PulsePoint for Opioid Overdose

(PP-OD Trial)

Overseen By Jon Agley

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a feasibility trial to assess whether, in a random sample of 180 agencies where PulsePoint is already active, revised procedures (hereinafter PulsePoint-OD) to facilitate opioid overdose and naloxone distribution (OEND) can successfully recruit first responder agencies and layperson responders. For this study, agency refers to a single implementation site where PulsePoint is active and that is bound by the service area or jurisdiction of the first responder agency collaborating with PulsePoint. The study will test the following hypotheses: H1: more first responder agencies will be successfully recruited by arm 2 than by arm 1. H2: more layperson responders will report engaging with OEND programming in arm 2 than in arms 1 or 3 and in arm 1 than in arm 3 \[only this hypothesis is covered by the IRB, hypothesis 1 is not human subjects research\].

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is PulsePoint for Opioid Overdose safe for humans?

The research articles do not provide specific safety data for PulsePoint for Opioid Overdose. However, they highlight the general risks associated with opioid use, such as overdose and adverse events, emphasizing the importance of careful monitoring and correct dosing to ensure safety. ^{1 2 3 4 5}

How does the PulsePoint treatment for opioid overdose differ from other treatments?

The PulsePoint treatment for opioid overdose is unique because it likely involves a community-based approach, similar to the modified community trailer model, which provides on-site harm reduction, addiction care, and community resources, rather than just emergency medical intervention. This approach may help reduce the burden on emergency departments and provide more comprehensive support for individuals experiencing an overdose. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment PulsePoint for opioid overdose?

The research highlights the importance of rapid response systems and technologies in addressing opioid overdoses, which are time-sensitive emergencies. While PulsePoint is not directly mentioned, similar systems have been shown to be effective in reversing overdoses when naloxone is administered quickly. ^{1 9 10 11 12}

Who Is on the Research Team?

Jon Agley

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for layperson responders registered with a local first responder agency through the PulsePoint system. It includes those who are alerted to incidents in public spaces and does not collect personal information beyond device ID.

Inclusion Criteria

I am registered with a PulsePoint agency as a lay responder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive customized or standard messaging to facilitate opioid overdose education and naloxone distribution

12 months

Follow-up

Participants are monitored for engagement and certification in OEND programming

12 months

What Are the Treatments Tested in This Trial?

Interventions

• PulsePoint

Trial Overview The study tests if revised procedures on the PulsePoint app can improve recruitment of agencies and engagement with opioid overdose education and naloxone distribution, comparing customized push messages against standard ones.

How Is the Trial Designed?

Group I: Customized layperson messaging (Arm 2) Experimental Treatment 1 Intervention

Arm 2 will follow the same procedures that are described for arm 1 but will use separate messaging. Specifically, the push messages and landing page will contain additional, brief messages that specifically provide factual information that counteracts misperceptions about overdose and naloxone.

Group II: Standard layperson messaging (Arm 1) Active Control 1 Intervention

Users randomized to arm 1 will receive standard monthly recruitment push messages. These push messages will differ from the certification messages because they will contain language intended to foster engagement with OEND services (eg, to get trained and carry naloxone) alongside the link to a landing page.

Group III: Control arm (Arm 3) Active Control 1 Intervention

Arm 3 functions as the control arm and will not receive any monthly recruitment messaging or encouragement.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study of 241 adults at high risk for opioid overdose, combining overdose education and take-home naloxone did not significantly reduce the risk of overdose events compared to usual care, with 24% experiencing at least one overdose during follow-up.

The high rates of overdose and healthcare utilization suggest that more intensive interventions, such as housing support and opioid agonist treatments, may be necessary to effectively address the needs of this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of an opioid overdose prevention intervention delivered subsequent to acute care. Banta-Green, CJ., Coffin, PO., Merrill, JO., et al.[2022]

A retrospective study showed that implementing data-based opioid risk reviews can potentially reduce serious adverse events (SAEs) related to opioid use, including overdoses and suicide-related events, in the 6 months following the review.

However, the study also found that tapering or discontinuing opioid therapy significantly increased the risk of suicide-related events and opioid-related SAEs, indicating that careful management is crucial during these processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Based Opioid Risk Review in Patients with Chronic Pain: A Retrospective Chart Review. Pogue, J., Lau, L., Boyer, J.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Impacts of an opioid overdose prevention intervention delivered subsequent to acute care. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Risk factors for 48-hours mortality after prehospital treatment of opioid overdose. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Development and process evaluation of an educational intervention for overdose prevention and naloxone distribution by general practice trainees. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Rapid induction onto extended-release injectable buprenorphine following opioid overdose: A case series. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Rapid opioid overdose response system technologies. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Joint Commission and the FDA take steps to curb adverse events related to the use and misuse of opioid drugs. [2012]

7. England pubmed.ncbi.nlm.nih.gov

Data-Based Opioid Risk Review in Patients with Chronic Pain: A Retrospective Chart Review. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Opioid overdose]. [2018]

9. Ireland pubmed.ncbi.nlm.nih.gov

Touchpoints - Opportunities to predict and prevent opioid overdose: A cohort study. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of an emergency department-based opioid overdose survivor intervention: Difference-in-difference analysis of electronic health record data to assess key outcomes. [2022]

11. England pubmed.ncbi.nlm.nih.gov

A qualitative study of overdose responses among Chicago IDUs. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Safety of a Modified Community Trailer to Manage Patients with Presumed Fentanyl Overdose. [2023]