Virtual Overdose Response
Primary Purpose
Drug Overdose
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Overdose Response
Sponsored by
About this trial
This is an interventional other trial for Drug Overdose
Eligibility Criteria
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
Sites / Locations
- Undetermined
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants
Arm Description
All participants will be given the phone number and encouraged to call any time they plan to use substances alone
Outcomes
Primary Outcome Measures
Usage
Number of times participants call the phone line
Secondary Outcome Measures
EMS response time
Amount of time from calling 911 to EMS arriving on scene
EMS dispatch outcome
qualitative description of dispatch outcome
Full Information
NCT ID
NCT04391192
First Posted
April 28, 2020
Last Updated
May 21, 2021
Sponsor
AHS Cancer Control Alberta
Collaborators
Alberta Innovates Health Solutions, AHS Addiction and Mental Health Strategic Clinical Network, TELUS
1. Study Identification
Unique Protocol Identification Number
NCT04391192
Brief Title
Virtual Overdose Response
Official Title
Virtual Overdose Response
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor determined that it must be terminated
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Alberta Innovates Health Solutions, AHS Addiction and Mental Health Strategic Clinical Network, TELUS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Overdose
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility of using a phone line to provide overdose response.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants
Arm Type
Experimental
Arm Description
All participants will be given the phone number and encouraged to call any time they plan to use substances alone
Intervention Type
Behavioral
Intervention Name(s)
Virtual Overdose Response
Intervention Description
All participants will be provided the phone number and encouraged to call when they use alone.
Primary Outcome Measure Information:
Title
Usage
Description
Number of times participants call the phone line
Time Frame
3 months
Secondary Outcome Measure Information:
Title
EMS response time
Description
Amount of time from calling 911 to EMS arriving on scene
Time Frame
3 months
Title
EMS dispatch outcome
Description
qualitative description of dispatch outcome
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Length of calls
Description
overall time required for a single call to the service
Time Frame
3 months
Title
Proportion of calls for which EMS is dispatched
Description
quantitative analysis of the number of times the operator calls 911 for a participant
Time Frame
3 months
Title
Timing of calls
Description
Analysis of what time of day most calls come in to the service
Time Frame
3 months
Title
Health care usage
Description
analysis of overall health system usage (based on administrative data) by the participants
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Rittenbach, PhD
Organizational Affiliation
Alberta Health services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Undetermined
City
Calgary
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share IPD
Citations:
PubMed Identifier
33978598
Citation
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.
Results Reference
derived
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Virtual Overdose Response
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