Clinical trial NCT03821649: SOONER Feasibility Study Protocol
Official title: Protocol for a Mixed Methods Feasibility Study for the Surviving Opioid Overdose With Naloxone Education and Resuscitation (SOONER) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overdose
Keywords: Education
Naloxone
Opioid
Overdose
Resuscitation
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: OCAD University
name: Toronto Public Health
First posted: 2019-01-30
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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).

Primary outcomes:
measure: Participant recruitment rate (participants recruited in 4 weeks)
timeFrame: 4 weeks
measure: Participant attrition at the underlying study's outcome simulation
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Site recruitment rates
timeFrame: 28 days
measure: Participant retention rates
timeFrame: 4-6 weeks
measure: Descriptions of study process problems
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Inner City Family Health Team
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital Emergency Department
state: Ontario
city: Toronto
country: Canada
facility: St Micheal's Health Centre at 410
state: Ontario
city: Toronto
country: Canada
facility: St Micheal's Hospital Rapid Access Addictions Medicine Clinic
Study officials:
References:
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)
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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: 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.
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.