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SOONER Feasibility Study Protocol (SOONER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821649
Recruitment Status : Suspended (Suspended due to non-essential research prohibitions at the study's recruitment and outcome assessment sites in the context of COVID-19.)
First Posted : January 30, 2019
Last Update Posted : September 3, 2020
Sponsor:
Collaborators:
OCAD University
Toronto Public Health
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overdose Behavioral: SOONER Training and Naloxone Kit Kit Behavioral: Community or Hospital-Based Training Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Protocol for a Mixed Methods Feasibility Study for the Surviving Opioid Overdose With Naloxone Education and Resuscitation (SOONER) Trial
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SOONER Training and Naloxone Kit
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.
Behavioral: SOONER Training and Naloxone Kit Kit
Participants are shown our unique overdose response education video and given the associated kit to take home.

Active Comparator: Community or Hospital-Based Training
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..
Behavioral: Community or Hospital-Based Training
Referral to standard of care for Naloxone training




Primary Outcome Measures :
  1. Participant recruitment rate (participants recruited in 4 weeks) [ Time Frame: 4 weeks ]

    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.


  2. Participant attrition at the underlying study's outcome simulation [ Time Frame: 4-6 weeks ]

    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.



Secondary Outcome Measures :
  1. Site recruitment rates [ Time Frame: 28 days ]
    Rate of participant recruitment in each of the family practice, emergency department, and addiction medicine sites associated with a single academic health care centre.

  2. Participant retention rates [ Time Frame: 4-6 weeks ]
    Comparison of retention rate between intervention and control arms

  3. Descriptions of study process problems [ Time Frame: 4-6 weeks ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Participants are eligible by meeting any one or more of the following:

  1. Have a history of taking opioids at recognized 'high doses' (whether by prescription or otherwise, defined as >100mg morphine equivalent per day).
  2. Live with or is in frequent contact with others who use opioids or heroin.
  3. Have required emergency care for opioid overdose previously.
  4. Are enrolled in opioid agonist treatment programs (or has been in the last 6 months), including methadone or buprenorphine maintenance programs, particularly at high risk periods such as induction or discharge.
  5. Are being released from prison, and have a history of non-medical opioid use.
  6. Are receiving prescription opioid therapy with risk factors for adverse effects, including relevant comorbidities, co-prescriptions of benzodiazepines or other sedatives, concomitant ongoing alcohol use, or high dose prescription opioid therapy.
  7. Uses non-medical opioids, injects opioids, or acquires opioids from sources other than a pharmacy or healthcare setting.

Exclusion Criteria: Participants are ineligible by meeting any one or more of the following:

  1. Have a community do not resuscitate order.
  2. Have a terminal illness, end-of-life care, or illness likely to result in death within the study period.
  3. Have no mode of contact or follow-up.
  4. Plan to move away from Toronto during the study period.
  5. Have insufficient English language skills to participate in the study.
  6. Are an active or previously practicing healthcare professional or professional first responder (e.g.: firefighter, police officer, lifeguard, industrial first responder).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821649


Locations
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Canada, Ontario
Inner City Family Health Team
Toronto, Ontario, Canada
St Michael's Hospital Emergency Department
Toronto, Ontario, Canada
St Micheal's Health Centre at 410
Toronto, Ontario, Canada
Canada
St Micheal's Hospital Rapid Access Addictions Medicine Clinic
Toronto, Canada
Sponsors and Collaborators
St. Michael's Hospital, Toronto
OCAD University
Toronto Public Health
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03821649    
Other Study ID Numbers: 1
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Michael's Hospital, Toronto:
Education
Naloxone
Opioid
Overdose
Resuscitation
Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents