<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/NCT02244359</url>
  </required_header>
  <id_info>
    <org_study_id>CORE 2013-56</org_study_id>
    <nct_id>NCT02244359</nct_id>
  </id_info>
  <brief_title>Improving Decision Making On Location of Care With the Frail Elderly and Their Caregivers</brief_title>
  <acronym>DOLCE</acronym>
  <official_title>Improving the Decision Making Process About Location of Care With the Frail Elderly and Their Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Quebec-Universite Laval</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TVN 2013 Core Research Grant Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministere de la Sante et des Services Sociaux</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health and Social Services Agency, Montreal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CHU de Quebec-Universite Laval</source>
  <brief_summary>
    <textblock>
      One of the toughest decisions faced by the frail elderly in Canada is whether to stay at home&#xD;
      or move to a care facility. It is certainly difficult to make this decision alone, but can be&#xD;
      even harder if someone else makes it for you. Shared decision making is when, instead of&#xD;
      making decisions for the patient, healthcare professionals share information about what the&#xD;
      evidence says, and they talk about what's important with the patient, and then make the&#xD;
      decision together. In the case of the frail elderly in home care services, there are many&#xD;
      health care professionals involved, e.g. the doctor, nurse and social worker. In this case&#xD;
      decisions should be shared by all the professionals involved with the elderly person along&#xD;
      with his or her caregivers. Unfortunately, in this context, shared decision making rarely&#xD;
      occurs.&#xD;
&#xD;
      We have designed a training program that teaches interprofessional teams how to share&#xD;
      decisions with their frail elderly patients, and tested it in one Quebec City and one&#xD;
      Edmonton home care team. This project tests the training program on a broader scale with 16&#xD;
      home care teams attached to community health centres across the province of Quebec, and will&#xD;
      compare the results with what happens when no one has completed the training (usual care).&#xD;
      Home care is a rapidly growing sector and this study will lay the foundations for a national&#xD;
      strategy to ensure that no one has to make this difficult decision alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The assumed role in the decision making process, and the preferred and chosen options.</measure>
    <time_frame>3 to 6 months</time_frame>
    <description>We will use the modified version of the Control Preferences Scale designed to assess the assumed role in the decision making process reported by the client.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">455</enrollment>
  <condition>Decision Process About the Location of Care Among Frail Elderly</condition>
  <arm_group>
    <arm_group_label>Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Online tutorial, decision aid and interactive workshop</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training</intervention_name>
    <arm_group_label>Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Receiving care from the home care team&#xD;
&#xD;
          -  Faced the decision about whether to stay at home or move to a care facility in the&#xD;
             previous 3 to 6 months&#xD;
&#xD;
          -  Able to read, understand and write french or english&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  For the case of clients unable to provide informed consent, their caregivers who was&#xD;
             involved into decision making process will be eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clients who cannot provide informed consent (e. g. clients with cognitive impairment)&#xD;
             without a caregiver&#xD;
&#xD;
          -  Clients who require acute care hospitalization and whom the location of care decision&#xD;
             is transferred to hospital-based social services&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>France Légaré, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHUQ Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Québec</name>
      <address>
        <city>Quebec</city>
        <zip>G1L 3L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>August 24, 2016</last_update_submitted>
  <last_update_submitted_qc>August 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CHU de Quebec-Universite Laval</investigator_affiliation>
    <investigator_full_name>France Legare</investigator_full_name>
    <investigator_title>B. Sc. Arch, MD, PhD, CCMF, FCMF</investigator_title>
  </responsible_party>
  <keyword>Shared Decision making</keyword>
  <keyword>Patient Centred care</keyword>
  <keyword>Interprofessionalism</keyword>
  <keyword>Home care</keyword>
  <keyword>Frail elderly</keyword>
  <!-- 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/NCT02244359
org study id: CORE 2013-56
nct id: NCT02244359
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
One of the toughest decisions faced by the frail elderly in Canada is whether to stay at home
      or move to a care facility. It is certainly difficult to make this decision alone, but can be
      even harder if someone else makes it for you. Shared decision making is when, instead of
      making decisions for the patient, healthcare professionals share information about what the
      evidence says, and they talk about what's important with the patient, and then make the
      decision together. In the case of the frail elderly in home care services, there are many
      health care professionals involved, e.g. the doctor, nurse and social worker. In this case
      decisions should be shared by all the professionals involved with the elderly person along
      with his or her caregivers. Unfortunately, in this context, shared decision making rarely
      occurs.

      We have designed a training program that teaches interprofessional teams how to share
      decisions with their frail elderly patients, and tested it in one Quebec City and one
      Edmonton home care team. This project tests the training program on a broader scale with 16
      home care teams attached to community health centres across the province of Quebec, and will
      compare the results with what happens when no one has completed the training (usual care).
      Home care is a rapidly growing sector and this study will lay the foundations for a national
      strategy to ensure that no one has to make this difficult decision alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: The assumed role in the decision making process, and the preferred and chosen options.
time frame: 3 to 6 months
description: We will use the modified version of the Control Preferences Scale designed to assess the assumed role in the decision making process reported by the client.
arm group label: Training
arm group type: Experimental
description: Online tutorial, decision aid and interactive workshop
arm group label: Usual care
arm group type: Other
description: Usual care
intervention type: Behavioral
intervention name: Training
arm group label: Training
intervention type: Behavioral
intervention name: Usual care
arm group label: Usual care
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: France Légaré, MD, PhD
role: Principal Investigator
affiliation: CHUQ Research Center
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: CHU de Quebec-Universite Laval
investigator full name: France Legare
investigator title: B. Sc. Arch, MD, PhD, CCMF, FCMF