<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/NCT03271658</url>
  </required_header>
  <id_info>
    <org_study_id>BEH12334</org_study_id>
    <nct_id>NCT03271658</nct_id>
  </id_info>
  <brief_title>Mixed Methods Study Web-based Life Support Decision Aid</brief_title>
  <acronym>eLSDA</acronym>
  <official_title>Development of an Individualized, Web-Based Life Support Decision Aid (eLSDA) Concerning Goals of Care for the Seriously Ill Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Saskatchewan Health Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Saskatchewan</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>
      Patients and families want to be involved in healthcare decisions. When the decision-making&#xD;
      process does not engage older patients and their families, the care provided does not match&#xD;
      patient preferences or meet their needs. Healthcare teams can collaborate to support patients&#xD;
      and families facing difficult healthcare decisions, such as decisions about the use of&#xD;
      technology used to keep a person alive when they are critically ill. Tools called patient&#xD;
      decision aids are used in many health care settings to help patients and families understand&#xD;
      their options and figure out the benefits and harms of a treatment to decide what is right&#xD;
      for them. The healthcare team can make sure that patients understand the information&#xD;
      provided, give them opportunities to ask questions, and help them talk more about the&#xD;
      decision with others. This research study is trialing a web based patient decision aid class&#xD;
      of intervention. It is anticipated that 120 hospitalized, seriously ill, older adult&#xD;
      patients/ families and their healthcare professionals will be recruited. The study will&#xD;
      determine if the intervention can improve dialogue about whether life sustaining technology&#xD;
      for seriously ill older patients. The findings will contribute to what is already known about&#xD;
      overcoming challenges to involving patients and families with a goal of keeping patients and&#xD;
      families at the centre of decisions about their health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A concurrent mixed method study of a life support decision aid (eLSDA) intends to prepare&#xD;
      hospitalized, seriously ill older adult patients and their families to participate in shared&#xD;
      decision-making. The study includes 1) randomized controlled trial and 2) a qualitative&#xD;
      (naturalistic observation) study. The experimental study compares a convenience cohort of&#xD;
      participants who receive usual care (n=60 patients or patient/surrogate pairs) to a cohort of&#xD;
      participants who receive the intervention (n=60 patients or patient/surrogate pairs). The&#xD;
      investigators intend to measure a) knowledge of life-sustaining technologies, b) clarity of&#xD;
      values, c) congruence between documented physician's orders and patient choice, d) decisional&#xD;
      conflict, and e) quality of communication. For the intervention group only, investigators&#xD;
      will measure comprehensibility and acceptability of the eLSDA. The observational qualitative&#xD;
      study derived from naturalistic observation will involve participant observation to examine&#xD;
      dialogue about life support between hospitalized, seriously ill older adult patients,&#xD;
      families and their healthcare professionals. Quantitative and qualitative data will be&#xD;
      collected to better understand the comprehensibility, acceptability, usability, feasibility&#xD;
      and impact of the eLSDA used in routine clinical practice.&#xD;
&#xD;
      Questionnaires, patient/family/physician discussions and web based tool viewing will be&#xD;
      completed in a hospital setting. The investigator will administer pre-intervention&#xD;
      questionnaires to the participants, which will take approximately 15 minutes. Participants&#xD;
      will then be randomized to groups, and be invited to use the web based eLSDA or usual care&#xD;
      materials on a laptop computer or tablet (30 minutes). This will be followed by&#xD;
      post-intervention questionnaires in a second interview (15 minutes). Physicians and&#xD;
      nurses/social workers will be asked to complete a survey to examine the barriers to&#xD;
      discussions about goals of care (15 minutes). The investigator will also fill out the chart&#xD;
      abstraction tool after the participants give consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2014</start_date>
  <completion_date type="Actual">January 29, 2017</completion_date>
  <primary_completion_date type="Actual">January 29, 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>
    <intervention_model_description>This study includes 1) a randomized controlled trial and 2) an embedded observational qualitative study. The randomized control trial will compare a convenience cohort of participants who receive usual care (approximately n=60 patients or patient/surrogate pairs) to a cohort of participants who receive the intervention (approximately n=60 patients or patient/surrogate pairs).</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>The doctor will not be told which intervention was used with the patient. The patient/family are told that they will have one of two ways to see the information about life support, but are blind to which is classified as the study intervention and standard care.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability &amp; Usability of the eLSDA</measure>
    <time_frame>up to 15 minutes</time_frame>
    <description>The acceptability and usability is assessed by conducting an Acceptability Survey which asks participants 8 validated questions about the use, amount of information, length, clarity, balance in presentation, willingness to recommend to others and overall suitability for decision making. The intervention will be considered acceptable if score of the acceptability survey exceeds 80%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge about life-sustaining technologies</measure>
    <time_frame>up to 15 minutes</time_frame>
    <description>This knowledge of life-sustaining technologies will be measured after using the eLSDA using the self-report questionnaire. The knowledge questionnaire was developed for this study based on the eLSDA to test users' knowledge of life-sustaining technologies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clarity of values regarding life-sustaining technologies</measure>
    <time_frame>up to 30 minutes</time_frame>
    <description>The patient's values will be collected in the eLSDA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Congruence between the documented physician's orders and patient choice</measure>
    <time_frame>up to 5 minutes</time_frame>
    <description>Congruence between documented physician orders and patient choice when participants use the eLSDA and/or based on patient communication during the discussion with their physician will be reported as simple agreement: (Yes/No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Evaluation Process</measure>
    <time_frame>up to 30 minutes</time_frame>
    <description>The measures of feasibility are established by the rate of completion of the eLSDA, debriefing and study procedures. The study will be considered feasible if 60% of those approached agreed to participate in the study; &gt;75% of participants discuss the decision about life support during the encounter, &lt;5% of the participants are distressed by the eLSDA, and 80% of participants complete data collection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Clinical Decision-Making</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient/family are randomized to either the active intervention (web based life support patient decision aid - eLSDA and decision coaching) or usual care comparison.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients may also randomized to review current web based resources provided by the health region for seriously ill patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Web based life support patient decision aid</intervention_name>
    <description>The web-based life support decision aid (eLSDA) was adapted from a print-based decision aid. The eLSDA includes information on the pros and cons of both life support and comfort care. The eLSDA lays out the decision about life support for an individual patient/family in a logical stepwise fashion to permit discussion, ask questions, and permit reflection on each step. At the end of the eLSDA, unmet decision-making needs are identified to seek support from the healthcare team.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>eLSDA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Decision coaching</intervention_name>
    <description>During the interactive process of using the eLSDA, the study nurse provides decision coaching for patient/family, specifically a facilitated values clarification exercise.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>expert facilitation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Potential users of eLSDA, which are those who are hospitalized, seriously ill, older&#xD;
             patients, their families, and their health care providers.&#xD;
&#xD;
          -  Age 55 + with one or more of the following diseases:&#xD;
&#xD;
               1. Chronic obstructive lung disease&#xD;
&#xD;
               2. Congestive heart failure&#xD;
&#xD;
               3. Cirrhosis&#xD;
&#xD;
               4. Cancer&#xD;
&#xD;
               5. End-stage dementia&#xD;
&#xD;
               6. Renal failure&#xD;
&#xD;
          -  Any patient 70 + admitted to the hospital from the community because of an acute&#xD;
             medical or surgical condition.&#xD;
&#xD;
          -  Any patient 55 - 69 years of age admitted to the hospital, who has high likelihood of&#xD;
             death in the next 6 months, in the opinion of the treating physician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People who are not hospitalized or do not have family members that are hospitalized&#xD;
             and are not a potential user of the eLSDA.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Kryworuchko, PhD RN CNCC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wanda Martin, PhD RN</last_name>
    <role>Study Director</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Donna Goodridge</last_name>
    <role>Study Chair</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Petrina McGrath</last_name>
    <role>Study Chair</role>
    <affiliation>Saskatoon Health Region</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karen Levesque</last_name>
    <role>Study Chair</role>
    <affiliation>Saskatoon Health Region</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal University Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://fluidsurveys.usask.ca/s/decidetogether/</url>
    <description>Decide Together Survey - Life Support Decision Aid</description>
  </link>
  <reference>
    <citation>The Change Foundation. Consumers and Canadian Health Care Trending Analysis 2004. The Change Foundation: Toronto. 2005.</citation>
  </reference>
  <reference>
    <citation>Heyland DK, Groll D, Rocker G, Dodek P, Gafni A, Tranmer J, Pichora D, Lazar N, Kutsogiannis J, Shortt S, Lam M; Canadian Researchers at the End of Life Network (CARENET). End-of-life care in acute care hospitals in Canada: a quality finish? J Palliat Care. 2005 Autumn;21(3):142-50.</citation>
    <PMID>16334968</PMID>
  </reference>
  <reference>
    <citation>Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.</citation>
    <PMID>16908462</PMID>
  </reference>
  <reference>
    <citation>O'Connor AM, Graham ID, Visser A. Implementing shared decision making in diverse health care systems: the role of patient decision aids. Patient Educ Couns. 2005 Jun;57(3):247-9. doi: 10.1016/j.pec.2005.04.010. No abstract available.</citation>
    <PMID>15893205</PMID>
  </reference>
  <verification_date>October 2018</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">September 5, 2017</study_first_posted>
  <last_update_submitted>October 26, 2018</last_update_submitted>
  <last_update_submitted_qc>October 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Anh Pham</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>patient decision aid</keyword>
  <keyword>end-of-life care</keyword>
  <keyword>shared decision making</keyword>
  <keyword>informed decision</keyword>
  <keyword>decision-making</keyword>
  <keyword>clinical decision-making</keyword>
  <keyword>web-based decision aid</keyword>
  <keyword>palliative</keyword>
  <keyword>critical care</keyword>
  <keyword>nursing</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available.</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/NCT03271658
org study id: BEH12334
nct id: NCT03271658
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients and families want to be involved in healthcare decisions. When the decision-making
      process does not engage older patients and their families, the care provided does not match
      patient preferences or meet their needs. Healthcare teams can collaborate to support patients
      and families facing difficult healthcare decisions, such as decisions about the use of
      technology used to keep a person alive when they are critically ill. Tools called patient
      decision aids are used in many health care settings to help patients and families understand
      their options and figure out the benefits and harms of a treatment to decide what is right
      for them. The healthcare team can make sure that patients understand the information
      provided, give them opportunities to ask questions, and help them talk more about the
      decision with others. This research study is trialing a web based patient decision aid class
      of intervention. It is anticipated that 120 hospitalized, seriously ill, older adult
      patients/ families and their healthcare professionals will be recruited. The study will
      determine if the intervention can improve dialogue about whether life sustaining technology
      for seriously ill older patients. The findings will contribute to what is already known about
      overcoming challenges to involving patients and families with a goal of keeping patients and
      families at the centre of decisions about their health.
A concurrent mixed method study of a life support decision aid (eLSDA) intends to prepare
      hospitalized, seriously ill older adult patients and their families to participate in shared
      decision-making. The study includes 1) randomized controlled trial and 2) a qualitative
      (naturalistic observation) study. The experimental study compares a convenience cohort of
      participants who receive usual care (n=60 patients or patient/surrogate pairs) to a cohort of
      participants who receive the intervention (n=60 patients or patient/surrogate pairs). The
      investigators intend to measure a) knowledge of life-sustaining technologies, b) clarity of
      values, c) congruence between documented physician's orders and patient choice, d) decisional
      conflict, and e) quality of communication. For the intervention group only, investigators
      will measure comprehensibility and acceptability of the eLSDA. The observational qualitative
      study derived from naturalistic observation will involve participant observation to examine
      dialogue about life support between hospitalized, seriously ill older adult patients,
      families and their healthcare professionals. Quantitative and qualitative data will be
      collected to better understand the comprehensibility, acceptability, usability, feasibility
      and impact of the eLSDA used in routine clinical practice.

      Questionnaires, patient/family/physician discussions and web based tool viewing will be
      completed in a hospital setting. The investigator will administer pre-intervention
      questionnaires to the participants, which will take approximately 15 minutes. Participants
      will then be randomized to groups, and be invited to use the web based eLSDA or usual care
      materials on a laptop computer or tablet (30 minutes). This will be followed by
      post-intervention questionnaires in a second interview (15 minutes). Physicians and
      nurses/social workers will be asked to complete a survey to examine the barriers to
      discussions about goals of care (15 minutes). The investigator will also fill out the chart
      abstraction tool after the participants give consent.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study includes 1) a randomized controlled trial and 2) an embedded observational qualitative study. The randomized control trial will compare a convenience cohort of participants who receive usual care (approximately n=60 patients or patient/surrogate pairs) to a cohort of participants who receive the intervention (approximately n=60 patients or patient/surrogate pairs).
primary purpose: Health Services Research
masking: Double (Participant, Care Provider)
masking description: The doctor will not be told which intervention was used with the patient. The patient/family are told that they will have one of two ways to see the information about life support, but are blind to which is classified as the study intervention and standard care.
measure: Acceptability & Usability of the eLSDA
time frame: up to 15 minutes
description: The acceptability and usability is assessed by conducting an Acceptability Survey which asks participants 8 validated questions about the use, amount of information, length, clarity, balance in presentation, willingness to recommend to others and overall suitability for decision making. The intervention will be considered acceptable if score of the acceptability survey exceeds 80%.
measure: Knowledge about life-sustaining technologies
time frame: up to 15 minutes
description: This knowledge of life-sustaining technologies will be measured after using the eLSDA using the self-report questionnaire. The knowledge questionnaire was developed for this study based on the eLSDA to test users' knowledge of life-sustaining technologies.
measure: Clarity of values regarding life-sustaining technologies
time frame: up to 30 minutes
description: The patient's values will be collected in the eLSDA.
measure: Congruence between the documented physician's orders and patient choice
time frame: up to 5 minutes
description: Congruence between documented physician orders and patient choice when participants use the eLSDA and/or based on patient communication during the discussion with their physician will be reported as simple agreement: (Yes/No)
measure: Feasibility of Evaluation Process
time frame: up to 30 minutes
description: The measures of feasibility are established by the rate of completion of the eLSDA, debriefing and study procedures. The study will be considered feasible if 60% of those approached agreed to participate in the study; >75% of participants discuss the decision about life support during the encounter, <5% of the participants are distressed by the eLSDA, and 80% of participants complete data collection.
arm group label: Intervention
arm group type: Experimental
description: Patient/family are randomized to either the active intervention (web based life support patient decision aid - eLSDA and decision coaching) or usual care comparison.
arm group label: Usual Care Comparison
arm group type: No Intervention
description: Patients may also randomized to review current web based resources provided by the health region for seriously ill patients.
intervention type: Behavioral
intervention name: Web based life support patient decision aid
description: The web-based life support decision aid (eLSDA) was adapted from a print-based decision aid. The eLSDA includes information on the pros and cons of both life support and comfort care. The eLSDA lays out the decision about life support for an individual patient/family in a logical stepwise fashion to permit discussion, ask questions, and permit reflection on each step. At the end of the eLSDA, unmet decision-making needs are identified to seek support from the healthcare team.
arm group label: Intervention
other name: eLSDA
intervention type: Behavioral
intervention name: Decision coaching
description: During the interactive process of using the eLSDA, the study nurse provides decision coaching for patient/family, specifically a facilitated values clarification exercise.
arm group label: Intervention
other name: expert facilitation
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Kryworuchko, PhD RN CNCC
role: Principal Investigator
affiliation: University of British Columbia
last name: Wanda Martin, PhD RN
role: Study Director
affiliation: University of Saskatchewan
last name: Donna Goodridge
role: Study Chair
affiliation: University of Saskatchewan
last name: Petrina McGrath
role: Study Chair
affiliation: Saskatoon Health Region
last name: Karen Levesque
role: Study Chair
affiliation: Saskatoon Health Region
facility: 
country: Canada
url: https://fluidsurveys.usask.ca/s/decidetogether/
description: Decide Together Survey - Life Support Decision Aid
citation: The Change Foundation. Consumers and Canadian Health Care Trending Analysis 2004. The Change Foundation: Toronto. 2005.
citation: Heyland DK, Groll D, Rocker G, Dodek P, Gafni A, Tranmer J, Pichora D, Lazar N, Kutsogiannis J, Shortt S, Lam M; Canadian Researchers at the End of Life Network (CARENET). End-of-life care in acute care hospitals in Canada: a quality finish? J Palliat Care. 2005 Autumn;21(3):142-50.
PMID: 16334968
citation: Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.
PMID: 16908462
citation: O'Connor AM, Graham ID, Visser A. Implementing shared decision making in diverse health care systems: the role of patient decision aids. Patient Educ Couns. 2005 Jun;57(3):247-9. doi: 10.1016/j.pec.2005.04.010. No abstract available.
PMID: 15893205
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Anh Pham
investigator title: Professor
sharing ipd: No
ipd description: There is not a plan to make IPD available.