<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/NCT03023930</url>
  </required_header>
  <id_info>
    <org_study_id>1611018631</org_study_id>
    <secondary_id>5UG1DA015831-15</secondary_id>
    <nct_id>NCT03023930</nct_id>
  </id_info>
  <brief_title>Opioid Use Disorder in the Emergency Department: CTN 0069</brief_title>
  <official_title>Opioid Use Disorder in the Emergency Department: Clinical Trials Network-0069</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Emmes Company, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</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>
      The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF)&#xD;
      on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP)&#xD;
      treatment with referral for ongoing medication-assisted treatment (MAT) and the (2)&#xD;
      effectiveness of IF on patient engagement in formal addiction treatment at 30 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was originally proposed to use a Hybrid Type 3 Effectiveness-Implementation&#xD;
      framework and a modified stepped wedge design.&#xD;
&#xD;
      Original protocol registration language: The study will be conducted at four EDs with a high&#xD;
      prevalence of patients with untreated opioid use disorder (OUD). The four sites will receive&#xD;
      the same sequence of evaluations and interventions: the baseline evaluation period after the&#xD;
      standard dissemination practice, the IF phase, and continuation of facilitation into the IF&#xD;
      evaluation period. The timing of initiation of the study activities at each site will be&#xD;
      randomly offset by ~ 3 month increments to accommodate logistical constraints of simultaneous&#xD;
      implementation at all sites. The study populations will include (1) ED providers and staff&#xD;
      involved in the treatment of patients with OUD; (2) Community opioid treatment provider and&#xD;
      program staff involved in providing care for patients with OUD referred from the ED; and (3)&#xD;
      ED patients with moderate to severe OUD.&#xD;
&#xD;
      Exploratory analyses have been added to assess the impact of COVID-19 and social distancing&#xD;
      guidance on drug use and drug supply; access to medications for opioid use disorder; and&#xD;
      COVID19 disease from the perspectives of patient participants and ED leadership.&#xD;
&#xD;
      Upon results entry, changes were made to reflect that the study design originally was&#xD;
      described as a &quot;modified step wedge&quot; but ultimately was not designed or implemented as such,&#xD;
      as there was no substantial overlap of the baseline evaluation and IF evaluation periods.&#xD;
      Thus, the statistical plan was adjusted accordingly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">April 23, 2022</completion_date>
  <primary_completion_date type="Actual">July 16, 2021</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Note: Care Providers and Research Associates are masked during Baseline Evaluation Period</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Implementation (Considered the Primary Outcome)</measure>
    <time_frame>12 months</time_frame>
    <description>The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness</measure>
    <time_frame>30 Days Post Enrollment</time_frame>
    <description>The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implementation: Fidelity</measure>
    <time_frame>Baseline Period (Baseline)</time_frame>
    <description>Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: Fidelity</measure>
    <time_frame>IF Evaluation Period (18 months)</time_frame>
    <description>Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: ED Provider Readiness and Preparedness Ruler Score</measure>
    <time_frame>Pre IF (Baseline)</time_frame>
    <description>ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: ED Provider Readiness and Preparedness Ruler Score</measure>
    <time_frame>Post IF (6 months)</time_frame>
    <description>ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: ED Provider Readiness and Preparedness Ruler Score</measure>
    <time_frame>post IF Evaluation Period (12 months)</time_frame>
    <description>ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score</measure>
    <time_frame>Pre IF (Baseline)</time_frame>
    <description>ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score</measure>
    <time_frame>Post IF (6 months)</time_frame>
    <description>ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score</measure>
    <time_frame>Post IF Evaluation Period (12 months)</time_frame>
    <description>ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: Community Readiness and Preparedness Ruler Score</measure>
    <time_frame>Pre IF (Baseline)</time_frame>
    <description>Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: Community Readiness and Preparedness Ruler Score</measure>
    <time_frame>Post IF (6 months)</time_frame>
    <description>Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: Community Readiness and Preparedness Ruler Score</measure>
    <time_frame>post IF Evaluation Period (12 months)</time_frame>
    <description>Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: Community ORCA Score</measure>
    <time_frame>Pre IF (Baseline)</time_frame>
    <description>Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: Community ORCA Score</measure>
    <time_frame>Post IF (6 months)</time_frame>
    <description>Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation: Community ORCA Score</measure>
    <time_frame>post IF Evaluation Period (12 months)</time_frame>
    <description>Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: Opioid Use</measure>
    <time_frame>30 days post enrollment</time_frame>
    <description>Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: Overdose Event</measure>
    <time_frame>30 days post enrollment</time_frame>
    <description>Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: HIV Risk</measure>
    <time_frame>30 days post enrollment</time_frame>
    <description>HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: Healthcare Service Utilization</measure>
    <time_frame>30 days post enrollment</time_frame>
    <description>All Healthcare Service Utilization Inpatient and Outpatient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: Illicit Opioid Urine Toxicology</measure>
    <time_frame>30 days post enrollment</time_frame>
    <description>Rates of illicit opioid negative urines</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1731</enrollment>
  <condition>Opioid Use Disorder</condition>
  <arm_group>
    <arm_group_label>Evidenced-based Practice Dissemination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluating standard dissemination practice compared with implementation facilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Dissemination Practice</intervention_name>
    <description>Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.</description>
    <arm_group_label>Evidenced-based Practice Dissemination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Implementation Facilitation (IF)</intervention_name>
    <description>IF involves a &quot;formative evaluation&quot; to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.</description>
    <arm_group_label>Evidenced-based Practice Dissemination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are treated in the ED during study screening hours with Diagnostic and&#xD;
             Statistical Manual (DSM)-5 criteria for moderate to severe OUD and provide an opioid&#xD;
             positive urine sample will be eligible to participate.&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
          -  Patients who test positive for fentanyl only are not eligible due to lack of uniformly&#xD;
             available rapid urine tests.&#xD;
&#xD;
          -  Patients will be excluded if they have a medical or psychiatric condition requiring&#xD;
             hospitalization at the index ED visit, are acutely suicidal or severely cognitively&#xD;
             impaired precluding informed consent, present from an extended care facility, require&#xD;
             continued prescription opioids for a pain condition, are a prisoner or in police&#xD;
             custody at time of index ED visit, are currently (past 30 days) enrolled in formal&#xD;
             addiction treatment including by court order, are unable to provide 2 contact numbers,&#xD;
             are unwilling to follow study procedures, have been previously enrolled in the current&#xD;
             study or do not speak English.&#xD;
&#xD;
        ED and Community Participants Inclusion Criteria:&#xD;
&#xD;
          -  ED and community providers and administrators (i.e. physicians, residents, fellows,&#xD;
             nursing, nurse practitioners, physician assistants, pharmacists, social workers,&#xD;
             counselors, administrative directors, office-based physicians and opioid treatment&#xD;
             program representatives) as well as ED patients with OUD.&#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>Gail D'Onofrio, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Emergency Medicine, Yale School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David A Fiellin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Internal Medicine, Yale School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>D'Onofrio G, O'Connor PG, Pantalon MV, Chawarski MC, Busch SH, Owens PH, Bernstein SL, Fiellin DA. Emergency department-initiated buprenorphine/naloxone treatment for opioid dependence: a randomized clinical trial. JAMA. 2015 Apr 28;313(16):1636-44. doi: 10.1001/jama.2015.3474.</citation>
    <PMID>25919527</PMID>
  </reference>
  <reference>
    <citation>Coupet E Jr, D'Onofrio G, Chawarski M, Edelman EJ, O'Connor PG, Owens P, Martel S, Fiellin DA, Cowan E, Richardson L, Huntley K, Whiteside LK, Lyons MS, Rothman RE, Pantalon M, Hawk K. Emergency department patients with untreated opioid use disorder: A comparison of those seeking versus not seeking referral to substance use treatment. Drug Alcohol Depend. 2021 Feb 1;219:108428. doi: 10.1016/j.drugalcdep.2020.108428. Epub 2020 Nov 26.</citation>
    <PMID>33307301</PMID>
  </reference>
  <reference>
    <citation>Chawarski MC, Hawk K, Edelman EJ, O'Connor P, Owens P, Martel S, Coupet E Jr, Whiteside L, Tsui JI, Rothman R, Cowan E, Richardson L, Lyons MS, Fiellin DA, D'Onofrio G. Use of Amphetamine-Type Stimulants Among Emergency Department Patients With Untreated Opioid Use Disorder. Ann Emerg Med. 2020 Dec;76(6):782-787. doi: 10.1016/j.annemergmed.2020.06.046. Epub 2020 Aug 8.</citation>
    <PMID>32782084</PMID>
  </reference>
  <reference>
    <citation>Hawk KF, D'Onofrio G, Chawarski MC, O'Connor PG, Cowan E, Lyons MS, Richardson L, Rothman RE, Whiteside LK, Owens PH, Martel SH, Coupet E Jr, Pantalon M, Curry L, Fiellin DA, Edelman EJ. Barriers and Facilitators to Clinician Readiness to Provide Emergency Department-Initiated Buprenorphine. JAMA Netw Open. 2020 May 1;3(5):e204561. doi: 10.1001/jamanetworkopen.2020.4561.</citation>
    <PMID>32391893</PMID>
  </reference>
  <reference>
    <citation>D'Onofrio G, Edelman EJ, Hawk KF, Pantalon MV, Chawarski MC, Owens PH, Martel SH, VanVeldhuisen P, Oden N, Murphy SM, Huntley K, O'Connor PG, Fiellin DA. Implementation facilitation to promote emergency department-initiated buprenorphine for opioid use disorder: protocol for a hybrid type III effectiveness-implementation study (Project ED HEALTH). Implement Sci. 2019 May 7;14(1):48. doi: 10.1186/s13012-019-0891-5.</citation>
    <PMID>31064390</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>July 15, 2022</results_first_submitted>
  <results_first_submitted_qc>February 16, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2023</results_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid Use Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 22, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03023930/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03023930/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 18, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03023930/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 27,748 patients were screened during the baseline evaluation period and 394 were enrolled and analyzed. During the IF evaluation period, 26,456 were screened and 362 enrolled and analyzed. The study was originally conceived as a &quot;modified step wedge&quot; but not designed or implemented as such, as there was no substantial overlap of the baseline evaluation and IF evaluation periods. A total of 975 unique providers were assessed across the study periods via survey.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Baseline Evaluation Period Cohort</title>
          <description>Evaluating standard dissemination practice compared with implementation facilitation&#xD;
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.&#xD;
Implementation Facilitation (IF): IF involves a &quot;formative evaluation&quot; to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.</description>
        </group>
        <group group_id="P2">
          <title>IF Evaluation Period</title>
          <description>Evaluating standard dissemination practice compared with implementation facilitation&#xD;
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.&#xD;
Implementation Facilitation (IF): IF involves a &quot;formative evaluation&quot; to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.</description>
        </group>
        <group group_id="P3">
          <title>Providers - Baseline Period</title>
          <description>Unique total number of providers added during Baseline Period</description>
        </group>
        <group group_id="P4">
          <title>Providers - 6 Month Period</title>
          <description>Unique total number of providers added at 6 Month Period</description>
        </group>
        <group group_id="P5">
          <title>Providers - 12 Month Period</title>
          <description>Unique total number of providers added at the 12 Month Period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="394"/>
                <participants group_id="P2" count="362"/>
                <participants group_id="P3" count="706"/>
                <participants group_id="P4" count="92"/>
                <participants group_id="P5" count="177"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="394"/>
                <participants group_id="P2" count="362"/>
                <participants group_id="P3" count="706"/>
                <participants group_id="P4" count="92"/>
                <participants group_id="P5" count="177"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics were not collected for providers.</population>
      <group_list>
        <group group_id="B1">
          <title>Baseline Evaluation Period Cohort</title>
          <description>Evaluating standard dissemination practice compared with implementation facilitation&#xD;
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.&#xD;
Implementation Facilitation (IF): IF involves a &quot;formative evaluation&quot; to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.</description>
        </group>
        <group group_id="B2">
          <title>IF Evaluation Period Cohort</title>
          <description>Evaluating standard dissemination practice compared with implementation facilitation&#xD;
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.&#xD;
Implementation Facilitation (IF): IF involves a &quot;formative evaluation&quot; to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="394"/>
            <count group_id="B2" value="362"/>
            <count group_id="B3" value="756"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.9" spread="11.7"/>
                    <measurement group_id="B2" value="39.7" spread="11.7"/>
                    <measurement group_id="B3" value="39.3" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="121"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="216"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="273"/>
                    <measurement group_id="B2" value="267"/>
                    <measurement group_id="B3" value="540"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="345"/>
                    <measurement group_id="B2" value="323"/>
                    <measurement group_id="B3" value="668"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="223"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="206"/>
                    <measurement group_id="B2" value="188"/>
                    <measurement group_id="B3" value="394"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="394"/>
                    <measurement group_id="B2" value="362"/>
                    <measurement group_id="B3" value="756"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than high school diploma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="266"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school graduate or equivalent (GED)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="146"/>
                    <measurement group_id="B3" value="276"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some college, no degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ College degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Working</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unemployed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="228"/>
                    <measurement group_id="B2" value="192"/>
                    <measurement group_id="B3" value="420"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disabled permanently or temporarily</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Unstable Housing</title>
          <description>Spent at least one night in the past 12 months in any of the following places.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Shelter for homeless persons</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>On the street/public place not intended for sleeping</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="191"/>
                    <measurement group_id="B2" value="192"/>
                    <measurement group_id="B3" value="383"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Doubled up in someone else's house apartment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="190"/>
                    <measurement group_id="B2" value="135"/>
                    <measurement group_id="B3" value="325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Currently living in any of the following places</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Shelter for homeless persons</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>On the street or public place not intended for sleeping</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Welfare hotel or SRO</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emergency, temporary, transitional or halfway house</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Health insurance</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Private/commercial</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medicare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medicaid</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="287"/>
                    <measurement group_id="B2" value="254"/>
                    <measurement group_id="B3" value="541"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Medical Provider</title>
          <population>393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="393"/>
                    <count group_id="B2" value="361"/>
                    <count group_id="B3" value="754"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Private physician office</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Clinic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="212"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Emergency Department or none</title>
                  <measurement_list>
                    <measurement group_id="B1" value="217"/>
                    <measurement group_id="B2" value="204"/>
                    <measurement group_id="B3" value="421"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Positive UDS results by substance</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Benzodiazepines</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amphetamine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marijuana</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Methamphetamine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="146"/>
                    <measurement group_id="B2" value="141"/>
                    <measurement group_id="B3" value="287"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Opiates (300 ng)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="328"/>
                    <measurement group_id="B2" value="283"/>
                    <measurement group_id="B3" value="611"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cocaine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="177"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="342"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ecstasy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oxycodone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="159"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="298"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Methadone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Barbiturates</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Buprenorphine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="169"/>
                    <measurement group_id="B3" value="313"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fentanyl</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                    <measurement group_id="B2" value="216"/>
                    <measurement group_id="B3" value="416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Overdose History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Overdosed at least once in the past 30 days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Report a medical intervention overdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection drug use past month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="232"/>
                    <measurement group_id="B2" value="185"/>
                    <measurement group_id="B3" value="417"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mental Health History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Psych eval during the ED visit?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lifetime psychiatric treatment: Inpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="161"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lifetime psychiatric treatment: Outpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="185"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="335"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any psychiatric treatment, past 30 day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="394"/>
                    <count group_id="B2" value="362"/>
                    <count group_id="B3" value="756"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Implementation (Considered the Primary Outcome)</title>
        <description>The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Baseline Evaluation Period Cohort</title>
            <description>Evaluating standard dissemination practice compared with implementation facilitation&#xD;
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.&#xD;
Implementation Facilitation (IF): IF involves a &quot;formative evaluation&quot; to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.</description>
          </group>
          <group group_id="O2">
            <title>IF Evaluation Period Cohort</title>
            <description>Evaluating standard dissemination practice compared with implementation facilitation&#xD;
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.&#xD;
Implementation Facilitation (IF): IF involves a &quot;formative evaluation&quot; to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Implementation (Considered the Primary Outcome)</title>
          <description>The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="394"/>
                <count group_id="O2" value="362"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <method_desc>proc logistic</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Effectiveness</title>
        <description>The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.</description>
        <time_frame>30 Days Post Enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Baseline Evaluation Period Cohort</title>
            <description>Evaluating standard dissemination practice compared with implementation facilitation&#xD;
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.&#xD;
Implementation Facilitation (IF): IF involves a &quot;formative evaluation&quot; to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.</description>
          </group>
          <group group_id="O2">
            <title>IF Evaluation Period Cohort</title>
            <description>Evaluating standard dissemination practice compared with implementation facilitation&#xD;
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.&#xD;
Implementation Facilitation (IF): IF involves a &quot;formative evaluation&quot; to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Effectiveness</title>
          <description>The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="394"/>
                <count group_id="O2" value="362"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011</p_value>
            <method>Regression, Logistic</method>
            <method_desc>proc logistic</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: Fidelity</title>
        <description>Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.</description>
        <time_frame>Baseline Period (Baseline)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: Fidelity</title>
        <description>Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.</description>
        <time_frame>IF Evaluation Period (18 months)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: ED Provider Readiness and Preparedness Ruler Score</title>
        <description>ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT</description>
        <time_frame>Pre IF (Baseline)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: ED Provider Readiness and Preparedness Ruler Score</title>
        <description>ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT</description>
        <time_frame>Post IF (6 months)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: ED Provider Readiness and Preparedness Ruler Score</title>
        <description>ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT</description>
        <time_frame>post IF Evaluation Period (12 months)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score</title>
        <description>ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT</description>
        <time_frame>Pre IF (Baseline)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score</title>
        <description>ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT</description>
        <time_frame>Post IF (6 months)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score</title>
        <description>ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT</description>
        <time_frame>Post IF Evaluation Period (12 months)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: Community Readiness and Preparedness Ruler Score</title>
        <description>Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP</description>
        <time_frame>Pre IF (Baseline)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: Community Readiness and Preparedness Ruler Score</title>
        <description>Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP</description>
        <time_frame>Post IF (6 months)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: Community Readiness and Preparedness Ruler Score</title>
        <description>Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP</description>
        <time_frame>post IF Evaluation Period (12 months)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: Community ORCA Score</title>
        <description>Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP</description>
        <time_frame>Pre IF (Baseline)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: Community ORCA Score</title>
        <description>Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP</description>
        <time_frame>Post IF (6 months)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implementation: Community ORCA Score</title>
        <description>Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP</description>
        <time_frame>post IF Evaluation Period (12 months)</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effectiveness: Opioid Use</title>
        <description>Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days</description>
        <time_frame>30 days post enrollment</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effectiveness: Overdose Event</title>
        <description>Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records</description>
        <time_frame>30 days post enrollment</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effectiveness: HIV Risk</title>
        <description>HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale</description>
        <time_frame>30 days post enrollment</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effectiveness: Healthcare Service Utilization</title>
        <description>All Healthcare Service Utilization Inpatient and Outpatient</description>
        <time_frame>30 days post enrollment</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effectiveness: Illicit Opioid Urine Toxicology</title>
        <description>Rates of illicit opioid negative urines</description>
        <time_frame>30 days post enrollment</time_frame>
        <posting_date>04/2023</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data was collected over 12 months.</time_frame>
      <desc>There was no adverse event monitoring for providers taking part in the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Baseline Evaluation Period Cohort</title>
          <description>Evaluating standard dissemination practice compared with implementation facilitation&#xD;
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.&#xD;
Implementation Facilitation (IF): IF involves a &quot;formative evaluation&quot; to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.</description>
        </group>
        <group group_id="E2">
          <title>IF Evaluation Period</title>
          <description>Evaluating standard dissemination practice compared with implementation facilitation&#xD;
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.&#xD;
Implementation Facilitation (IF): IF involves a &quot;formative evaluation&quot; to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="394"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="394"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="394"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Gail D'Onofrio</name_or_title>
      <organization>Yale University</organization>
      <phone>(203) 785-7059</phone>
      <email>gail.donofrio@yale.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03023930
org study id: 1611018631
secondary id: 5UG1DA015831-15
nct id: NCT03023930
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF)
      on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP)
      treatment with referral for ongoing medication-assisted treatment (MAT) and the (2)
      effectiveness of IF on patient engagement in formal addiction treatment at 30 days.
The study was originally proposed to use a Hybrid Type 3 Effectiveness-Implementation
      framework and a modified stepped wedge design.

      Original protocol registration language: The study will be conducted at four EDs with a high
      prevalence of patients with untreated opioid use disorder (OUD). The four sites will receive
      the same sequence of evaluations and interventions: the baseline evaluation period after the
      standard dissemination practice, the IF phase, and continuation of facilitation into the IF
      evaluation period. The timing of initiation of the study activities at each site will be
      randomly offset by ~ 3 month increments to accommodate logistical constraints of simultaneous
      implementation at all sites. The study populations will include (1) ED providers and staff
      involved in the treatment of patients with OUD; (2) Community opioid treatment provider and
      program staff involved in providing care for patients with OUD referred from the ED; and (3)
      ED patients with moderate to severe OUD.

      Exploratory analyses have been added to assess the impact of COVID-19 and social distancing
      guidance on drug use and drug supply; access to medications for opioid use disorder; and
      COVID19 disease from the perspectives of patient participants and ED leadership.

      Upon results entry, changes were made to reflect that the study design originally was
      described as a "modified step wedge" but ultimately was not designed or implemented as such,
      as there was no substantial overlap of the baseline evaluation and IF evaluation periods.
      Thus, the statistical plan was adjusted accordingly.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
masking description: Note: Care Providers and Research Associates are masked during Baseline Evaluation Period
measure: Implementation (Considered the Primary Outcome)
time frame: 12 months
description: The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT
measure: Effectiveness
time frame: 30 Days Post Enrollment
description: The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.
measure: Implementation: Fidelity
time frame: Baseline Period (Baseline)
description: Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
measure: Implementation: Fidelity
time frame: IF Evaluation Period (18 months)
description: Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
measure: Implementation: ED Provider Readiness and Preparedness Ruler Score
time frame: Pre IF (Baseline)
description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
measure: Implementation: ED Provider Readiness and Preparedness Ruler Score
time frame: Post IF (6 months)
description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
measure: Implementation: ED Provider Readiness and Preparedness Ruler Score
time frame: post IF Evaluation Period (12 months)
description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
time frame: Pre IF (Baseline)
description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
time frame: Post IF (6 months)
description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
time frame: Post IF Evaluation Period (12 months)
description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
measure: Implementation: Community Readiness and Preparedness Ruler Score
time frame: Pre IF (Baseline)
description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
measure: Implementation: Community Readiness and Preparedness Ruler Score
time frame: Post IF (6 months)
description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
measure: Implementation: Community Readiness and Preparedness Ruler Score
time frame: post IF Evaluation Period (12 months)
description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
measure: Implementation: Community ORCA Score
time frame: Pre IF (Baseline)
description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
measure: Implementation: Community ORCA Score
time frame: Post IF (6 months)
description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
measure: Implementation: Community ORCA Score
time frame: post IF Evaluation Period (12 months)
description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
measure: Effectiveness: Opioid Use
time frame: 30 days post enrollment
description: Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days
measure: Effectiveness: Overdose Event
time frame: 30 days post enrollment
description: Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records
measure: Effectiveness: HIV Risk
time frame: 30 days post enrollment
description: HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale
measure: Effectiveness: Healthcare Service Utilization
time frame: 30 days post enrollment
description: All Healthcare Service Utilization Inpatient and Outpatient
measure: Effectiveness: Illicit Opioid Urine Toxicology
time frame: 30 days post enrollment
description: Rates of illicit opioid negative urines
arm group label: Evidenced-based Practice Dissemination
arm group type: Experimental
description: Evaluating standard dissemination practice compared with implementation facilitation
intervention type: Other
intervention name: Standard Dissemination Practice
description: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.
arm group label: Evidenced-based Practice Dissemination
intervention type: Other
intervention name: Implementation Facilitation (IF)
description: IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.
arm group label: Evidenced-based Practice Dissemination
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gail D'Onofrio, MD, MS
role: Principal Investigator
affiliation: Department of Emergency Medicine, Yale School of Medicine
last name: David A Fiellin, MD
role: Principal Investigator
affiliation: Department of Internal Medicine, Yale School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: D'Onofrio G, O'Connor PG, Pantalon MV, Chawarski MC, Busch SH, Owens PH, Bernstein SL, Fiellin DA. Emergency department-initiated buprenorphine/naloxone treatment for opioid dependence: a randomized clinical trial. JAMA. 2015 Apr 28;313(16):1636-44. doi: 10.1001/jama.2015.3474.
PMID: 25919527
citation: Coupet E Jr, D'Onofrio G, Chawarski M, Edelman EJ, O'Connor PG, Owens P, Martel S, Fiellin DA, Cowan E, Richardson L, Huntley K, Whiteside LK, Lyons MS, Rothman RE, Pantalon M, Hawk K. Emergency department patients with untreated opioid use disorder: A comparison of those seeking versus not seeking referral to substance use treatment. Drug Alcohol Depend. 2021 Feb 1;219:108428. doi: 10.1016/j.drugalcdep.2020.108428. Epub 2020 Nov 26.
PMID: 33307301
citation: Chawarski MC, Hawk K, Edelman EJ, O'Connor P, Owens P, Martel S, Coupet E Jr, Whiteside L, Tsui JI, Rothman R, Cowan E, Richardson L, Lyons MS, Fiellin DA, D'Onofrio G. Use of Amphetamine-Type Stimulants Among Emergency Department Patients With Untreated Opioid Use Disorder. Ann Emerg Med. 2020 Dec;76(6):782-787. doi: 10.1016/j.annemergmed.2020.06.046. Epub 2020 Aug 8.
PMID: 32782084
citation: Hawk KF, D'Onofrio G, Chawarski MC, O'Connor PG, Cowan E, Lyons MS, Richardson L, Rothman RE, Whiteside LK, Owens PH, Martel SH, Coupet E Jr, Pantalon M, Curry L, Fiellin DA, Edelman EJ. Barriers and Facilitators to Clinician Readiness to Provide Emergency Department-Initiated Buprenorphine. JAMA Netw Open. 2020 May 1;3(5):e204561. doi: 10.1001/jamanetworkopen.2020.4561.
PMID: 32391893
citation: D'Onofrio G, Edelman EJ, Hawk KF, Pantalon MV, Chawarski MC, Owens PH, Martel SH, VanVeldhuisen P, Oden N, Murphy SM, Huntley K, O'Connor PG, Fiellin DA. Implementation facilitation to promote emergency department-initiated buprenorphine for opioid use disorder: protocol for a hybrid type III effectiveness-implementation study (Project ED HEALTH). Implement Sci. 2019 May 7;14(1):48. doi: 10.1186/s13012-019-0891-5.
PMID: 31064390
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Opioid-Related Disorders
mesh term: Substance-Related Disorders
sharing ipd: Yes
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 