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SOONER Feasibility Study Protocol (SOONER)

Primary Purpose

Overdose

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SOONER Training and Naloxone Kit Kit
Community or Hospital-Based Training
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overdose focused on measuring Education, Naloxone, Opioid, Overdose, Resuscitation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Inner City Family Health Team
  • St Michael's Hospital Emergency Department
  • St Micheal's Health Centre at 410
  • St Micheal's Hospital Rapid Access Addictions Medicine Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SOONER Training and Naloxone Kit

Community or Hospital-Based Training

Arm 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.

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..

Outcomes

Primary Outcome Measures

Participant recruitment rate (participants recruited in 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.
Participant attrition at the underlying study's outcome simulation
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

Site recruitment rates
Rate of participant recruitment in each of the family practice, emergency department, and addiction medicine sites associated with a single academic health care centre.
Participant retention rates
Comparison of retention rate between intervention and control arms
Descriptions of study process problems
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).

Full Information

First Posted
January 17, 2019
Last Updated
May 20, 2022
Sponsor
Unity Health Toronto
Collaborators
OCAD University, Toronto Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT03821649
Brief Title
SOONER Feasibility Study Protocol
Acronym
SOONER
Official Title
Protocol for a Mixed Methods Feasibility Study for the Surviving Opioid Overdose With Naloxone Education and Resuscitation (SOONER) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
OCAD University, Toronto Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overdose
Keywords
Education, Naloxone, Opioid, Overdose, Resuscitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOONER Training and Naloxone Kit
Arm Type
Experimental
Arm 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 Title
Community or Hospital-Based Training
Arm Type
Active Comparator
Arm 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(s)
SOONER Training and Naloxone Kit Kit
Intervention Description
Participants are shown our unique overdose response education video and given the associated kit to take home.
Intervention Type
Behavioral
Intervention Name(s)
Community or Hospital-Based Training
Intervention Description
Referral to standard of care for Naloxone training
Primary Outcome Measure Information:
Title
Participant recruitment rate (participants recruited in 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.
Time Frame
4 weeks
Title
Participant attrition at the underlying study's outcome simulation
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.
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
Site recruitment rates
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.
Time Frame
28 days
Title
Participant retention rates
Description
Comparison of retention rate between intervention and control arms
Time Frame
4-6 weeks
Title
Descriptions of study process problems
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).
Time Frame
4-6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participants are eligible by meeting any one or more of the following: Have a history of taking opioids at recognized 'high doses' (whether by prescription or otherwise, defined as >100mg morphine equivalent per day). Live with or is in frequent contact with others who use opioids or heroin. Have required emergency care for opioid overdose previously. 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. Are being released from prison, and have a history of non-medical opioid use. 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. 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: Have a community do not resuscitate order. Have a terminal illness, end-of-life care, or illness likely to result in death within the study period. Have no mode of contact or follow-up. Plan to move away from Toronto during the study period. Have insufficient English language skills to participate in the study. Are an active or previously practicing healthcare professional or professional first responder (e.g.: firefighter, police officer, lifeguard, industrial first responder).
Facility Information:
Facility Name
Inner City Family Health Team
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
St Michael's Hospital Emergency Department
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
St Micheal's Health Centre at 410
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
St Micheal's Hospital Rapid Access Addictions Medicine Clinic
City
Toronto
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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)
Results Reference
background
PubMed Identifier
24874759
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.
Results Reference
background
PubMed Identifier
25316516
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.
Results Reference
background
PubMed Identifier
17146712
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.
Results Reference
background
PubMed Identifier
12791804
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.
Results Reference
background
PubMed Identifier
12536068
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.
Results Reference
background
PubMed Identifier
34223388
Citation
Orkin AM, Charles M, Norris K, Thomas R, Chapman L, Wright A, Campbell DM, Handford C, Klaiman M, Hopkins S, Shahin R, Thorpe K, Juni P, Parsons J, Sellen K, Goso N, Hunt R, Leece P, Morrison LJ, Stergiopoulos V, Turner S, Strike C. Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial. Resusc Plus. 2021 May 14;6:100131. doi: 10.1016/j.resplu.2021.100131. eCollection 2021 Jun. Erratum In: Resusc Plus. 2021 Sep 10;7:100158.
Results Reference
derived
PubMed Identifier
31722937
Citation
Orkin A, Campbell D, Handford C, Hopkins S, Klaiman M, Leece P, Parsons JA, Shahin R, Strike C, Thorpe K, Sellen K, Milos G, Wright A, Charles M, Sniderman R, Morrison L; SOONER Investigators. Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial. BMJ Open. 2019 Nov 12;9(11):e029436. doi: 10.1136/bmjopen-2019-029436.
Results Reference
derived

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SOONER Feasibility Study Protocol

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