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Virtual Overdose Response

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ClinicalTrials.gov Identifier: NCT04391192
Recruitment Status : Withdrawn (Sponsor determined that it must be terminated)
First Posted : May 18, 2020
Last Update Posted : May 25, 2021
Sponsor:
Collaborators:
Alberta Innovates Health Solutions
AHS Addiction and Mental Health Strategic Clinical Network
TELUS
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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.

Condition or disease Intervention/treatment Phase
Drug Overdose Behavioral: Virtual Overdose Response Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility of using a phone line to provide overdose response.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Virtual Overdose Response
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : February 2021

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.




Primary Outcome Measures :
  1. Usage [ Time Frame: 3 months ]
    Number of times participants call the phone line


Secondary Outcome Measures :
  1. EMS response time [ Time Frame: 3 months ]
    Amount of time from calling 911 to EMS arriving on scene

  2. EMS dispatch outcome [ Time Frame: 3 months ]
    qualitative description of dispatch outcome


Other Outcome Measures:
  1. Length of calls [ Time Frame: 3 months ]
    overall time required for a single call to the service

  2. Proportion of calls for which EMS is dispatched [ Time Frame: 3 months ]
    quantitative analysis of the number of times the operator calls 911 for a participant

  3. Timing of calls [ Time Frame: 3 months ]
    Analysis of what time of day most calls come in to the service

  4. Health care usage [ Time Frame: 3 months ]
    analysis of overall health system usage (based on administrative data) by the participants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391192


Locations
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Canada, Alberta
Undetermined
Calgary, Alberta, Canada
Sponsors and Collaborators
AHS Cancer Control Alberta
Alberta Innovates Health Solutions
AHS Addiction and Mental Health Strategic Clinical Network
TELUS
Investigators
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Principal Investigator: Katherine Rittenbach, PhD Alberta Health Services
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT04391192    
Other Study ID Numbers: AMH-SCN-05
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders