<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/NCT03306147</url>
  </required_header>
  <id_info>
    <org_study_id>5170244</org_study_id>
    <nct_id>NCT03306147</nct_id>
  </id_info>
  <brief_title>Negating Opioid and Pain Actively Through Intervention</brief_title>
  <acronym>NOPAIN</acronym>
  <official_title>Negating Opioid and Pain Actively Through Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cardinal Health</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Loma Linda University</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>
      Chronic pain is one of the most prevalent and debilitating medical conditions and opioid&#xD;
      analgesics are a commonly prescribed class of medications in the United States. Opioid&#xD;
      efficacy has been proven in terms of managing acute and chronic pain; however, opioid&#xD;
      overdose deaths, addictions, and diversions have all continued to increase over the years.&#xD;
      The purpose of this study is to increase patient engagement in pain management and education,&#xD;
      and to decrease opioid use by 10% over the study period. This study will also help present&#xD;
      opportunities for future studies to obtain insight regarding the chronic use of opioids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The institutional review board has approved this prospective single-center study at a large&#xD;
      900-bed academic university medical center. The electronic medical record system will&#xD;
      identify 300 patients, who are at least 18 years of age, with a history of opioid use for 3&#xD;
      or more months, or who are currently prescribed and are using long-acting or extended release&#xD;
      opioids. Procedures by student pharmacists, pharmacy residents, and pharmacists will include&#xD;
      reviewing medical records and prescription drug monitoring programs for the use of opioids,&#xD;
      evaluating baseline pain, quality of life, and satisfaction via questionnaires and assessment&#xD;
      questions, and performing thorough medication consultations on current opioid regimens.&#xD;
      Education of pain and promotion of adjunct and non-pharmacologic alternative therapies will&#xD;
      be completed to engage patients in assessing their pain and seeing the effectiveness of their&#xD;
      treatment. Patients will receive 3 follow-up interventions: 2 phone calls with a pharmacist&#xD;
      or student pharmacist at weeks 2 and 6, and a follow-up visit with a pain or primary care&#xD;
      physician. Opioid usage, pain, quality of life, and patient satisfaction will be assessed.&#xD;
      The primary outcome measured will be a decrease in opioid usage in morphine milligram&#xD;
      equivalents. Secondary outcomes include change in quality of life and patient satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Actual">May 17, 2018</completion_date>
  <primary_completion_date type="Actual">May 17, 2018</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>Decrease in opioid prescription strength</measure>
    <time_frame>Change in prescription strength between date of subject enrollment and 90 days after subject enrollment date</time_frame>
    <description>Opioid usage will be measured by changes in prescription strength of morphine milligram equivalents</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in pain as evidenced by decrease in opioid daily dose</measure>
    <time_frame>Change in daily opioid use between date of subject enrollment and 90 days after subject enrollment date</time_frame>
    <description>Subject will keep a daily opioid calendar to track their opioid daily dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in quality of life score as measured by the PEG pain screening tool by units on a scale</measure>
    <time_frame>Change in quality of life score as measured by the PEG pain screening tool by units on a scale between date of subject enrollment and 90 days after subject enrollment date</time_frame>
    <description>Survey will be administered by investigators and completed by the patients before and after the interventions</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Pain</condition>
  <condition>Chronic Pain</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Chronic pain or long-acting opioid use</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Education of pain and promotion of adjunct and non-pharmacologic alternative therapies will be completed to engage patients in assessing their pain and seeing the effectiveness of their treatment. Patients will receive 3 follow-up interventions: 2 phone calls with a pharmacist or student pharmacist at weeks 2 and 6, and a follow-up visit with a pain or primary care physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pain education with follow up encounters</intervention_name>
    <description>Patient pain review, counseling and education by pharmacists and physicians in follow up encounters</description>
    <arm_group_label>Chronic pain or long-acting opioid use</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 18 years of age&#xD;
&#xD;
          -  history of opioid use for 3 or more months or&#xD;
&#xD;
          -  currently prescribed and are using long-acting or extended release opioids&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  substance use&#xD;
&#xD;
          -  oncology patients&#xD;
&#xD;
          -  hematology patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huy Le, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loma Linda University</investigator_affiliation>
    <investigator_full_name>Huy Le</investigator_full_name>
    <investigator_title>Medication Safety/Pharmacy Quality Management Coordinator</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Opioid</keyword>
  <keyword>Drug monitoring</keyword>
  <keyword>Pain education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <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/NCT03306147
org study id: 5170244
nct id: NCT03306147
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic pain is one of the most prevalent and debilitating medical conditions and opioid
      analgesics are a commonly prescribed class of medications in the United States. Opioid
      efficacy has been proven in terms of managing acute and chronic pain; however, opioid
      overdose deaths, addictions, and diversions have all continued to increase over the years.
      The purpose of this study is to increase patient engagement in pain management and education,
      and to decrease opioid use by 10% over the study period. This study will also help present
      opportunities for future studies to obtain insight regarding the chronic use of opioids.
The institutional review board has approved this prospective single-center study at a large
      900-bed academic university medical center. The electronic medical record system will
      identify 300 patients, who are at least 18 years of age, with a history of opioid use for 3
      or more months, or who are currently prescribed and are using long-acting or extended release
      opioids. Procedures by student pharmacists, pharmacy residents, and pharmacists will include
      reviewing medical records and prescription drug monitoring programs for the use of opioids,
      evaluating baseline pain, quality of life, and satisfaction via questionnaires and assessment
      questions, and performing thorough medication consultations on current opioid regimens.
      Education of pain and promotion of adjunct and non-pharmacologic alternative therapies will
      be completed to engage patients in assessing their pain and seeing the effectiveness of their
      treatment. Patients will receive 3 follow-up interventions: 2 phone calls with a pharmacist
      or student pharmacist at weeks 2 and 6, and a follow-up visit with a pain or primary care
      physician. Opioid usage, pain, quality of life, and patient satisfaction will be assessed.
      The primary outcome measured will be a decrease in opioid usage in morphine milligram
      equivalents. Secondary outcomes include change in quality of life and patient satisfaction.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Decrease in opioid prescription strength
time frame: Change in prescription strength between date of subject enrollment and 90 days after subject enrollment date
description: Opioid usage will be measured by changes in prescription strength of morphine milligram equivalents
measure: Reduction in pain as evidenced by decrease in opioid daily dose
time frame: Change in daily opioid use between date of subject enrollment and 90 days after subject enrollment date
description: Subject will keep a daily opioid calendar to track their opioid daily dose
measure: Improvement in quality of life score as measured by the PEG pain screening tool by units on a scale
time frame: Change in quality of life score as measured by the PEG pain screening tool by units on a scale between date of subject enrollment and 90 days after subject enrollment date
description: Survey will be administered by investigators and completed by the patients before and after the interventions
arm group label: Chronic pain or long-acting opioid use
arm group type: Experimental
description: Education of pain and promotion of adjunct and non-pharmacologic alternative therapies will be completed to engage patients in assessing their pain and seeing the effectiveness of their treatment. Patients will receive 3 follow-up interventions: 2 phone calls with a pharmacist or student pharmacist at weeks 2 and 6, and a follow-up visit with a pain or primary care physician.
intervention type: Behavioral
intervention name: Pain education with follow up encounters
description: Patient pain review, counseling and education by pharmacists and physicians in follow up encounters
arm group label: Chronic pain or long-acting opioid use
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Huy Le, PharmD
role: Principal Investigator
affiliation: Loma Linda University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Loma Linda University
investigator full name: Huy Le
investigator title: Medication Safety/Pharmacy Quality Management Coordinator
mesh term: Chronic Pain
sharing ipd: No