<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/NCT02211287</url>
  </required_header>
  <id_info>
    <org_study_id>B14/25</org_study_id>
    <nct_id>NCT02211287</nct_id>
  </id_info>
  <brief_title>Promoting Informed Decision Making Through Advance Care Planning</brief_title>
  <official_title>Promoting Informed Decision Making and Effective Communication Through Advance Care Planning for People With Dementia and Their Family Carers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University, Belfast</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Four Seasons Health Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen's University, Belfast</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the application of a best-practice Advance Care&#xD;
      Planning (ACP) model for individuals living with dementia in a sample of nursing homes in&#xD;
      Northern Ireland&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Level of family carer satisfaction in decision making about the care of the resident</measure>
    <time_frame>Baseline, up to 2 months</time_frame>
    <description>Decisional Conflict Scale (DCS). This measures uncertainty and difficulties in the decision making process. The 16 item version measures four domains: a) uncertainty in choosing options; b) unsupported in decision making; c) feeling informed; d) decision is consistent with values</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The level of family carer satisfaction with nursing home care</measure>
    <time_frame>Baseline up to 2 months</time_frame>
    <description>The Family Perception of Care Scale (FPCS). This instrument will represent a global measure on the quality of nursing home care. It is comprised of four subscales: 1) resident care, 2) family support, 3) communication, and 4) rooming. One can investigate both the total and the subscale scores. Family members will also be asked to identify three of the 25 items in the instrument as the highest priorities for providing quality care in the nursing home. Respondents will also be invited to include written comments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of family carer anxiety and depression</measure>
    <time_frame>Baseline up to 2 months</time_frame>
    <description>General Health Questionnaire (GHQ-12). This 12-item instrument is a self-report measure of psychological morbidity. It is widely used in clinical practice, epidemiological research and for research in psychology. The GHQ-12 is often used to assess general distress. It is designed to cover four identifiable elements of distress: anxiety, depression, social impairment, and hypochondriasis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The comfort of the resident at the end of life</measure>
    <time_frame>Baseline up to 2 months</time_frame>
    <description>Quality of Dying in Long Term Care (QoDLTC). This instrument is a retrospective scale representing psychosocial aspects of quality of dying. The questionnaire contains 11 items with three subscales: personhood (5 items), closure (3 items) and preparatory tasks (3 items). Factor scores (means of item scores within each factor) may be averaged for an overall quality of dying score (range 1 - 5), with a higher score indicating a more positive experience. Individual factor scores may also be used separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of unnecessary hospitalisations</measure>
    <time_frame>Baseline up to 12 months</time_frame>
    <description>Assessed through the facility care home administrative records</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">420</enrollment>
  <condition>Dementia</condition>
  <condition>Neurodegenerative Diseases</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will include five key elements: a Project Nurse - ACP facilitator; family education on comfort care at the end of life for individuals with dementia using the 'Comfort Care at the end of life for persons with dementia' booklet; a family meeting with follow-up telephone call; documentation of ACP decisions, and orientation and education directed towards General Practitioners (GPs) and nursing home staff about the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Care will continue as usual for the nursing home residents</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>'Comfort Care at the End of Life for Persons with Dementia'</intervention_name>
    <description>A guide for caregivers to provide information on the trajectory of the disease, clinical issues, decision-making processes, and symptom management. The guide is written in a Q&amp;A form and can help answer frequent family questions.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Project Nurse - ACP Facilitator</intervention_name>
    <description>A nurse will receive training in the 'Respecting Choices Facilitator Curriculum' - an online program consisting of a series of six critical thinking modules designed for healthcare professionals who want to enhance their ACP facilitation skills. Local training resources in Northern Ireland will supplement.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Family Caregivers&#xD;
&#xD;
               -  Family caregivers of a resident who does not have decision making capacity to&#xD;
                  participate in ACP discussion&#xD;
&#xD;
               -  Individuals identified by the nursing home manager as the family member who&#xD;
                  possess power of attorney for personal care and/or viewed by the nursing home&#xD;
                  staff as most involved in the care of the resident who does not have decision&#xD;
                  making capacity.&#xD;
&#xD;
          2. Health Care Professionals&#xD;
&#xD;
        Nursing home managers, registered nursing staff and GPs who:&#xD;
&#xD;
          -  are employed, or in the case of GPs, care for residents, in the six nursing homes that&#xD;
             were part of the intervention group&#xD;
&#xD;
          -  were familiar with the intervention to discuss its strengths and weaknesses in an&#xD;
             interview&#xD;
&#xD;
          -  are able to speak English as they are required to participate in interviews.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Family caregivers and health care professionals who are unable to communicate through&#xD;
             written and spoken English.&#xD;
&#xD;
          -  Family caregivers who has a family resident considered to have the ability to&#xD;
             participate in ACP discussions.&#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>Kevin Brazil, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's University, Belfast</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kevin Brazil, PhD</last_name>
    <phone>0044 289097</phone>
    <phone_ext>5782</phone_ext>
    <email>k.brazil@qub.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Four Seasons Health Care -- Nursing Homes</name>
      <address>
        <city>Belfast</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Jim McCall</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 6, 2014</last_update_submitted>
  <last_update_submitted_qc>August 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University, Belfast</investigator_affiliation>
    <investigator_full_name>Kevin Brazil</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Dementia</keyword>
  <keyword>Decision-making</keyword>
  <keyword>Communication</keyword>
  <keyword>Advance Care Planning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Neurodegenerative Diseases</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>April 4, 2017</submitted>
    <returned>June 16, 2017</returned>
    <submitted>July 4, 2019</submitted>
    <returned>August 14, 2019</returned>
    <submitted>February 20, 2020</submitted>
    <returned>March 13, 2020</returned>
  </pending_results>
  <!-- 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/NCT02211287
org study id: B14/25
nct id: NCT02211287
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the application of a best-practice Advance Care
      Planning (ACP) model for individuals living with dementia in a sample of nursing homes in
      Northern Ireland
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
measure: Level of family carer satisfaction in decision making about the care of the resident
time frame: Baseline, up to 2 months
description: Decisional Conflict Scale (DCS). This measures uncertainty and difficulties in the decision making process. The 16 item version measures four domains: a) uncertainty in choosing options; b) unsupported in decision making; c) feeling informed; d) decision is consistent with values
measure: The level of family carer satisfaction with nursing home care
time frame: Baseline up to 2 months
description: The Family Perception of Care Scale (FPCS). This instrument will represent a global measure on the quality of nursing home care. It is comprised of four subscales: 1) resident care, 2) family support, 3) communication, and 4) rooming. One can investigate both the total and the subscale scores. Family members will also be asked to identify three of the 25 items in the instrument as the highest priorities for providing quality care in the nursing home. Respondents will also be invited to include written comments.
measure: Level of family carer anxiety and depression
time frame: Baseline up to 2 months
description: General Health Questionnaire (GHQ-12). This 12-item instrument is a self-report measure of psychological morbidity. It is widely used in clinical practice, epidemiological research and for research in psychology. The GHQ-12 is often used to assess general distress. It is designed to cover four identifiable elements of distress: anxiety, depression, social impairment, and hypochondriasis.
measure: The comfort of the resident at the end of life
time frame: Baseline up to 2 months
description: Quality of Dying in Long Term Care (QoDLTC). This instrument is a retrospective scale representing psychosocial aspects of quality of dying. The questionnaire contains 11 items with three subscales: personhood (5 items), closure (3 items) and preparatory tasks (3 items). Factor scores (means of item scores within each factor) may be averaged for an overall quality of dying score (range 1 - 5), with a higher score indicating a more positive experience. Individual factor scores may also be used separately.
measure: Number of unnecessary hospitalisations
time frame: Baseline up to 12 months
description: Assessed through the facility care home administrative records
arm group label: Intervention
arm group type: Experimental
description: The intervention will include five key elements: a Project Nurse - ACP facilitator; family education on comfort care at the end of life for individuals with dementia using the 'Comfort Care at the end of life for persons with dementia' booklet; a family meeting with follow-up telephone call; documentation of ACP decisions, and orientation and education directed towards General Practitioners (GPs) and nursing home staff about the intervention.
arm group label: Usual care
arm group type: No Intervention
description: Care will continue as usual for the nursing home residents
intervention type: Other
intervention name: 'Comfort Care at the End of Life for Persons with Dementia'
description: A guide for caregivers to provide information on the trajectory of the disease, clinical issues, decision-making processes, and symptom management. The guide is written in a Q&A form and can help answer frequent family questions.
arm group label: Intervention
intervention type: Other
intervention name: Project Nurse - ACP Facilitator
description: A nurse will receive training in the 'Respecting Choices Facilitator Curriculum' - an online program consisting of a series of six critical thinking modules designed for healthcare professionals who want to enhance their ACP facilitation skills. Local training resources in Northern Ireland will supplement.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin Brazil, PhD
role: Principal Investigator
affiliation: Queen's University, Belfast
last name: Kevin Brazil, PhD
phone: 0044 289097
phone ext: 5782
email: k.brazil@qub.ac.uk
facility: 
contact: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Queen's University, Belfast
investigator full name: Kevin Brazil
investigator title: Professor
mesh term: Dementia
mesh term: Neurodegenerative Diseases
submitted: April 4, 2017
returned: June 16, 2017
submitted: July 4, 2019
returned: August 14, 2019
submitted: February 20, 2020
returned: March 13, 2020