<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/NCT03267706</url>
  </required_header>
  <id_info>
    <org_study_id>PaCCT</org_study_id>
    <nct_id>NCT03267706</nct_id>
  </id_info>
  <brief_title>Introducing the Palliative Care Comprehensive Tool in Family Medicine</brief_title>
  <official_title>Introducing the Comprehensive Palliative Care Tool in Family Medicine : A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</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 purpose of this study is to pilot the introduction of a newly developed palliative care&#xD;
      tool to clinicians in a family health team. The intent of the tool is to improve the quality&#xD;
      and comprehensiveness of palliative care, which effects caregiver and patient satisfaction&#xD;
      with care received, as well as clinician satisfaction with their delivery of care. Tool&#xD;
      effectiveness will be evaluated by measuring satisfaction scores of caregivers, patients and&#xD;
      clinicians who receive training and access to the tool compared to caregivers, patients and&#xD;
      clinicians providing usual care (without the tool). Uptake of the tool and user feedback will&#xD;
      be collected&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A newly developed tool to guide clinicians in best palliative care practices was developed&#xD;
      based on a combination of published tools and consultation with primary care, end users&#xD;
      (clinicians). The tool will be introduced as a pilot to clinicians who will receive training&#xD;
      on use of the tool and access to the tool within a family health team in Ontario, Canada. The&#xD;
      tool will be applied in a controlled study environment that randomly assigns clinicians to&#xD;
      one of two groups. One group will receive training and access to the tool and the other group&#xD;
      of clinicians will continue to provide usual care.The tool will be evaluated based on&#xD;
      validated satisfaction surveys completed by caregivers, patients and clinicians. Satisfaction&#xD;
      scores of those randomly assigned to care enhanced by the tool will be compared to those&#xD;
      receiving usual care at the beginning and end of the study. Uptake of the tool will be&#xD;
      measured, as well as user experience with the tool (feasibility and acceptability)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</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>
    <intervention_model_description>Pilot prospective randomized controlled trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients and caregivers are blinded as to whether their clinician received training and access to the newly introduced comprehensive palliative care tool. Clinicians delivering care are not blinded to use of the tool, outcome assessors are not blinded to the data</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Caregiver satisfaction</measure>
    <time_frame>3 months</time_frame>
    <description>FAMCARE-2 survey to measure caregiver satisfaction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>3 months</time_frame>
    <description>FAMCARE-P13</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician satisfaction</measure>
    <time_frame>3 months</time_frame>
    <description>Physician Satisfaction with Aspects of Chronic Care (modified)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User feedback</measure>
    <time_frame>3 months</time_frame>
    <description>Acceptability and feasibility of the Palliative Care Comprehensive Tool will be sought using the Clinical Sensibility Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uptake of tool</measure>
    <time_frame>3 month</time_frame>
    <description>Tool implementation will be (rate of tool uptake by clinician)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">149</enrollment>
  <condition>Palliative Care</condition>
  <condition>Primary Care</condition>
  <condition>Satisfaction</condition>
  <arm_group>
    <arm_group_label>Palliative Care Comprehensive Tool</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Clinicians within the study will be randomly assigned and trained on the use of the Palliative Care Comprehensive Tool</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Clinicians within the study will be randomly assigned to usual palliative care (without the newly introduced tool)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Palliative Care Comprehensive Tool</intervention_name>
    <description>Clinicians assigned to the newly developed Palliative Care Comprehensive Tool will be trained during a 1 hour period on the application of the tool; Including rationale for tool development, objective of the tool and demonstration of the tool in action</description>
    <arm_group_label>Palliative Care Comprehensive Tool</arm_group_label>
    <other_name>PaCCT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusive sample of all clinicians employed at Stonechurch Family Health Centre&#xD;
&#xD;
          -  Inclusive sample of all patients over 18 years of age, registered as palliative within&#xD;
             Stonechurch Family Health Centre and who are English speaking&#xD;
&#xD;
        Exclusion Criteria: Patients younger than 18 years of age, patients who are non-English&#xD;
        speaking&#xD;
&#xD;
        -&#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>Ainsley Moore, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Family Medicine McMaster University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sarah Xu, MD</last_name>
    <phone>9055751300</phone>
    <email>sarah.xu@medportal.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amanpaul Bhamber, MD</last_name>
    <phone>9055751300</phone>
    <email>amanpaul.bhamber@medportal.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stonechurch Family Health Centre, Department of Family Medicine McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8W3J6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Sarah Xu, MD</last_name>
      <phone>9055751300</phone>
      <email>sarah.xu@medportal.ca</email>
    </contact>
    <contact_backup>
      <last_name>Amanpaul Bhamber, MD</last_name>
      <phone>9055751300</phone>
      <email>amanpaul.bhamber@medportal.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Ainsley Moore, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sarah Xu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amanpaul Bhamber, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amanda Ramdyal, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Ainsley Moore</investigator_full_name>
    <investigator_title>Associate Professor of Family Medicine</investigator_title>
  </responsible_party>
  <keyword>Primary care</keyword>
  <keyword>Palliative care</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share data. Data will be stored on secured facility servers.</ipd_description>
  </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/NCT03267706
org study id: PaCCT
nct id: NCT03267706
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to pilot the introduction of a newly developed palliative care
      tool to clinicians in a family health team. The intent of the tool is to improve the quality
      and comprehensiveness of palliative care, which effects caregiver and patient satisfaction
      with care received, as well as clinician satisfaction with their delivery of care. Tool
      effectiveness will be evaluated by measuring satisfaction scores of caregivers, patients and
      clinicians who receive training and access to the tool compared to caregivers, patients and
      clinicians providing usual care (without the tool). Uptake of the tool and user feedback will
      be collected
A newly developed tool to guide clinicians in best palliative care practices was developed
      based on a combination of published tools and consultation with primary care, end users
      (clinicians). The tool will be introduced as a pilot to clinicians who will receive training
      on use of the tool and access to the tool within a family health team in Ontario, Canada. The
      tool will be applied in a controlled study environment that randomly assigns clinicians to
      one of two groups. One group will receive training and access to the tool and the other group
      of clinicians will continue to provide usual care.The tool will be evaluated based on
      validated satisfaction surveys completed by caregivers, patients and clinicians. Satisfaction
      scores of those randomly assigned to care enhanced by the tool will be compared to those
      receiving usual care at the beginning and end of the study. Uptake of the tool will be
      measured, as well as user experience with the tool (feasibility and acceptability)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pilot prospective randomized controlled trial
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Patients and caregivers are blinded as to whether their clinician received training and access to the newly introduced comprehensive palliative care tool. Clinicians delivering care are not blinded to use of the tool, outcome assessors are not blinded to the data
measure: Caregiver satisfaction
time frame: 3 months
description: FAMCARE-2 survey to measure caregiver satisfaction
measure: Patient satisfaction
time frame: 3 months
description: FAMCARE-P13
measure: Clinician satisfaction
time frame: 3 months
description: Physician Satisfaction with Aspects of Chronic Care (modified)
measure: User feedback
time frame: 3 months
description: Acceptability and feasibility of the Palliative Care Comprehensive Tool will be sought using the Clinical Sensibility Questionnaire
measure: Uptake of tool
time frame: 3 month
description: Tool implementation will be (rate of tool uptake by clinician)
arm group label: Palliative Care Comprehensive Tool
arm group type: Active Comparator
description: Clinicians within the study will be randomly assigned and trained on the use of the Palliative Care Comprehensive Tool
arm group label: Usual Care
arm group type: No Intervention
description: Clinicians within the study will be randomly assigned to usual palliative care (without the newly introduced tool)
intervention type: Other
intervention name: Palliative Care Comprehensive Tool
description: Clinicians assigned to the newly developed Palliative Care Comprehensive Tool will be trained during a 1 hour period on the application of the tool; Including rationale for tool development, objective of the tool and demonstration of the tool in action
arm group label: Palliative Care Comprehensive Tool
other name: PaCCT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ainsley Moore, MD
role: Principal Investigator
affiliation: Department of Family Medicine McMaster University
last name: Sarah Xu, MD
phone: 9055751300
email: sarah.xu@medportal.ca
last name: Amanpaul Bhamber, MD
phone: 9055751300
email: amanpaul.bhamber@medportal.ca
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Ainsley Moore
investigator title: Associate Professor of Family Medicine
sharing ipd: No
ipd description: No plan to share data. Data will be stored on secured facility servers.