Virtual Overdose Response

To help prevent deaths in populations that cannot or will not access physical safer consumption services in Alberta, which may disproportionately include women and those who are not able to self-inject (Potier et al., 2014) the investigators propose to provide virtual (phone-based) supervised consumption services, staffed by people with lived experience.

Study Overview

• Status: Withdrawn
• Conditions: Drug Overdose
• Intervention / Treatment: Behavioral: Virtual Overdose Response

Detailed Description

Designed as a small open label clinical study to demonstrate proof of concept which will follow CONSORT guidelines, the investigators aim to recruit approximately 15 people who are currently using illicit substances and who currently use opioids (illicit or prescription - non-medically). The sample size of 15 balances pragmatic issues (difficulty in recruiting people who are actively using illicit substances) and the need to have a good sample of the population. These participants will be interviewed by the research coordinator in person prior to intervention initiation to determine baseline use; history of overdose; and current harm reduction activities (see appendix). They will then be asked to call the intervention number if they are going to be using alone (see appendix for call flow).

Each time a participant dials the number, the operator will gather (as part of the intervention) the address the participant is at, their name/pseudonym and a phone number that can be used as a call back number in case the call is disconnected. The phone line operator will then ask a) what they planned on using, b) the method of use, c) if the participant is using safe sterile supplies (and provide information on where they can get new supplies in their community), and d) if they have a naloxone kit (overdose reversal kit) available. They will then inform the participant that they will be checking in on them every 5 - 10 minutes and if they do not respond, they will call emergency medical services for them.

If the participant responds to each verbal prompt (calling their name) over a minimum of 30 minutes, the operator will let them know that they are disconnecting the call. The operator will offer to connect the participant to other health services, such as the location of new supplies, social services, addiction treatment and opioid agonist therapy. If the participant fails to respond to a prompt (or the call is disconnected and is not able to be reconnected), the operator will contact the dispatch supervisor and the process for emergency services dispatch will be initiated.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Undetermined

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to give informed consent - able to speak and understand English and over 18 years of age
• Admit to using opioids non-medically: using illicit opioids; using prescription opioids without a current prescription; using doses greater than those prescribed; using opioids recreationally
• Have access to a phone line in the location they primarily use opioids: this can be a land line or a cell phone
• Resident of Calgary

Exclusion Criteria:

• Unable to give informed consent - unable to understand English, under 18 years of age or otherwise not legally able
• Do not knowingly use opioids non-medically
• No access to a phone
• Live outside of Calgary

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants; All participants will be given the phone number and encouraged to call any time they plan to use substances alone	Behavioral: Virtual Overdose Response; All participants will be provided the phone number and encouraged to call when they use alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usage	Number of times participants call the phone line	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EMS response time	Amount of time from calling 911 to EMS arriving on scene	3 months
EMS dispatch outcome	qualitative description of dispatch outcome	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of calls	overall time required for a single call to the service	3 months
Proportion of calls for which EMS is dispatched	quantitative analysis of the number of times the operator calls 911 for a participant	3 months
Timing of calls	Analysis of what time of day most calls come in to the service	3 months
Health care usage	analysis of overall health system usage (based on administrative data) by the participants	3 months

Collaborators and Investigators

• Sponsor: AHS Cancer Control Alberta
• Collaborators: Alberta Innovates Health Solutions; TELUS; AHS Addiction and Mental Health Strategic Clinical Network
• Investigators: Principal Investigator: Katherine Rittenbach, PhD, Alberta Health services

Publications and helpful links

General Publications

• Bristowe SK, Ghosh SM, Trew M; Canadian Mental Health Association - Calgary Region; Rittenbach K. Virtual Overdose Response for People Who Use Opioids Alone: Protocol for a Feasibility and Clinical Trial Study. JMIR Res Protoc. 2021 May 12;10(5):e20183. doi: 10.2196/20183.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Drug Overdose
• Other Study ID Numbers: AMH-SCN-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No