<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/NCT04410627</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00105058</org_study_id>
    <nct_id>NCT04410627</nct_id>
  </id_info>
  <brief_title>HoPE (Hospice Preparation and Education)</brief_title>
  <official_title>Pilot Trial Evaluating Usability, Acceptability, and Feasibility of the HoPE (Hospice Preparation and Education) Web-Based Tool</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</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 investigator will conduct a two-site, randomized, controlled study of the HoPE (Hospice&#xD;
      Preparation and Education) web-based tool versus usual care to assess: Technology usability&#xD;
      (primary), study feasibility (secondary), user acceptability (secondary), and hospice service&#xD;
      conversion rate (exploratory). Technology usability will be assessed through a one-time&#xD;
      quantitative survey using established instruments. Study feasibility and user accessibility&#xD;
      will be assessed through trial enrollment and retention alongside analytics assessing tool&#xD;
      usage (e.g. time spent on each page of the website). Conversion rate is the percent of&#xD;
      patients introduced to hospice who eventually enroll. The investigators will evaluate in an&#xD;
      exploratory manner the differential effect of HoPE versus usual care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Covid/PI Vacancy&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 1, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Technology usability as measured by System Usability Scale</measure>
    <time_frame>At study completion, up to 4 months.</time_frame>
    <description>To determine usability, the System Usability Scale will be administered to each participant in the intervention arm. As described by usability.gov: &quot;The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves &quot;normalizing&quot; the scores to produce a percentile ranking.&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Study Feasibility as measured by enrollment efficiency</measure>
    <time_frame>At study completion, up to 4 months</time_frame>
    <description>Enrollment efficiency will be measured by the percentage of patients approached who enroll in the study, with the goal of &gt;50% enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study Feasibility as measured by intervention completion</measure>
    <time_frame>At study completion, up to 4 months</time_frame>
    <description>Intervention completion will be measured by the percentage of participants on the intervention arm who complete at least 50% of the modules within the intervention website, with a goal of &gt;50% of the participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User Accessibility as measured by Net Promoter score</measure>
    <time_frame>At study completion, up to 4 months</time_frame>
    <description>The Net Promoter scale is administered to participants in the intervention arm of the study only. This scale is an eleven-item likert scale assessing likelihood to recommend the intervention to a family member or friend. The percentage of participants who give a score of 0 through 6 is subtracted by the percentage of participants who give a score of 9 or 10 to give the overall Net Promoter score. This score is then compared to other scores of similar technologies.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hospice Care</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care + HoPE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HoPE Website</intervention_name>
    <description>Educational website focused on hospice care</description>
    <arm_group_label>Standard of Care + HoPE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible for and referral made for home hospice services (Note: this excludes home&#xD;
             palliative care, home infusion, home nursing, home physical therapy, and bridge&#xD;
             services)&#xD;
&#xD;
          -  Aged between 21 and 89&#xD;
&#xD;
          -  Capacity to give consent&#xD;
&#xD;
          -  Ability to speak and understand English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arif Kamal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WakeMed Health &amp; Hospitals</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>March 4, 2022</last_update_submitted>
  <last_update_submitted_qc>March 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04410627
org study id: Pro00105058
nct id: NCT04410627
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigator will conduct a two-site, randomized, controlled study of the HoPE (Hospice
      Preparation and Education) web-based tool versus usual care to assess: Technology usability
      (primary), study feasibility (secondary), user acceptability (secondary), and hospice service
      conversion rate (exploratory). Technology usability will be assessed through a one-time
      quantitative survey using established instruments. Study feasibility and user accessibility
      will be assessed through trial enrollment and retention alongside analytics assessing tool
      usage (e.g. time spent on each page of the website). Conversion rate is the percent of
      patients introduced to hospice who eventually enroll. The investigators will evaluate in an
      exploratory manner the differential effect of HoPE versus usual care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Technology usability as measured by System Usability Scale
time frame: At study completion, up to 4 months.
description: To determine usability, the System Usability Scale will be administered to each participant in the intervention arm. As described by usability.gov: "The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking."
measure: Study Feasibility as measured by enrollment efficiency
time frame: At study completion, up to 4 months
description: Enrollment efficiency will be measured by the percentage of patients approached who enroll in the study, with the goal of >50% enrollment.
measure: Study Feasibility as measured by intervention completion
time frame: At study completion, up to 4 months
description: Intervention completion will be measured by the percentage of participants on the intervention arm who complete at least 50% of the modules within the intervention website, with a goal of >50% of the participants.
measure: User Accessibility as measured by Net Promoter score
time frame: At study completion, up to 4 months
description: The Net Promoter scale is administered to participants in the intervention arm of the study only. This scale is an eleven-item likert scale assessing likelihood to recommend the intervention to a family member or friend. The percentage of participants who give a score of 0 through 6 is subtracted by the percentage of participants who give a score of 9 or 10 to give the overall Net Promoter score. This score is then compared to other scores of similar technologies.
arm group label: Standard of Care
arm group type: No Intervention
arm group label: Standard of Care + HoPE
arm group type: Experimental
intervention type: Other
intervention name: HoPE Website
description: Educational website focused on hospice care
arm group label: Standard of Care + HoPE
criteria: 
gender: All
minimum age: 21 Years
maximum age: 89 Years
healthy volunteers: No
last name: Arif Kamal, MD
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No