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/NCT06027684</url>
    </required_header>
    <id_info>
      <org_study_id>NHS002026</org_study_id>
      <secondary_id>317639</secondary_id>
      <nct_id>NCT06027684</nct_id>
    </id_info>
    <brief_title>Intensive Care Decision-making, Survival and Dying Well</brief_title>
    <official_title>Intensive Care Decision-making, Survival and Dying Well: How do the Experiences of Intensive Care Patients and Their End-of-life Wishes Affect Their Willingness to Accept Intensive Care Treatment at Different Chances of Survival?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Manchester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Royal College of Anaesthetists</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Manchester</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>
        The goal of this study is to investigate how the experiences of intensive care patients and&#xD;
        their end-of-life wishes affect their willingness to accept intensive care treatment at&#xD;
        different chances of survival.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  What can ICU survivors' experiences of ICU treatment tell us about what it would be like&#xD;
             to die whilst receiving ICU treatment?&#xD;
  &#xD;
          -  How do ICU survivors' reflections about what it might be like to die on ICU relate to&#xD;
             their own preferences for their end-of-life care?&#xD;
  &#xD;
          -  What chance of survival would make ICU survivors willing to go through ICU treatment&#xD;
             again, in light of the fact that the alternative chance is dying whilst experiencing ICU&#xD;
             treatment?&#xD;
  &#xD;
          -  How does the possibility of reduction in health-related quality of life and functional&#xD;
             decline as a result of critical illness impact ICU survivors' willingness to accept ICU&#xD;
             treatment again?&#xD;
  &#xD;
        Participating in this study will involve filling out a questionnaire and then taking part in&#xD;
        an interview. Participants will be recruited through ICU review clinics and ICU steps groups.&#xD;
        The study will last for two years and will be conducted at locations convenient to the&#xD;
        participants or via zoom.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The ageing population of many countries has led to more elderly and increasingly co-morbid&#xD;
        patients accessing healthcare services, and intensive care is no exception. This creates an&#xD;
        increasing demand for intensive care treatment for patients with a low chance of surviving&#xD;
        their critical illness, even with intensive care treatment.&#xD;
  &#xD;
        A sedated intensive care patient receiving mechanical ventilation may have the appearance of&#xD;
        being unconscious, but follow-up studies with survivors show that many patients have memories&#xD;
        of their experiences, which have been described as frightening and chaotic, leading to&#xD;
        feelings of instability, vulnerability and fear. Studies have reported recall of pain,&#xD;
        disturbing dreams, procedures, thirst, noise, difficulty communicating, difficulty&#xD;
        swallowing, awareness of invasive tubes, panic/fear, helplessness, lack of control, feeling&#xD;
        tense and patients thinking they were dying. In one study, 67% of patients had recollections&#xD;
        of stressful experiences whilst receiving intensive care treatment and 66-92% of these&#xD;
        experiences were rated as moderately to extremely distressing. It must be assumed that all&#xD;
        intensive care patients (survivors and non-survivors) have similar experiences of their&#xD;
        treatment. Therefore, the negative experiences described by survivors must be assumed to be&#xD;
        shared by patients who die whilst receiving such treatment. Consequently, dying whilst&#xD;
        receiving intensive care treatment is likely to be a significantly distressing experience.&#xD;
  &#xD;
        Intensive care treatment may not be beneficial for patients with a low chance of surviving&#xD;
        critical illness if the treatment has a high chance of exposing them to a negative dying&#xD;
        experience. For intensive care treatment to be ethically justifiable it should offer patients&#xD;
        a reasonable chance of survival to justify the burdens inherent in the treatment, and the&#xD;
        risks of a negative dying experience. Therefore, a key question in the provision of intensive&#xD;
        care treatment is at what chance of survival is this treatment ethically justifiable? An&#xD;
        adequate answer to this question will require consideration of both the quantitative benefits&#xD;
        of the treatment, such as survival, and the qualitative harms, including suffering and the&#xD;
        risk of exposure to a negative dying experience.&#xD;
  &#xD;
        Even though dying whilst receiving intensive care treatment is likely to be a negative dying&#xD;
        experience, it is not possible to ask patients who did not survive their critical illness&#xD;
        about their dying experience or whether they retrospectively agree with the decision to&#xD;
        provide them with intensive care treatment. However, all intensive care patients (survivors&#xD;
        and non-survivors) have experiences of what it is like to receive intensive care treatment.&#xD;
        All ICU patients can be considered a population whose experiences can be represented by the&#xD;
        survivors of ICU. Therefore, the experiences described by survivors can provide a window into&#xD;
        the experience of patients who die whilst receiving such treatment.&#xD;
  &#xD;
        Research to establish the harm-to-benefit ratio that most people would be willing to accept&#xD;
        with regards to intensive care treatment is, therefore, of great importance to guide ethical&#xD;
        decision-making regarding the provision of intensive care treatment. Of particular importance&#xD;
        will be elderly and co-morbid patients' evaluations of their negative intensive care&#xD;
        experiences, as these patients are likely to be the ones with the lowest chance of surviving&#xD;
        a critical illness. This information could be used to guide intensive care decision-making&#xD;
        and to better inform patients of the harms of intensive care treatment. Such research could&#xD;
        provide guidance regarding what chance of survival makes the suffering involved in intensive&#xD;
        care treatment, acceptable to patients and ensure that intensive care treatment is not&#xD;
        routinely offered to patients with a very low chance of surviving their critical illness, for&#xD;
        whom the benefit does not outweigh the cost.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</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>The chance of survival that would make participants willing to go through critical care treatment again.</measure>
      <time_frame>2 years</time_frame>
      <description>The mixed methods approach will involve triangulation of qualitative and questionnaire data about participants' experiences of intensive care treatment, end-of-life wishes, and the chance of survival that would make them willing to go through critical care treatment again.</description>
    </primary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Critical Illness</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult (over the age of 18) participants who have experience as a patient on an intensive&#xD;
          care/critical care unit will be recruited in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The principle inclusion criteria are being 18 years or older and having previously&#xD;
               been a patient on an intensive care/critical care unit in the past.&#xD;
  &#xD;
            -  Being willing to talk about experiences of intensive care treatment, end-of-life&#xD;
               wishes, and the context (chances of survival/functional decline) which would make&#xD;
               intensive care treatments acceptable and being willing to either meet in person or&#xD;
               have access to a computer, tablet or mobile phone with video and a stable internet&#xD;
               connection (for a Zoom conversation) are also inclusion criteria.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The exclusion criteria are being under the age of 18, having had a planned admission&#xD;
               to an intensive care/critical care unit (e.g. after an elective operation), being&#xD;
               unable to consent to participate in the research and having a significant language&#xD;
               barrier (as there is no available funding to pay for translation).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Thomas M Donaldson, MB/BChir</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Manchester</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Thomas M Donaldson, MB/BChir</last_name>
      <phone>07737298024</phone>
      <email>thomas.donaldson-2@postgrad.manchester.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Soren Holm</last_name>
      <phone>0161 275 3588</phone>
      <email>soren.holm@manchester.ac.uk</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Manchester</investigator_affiliation>
      <investigator_full_name>Thomas Donaldson</investigator_full_name>
      <investigator_title>PhD Student</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>At the end of the project, the investigators will deposit a fully anonymised dataset [e.g., including de-identified interview transcripts] in an open data repository where it will be permanently stored. The investigators will use Figshare at the University of Manchester Library. Researchers at other institutions and others can access the anonymised data directly from the repository and use it for further research or to check the analysis and results. Participants are informed of this in the participant information sheet and will be asked to consent to this on the consent form.</ipd_description>
      <ipd_time_frame>At the end of the study.</ipd_time_frame>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>April 19, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT06027684/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>October 19, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT06027684/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06027684
  org study id: NHS002026
  secondary id: 317639
  nct id: NCT06027684
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to investigate how the experiences of intensive care patients and
        their end-of-life wishes affect their willingness to accept intensive care treatment at
        different chances of survival.
  
        The main questions it aims to answer are:
  
          -  What can ICU survivors' experiences of ICU treatment tell us about what it would be like
             to die whilst receiving ICU treatment?
  
          -  How do ICU survivors' reflections about what it might be like to die on ICU relate to
             their own preferences for their end-of-life care?
  
          -  What chance of survival would make ICU survivors willing to go through ICU treatment
             again, in light of the fact that the alternative chance is dying whilst experiencing ICU
             treatment?
  
          -  How does the possibility of reduction in health-related quality of life and functional
             decline as a result of critical illness impact ICU survivors' willingness to accept ICU
             treatment again?
  
        Participating in this study will involve filling out a questionnaire and then taking part in
        an interview. Participants will be recruited through ICU review clinics and ICU steps groups.
        The study will last for two years and will be conducted at locations convenient to the
        participants or via zoom.
  The ageing population of many countries has led to more elderly and increasingly co-morbid
        patients accessing healthcare services, and intensive care is no exception. This creates an
        increasing demand for intensive care treatment for patients with a low chance of surviving
        their critical illness, even with intensive care treatment.
  
        A sedated intensive care patient receiving mechanical ventilation may have the appearance of
        being unconscious, but follow-up studies with survivors show that many patients have memories
        of their experiences, which have been described as frightening and chaotic, leading to
        feelings of instability, vulnerability and fear. Studies have reported recall of pain,
        disturbing dreams, procedures, thirst, noise, difficulty communicating, difficulty
        swallowing, awareness of invasive tubes, panic/fear, helplessness, lack of control, feeling
        tense and patients thinking they were dying. In one study, 67% of patients had recollections
        of stressful experiences whilst receiving intensive care treatment and 66-92% of these
        experiences were rated as moderately to extremely distressing. It must be assumed that all
        intensive care patients (survivors and non-survivors) have similar experiences of their
        treatment. Therefore, the negative experiences described by survivors must be assumed to be
        shared by patients who die whilst receiving such treatment. Consequently, dying whilst
        receiving intensive care treatment is likely to be a significantly distressing experience.
  
        Intensive care treatment may not be beneficial for patients with a low chance of surviving
        critical illness if the treatment has a high chance of exposing them to a negative dying
        experience. For intensive care treatment to be ethically justifiable it should offer patients
        a reasonable chance of survival to justify the burdens inherent in the treatment, and the
        risks of a negative dying experience. Therefore, a key question in the provision of intensive
        care treatment is at what chance of survival is this treatment ethically justifiable? An
        adequate answer to this question will require consideration of both the quantitative benefits
        of the treatment, such as survival, and the qualitative harms, including suffering and the
        risk of exposure to a negative dying experience.
  
        Even though dying whilst receiving intensive care treatment is likely to be a negative dying
        experience, it is not possible to ask patients who did not survive their critical illness
        about their dying experience or whether they retrospectively agree with the decision to
        provide them with intensive care treatment. However, all intensive care patients (survivors
        and non-survivors) have experiences of what it is like to receive intensive care treatment.
        All ICU patients can be considered a population whose experiences can be represented by the
        survivors of ICU. Therefore, the experiences described by survivors can provide a window into
        the experience of patients who die whilst receiving such treatment.
  
        Research to establish the harm-to-benefit ratio that most people would be willing to accept
        with regards to intensive care treatment is, therefore, of great importance to guide ethical
        decision-making regarding the provision of intensive care treatment. Of particular importance
        will be elderly and co-morbid patients' evaluations of their negative intensive care
        experiences, as these patients are likely to be the ones with the lowest chance of surviving
        a critical illness. This information could be used to guide intensive care decision-making
        and to better inform patients of the harms of intensive care treatment. Such research could
        provide guidance regarding what chance of survival makes the suffering involved in intensive
        care treatment, acceptable to patients and ensure that intensive care treatment is not
        routinely offered to patients with a very low chance of surviving their critical illness, for
        whom the benefit does not outweigh the cost.
  observational model: Other
  time perspective: Other
  measure: The chance of survival that would make participants willing to go through critical care treatment again.
  time frame: 2 years
  description: The mixed methods approach will involve triangulation of qualitative and questionnaire data about participants' experiences of intensive care treatment, end-of-life wishes, and the chance of survival that would make them willing to go through critical care treatment again.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Thomas M Donaldson, MB/BChir
  role: Principal Investigator
  affiliation: University of Manchester
  last name: Thomas M Donaldson, MB/BChir
  phone: 07737298024
  email: thomas.donaldson-2@postgrad.manchester.ac.uk
  last name: Soren Holm
  phone: 0161 275 3588
  email: soren.holm@manchester.ac.uk
  responsible party type: Principal Investigator
  investigator affiliation: University of Manchester
  investigator full name: Thomas Donaldson
  investigator title: PhD Student
  mesh term: Critical Illness
  sharing ipd: Yes
  ipd description: At the end of the project, the investigators will deposit a fully anonymised dataset [e.g., including de-identified interview transcripts] in an open data repository where it will be permanently stored. The investigators will use Figshare at the University of Manchester Library. Researchers at other institutions and others can access the anonymised data directly from the repository and use it for further research or to check the analysis and results. Participants are informed of this in the participant information sheet and will be asked to consent to this on the consent form.
  ipd time frame: At the end of the study.
  provided document: 
  provided document: 