Royal Brompton&#xD;
               Hospital, Harefield Hospital, St Thomas Hospital, and King's College Hospital;&#xD;
  &#xD;
            -  not having any recorded contact details in the form of mobile phone and home address&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996640
  org study id: 319498
  nct id: NCT05996640
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Waiting for heart surgery could be difficult and anxiety-provoking for some patients.
        Research suggests that some specific factors (e.g., individual coping strategies,
        communication with the clinical team, having a more active role in care decision-making)
        could reduce the stress associated with waiting. However, most of this research has looked at
        patients waiting for other types of surgery (e.g., cancer surgery). Therefore, more research
        focusing on patients waiting for heart surgery is needed.
  
        This project aims to investigate patients' experiences, perceptions and preferences about
        waiting for elective (non-emergency) heart surgery across four London-based National Health
        Service (NHS) hospitals that belong to King's Health Partners (KHP): Royal Brompton,
        Harefield, St Thomas', and King's College hospitals. The project is led by the research team
        at King's Improvement Science, (King's College London), in collaboration with clinicians and
        patients with lived experience of waiting for heart surgery.
  
        This project will look at:
  
          -  how patients feel their heart condition affects their day-to-day life;
  
          -  how patients experience being on a waiting list;
  
          -  what factors patients consider as most important for their upcoming surgery (e.g. to
             have their surgery as soon as possible, at their nearest hospital, or carried out by a
             specific surgeon);
  
          -  patients' opinions about how the heart surgery waiting list process could be improved.
  
        Adult patients (>18 years old) waiting for elective heart surgery at the four hospitals
        listed above will be invited, via a text message and a letter, to complete an online survey
        (i.e. a list of questions). Completing reading study information and completing the survey
        will likely take approximately 30 minutes. The survey will be open for 8 weeks in total.
  
        Findings from this project, together with other work looking at clinical processes and
        outcomes across heart surgery services at the four KHP hospitals, will inform a wider quality
        improvement project.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Patient experience
  time frame: 8 weeks
  description: ratings on impact of heart condition on life
  measure: Patient preferences
  time frame: 8 weeks
  description: qualitative description of preferences about service improvement
  intervention type: Other
  intervention name: This is study does not use an intervention
  description: This is study does not use an intervention. A survey will be used to collected data on patients' experiences and preferences about waiting list for heart surgery.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Heart Diseases
  sharing ipd: No