Virtual Overdose Response

Drug Overdose Clinical Trial

Official title:

Virtual Overdose Response

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04391192
• Other study ID #: AMH-SCN-05
• Status: Withdrawn
• Phase: N/A
• Start date: September 2020
• Est. completion date: February 2021

Study information

• Verified date: May 2021
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose

Intervention

Behavioral:
• Virtual Overdose Response
All participants will be provided the phone number and encouraged to call when they use alone.

Locations

Country	Name	City	State
Canada	Undetermined	Calgary	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	AHS Addiction and Mental Health Strategic Clinical Network, Alberta Innovates Health Solutions, TELUS

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of calls	overall time required for a single call to the service	3 months
Other	Proportion of calls for which EMS is dispatched	quantitative analysis of the number of times the operator calls 911 for a participant	3 months
Other	Timing of calls	Analysis of what time of day most calls come in to the service	3 months
Other	Health care usage	analysis of overall health system usage (based on administrative data) by the participants	3 months
Primary	Usage	Number of times participants call the phone line	3 months
Secondary	EMS response time	Amount of time from calling 911 to EMS arriving on scene	3 months
Secondary	EMS dispatch outcome	qualitative description of dispatch outcome	3 months