<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/NCT02995278</url>
  </required_header>
  <id_info>
    <org_study_id>PAS1459</org_study_id>
    <nct_id>NCT02995278</nct_id>
  </id_info>
  <brief_title>Usage and Plan of Care Changes Due to Drug Screenings</brief_title>
  <official_title>Clinical Researcher Experience Assessment Documenting Usage and Plan of Care Changes Due to Drug Screenings ©</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Data Collection Analysis Business Management</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PAS Research Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Data Collection Analysis Business Management</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this minimal risk, observational survey is to document the accuracy, benefits,&#xD;
      and how qualitative and quantitative results affect patients' plan of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain is the most common reason patients consult primary care providers. According to recent&#xD;
      surveys, One in six Americans live with chronic or recurrent pain and pay an estimated $120&#xD;
      billion a year in medical costs in the United States. Oral opioids are the common treatment&#xD;
      options for various chronic pains including joint pain, musculoskeletal pain, neuropathic&#xD;
      pain and migraines. This narcotic-based management of pain is often associated with&#xD;
      undesirable side effects with addictive and potential abuse.&#xD;
&#xD;
      To ensure proper usage of prescribed medications, physicians use drug screens to monitor&#xD;
      therapeutic levels and test for presence of illegal drugs or medications that may cause a&#xD;
      drug-drug interaction. Upon receiving quantitative or qualitative results from these drug&#xD;
      screens, the physician may change the treatment plan for patients to improve efficacy of&#xD;
      prescribed medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Plan of Care Changes due to Drug Screenings</measure>
    <time_frame>3 years</time_frame>
    <description>Provider based observational survey</description>
  </primary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Pain Management</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Does not include a drug needing FDA approval and therefore it is not by definition, a Clinical Drug Trial as defined by FDA.</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Providers who already drug screen for their current patient population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be a Medical Practioner&#xD;
&#xD;
               -  Medical Doctor (MD)&#xD;
&#xD;
               -  Doctor of Osteopathic (DO)&#xD;
&#xD;
               -  Physician Assistant (PA)&#xD;
&#xD;
               -  Advanced Practice Registered Nurse (APRN)&#xD;
&#xD;
               -  Nurse Practioner (NP)&#xD;
&#xD;
          -  Must have a current standard operating procedure that includes obtaining/reviewing&#xD;
             medical history.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Government-funded insurance data cannot be included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Plan of care changes by providers after toxicology testing</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/NCT02995278
org study id: PAS1459
nct id: NCT02995278
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this minimal risk, observational survey is to document the accuracy, benefits,
      and how qualitative and quantitative results affect patients' plan of care.
Pain is the most common reason patients consult primary care providers. According to recent
      surveys, One in six Americans live with chronic or recurrent pain and pay an estimated $120
      billion a year in medical costs in the United States. Oral opioids are the common treatment
      options for various chronic pains including joint pain, musculoskeletal pain, neuropathic
      pain and migraines. This narcotic-based management of pain is often associated with
      undesirable side effects with addictive and potential abuse.

      To ensure proper usage of prescribed medications, physicians use drug screens to monitor
      therapeutic levels and test for presence of illegal drugs or medications that may cause a
      drug-drug interaction. Upon receiving quantitative or qualitative results from these drug
      screens, the physician may change the treatment plan for patients to improve efficacy of
      prescribed medications.
observational model: Other
time perspective: Other
measure: Plan of Care Changes due to Drug Screenings
time frame: 3 years
description: Provider based observational survey
intervention type: Other
intervention name: Does not include a drug needing FDA approval and therefore it is not by definition, a Clinical Drug Trial as defined by FDA.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: Plan of care changes by providers after toxicology testing