<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/NCT03241771</url>
  </required_header>
  <id_info>
    <org_study_id>CO-16-2405</org_study_id>
    <secondary_id>1R01DA042059-01</secondary_id>
    <nct_id>NCT03241771</nct_id>
  </id_info>
  <brief_title>Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders</brief_title>
  <official_title>Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Denver Health and Hospital Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Kaiser Permanente</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>
      In the setting of naloxone standing orders, this study will assess if direct outreach with a&#xD;
      web-based &quot;Naloxone Navigator 1.0&quot; to patients prescribed chronic opioid therapy (COT)&#xD;
      changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about&#xD;
      overdose and naloxone&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized study of a web-based naloxone educational resource (Naloxone Navigator&#xD;
      1.0) for adults prescribed chronic opioid therapy. This study will be conducted under new&#xD;
      naloxone standing order legislation passed in Colorado. The Naloxone Navigator 1.0 will&#xD;
      provide online training on how to recognize an opioid overdose and respond using naloxone.&#xD;
      There will be two arms: one will receive a link to the Naloxone Navigator 1.0 and the other&#xD;
      will receive usual care (no link). Outcomes will include opioid risk behavior, overdose and&#xD;
      naloxone knowledge, naloxone dispensings, and overdose rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 14, 2018</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Risk Behavior</measure>
    <time_frame>4 months</time_frame>
    <description>Risk behavior will be assessed using the Opioid-Related Behaviors in Treatment (ORBIT) scale. The ORBIT is a brief scale used to identify recent risk behavior among patients receiving chronic opioid therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Knowledge</measure>
    <time_frame>Within 1 month of study enrollment</time_frame>
    <description>Patient knowledge of overdose and naloxone will be measured using survey items adapted from the Opioid Overdose Knowledge Scale (OOKS). The OOKS is a scale measuring knowledge of overdose risks, warning signs, steps to address the overdose and appropriate use of naloxone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Naloxone Dispensings</measure>
    <time_frame>4 months</time_frame>
    <description>Electronic health records and pharmacy databases will be used to identify naloxone dispensings in the outpatient setting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid dose</measure>
    <time_frame>4 months</time_frame>
    <description>We will calculate changes in the milligrams morphine equivalent dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug Use Risk Behavior</measure>
    <time_frame>4 months</time_frame>
    <description>Drug Use Risk Behavior will be assessed using the validated National Institutes on Drug Abuse-Modified (ASSIST) scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Use Risk Behavior</measure>
    <time_frame>4 months</time_frame>
    <description>Alcohol Use Risk Behavior will be assessed using the validated Alcohol Use Disorders Identification Test--Consumption (AUDIT-C Lite) scale. AUDIT-C Lite is a brief screener used to identify patients with alcohol use disorders or hazardous drinking behavior</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>4 months</time_frame>
    <description>Pain intensity will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS Pain Intensity - Short Form instrument measures pain intensity over time</description>
  </other_outcome>
  <other_outcome>
    <measure>Overdose</measure>
    <time_frame>4 months</time_frame>
    <description>Fatal and nonfatal overdoses will be assessed using International Classification of Disease (ICD)-10 codes in the electronic health record data and death records.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">325</enrollment>
  <condition>Opioid Abuse</condition>
  <condition>Overdose</condition>
  <condition>Risk Behavior</condition>
  <arm_group>
    <arm_group_label>Naloxone Navigator 1.0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the Naloxone Navigator 1.0 arm will receive a link to the web-based resource. They will also receive usual care from their health plan, pharmacy and physicians. As part of usual care, participants will have access to naloxone through standing orders (i.e., they can request it without a prescription under their usual pharmacy benefit).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the usual care arm will receive usual care from their health plan, pharmacy and physicians. As part of usual care, participants will have access to naloxone through standing orders (i.e., they can request it without a prescription under their usual pharmacy benefit).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Naloxone Navigator 1.0</intervention_name>
    <description>Patients on chronic opioid therapy will be outreached via email, mail and phone. Within 1 month of enrollment into the trial, intervention participants will receive a link to the web-based resource to view. This is designed to provide overdose education, increase opioid risk awareness, and encourage patients to obtain naloxone.</description>
    <arm_group_label>Naloxone Navigator 1.0</arm_group_label>
    <other_name>Naloxone Navigator (NN)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or greater prescribed chronic opioid therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking, hospice enrollment, do-not-resuscitate order, receipt of&#xD;
             naloxone in the last 12 months, no internet access, not planning to continue to&#xD;
             receive care in the same setting for the next 4 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingrid Binswanger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jason Glanz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Denver Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naloxone</mesh_term>
  </intervention_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/NCT03241771
org study id: CO-16-2405
secondary id: 1R01DA042059-01
nct id: NCT03241771
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In the setting of naloxone standing orders, this study will assess if direct outreach with a
      web-based "Naloxone Navigator 1.0" to patients prescribed chronic opioid therapy (COT)
      changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about
      overdose and naloxone
This is a randomized study of a web-based naloxone educational resource (Naloxone Navigator
      1.0) for adults prescribed chronic opioid therapy. This study will be conducted under new
      naloxone standing order legislation passed in Colorado. The Naloxone Navigator 1.0 will
      provide online training on how to recognize an opioid overdose and respond using naloxone.
      There will be two arms: one will receive a link to the Naloxone Navigator 1.0 and the other
      will receive usual care (no link). Outcomes will include opioid risk behavior, overdose and
      naloxone knowledge, naloxone dispensings, and overdose rates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Risk Behavior
time frame: 4 months
description: Risk behavior will be assessed using the Opioid-Related Behaviors in Treatment (ORBIT) scale. The ORBIT is a brief scale used to identify recent risk behavior among patients receiving chronic opioid therapy.
measure: Patient Knowledge
time frame: Within 1 month of study enrollment
description: Patient knowledge of overdose and naloxone will be measured using survey items adapted from the Opioid Overdose Knowledge Scale (OOKS). The OOKS is a scale measuring knowledge of overdose risks, warning signs, steps to address the overdose and appropriate use of naloxone.
measure: Naloxone Dispensings
time frame: 4 months
description: Electronic health records and pharmacy databases will be used to identify naloxone dispensings in the outpatient setting.
measure: Opioid dose
time frame: 4 months
description: We will calculate changes in the milligrams morphine equivalent dose
measure: Drug Use Risk Behavior
time frame: 4 months
description: Drug Use Risk Behavior will be assessed using the validated National Institutes on Drug Abuse-Modified (ASSIST) scale.
measure: Alcohol Use Risk Behavior
time frame: 4 months
description: Alcohol Use Risk Behavior will be assessed using the validated Alcohol Use Disorders Identification Test--Consumption (AUDIT-C Lite) scale. AUDIT-C Lite is a brief screener used to identify patients with alcohol use disorders or hazardous drinking behavior
measure: Pain Intensity
time frame: 4 months
description: Pain intensity will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS Pain Intensity - Short Form instrument measures pain intensity over time
measure: Overdose
time frame: 4 months
description: Fatal and nonfatal overdoses will be assessed using International Classification of Disease (ICD)-10 codes in the electronic health record data and death records.
arm group label: Naloxone Navigator 1.0
arm group type: Experimental
description: Participants randomized to the Naloxone Navigator 1.0 arm will receive a link to the web-based resource. They will also receive usual care from their health plan, pharmacy and physicians. As part of usual care, participants will have access to naloxone through standing orders (i.e., they can request it without a prescription under their usual pharmacy benefit).
arm group label: Usual Care
arm group type: No Intervention
description: Participants in the usual care arm will receive usual care from their health plan, pharmacy and physicians. As part of usual care, participants will have access to naloxone through standing orders (i.e., they can request it without a prescription under their usual pharmacy benefit).
intervention type: Behavioral
intervention name: Naloxone Navigator 1.0
description: Patients on chronic opioid therapy will be outreached via email, mail and phone. Within 1 month of enrollment into the trial, intervention participants will receive a link to the web-based resource to view. This is designed to provide overdose education, increase opioid risk awareness, and encourage patients to obtain naloxone.
arm group label: Naloxone Navigator 1.0
other name: Naloxone Navigator (NN)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ingrid Binswanger, MD
role: Principal Investigator
affiliation: Kaiser Permanente
last name: Jason Glanz, PhD
role: Principal Investigator
affiliation: Kaiser Permanente
facility: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Naloxone
sharing ipd: Undecided