Ignite Creation Date:
2024-05-06 @ 2:40 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04391192
Status:
WITHDRAWN
Last Update Posted:
2021-05-25
First Post:
2020-04-28
Brief Title:
Virtual Overdose Response
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
Virtual Overdose Response
Status:
WITHDRAWN
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor determined that it must be terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 namepseudonym 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
Each time a participant dials the number the operator will gather as part of the intervention the address the participant is at their namepseudonym 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None