<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/NCT02230722</url>
  </required_header>
  <id_info>
    <org_study_id>13-11892</org_study_id>
    <secondary_id>R34AT008319-01</secondary_id>
    <nct_id>NCT02230722</nct_id>
  </id_info>
  <brief_title>Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support</brief_title>
  <acronym>OPTI</acronym>
  <official_title>Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Francisco Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>San Francisco Veterans Affairs Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to develop a novel intervention that targets the system&#xD;
      (Collaborative Care), PCP (computerized decision support for opioid therapy) and veteran&#xD;
      (CM-delivered MI) to reduce problematic prescription opioid use and encourage non-opioid pain&#xD;
      management alternatives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will develop and test the acceptability, feasibility, and preliminary&#xD;
      efficacy of a Collaborative Care intervention in which one of two Care Managers delivering&#xD;
      both interventions will assist primary care providers (PCPs) by using Motivational&#xD;
      Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support&#xD;
      guidelines to veterans with chronic pain. Specifically, after honing the intervention, the&#xD;
      investigators will conduct a pilot randomized controlled trial of Collaborative&#xD;
      Care/Motivational Interviewing in 100 veterans (ages 18 and older) with chronic pain in&#xD;
      primary care who are prescribed opioid pain medications and exhibit at least one &quot;high-risk&quot;&#xD;
      opioid use behavior (e.g. obtaining early opioid refills, etc.). Using ATHENA-OT decision&#xD;
      support, PCPs will make guideline-concordant recommendations to all enrolled study patients&#xD;
      and initiate a Pain Care Plan. Veterans randomized to Collaborative Care, will have one MI&#xD;
      session with their assigned study Care Manager followed by 3 Care Manager-delivered telephone&#xD;
      MI/monitoring sessions; patients randomized to the Attention Control arm will have one brief&#xD;
      session with their assigned Care Manager, followed by 3 Care Manager-delivered neutral&#xD;
      telephone sessions&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">June 12, 2017</completion_date>
  <primary_completion_date type="Actual">June 12, 2017</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention.</measure>
    <time_frame>20 weeks post baseline</time_frame>
    <description>PCPs and the CM in the Collaborative Care arm will report greater self-efficacy in communicating ATHENA-OT pain management recommendations and in developing a Pain Care Plan with chronic pain patients&#xD;
The CM will conduct MI communication with high fidelity.&#xD;
Veterans in the Collaborative Care arm will report greater satisfaction with pain-related care.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To preliminarily evaluate the efficacy of ATHENA-OT decision support plus Collaborative Care (CC) to improve prescription opioid safety and adherence to non-opioid pain management alternatives among primary care patients.</measure>
    <time_frame>20 weeks post baseline</time_frame>
    <description>Compared to ATHENA-OT plus Attention Control:&#xD;
H2.a. Veterans randomized to Collaborative Care (CC) will be more likely to achieve a decrease in opioid risk behavior that is sustained during an 8-week post-intervention period of no contact.&#xD;
H2.b. Veterans randomized to CC are more likely to initiate and sustain ≥ 1 non-opioid strategies.&#xD;
H2.c. Veterans randomized to CC are more likely to report sustained improvements in pain disability.&#xD;
H2.d. Substance use disorders and treatment will moderate CC efficacy; Care Manager MI-consistent communication in the CC arm will correlate with reduced opioid risk behavior in veterans.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The neutral 10-15 minute visit with the Care Manager will consist of a brief review of ATHENA-OT safety education and the patient's Pain Care Plan. The CM will answer patient questions, but will avoid using Motivational Interviewing communication. The Care Manager will review upcoming telephone check-in and assessment sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Collaborative Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Collaborative Care intervention in which one of two Care Managers delivering both interventions will assist primary care providers (PCPs) by using Motivational Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support guidelines to veterans with chronic pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing</intervention_name>
    <arm_group_label>Collaborative Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <arm_group_label>Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current Male or Female patient at San Francisco VA Medical Center or affiliated VA&#xD;
             clinics&#xD;
&#xD;
          -  Must be older than 18 years&#xD;
&#xD;
          -  Chronic musculoskeletal pain of at least 6 months duration and&#xD;
&#xD;
          -  Prescribed one or more opioid pain medication for more than three months and&#xD;
&#xD;
          -  Evidence of being a high-risk opioid user as determined by PI, electronic medical&#xD;
             record, and study measures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speakers&#xD;
&#xD;
          -  Plans to relocate within 6 months; not able to come to San Francisco VA Medical Center&#xD;
             for three in-person visits&#xD;
&#xD;
          -  Cancer or other terminal illness involving palliative care with opioid medications&#xD;
&#xD;
          -  Serious or untreated mental illness&#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>Karen Seal, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>SFVAMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Francisco VA Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://vetsreturnhome.com/index.html</url>
    <description>Veterans Return Home Research Group</description>
  </link>
  <reference>
    <citation>Okie S. A flood of opioids, a rising tide of deaths. N Engl J Med. 2010 Nov 18;363(21):1981-5. doi: 10.1056/NEJMp1011512. No abstract available. Erratum In: N Engl J Med. 2011 Jan 20;364(3):290.</citation>
    <PMID>21083382</PMID>
  </reference>
  <reference>
    <citation>Paulozzi LJ, Kilbourne EM, Desai HA. Prescription drug monitoring programs and death rates from drug overdose. Pain Med. 2011 May;12(5):747-54. doi: 10.1111/j.1526-4637.2011.01062.x. Epub 2011 Feb 18.</citation>
    <PMID>21332934</PMID>
  </reference>
  <reference>
    <citation>Boudreau D, Von Korff M, Rutter CM, Saunders K, Ray GT, Sullivan MD, Campbell CI, Merrill JO, Silverberg MJ, Banta-Green C, Weisner C. Trends in long-term opioid therapy for chronic non-cancer pain. Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1166-75. doi: 10.1002/pds.1833.</citation>
    <PMID>19718704</PMID>
  </reference>
  <reference>
    <citation>Paulozzi LJ; Centers for Disease Control and Prevention (CDC). Drug-induced deaths - United States, 2003-2007. MMWR Suppl. 2011 Jan 14;60(1):60-1. No abstract available.</citation>
    <PMID>21430623</PMID>
  </reference>
  <reference>
    <citation>Seal KH, Shi Y, Cohen G, Cohen BE, Maguen S, Krebs EE, Neylan TC. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. JAMA. 2012 Mar 7;307(9):940-7. doi: 10.1001/jama.2012.234. Erratum In: JAMA. 2012 Jun 20;307(23):2489.</citation>
    <PMID>22396516</PMID>
  </reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>June 29, 2017</last_update_submitted>
  <last_update_submitted_qc>June 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Francisco Veterans Affairs Medical Center</investigator_affiliation>
    <investigator_full_name>Karen Seal</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>opioids</keyword>
  <keyword>chronic pain</keyword>
  <keyword>collaborative care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT02230722
org study id: 13-11892
secondary id: R34AT008319-01
nct id: NCT02230722
lead sponsor: 
collaborator: 
has dmc: No
The investigators propose to develop a novel intervention that targets the system
      (Collaborative Care), PCP (computerized decision support for opioid therapy) and veteran
      (CM-delivered MI) to reduce problematic prescription opioid use and encourage non-opioid pain
      management alternatives.
The investigators will develop and test the acceptability, feasibility, and preliminary
      efficacy of a Collaborative Care intervention in which one of two Care Managers delivering
      both interventions will assist primary care providers (PCPs) by using Motivational
      Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support
      guidelines to veterans with chronic pain. Specifically, after honing the intervention, the
      investigators will conduct a pilot randomized controlled trial of Collaborative
      Care/Motivational Interviewing in 100 veterans (ages 18 and older) with chronic pain in
      primary care who are prescribed opioid pain medications and exhibit at least one "high-risk"
      opioid use behavior (e.g. obtaining early opioid refills, etc.). Using ATHENA-OT decision
      support, PCPs will make guideline-concordant recommendations to all enrolled study patients
      and initiate a Pain Care Plan. Veterans randomized to Collaborative Care, will have one MI
      session with their assigned study Care Manager followed by 3 Care Manager-delivered telephone
      MI/monitoring sessions; patients randomized to the Attention Control arm will have one brief
      session with their assigned Care Manager, followed by 3 Care Manager-delivered neutral
      telephone sessions
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention.
time frame: 20 weeks post baseline
description: PCPs and the CM in the Collaborative Care arm will report greater self-efficacy in communicating ATHENA-OT pain management recommendations and in developing a Pain Care Plan with chronic pain patients
The CM will conduct MI communication with high fidelity.
Veterans in the Collaborative Care arm will report greater satisfaction with pain-related care.
measure: To preliminarily evaluate the efficacy of ATHENA-OT decision support plus Collaborative Care (CC) to improve prescription opioid safety and adherence to non-opioid pain management alternatives among primary care patients.
time frame: 20 weeks post baseline
description: Compared to ATHENA-OT plus Attention Control:
H2.a. Veterans randomized to Collaborative Care (CC) will be more likely to achieve a decrease in opioid risk behavior that is sustained during an 8-week post-intervention period of no contact.
H2.b. Veterans randomized to CC are more likely to initiate and sustain ≥ 1 non-opioid strategies.
H2.c. Veterans randomized to CC are more likely to report sustained improvements in pain disability.
H2.d. Substance use disorders and treatment will moderate CC efficacy; Care Manager MI-consistent communication in the CC arm will correlate with reduced opioid risk behavior in veterans.
arm group label: Attention Control
arm group type: Active Comparator
description: The neutral 10-15 minute visit with the Care Manager will consist of a brief review of ATHENA-OT safety education and the patient's Pain Care Plan. The CM will answer patient questions, but will avoid using Motivational Interviewing communication. The Care Manager will review upcoming telephone check-in and assessment sessions.
arm group label: Collaborative Care
arm group type: Experimental
description: Collaborative Care intervention in which one of two Care Managers delivering both interventions will assist primary care providers (PCPs) by using Motivational Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support guidelines to veterans with chronic pain.
intervention type: Behavioral
intervention name: Motivational Interviewing
arm group label: Collaborative Care
intervention type: Behavioral
intervention name: Attention Control
arm group label: Attention Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karen Seal, MD, MPH
role: Principal Investigator
affiliation: SFVAMC
facility: 
country: United States
url: http://vetsreturnhome.com/index.html
description: Veterans Return Home Research Group
citation: Okie S. A flood of opioids, a rising tide of deaths. N Engl J Med. 2010 Nov 18;363(21):1981-5. doi: 10.1056/NEJMp1011512. No abstract available. Erratum In: N Engl J Med. 2011 Jan 20;364(3):290.
PMID: 21083382
citation: Paulozzi LJ, Kilbourne EM, Desai HA. Prescription drug monitoring programs and death rates from drug overdose. Pain Med. 2011 May;12(5):747-54. doi: 10.1111/j.1526-4637.2011.01062.x. Epub 2011 Feb 18.
PMID: 21332934
citation: Boudreau D, Von Korff M, Rutter CM, Saunders K, Ray GT, Sullivan MD, Campbell CI, Merrill JO, Silverberg MJ, Banta-Green C, Weisner C. Trends in long-term opioid therapy for chronic non-cancer pain. Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1166-75. doi: 10.1002/pds.1833.
PMID: 19718704
citation: Paulozzi LJ; Centers for Disease Control and Prevention (CDC). Drug-induced deaths - United States, 2003-2007. MMWR Suppl. 2011 Jan 14;60(1):60-1. No abstract available.
PMID: 21430623
citation: Seal KH, Shi Y, Cohen G, Cohen BE, Maguen S, Krebs EE, Neylan TC. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. JAMA. 2012 Mar 7;307(9):940-7. doi: 10.1001/jama.2012.234. Erratum In: JAMA. 2012 Jun 20;307(23):2489.
PMID: 22396516
responsible party type: Principal Investigator
investigator affiliation: San Francisco Veterans Affairs Medical Center
investigator full name: Karen Seal
investigator title: Principal Investigator
mesh term: Chronic Pain