<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/NCT03295097</url>
  </required_header>
  <id_info>
    <org_study_id>TRHC2017-SERD101</org_study_id>
    <nct_id>NCT03295097</nct_id>
  </id_info>
  <brief_title>Characteristics and Clinical Implications of a Clinical Decision Support System</brief_title>
  <official_title>A Prospective Multicenter Cohort Study to Evaluate The Characteristics and Clinical Implications of a Clinical Decision Support System and of Pharmacogenomic Information Relevant to Polypharmacy Actions in Patients With Advanced Illness Who Are Receiving Multiple Drugs for Pain and Other Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospice of Henderson County, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tabula Rasa HealthCare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospice of Henderson County, Inc.</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 investigators propose to study the feasibility, acceptability, usability and outcomes of&#xD;
      a new clinical decision support system for clinicians of opioid therapy in the context of&#xD;
      specialist palliative care for serious chronic illness. The system provides clinicians with&#xD;
      patient-specific genetic information on opioid responsiveness and multi-drug interactions.&#xD;
      This clinical decision support system should improve the clinician's ability to identify the&#xD;
      optimal pain medication and dosage, and reduce risks associated with multi-drug treatment.&#xD;
      Investigators will conduct clinician survey's to collection information about the clinical&#xD;
      decision support system. Investigators will also conduct patient related questionnaires to&#xD;
      determine any benefits or improvements in quality of life and symptom management from the&#xD;
      clinical decision support system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2018</start_date>
  <completion_date type="Actual">January 21, 2020</completion_date>
  <primary_completion_date type="Actual">January 21, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinician Feasibility</measure>
    <time_frame>through study completion, an average of 24 months</time_frame>
    <description>Clinical questionnaire to determine feasibility of the system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinician Usability</measure>
    <time_frame>through study completion, an average of 24 months</time_frame>
    <description>Clinical questionnaire to determine usability of the system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Quality of Life</measure>
    <time_frame>through study completion,an average of 24 months</time_frame>
    <description>Functional Assessment of Chronic Illness - Palliative (FACIT-PAL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Pain</measure>
    <time_frame>through study completion, an average of 24 months</time_frame>
    <description>Numerical Rating Scale to assess pain</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Chronic Illness</condition>
  <condition>Opioid Use</condition>
  <condition>Palliative Care</condition>
  <arm_group>
    <arm_group_label>Clinical Decision Support System</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The Clinical Decision Support System is composed of pharmacogenomic results and a pharmacist evaluated drug to drug interaction review. This system provides clinicians with patient-specific genetic information on opioid responsiveness and multi-drug interactions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Decision Support System</intervention_name>
    <description>The system provides clinicians with patient-specific genetic information on opioid responsiveness and multi-drug interactions. This clinical decision support system should improve the clinician's ability to identify the optimal pain medication and dosage, and reduce risks associated with multi-drug treatment.</description>
    <arm_group_label>Clinical Decision Support System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinicians will be eligible if:&#xD;
&#xD;
          1. Physicians or nurse practitioners who are practicing hospice and palliative care&#xD;
&#xD;
          2. Responsible for making and implementing decisions about opioid therapy for pain&#xD;
&#xD;
        Patients will be identified by their treating clinicians. Patients will be eligible if:&#xD;
&#xD;
          1. &gt; 18 years of age&#xD;
&#xD;
          2. Palliative Performance Score ≥ 30%&#xD;
&#xD;
          3. Reside in the community or at a nursing home&#xD;
&#xD;
          4. Have &gt;1 serious chronic illness&#xD;
&#xD;
          5. Have an assessed life-expectancy of at least 4 weeks&#xD;
&#xD;
          6. Have a history of pain and have been taking prescribed opioid medication with a&#xD;
             regimen that provides a minimum dose of 20 mg morphine or equivalent per day in&#xD;
             scheduled doses for at least one week prior to recruitment&#xD;
&#xD;
          7. Is expected to continue opioid therapy for the duration of study participation&#xD;
&#xD;
          8. Is taking &gt; 4 non-opioid medications, each in a regimen providing continuous treatment&#xD;
             of pain or another disorder&#xD;
&#xD;
          9. Is expected to continue drug therapy for the duration of study participation&#xD;
&#xD;
         10. Able to read, understand, and provide Informed Consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        There are no exclusion criteria for clinicians.&#xD;
&#xD;
        Patients will be excluded if:&#xD;
&#xD;
          1. Pregnant women or women trying to become pregnant or nursing. Women of childbearing&#xD;
             potential must use an acceptable method of birth control for the duration of the&#xD;
             study. (acceptable forms are oral birth control pills, condoms in combination with&#xD;
             spermicide foam, IUD, transdermal patches, birth control implants, vaginal ring)&#xD;
&#xD;
          2. Palliative Performance Score &lt;30%&#xD;
&#xD;
          3. Have taken an investigational product in the last 30 days&#xD;
&#xD;
          4. Current use of illicit substances&#xD;
&#xD;
          5. Immediate family members of site staff, or site staff may not be enrolled in the study&#xD;
             without first obtaining IRB authorization&#xD;
&#xD;
          6. Any other medical or physical abnormality, disease, or disorder that would prohibit&#xD;
             the patient from completing study procedures in the judgement of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>MJHS Hospice and Palliative Care</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospice of Henderson County, Inc. d/b/a Four Seasons Compassion for Life</name>
      <address>
        <city>Flat Rock</city>
        <state>North Carolina</state>
        <zip>28731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pharmacogenomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03295097
org study id: TRHC2017-SERD101
nct id: NCT03295097
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators propose to study the feasibility, acceptability, usability and outcomes of
      a new clinical decision support system for clinicians of opioid therapy in the context of
      specialist palliative care for serious chronic illness. The system provides clinicians with
      patient-specific genetic information on opioid responsiveness and multi-drug interactions.
      This clinical decision support system should improve the clinician's ability to identify the
      optimal pain medication and dosage, and reduce risks associated with multi-drug treatment.
      Investigators will conduct clinician survey's to collection information about the clinical
      decision support system. Investigators will also conduct patient related questionnaires to
      determine any benefits or improvements in quality of life and symptom management from the
      clinical decision support system.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Clinician Feasibility
time frame: through study completion, an average of 24 months
description: Clinical questionnaire to determine feasibility of the system
measure: Clinician Usability
time frame: through study completion, an average of 24 months
description: Clinical questionnaire to determine usability of the system
measure: Patient Quality of Life
time frame: through study completion,an average of 24 months
description: Functional Assessment of Chronic Illness - Palliative (FACIT-PAL)
measure: Patient Pain
time frame: through study completion, an average of 24 months
description: Numerical Rating Scale to assess pain
arm group label: Clinical Decision Support System
arm group type: Other
description: The Clinical Decision Support System is composed of pharmacogenomic results and a pharmacist evaluated drug to drug interaction review. This system provides clinicians with patient-specific genetic information on opioid responsiveness and multi-drug interactions.
intervention type: Other
intervention name: Clinical Decision Support System
description: The system provides clinicians with patient-specific genetic information on opioid responsiveness and multi-drug interactions. This clinical decision support system should improve the clinician's ability to identify the optimal pain medication and dosage, and reduce risks associated with multi-drug treatment.
arm group label: Clinical Decision Support System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Disease
sharing ipd: Undecided