<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/NCT04445896</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS: 275766</org_study_id>
    <nct_id>NCT04445896</nct_id>
  </id_info>
  <brief_title>The Responses Study</brief_title>
  <official_title>Exploring Patient Responses to Advance Care Planning: A Qualitative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Princess Alice Hospice</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</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 issue Patients who are living with a life-limiting and progressive illness are often&#xD;
      encouraged by the healthcare professionals looking after them to undergo a process called&#xD;
      Advance Care Planning (ACP). An advance care plan is a written guide of a patient's likes,&#xD;
      dislikes, wishes, and the treatments they would want to refuse or the rituals they would want&#xD;
      to follow - whether during illness or at the end of life. The planning process helps patients&#xD;
      and their relatives think about different scenarios, and the plans that would be used by&#xD;
      medical staff if that patient becomes too ill to communicate. ACP discussions can take many&#xD;
      forms and are often described as a process.&#xD;
&#xD;
      It is accepted by healthcare professionals that ACP is useful to patients and their&#xD;
      relatives. Research has also focussed on the positive nature of ACP, traditionally looking at&#xD;
      issues such as how many patients have achieved their wishes and why, what makes ACP possible,&#xD;
      and what prevents patients or healthcare professionals from starting these discussions. Some&#xD;
      research has also looked at how patients experience the actual process of ACP itself.&#xD;
&#xD;
      However, there has been little research into the effect ACP discussions can have on a patient&#xD;
      and their relatives, or how patients react to ACP discussions. As a result, researchers and&#xD;
      healthcare professionals do not have a full understanding of the psychological impact on&#xD;
      patients and their families, and any resulting changes in patients' outlook, emotional state,&#xD;
      family and clinical relationships, and their behaviours.&#xD;
&#xD;
      Learning more about how patients respond to such important and challenging discussions about&#xD;
      their care will be vital in improving healthcare professionals' understanding of how best to&#xD;
      carry out ACP conversations, and how best to support patients and their relatives following&#xD;
      ACP conversations. It is also important to explore not only the benefits of ACP but also the&#xD;
      potential downsides or unexpected problems of having such a difficult conversation.&#xD;
&#xD;
      What the investigators will do The aim of this study is to explore how patients are affected&#xD;
      by discussions about their future care, and if these discussions affect how patients think or&#xD;
      feel in themselves and what they do. The investigators will conduct qualitative interviews&#xD;
      with patients living with a life-limiting illness who have already had ACP discussions with a&#xD;
      healthcare professional, to explore how and in what ways ACP discussions have affected&#xD;
      patients and their families. Qualitative interviews are semi-structured interviews that are&#xD;
      designed to explore issues and what these mean to people in-depth, in order to gather rich&#xD;
      data that provides insight into a person's perspectives. They are well suited to exploring&#xD;
      subjects about which little is yet known, and also subjects which can be sensitive or&#xD;
      challenging.&#xD;
&#xD;
      Location of the study, and participation The study will be conducted from Princess Alice&#xD;
      Hospice in Surrey, which provides both inpatient and community palliative care services to a&#xD;
      large catchment population of approximately 1 million people, in South West London and&#xD;
      Surrey.&#xD;
&#xD;
      The investigators aim to recruit 20 participants to represent a broad range of clinical and&#xD;
      demographic characteristics, such as age, gender, ethnicity, diagnosis and borough in which&#xD;
      they live, in order to explore the experiences of as diverse a group as possible.&#xD;
      Participants will be interviewed in a place convenient for them, such as in their home or the&#xD;
      Hospice.&#xD;
&#xD;
      Who the investigators are The study will be led by a clinician currently working in&#xD;
      Palliative Care, as part of a Masters in Palliative Care, being undertaken at King's College&#xD;
      London. The researcher will be supervised at all times by Dr. Katherine Bristowe and Dr. Lisa&#xD;
      Brighton, of King's College London, who possess many years of experience in undertaking&#xD;
      research among patients living with and dying from advanced disease, and their families.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2022</start_date>
  <completion_date type="Actual">February 28, 2023</completion_date>
  <primary_completion_date type="Actual">October 20, 2022</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Themes emerging from Qualitative Interview</measure>
    <time_frame>Throughout study completion, estimated to be 1 year</time_frame>
    <description>Key themes and concepts that emerge from multiple participants qualitative interviews that describe their experiences</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Advance Care Planning</condition>
  <arm_group>
    <arm_group_label>Study Participants</arm_group_label>
    <description>Patients with a diagnosis of a life-limiting illness who have previosuly had a discussion with a healthcare professional about the care they would want at the end of life</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Qualitative Interview</intervention_name>
    <description>Qualitative Interview to explore thoughts and feelings related to previous discussions around care at end of life</description>
    <arm_group_label>Study Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be recruited from Princess Alice Hospice. Princess Alice is a large Hospice&#xD;
        in Surrey which provides inpatient, day services and community services to 9 boroughs in&#xD;
        South London, Surrey and Middlesex, with a catchment population of approximately 1 million&#xD;
        people. Community home visit and outpatient services are provided by a Consultant led,&#xD;
        multi-disciplinary team, and provide care to approximately 850 patients at any one time.&#xD;
        Princess Alice has a 20 bedded Palliative Medicine inpatient unit and accepts referrals for&#xD;
        symptom control and terminal care admissions, with a typical length of stay of 7-10 days.&#xD;
&#xD;
        Patients are referred to Princess Alice Hospice for Specialist Palliative Care if they have&#xD;
        a diagnosis of a life-limiting or life-threatening disease. Princess Alice Hospice provides&#xD;
        holistic palliative care that is aimed to provide physical, psychological, spiritual and&#xD;
        social support.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18 and over&#xD;
&#xD;
          2. A palliative care diagnosis confirmed by a referring healthcare professional, i.e. a&#xD;
             diagnosis of a life-threatening or life-limiting illness&#xD;
&#xD;
          3. Have completed one or multiple ACP discussions as defined below, at any time prior to&#xD;
             referral to study, with a healthcare professional&#xD;
&#xD;
          4. Sufficient cognitive capacity to provide informed consent and complete an interview&#xD;
&#xD;
        For the purposes of recruitment for this study, ACP is defined as:&#xD;
&#xD;
        Any significant discussion with a healthcare professional where patients have discussed&#xD;
        their values, goals or preferences for future care. These can include discussions about&#xD;
        wishes for further disease-modifying treatment, wishes for intensity of general medical&#xD;
        care, preferred places of care and death, discussions around resuscitation and transfer to&#xD;
        hospital, and completion of advanced directives. Healthcare professionals can include any&#xD;
        doctor, nurse or allied health professional.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any patient the researcher has ever met or cared for in a clinical capacity, or knows&#xD;
             in any other capacity&#xD;
&#xD;
          2. Any patient who has only had ACP discussions with a volunteer (trained or untrained)&#xD;
             or non-healthcare professional&#xD;
&#xD;
          3. Inability to provide informed consent&#xD;
&#xD;
          4. Any patient deemed by the referring healthcare professional to be potentially too&#xD;
             unwell or frail to undertake an interview&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine Bristowe, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Alice Hospice</name>
      <address>
        <city>Esher</city>
        <state>Surrey</state>
        <zip>KT10 8NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>March 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04445896
org study id: IRAS: 275766
nct id: NCT04445896
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The issue Patients who are living with a life-limiting and progressive illness are often
      encouraged by the healthcare professionals looking after them to undergo a process called
      Advance Care Planning (ACP). An advance care plan is a written guide of a patient's likes,
      dislikes, wishes, and the treatments they would want to refuse or the rituals they would want
      to follow - whether during illness or at the end of life. The planning process helps patients
      and their relatives think about different scenarios, and the plans that would be used by
      medical staff if that patient becomes too ill to communicate. ACP discussions can take many
      forms and are often described as a process.

      It is accepted by healthcare professionals that ACP is useful to patients and their
      relatives. Research has also focussed on the positive nature of ACP, traditionally looking at
      issues such as how many patients have achieved their wishes and why, what makes ACP possible,
      and what prevents patients or healthcare professionals from starting these discussions. Some
      research has also looked at how patients experience the actual process of ACP itself.

      However, there has been little research into the effect ACP discussions can have on a patient
      and their relatives, or how patients react to ACP discussions. As a result, researchers and
      healthcare professionals do not have a full understanding of the psychological impact on
      patients and their families, and any resulting changes in patients' outlook, emotional state,
      family and clinical relationships, and their behaviours.

      Learning more about how patients respond to such important and challenging discussions about
      their care will be vital in improving healthcare professionals' understanding of how best to
      carry out ACP conversations, and how best to support patients and their relatives following
      ACP conversations. It is also important to explore not only the benefits of ACP but also the
      potential downsides or unexpected problems of having such a difficult conversation.

      What the investigators will do The aim of this study is to explore how patients are affected
      by discussions about their future care, and if these discussions affect how patients think or
      feel in themselves and what they do. The investigators will conduct qualitative interviews
      with patients living with a life-limiting illness who have already had ACP discussions with a
      healthcare professional, to explore how and in what ways ACP discussions have affected
      patients and their families. Qualitative interviews are semi-structured interviews that are
      designed to explore issues and what these mean to people in-depth, in order to gather rich
      data that provides insight into a person's perspectives. They are well suited to exploring
      subjects about which little is yet known, and also subjects which can be sensitive or
      challenging.

      Location of the study, and participation The study will be conducted from Princess Alice
      Hospice in Surrey, which provides both inpatient and community palliative care services to a
      large catchment population of approximately 1 million people, in South West London and
      Surrey.

      The investigators aim to recruit 20 participants to represent a broad range of clinical and
      demographic characteristics, such as age, gender, ethnicity, diagnosis and borough in which
      they live, in order to explore the experiences of as diverse a group as possible.
      Participants will be interviewed in a place convenient for them, such as in their home or the
      Hospice.

      Who the investigators are The study will be led by a clinician currently working in
      Palliative Care, as part of a Masters in Palliative Care, being undertaken at King's College
      London. The researcher will be supervised at all times by Dr. Katherine Bristowe and Dr. Lisa
      Brighton, of King's College London, who possess many years of experience in undertaking
      research among patients living with and dying from advanced disease, and their families.
observational model: Other
time perspective: Retrospective
measure: Themes emerging from Qualitative Interview
time frame: Throughout study completion, estimated to be 1 year
description: Key themes and concepts that emerge from multiple participants qualitative interviews that describe their experiences
arm group label: Study Participants
description: Patients with a diagnosis of a life-limiting illness who have previosuly had a discussion with a healthcare professional about the care they would want at the end of life
intervention type: Other
intervention name: Qualitative Interview
description: Qualitative Interview to explore thoughts and feelings related to previous discussions around care at end of life
arm group label: Study Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katherine Bristowe, PhD
role: Principal Investigator
affiliation: King's College London
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No