<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/NCT02261935</url>
  </required_header>
  <id_info>
    <org_study_id>TVN-core2013-01 CCSRI-702597</org_study_id>
    <nct_id>NCT02261935</nct_id>
  </id_info>
  <brief_title>Supporting Family Caregivers of Palliative Patients at Home: the Carer Support Needs Assessment Intervention</brief_title>
  <acronym>CSNAT</acronym>
  <official_title>Clustered, Randomized, Controlled Trial of the Home Care Nurse Carer Support Needs Assessment Practice Tool With Family Caregivers of Palliative Patients at Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kelli Stajduhar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Frailty Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Cancer Society (CCS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Victoria</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this project the investigators will train home care nurses to use the Carer Support Needs&#xD;
      Assessment Tool (CSNAT) with a group of family caregivers (intervention group) and then&#xD;
      compare the family caregivers' quality of life, burden and other outcomes to a group of&#xD;
      family caregivers whose home care nurse is not using the CSNAT (control group). Findings will&#xD;
      allow us to determine the effectiveness of using the CSNAT as a tool to identify, monitor and&#xD;
      address family caregiver support needs in palliative home care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Caregiving places considerable burdens on family caregivers (FCG). While burden has been&#xD;
      studied as a FCG outcome, it is also a predictor of other outcomes, including FCG quality of&#xD;
      life (QoL). We have adapted a model of caregiver burden to hypothesize the various mechanisms&#xD;
      by which addressing support needs may contribute to FCG QoL. In this model, support needs are&#xD;
      closely associated with FCGs' perceived social support and preparedness for caregiving. These&#xD;
      variables operate as (partial) mediators of the relationships between primary stressors,&#xD;
      including patient functional dependence and symptom distress, and secondary appraisals, such&#xD;
      as the perceived burden associated with caregiving, which, in turn influences FCGs QoL. The&#xD;
      model further posits that FCGs' primary appraisal of patient caregiving needs (e.g., amount&#xD;
      of care provided) is influenced by the functional dependence and symptom distress of the&#xD;
      patient, and in turn influences perceived support, preparedness for caregiving, FCG burden,&#xD;
      and, ultimately, FCG QoL. These variables are associated with a variety of demographic and&#xD;
      health-related characteristics of the caregiver and patient.&#xD;
&#xD;
      Within the context of this conceptual framework outlined above, the CSNAT intervention is&#xD;
      viewed as a mediator of the relationships between primary stressors and appraisals and FCG&#xD;
      QoL (primary outcome). Also, the CSNAT intervention would lead to enhanced social support,&#xD;
      preparedness, and reduced caregiver burden.&#xD;
&#xD;
      A clustered randomized control trial (RCT) design will be used to ascertain the effectiveness&#xD;
      of the CSNAT as an intervention to improve the QoL of FCGs of patients receiving palliative&#xD;
      care at home. Participating home care nurses will be randomized to one of two comparator&#xD;
      groups (usual care and intervention) and the FCGs of their patients will be assigned to the&#xD;
      corresponding comparator group. Data will additionally be collected over the same time frame&#xD;
      and in the same manner from a non-randomized comparison usual care comparator group from a&#xD;
      separate home care site where no nurses will be delivering the intervention, to help&#xD;
      interpret the results (e.g., to determine the extent to which contamination may be have&#xD;
      occurred). Update - August 31, 2015 - Due to low recruitment the non-randomized, comparison,&#xD;
      usual care, comparator group has been discontinued.&#xD;
&#xD;
      Update - December 22, 2016 - Due to home care workloads of participant nurses and home care&#xD;
      visit schedules in some participating home care offices, delivery of the intervention will be&#xD;
      done by a dedicated study nurse (in some offices only). In these offices, family caregivers&#xD;
      will continue to be assigned based on the randomized group assignment of their home care&#xD;
      nurse. The dedicated study nurse will meet separately with FCGs who are in the intervention&#xD;
      group to deliver the CSNAT intervention. Information arising from the CSNAT about family&#xD;
      caregivers' support needs will be communicated by the study nurse to the home care nurse so&#xD;
      that the home care nurse can incorporate this into the home care plan for the patient and&#xD;
      patient's family. In home care offices that are not part of this change in procedures, the&#xD;
      home care nurses in the intervention group will continue to deliver the CSNAT intervention&#xD;
      during home care visits as before.&#xD;
&#xD;
      Our specific hypotheses are as follows:&#xD;
&#xD;
        -  Hypothesis 1: The use of the CSNAT as a practice support tool intervention will lead to&#xD;
           improved FCG QoL during the time prior to the patients' death and in bereavement.&#xD;
&#xD;
        -  Hypothesis 2: The use of the CSNAT as a practice support tool intervention will&#xD;
           contribute to the following secondary outcomes in FCGs during the time prior to the&#xD;
           patient's death: enhanced perceived social support, improved preparedness to provide&#xD;
           care and reduced caregiving burden.&#xD;
&#xD;
        -  Hypothesis 3: CSNAT use during home care of patient before death will reduce grief&#xD;
           symptoms during bereavement, among FCGs.&#xD;
&#xD;
      In addition to the RCT, qualitative and quantitative research will be conducted to understand&#xD;
      the process related to implementing the CSNAT intervention in palliative home care and to&#xD;
      explain the treatment results. We will specifically address the following questions:&#xD;
&#xD;
        -  How are the CSNAT support needs being documented and met by home care nurses?&#xD;
&#xD;
        -  How do home care nurses experience the use of the CSNAT in their daily practice?&#xD;
&#xD;
        -  How comfortable are FCGs speaking to home care nurses about their own personal needs?&#xD;
&#xD;
        -  To what extent are the relationships in the hypothesized conceptual framework supported?&#xD;
&#xD;
        -  What is the relative importance of different CSNAT support needs with respect to FCG QoL&#xD;
           and health during the illness trajectory, and the presence of post-bereavement grief&#xD;
           symptoms?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">December 20, 2017</completion_date>
  <primary_completion_date type="Actual">December 20, 2017</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>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Trajectory of change in family caregiver quality of life while caring for a palliative patient at home, as measured by the Quality of Life in Life Threatening Illness - Family carer version (QOLLTI-F) total score</measure>
    <time_frame>Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)</time_frame>
    <description>The QOLLTI-F is a self-report measure of family caregiver quality of life. It is composed of 16 items which assess the following 7 domains: state of carer, patient well-being, quality of care, outlook, environment, finances and relationships. Additional exploratory analyses will also be conducted on these subscales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Family caregiver grief symptoms after patient death, as measured by the Texas Revised Inventory of Grief (TRIG) subscale scores</measure>
    <time_frame>12 weeks after patient death (will not be collected if patient death does not occur within the first 92 weeks of the study)</time_frame>
    <description>The TRIG is a 21 item scale designed to assess grief symptoms. It relates to two points of time: past (immediate of shortly after the death) and present (the time of data collection). The 2 subscales measure a) feelings and actions at the time of the death and b) present feelings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Family caregiver quality of life after patient death, as measured by the Quality of Life in Life Threatening Illness - Family carer version Global Single-Item Scale (QOLLTI-F SIS)</measure>
    <time_frame>12 weeks after patient death</time_frame>
    <description>The QOLLTI-F is a self-report measure of family caregiver quality of life. We will be using the score from the single item score measuring global quality of life (Part A).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trajectory of change in family caregiver burden while caring for a palliative patient at home, as measured by the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Scale</measure>
    <time_frame>Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)</time_frame>
    <description>A 25 item measure of family caregiver's positive and negative appraisals of caregiving, including strain, positive appraisals, distress, and family wellbeing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trajectory of change in family caregiver preparedness for caregiving while caring for a palliative patient at home, as measured by the Family Caregiving Inventory: Preparedness Scale</measure>
    <time_frame>Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)</time_frame>
    <description>A caregiver self-rated instrument that consists of 8 items that asks caregivers how well prepared they believe they are for multiple domains of caregiving. Preparedness is defined as perceived readiness for multiple domains of the caregiving role such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of caregiving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trajectory of change in family caregiver perceived social supports while caring for a palliative patient at home, as measured by the Medical Outcome Survey (MOS) Social Support Survey</measure>
    <time_frame>Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)</time_frame>
    <description>Overall Support Index determined using the mean from 18 items within four sub-measures and the mean from the additional item; (a) emotional/information support, (b) tangible support, (c) affectionate support, and (d) positive social interaction support. Designed to assess the perceived availability of social support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trajectory of change in family caregiver health status and mental health status while caring for a palliative patient at home, as measured by the Veterans RAND 12 item health survey</measure>
    <time_frame>Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)</time_frame>
    <description>A 14 item scale, 12 of which are a sampling of items from each of the eight domains of health (physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and mental health). The eight scales are summarized into two summary scores, physical (PCS) and mental (MCS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trajectory of change in family caregiver satisfaction with healthcare provided while caring for a palliative patient at home until death, as measured by the Canadian Health Care Evaluation Project - Caregiver Questionnaire (CANHELP LITE)</measure>
    <time_frame>Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first), 12 weeks after patient death (will not be collected if patient death does not occur within the first 92 weeks of the study)</time_frame>
    <description>Overall score calculated as the unweighted average of all 21 items (22 for the bereavement version which will be used after patient death) answered. A tool to evaluate satisfaction with care for family members of older patients with life threatening illnesses up to and until death.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Family Caregiving for a Palliative Patient</condition>
  <arm_group>
    <arm_group_label>Existing Home Care Nursing Practice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Home care nurses provide care based on existing home care practice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Practice Support Tool Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The practice support tool intervention will be the routine use of the Carer Support Needs Assessment Tool (CSNAT) in the practice of home care nurses (once every 4 weeks with each family caregiver) to document, monitor and address family caregiver support needs.&#xD;
Update - December 22, 2016 - In some home care offices only, a study nurse will meet with family caregivers who are in the intervention group to deliver the CSNAT intervention. Information arising from the CSNAT about family caregivers' support needs will be communicated by the study nurse to the home care nurse, and incorporated by the home care nurse into the home care plan for the patient and patient's family.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Existing home care nursing practice</intervention_name>
    <description>Home care nurses in this comparator group will provide &quot;care as per usual&quot; to their patients and family caregivers. The family is seen as the unit of care but no formal assessment of the caregiver will be done.</description>
    <arm_group_label>Existing Home Care Nursing Practice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Practice support tool intervention</intervention_name>
    <description>The intervention will be the routine use of the Carer Support Needs Assessment Tool (CSNAT) in the practice of home care nurses (once every 4 weeks with each family caregiver) to document, monitor and address family caregiver support needs.&#xD;
The completed CSNAT tool will be kept in the patient chart and will be integrated into the care provided by the nurse.&#xD;
Update - December 22, 2016 - In some offices only, the CSNAT will be administered by a separate study nurse. Findings will be communicated to the home care nurse to inform the documenting, monitoring and addressing of family caregiver support needs.</description>
    <arm_group_label>Practice Support Tool Intervention</arm_group_label>
    <other_name>CSNAT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For home care nurse participants:&#xD;
&#xD;
          -  registered or licensed home care nurse at one of the following Vancouver Island Health&#xD;
             Authority Home and Community Care offices: Victoria, Esquimalt/Westshore, Peninsula,&#xD;
             Royal Oak, Duncan/Ladysmith, Oceanside, Comox Valley, Campbell River&#xD;
&#xD;
          -  practiced in home care for &gt; 6 months&#xD;
&#xD;
          -  work a minimum of 10 shifts per month&#xD;
&#xD;
          -  communicate well in English&#xD;
&#xD;
        For family caregiver participants:&#xD;
&#xD;
          -  currently a family caregiver of palliative patient at home&#xD;
&#xD;
          -  patient and family caregiver must be 18 years of age or older&#xD;
&#xD;
          -  must communicate well in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For family caregiver participants&#xD;
&#xD;
          -  diagnosed cognitive impairment&#xD;
&#xD;
          -  identified safety risks in the home care environment&#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>Kelli I Stajduhar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Victoria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard G Sawatzky, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Trinity Western University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vancouver Island Health Home and Community Care</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8T 3P7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>March 16, 2018</last_update_submitted>
  <last_update_submitted_qc>March 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Victoria</investigator_affiliation>
    <investigator_full_name>Kelli Stajduhar</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Family caregiver</keyword>
  <keyword>Home care nursing practice</keyword>
  <keyword>Palliative care</keyword>
  <keyword>End of life care</keyword>
  <keyword>Family caregiver quality of life</keyword>
  <keyword>Family caregiver grief symptoms</keyword>
  <keyword>Family caregiver burden</keyword>
  <keyword>Family caregiver preparedness for caregiving</keyword>
  <keyword>Family caregiver perceived social supports</keyword>
  <keyword>Family caregiver health status</keyword>
  <keyword>Family caregiver satisfaction with healthcare provided</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/NCT02261935
org study id: TVN-core2013-01 CCSRI-702597
nct id: NCT02261935
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
In this project the investigators will train home care nurses to use the Carer Support Needs
      Assessment Tool (CSNAT) with a group of family caregivers (intervention group) and then
      compare the family caregivers' quality of life, burden and other outcomes to a group of
      family caregivers whose home care nurse is not using the CSNAT (control group). Findings will
      allow us to determine the effectiveness of using the CSNAT as a tool to identify, monitor and
      address family caregiver support needs in palliative home care.
Caregiving places considerable burdens on family caregivers (FCG). While burden has been
      studied as a FCG outcome, it is also a predictor of other outcomes, including FCG quality of
      life (QoL). We have adapted a model of caregiver burden to hypothesize the various mechanisms
      by which addressing support needs may contribute to FCG QoL. In this model, support needs are
      closely associated with FCGs' perceived social support and preparedness for caregiving. These
      variables operate as (partial) mediators of the relationships between primary stressors,
      including patient functional dependence and symptom distress, and secondary appraisals, such
      as the perceived burden associated with caregiving, which, in turn influences FCGs QoL. The
      model further posits that FCGs' primary appraisal of patient caregiving needs (e.g., amount
      of care provided) is influenced by the functional dependence and symptom distress of the
      patient, and in turn influences perceived support, preparedness for caregiving, FCG burden,
      and, ultimately, FCG QoL. These variables are associated with a variety of demographic and
      health-related characteristics of the caregiver and patient.

      Within the context of this conceptual framework outlined above, the CSNAT intervention is
      viewed as a mediator of the relationships between primary stressors and appraisals and FCG
      QoL (primary outcome). Also, the CSNAT intervention would lead to enhanced social support,
      preparedness, and reduced caregiver burden.

      A clustered randomized control trial (RCT) design will be used to ascertain the effectiveness
      of the CSNAT as an intervention to improve the QoL of FCGs of patients receiving palliative
      care at home. Participating home care nurses will be randomized to one of two comparator
      groups (usual care and intervention) and the FCGs of their patients will be assigned to the
      corresponding comparator group. Data will additionally be collected over the same time frame
      and in the same manner from a non-randomized comparison usual care comparator group from a
      separate home care site where no nurses will be delivering the intervention, to help
      interpret the results (e.g., to determine the extent to which contamination may be have
      occurred). Update - August 31, 2015 - Due to low recruitment the non-randomized, comparison,
      usual care, comparator group has been discontinued.

      Update - December 22, 2016 - Due to home care workloads of participant nurses and home care
      visit schedules in some participating home care offices, delivery of the intervention will be
      done by a dedicated study nurse (in some offices only). In these offices, family caregivers
      will continue to be assigned based on the randomized group assignment of their home care
      nurse. The dedicated study nurse will meet separately with FCGs who are in the intervention
      group to deliver the CSNAT intervention. Information arising from the CSNAT about family
      caregivers' support needs will be communicated by the study nurse to the home care nurse so
      that the home care nurse can incorporate this into the home care plan for the patient and
      patient's family. In home care offices that are not part of this change in procedures, the
      home care nurses in the intervention group will continue to deliver the CSNAT intervention
      during home care visits as before.

      Our specific hypotheses are as follows:

        -  Hypothesis 1: The use of the CSNAT as a practice support tool intervention will lead to
           improved FCG QoL during the time prior to the patients' death and in bereavement.

        -  Hypothesis 2: The use of the CSNAT as a practice support tool intervention will
           contribute to the following secondary outcomes in FCGs during the time prior to the
           patient's death: enhanced perceived social support, improved preparedness to provide
           care and reduced caregiving burden.

        -  Hypothesis 3: CSNAT use during home care of patient before death will reduce grief
           symptoms during bereavement, among FCGs.

      In addition to the RCT, qualitative and quantitative research will be conducted to understand
      the process related to implementing the CSNAT intervention in palliative home care and to
      explain the treatment results. We will specifically address the following questions:

        -  How are the CSNAT support needs being documented and met by home care nurses?

        -  How do home care nurses experience the use of the CSNAT in their daily practice?

        -  How comfortable are FCGs speaking to home care nurses about their own personal needs?

        -  To what extent are the relationships in the hypothesized conceptual framework supported?

        -  What is the relative importance of different CSNAT support needs with respect to FCG QoL
           and health during the illness trajectory, and the presence of post-bereavement grief
           symptoms?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Trajectory of change in family caregiver quality of life while caring for a palliative patient at home, as measured by the Quality of Life in Life Threatening Illness - Family carer version (QOLLTI-F) total score
time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
description: The QOLLTI-F is a self-report measure of family caregiver quality of life. It is composed of 16 items which assess the following 7 domains: state of carer, patient well-being, quality of care, outlook, environment, finances and relationships. Additional exploratory analyses will also be conducted on these subscales.
measure: Family caregiver grief symptoms after patient death, as measured by the Texas Revised Inventory of Grief (TRIG) subscale scores
time frame: 12 weeks after patient death (will not be collected if patient death does not occur within the first 92 weeks of the study)
description: The TRIG is a 21 item scale designed to assess grief symptoms. It relates to two points of time: past (immediate of shortly after the death) and present (the time of data collection). The 2 subscales measure a) feelings and actions at the time of the death and b) present feelings.
measure: Family caregiver quality of life after patient death, as measured by the Quality of Life in Life Threatening Illness - Family carer version Global Single-Item Scale (QOLLTI-F SIS)
time frame: 12 weeks after patient death
description: The QOLLTI-F is a self-report measure of family caregiver quality of life. We will be using the score from the single item score measuring global quality of life (Part A).
measure: Trajectory of change in family caregiver burden while caring for a palliative patient at home, as measured by the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Scale
time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
description: A 25 item measure of family caregiver's positive and negative appraisals of caregiving, including strain, positive appraisals, distress, and family wellbeing.
measure: Trajectory of change in family caregiver preparedness for caregiving while caring for a palliative patient at home, as measured by the Family Caregiving Inventory: Preparedness Scale
time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
description: A caregiver self-rated instrument that consists of 8 items that asks caregivers how well prepared they believe they are for multiple domains of caregiving. Preparedness is defined as perceived readiness for multiple domains of the caregiving role such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of caregiving.
measure: Trajectory of change in family caregiver perceived social supports while caring for a palliative patient at home, as measured by the Medical Outcome Survey (MOS) Social Support Survey
time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
description: Overall Support Index determined using the mean from 18 items within four sub-measures and the mean from the additional item; (a) emotional/information support, (b) tangible support, (c) affectionate support, and (d) positive social interaction support. Designed to assess the perceived availability of social support.
measure: Trajectory of change in family caregiver health status and mental health status while caring for a palliative patient at home, as measured by the Veterans RAND 12 item health survey
time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
description: A 14 item scale, 12 of which are a sampling of items from each of the eight domains of health (physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and mental health). The eight scales are summarized into two summary scores, physical (PCS) and mental (MCS).
measure: Trajectory of change in family caregiver satisfaction with healthcare provided while caring for a palliative patient at home until death, as measured by the Canadian Health Care Evaluation Project - Caregiver Questionnaire (CANHELP LITE)
time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first), 12 weeks after patient death (will not be collected if patient death does not occur within the first 92 weeks of the study)
description: Overall score calculated as the unweighted average of all 21 items (22 for the bereavement version which will be used after patient death) answered. A tool to evaluate satisfaction with care for family members of older patients with life threatening illnesses up to and until death.
arm group label: Existing Home Care Nursing Practice
arm group type: Active Comparator
description: Home care nurses provide care based on existing home care practice
arm group label: Practice Support Tool Intervention
arm group type: Experimental
description: The practice support tool intervention will be the routine use of the Carer Support Needs Assessment Tool (CSNAT) in the practice of home care nurses (once every 4 weeks with each family caregiver) to document, monitor and address family caregiver support needs.
Update - December 22, 2016 - In some home care offices only, a study nurse will meet with family caregivers who are in the intervention group to deliver the CSNAT intervention. Information arising from the CSNAT about family caregivers' support needs will be communicated by the study nurse to the home care nurse, and incorporated by the home care nurse into the home care plan for the patient and patient's family.
intervention type: Other
intervention name: Existing home care nursing practice
description: Home care nurses in this comparator group will provide "care as per usual" to their patients and family caregivers. The family is seen as the unit of care but no formal assessment of the caregiver will be done.
arm group label: Existing Home Care Nursing Practice
intervention type: Other
intervention name: Practice support tool intervention
description: The intervention will be the routine use of the Carer Support Needs Assessment Tool (CSNAT) in the practice of home care nurses (once every 4 weeks with each family caregiver) to document, monitor and address family caregiver support needs.
The completed CSNAT tool will be kept in the patient chart and will be integrated into the care provided by the nurse.
Update - December 22, 2016 - In some offices only, the CSNAT will be administered by a separate study nurse. Findings will be communicated to the home care nurse to inform the documenting, monitoring and addressing of family caregiver support needs.
arm group label: Practice Support Tool Intervention
other name: CSNAT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kelli I Stajduhar, PhD
role: Principal Investigator
affiliation: University of Victoria
last name: Richard G Sawatzky, PhD
role: Principal Investigator
affiliation: Trinity Western University
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: University of Victoria
investigator full name: Kelli Stajduhar
investigator title: Professor