<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/NCT03821649</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03821649</nct_id>
  </id_info>
  <brief_title>SOONER Feasibility Study Protocol</brief_title>
  <acronym>SOONER</acronym>
  <official_title>Protocol for a Mixed Methods Feasibility Study for the Surviving Opioid Overdose With Naloxone Education and Resuscitation (SOONER) Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>OCAD University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Toronto Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Unity Health Toronto</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>
      Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and&#xD;
      equipping people who are likely to be bystanders to opioid overdose to recognize and respond&#xD;
      to opioid-related emergencies by activating emergency services, delivering basic life support&#xD;
      and administering naloxone. The goal of the Surviving Opioid Overdose with Naloxone Education&#xD;
      and Resuscitation (SOONER) trial is to identify if point-of-care OEND increases rates of&#xD;
      satisfactory bystander resuscitative performance to simulated opioid overdose in comparison&#xD;
      with the existing standard of care. Recruitment and retention of participants at risk of&#xD;
      overdose, and the acceptability of the simulated overdose outcome may challenge the&#xD;
      feasibility of the SOONER trial. The primary objective is to identify if an integrated&#xD;
      participant recruitment and retention strategy can recruit approximately 28 eligible&#xD;
      participants within 4 weeks and maintain less than 50% attrition in the context of a&#xD;
      randomized trial on point-of-care OEND and simulated overdose resuscitation performance in&#xD;
      family practice, emergency department, and addictions settings in Toronto, Ontario. After the&#xD;
      initial 28 participants, we are continuing to recruit up to 50 more participants in a&#xD;
      bridging phase that leads into the full trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Deaths from opioid overdose represent an important and expanding global public health&#xD;
      epidemic. Opioid Overdose Education and Naloxone Distribution programs (OEND) involve&#xD;
      training and equipping people who are likely to witness overdose to recognize these&#xD;
      emergencies and administer essential first aid interventions including naloxone, a widely&#xD;
      known and effective competitive opioid antagonist. Policymakers and practitioners have called&#xD;
      for expanded access to OEND programs in clinical settings such as emergency departments,&#xD;
      family practice, and addiction medicine clinics, or &quot;point-of-care OEND&quot;. Point-of-care OEND&#xD;
      would improve access to this potentially life-saving intervention. Simple and effective&#xD;
      point-of-care OEND tools are a prerequisite for the successful translation of this&#xD;
      intervention into general ambulatory settings, including family practice, addiction medicine&#xD;
      and psychiatry clinics, and emergency departments. The investigators plan to conduct a&#xD;
      randomized trial to evaluate the educational effectiveness of a novel point-of-care OEND kit&#xD;
      in a simulated opioid overdose, in comparison with existing community- and hospital-based&#xD;
      OEND programs.&#xD;
&#xD;
      Conducting trials among people who use drugs or who are likely to witness overdose involves&#xD;
      several well-documented scientific, logistical, and bioethical challenges. These challenges&#xD;
      contribute to the persistent under-evaluation of interventions to enhance the health of this&#xD;
      marginalized population, and threats to study validity when retention rates are low.&#xD;
&#xD;
      Recruitment, retention and attrition rates could alter the study timelines, logistics and&#xD;
      costs for the proposed trial. A feasibility study is needed to evaluate and refine an&#xD;
      integrated participant recruitment and retention strategy, develop expected retention rates,&#xD;
      establish the local acceptability of study procedures in recruitment sites, and reconsider&#xD;
      study design and analysis if required. A feasibility study will also permit the evaluation of&#xD;
      basic randomization and data collection procedures.&#xD;
&#xD;
      The primary objective of this feasibility study is to identify if an integrated participant&#xD;
      recruitment and retention strategy can recruit approximately 28 eligible participants within&#xD;
      4 weeks and maintain less than 50% attrition in the context of a randomized trial on&#xD;
      point-of-care OEND and simulated overdose resuscitation performance in family practice,&#xD;
      emergency department, and addiction medicine settings at St. Michael's Hospital, and in&#xD;
      family practice at the Inner City Family Health Team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Actual">December 10, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant recruitment rate (participants recruited in 4 weeks)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Approximately 28 participants are recruited within 4 weeks.&#xD;
The recruitment and retention strategy will be deemed &quot;feasible&quot; if BOTH of the following conditions are met:&#xD;
(A) approximately 28 participants are recruited within 4 weeks, AND (B) there is less than 50% attrition at the underlying study's outcome simulation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant attrition at the underlying study's outcome simulation</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>less than 50% attrition at the underlying study's outcome simulation.&#xD;
Primary outcome description: The recruitment and retention strategy will be deemed &quot;feasible&quot; if BOTH of the following conditions are met:&#xD;
(A) approximately 28 participants are recruited within 4 weeks, AND (B) there is less than 50% attrition at the underlying study's outcome simulation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Site recruitment rates</measure>
    <time_frame>28 days</time_frame>
    <description>Rate of participant recruitment in each of the family practice, emergency department, and addiction medicine sites associated with a single academic health care centre.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant retention rates</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Comparison of retention rate between intervention and control arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptions of study process problems</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Semi-structured interviews with study participants and unstructured verbal and written feedback from study and recruitment site staff concerning challenges and opportunities for improving any study processes (including participant recruitment, randomization, implementation of the intervention and control, retention, follow-up, outcome assessment and data collection).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Overdose</condition>
  <arm_group>
    <arm_group_label>SOONER Training and Naloxone Kit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will be shown the SOONER overdose response training video at the time of recruitment and given the SOONER Naloxone kit to take home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community or Hospital-Based Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control arm - participants in this arm will be referred to the standard of care for Naloxone training. This standard of care includes community-based OEND programs and/or an existing hospital-based OEND program..</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SOONER Training and Naloxone Kit Kit</intervention_name>
    <description>Participants are shown our unique overdose response education video and given the associated kit to take home.</description>
    <arm_group_label>SOONER Training and Naloxone Kit</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community or Hospital-Based Training</intervention_name>
    <description>Referral to standard of care for Naloxone training</description>
    <arm_group_label>Community or Hospital-Based Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Participants are eligible by meeting any one or more of the following:&#xD;
&#xD;
          1. Have a history of taking opioids at recognized 'high doses' (whether by prescription&#xD;
             or otherwise, defined as &gt;100mg morphine equivalent per day).&#xD;
&#xD;
          2. Live with or is in frequent contact with others who use opioids or heroin.&#xD;
&#xD;
          3. Have required emergency care for opioid overdose previously.&#xD;
&#xD;
          4. Are enrolled in opioid agonist treatment programs (or has been in the last 6 months),&#xD;
             including methadone or buprenorphine maintenance programs, particularly at high risk&#xD;
             periods such as induction or discharge.&#xD;
&#xD;
          5. Are being released from prison, and have a history of non-medical opioid use.&#xD;
&#xD;
          6. Are receiving prescription opioid therapy with risk factors for adverse effects,&#xD;
             including relevant comorbidities, co-prescriptions of benzodiazepines or other&#xD;
             sedatives, concomitant ongoing alcohol use, or high dose prescription opioid therapy.&#xD;
&#xD;
          7. Uses non-medical opioids, injects opioids, or acquires opioids from sources other than&#xD;
             a pharmacy or healthcare setting.&#xD;
&#xD;
        Exclusion Criteria: Participants are ineligible by meeting any one or more of the&#xD;
        following:&#xD;
&#xD;
          1. Have a community do not resuscitate order.&#xD;
&#xD;
          2. Have a terminal illness, end-of-life care, or illness likely to result in death within&#xD;
             the study period.&#xD;
&#xD;
          3. Have no mode of contact or follow-up.&#xD;
&#xD;
          4. Plan to move away from Toronto during the study period.&#xD;
&#xD;
          5. Have insufficient English language skills to participate in the study.&#xD;
&#xD;
          6. Are an active or previously practicing healthcare professional or professional first&#xD;
             responder (e.g.: firefighter, police officer, lifeguard, industrial first responder).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Inner City Family Health Team</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Michael's Hospital Emergency Department</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Micheal's Health Centre at 410</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Micheal's Hospital Rapid Access Addictions Medicine Clinic</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>United Nations Office on Drugs and Crime, World Health Organization. Discussion paper UNODC/WHO 2013: Opioid overdose: preventing and reducing opioid overdose mortality. 2013; Available at: http://www.unodc.org/docs/treatment/overdose.pdf. Accessed 04/23, 2014. Archived by WebCite© at http://www.webcitation.org/6U3qbjl2E)</citation>
  </reference>
  <reference>
    <citation>Clark AK, Wilder CM, Winstanley EL. A systematic review of community opioid overdose prevention and naloxone distribution programs. J Addict Med. 2014 May-Jun;8(3):153-63. doi: 10.1097/ADM.0000000000000034.</citation>
    <PMID>24874759</PMID>
  </reference>
  <reference>
    <citation>Doyon S, Aks SE, Schaeffer S. Expanding access to naloxone in the United States. J Med Toxicol. 2014 Dec;10(4):431-4. doi: 10.1007/s13181-014-0432-1. No abstract available.</citation>
    <PMID>25316516</PMID>
  </reference>
  <reference>
    <citation>Beletsky L, Ruthazer R, Macalino GE, Rich JD, Tan L, Burris S. Physicians' knowledge of and willingness to prescribe naloxone to reverse accidental opiate overdose: challenges and opportunities. J Urban Health. 2007 Jan;84(1):126-36. doi: 10.1007/s11524-006-9120-z.</citation>
    <PMID>17146712</PMID>
  </reference>
  <reference>
    <citation>Coffin PO, Fuller C, Vadnai L, Blaney S, Galea S, Vlahov D. Preliminary evidence of health care provider support for naloxone prescription as overdose fatality prevention strategy in New York City. J Urban Health. 2003 Jun;80(2):288-90. doi: 10.1093/jurban/jtg031.</citation>
    <PMID>12791804</PMID>
  </reference>
  <reference>
    <citation>Meyers K, Webb A, Frantz J, Randall M. What does it take to retain substance-abusing adolescents in research protocols? Delineation of effort required, strategies undertaken, costs incurred, and 6-month post-treatment differences by retention difficulty. Drug Alcohol Depend. 2003 Jan 24;69(1):73-85. doi: 10.1016/s0376-8716(02)00252-1.</citation>
    <PMID>12536068</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>May 20, 2022</last_update_submitted>
  <last_update_submitted_qc>May 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Education</keyword>
  <keyword>Naloxone</keyword>
  <keyword>Opioid</keyword>
  <keyword>Overdose</keyword>
  <keyword>Resuscitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug Overdose</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naloxone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03821649
org study id: 1
nct id: NCT03821649
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and
      equipping people who are likely to be bystanders to opioid overdose to recognize and respond
      to opioid-related emergencies by activating emergency services, delivering basic life support
      and administering naloxone. The goal of the Surviving Opioid Overdose with Naloxone Education
      and Resuscitation (SOONER) trial is to identify if point-of-care OEND increases rates of
      satisfactory bystander resuscitative performance to simulated opioid overdose in comparison
      with the existing standard of care. Recruitment and retention of participants at risk of
      overdose, and the acceptability of the simulated overdose outcome may challenge the
      feasibility of the SOONER trial. The primary objective is to identify if an integrated
      participant recruitment and retention strategy can recruit approximately 28 eligible
      participants within 4 weeks and maintain less than 50% attrition in the context of a
      randomized trial on point-of-care OEND and simulated overdose resuscitation performance in
      family practice, emergency department, and addictions settings in Toronto, Ontario. After the
      initial 28 participants, we are continuing to recruit up to 50 more participants in a
      bridging phase that leads into the full trial.
Deaths from opioid overdose represent an important and expanding global public health
      epidemic. Opioid Overdose Education and Naloxone Distribution programs (OEND) involve
      training and equipping people who are likely to witness overdose to recognize these
      emergencies and administer essential first aid interventions including naloxone, a widely
      known and effective competitive opioid antagonist. Policymakers and practitioners have called
      for expanded access to OEND programs in clinical settings such as emergency departments,
      family practice, and addiction medicine clinics, or "point-of-care OEND". Point-of-care OEND
      would improve access to this potentially life-saving intervention. Simple and effective
      point-of-care OEND tools are a prerequisite for the successful translation of this
      intervention into general ambulatory settings, including family practice, addiction medicine
      and psychiatry clinics, and emergency departments. The investigators plan to conduct a
      randomized trial to evaluate the educational effectiveness of a novel point-of-care OEND kit
      in a simulated opioid overdose, in comparison with existing community- and hospital-based
      OEND programs.

      Conducting trials among people who use drugs or who are likely to witness overdose involves
      several well-documented scientific, logistical, and bioethical challenges. These challenges
      contribute to the persistent under-evaluation of interventions to enhance the health of this
      marginalized population, and threats to study validity when retention rates are low.

      Recruitment, retention and attrition rates could alter the study timelines, logistics and
      costs for the proposed trial. A feasibility study is needed to evaluate and refine an
      integrated participant recruitment and retention strategy, develop expected retention rates,
      establish the local acceptability of study procedures in recruitment sites, and reconsider
      study design and analysis if required. A feasibility study will also permit the evaluation of
      basic randomization and data collection procedures.

      The primary objective of this feasibility study is to identify if an integrated participant
      recruitment and retention strategy can recruit approximately 28 eligible participants within
      4 weeks and maintain less than 50% attrition in the context of a randomized trial on
      point-of-care OEND and simulated overdose resuscitation performance in family practice,
      emergency department, and addiction medicine settings at St. Michael's Hospital, and in
      family practice at the Inner City Family Health Team.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Participant recruitment rate (participants recruited in 4 weeks)
time frame: 4 weeks
description: Approximately 28 participants are recruited within 4 weeks.
The recruitment and retention strategy will be deemed "feasible" if BOTH of the following conditions are met:
(A) approximately 28 participants are recruited within 4 weeks, AND (B) there is less than 50% attrition at the underlying study's outcome simulation.
measure: Participant attrition at the underlying study's outcome simulation
time frame: 4-6 weeks
description: less than 50% attrition at the underlying study's outcome simulation.
Primary outcome description: The recruitment and retention strategy will be deemed "feasible" if BOTH of the following conditions are met:
(A) approximately 28 participants are recruited within 4 weeks, AND (B) there is less than 50% attrition at the underlying study's outcome simulation.
measure: Site recruitment rates
time frame: 28 days
description: Rate of participant recruitment in each of the family practice, emergency department, and addiction medicine sites associated with a single academic health care centre.
measure: Participant retention rates
time frame: 4-6 weeks
description: Comparison of retention rate between intervention and control arms
measure: Descriptions of study process problems
time frame: 4-6 weeks
description: Semi-structured interviews with study participants and unstructured verbal and written feedback from study and recruitment site staff concerning challenges and opportunities for improving any study processes (including participant recruitment, randomization, implementation of the intervention and control, retention, follow-up, outcome assessment and data collection).
arm group label: SOONER Training and Naloxone Kit
arm group type: Experimental
description: Participants in this arm will be shown the SOONER overdose response training video at the time of recruitment and given the SOONER Naloxone kit to take home.
arm group label: Community or Hospital-Based Training
arm group type: Active Comparator
description: Control arm - participants in this arm will be referred to the standard of care for Naloxone training. This standard of care includes community-based OEND programs and/or an existing hospital-based OEND program..
intervention type: Behavioral
intervention name: SOONER Training and Naloxone Kit Kit
description: Participants are shown our unique overdose response education video and given the associated kit to take home.
arm group label: SOONER Training and Naloxone Kit
intervention type: Behavioral
intervention name: Community or Hospital-Based Training
description: Referral to standard of care for Naloxone training
arm group label: Community or Hospital-Based Training
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: Canada
citation: United Nations Office on Drugs and Crime, World Health Organization. Discussion paper UNODC/WHO 2013: Opioid overdose: preventing and reducing opioid overdose mortality. 2013; Available at: http://www.unodc.org/docs/treatment/overdose.pdf. Accessed 04/23, 2014. Archived by WebCite© at http://www.webcitation.org/6U3qbjl2E)
citation: Clark AK, Wilder CM, Winstanley EL. A systematic review of community opioid overdose prevention and naloxone distribution programs. J Addict Med. 2014 May-Jun;8(3):153-63. doi: 10.1097/ADM.0000000000000034.
PMID: 24874759
citation: Doyon S, Aks SE, Schaeffer S. Expanding access to naloxone in the United States. J Med Toxicol. 2014 Dec;10(4):431-4. doi: 10.1007/s13181-014-0432-1. No abstract available.
PMID: 25316516
citation: Beletsky L, Ruthazer R, Macalino GE, Rich JD, Tan L, Burris S. Physicians' knowledge of and willingness to prescribe naloxone to reverse accidental opiate overdose: challenges and opportunities. J Urban Health. 2007 Jan;84(1):126-36. doi: 10.1007/s11524-006-9120-z.
PMID: 17146712
citation: Coffin PO, Fuller C, Vadnai L, Blaney S, Galea S, Vlahov D. Preliminary evidence of health care provider support for naloxone prescription as overdose fatality prevention strategy in New York City. J Urban Health. 2003 Jun;80(2):288-90. doi: 10.1093/jurban/jtg031.
PMID: 12791804
citation: Meyers K, Webb A, Frantz J, Randall M. What does it take to retain substance-abusing adolescents in research protocols? Delineation of effort required, strategies undertaken, costs incurred, and 6-month post-treatment differences by retention difficulty. Drug Alcohol Depend. 2003 Jan 24;69(1):73-85. doi: 10.1016/s0376-8716(02)00252-1.
PMID: 12536068
responsible party type: Sponsor
mesh term: Drug Overdose
mesh term: Naloxone
sharing ipd: No