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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to better recruit first responders and layperson volunteers for opioid overdose situations. It uses PulsePoint, a mobile app, to send alerts and information about overdose emergencies and naloxone, a medication that can reverse an opioid overdose. Participants are divided into three groups: one receives standard messages, another receives messages that dispel myths about overdoses, and the last group receives no messages. Volunteers registered with PulsePoint through a local agency might participate in this trial and assist in public overdose emergencies. As an unphased trial, the study aims to enhance community response to opioid overdoses, giving volunteers the opportunity to make a significant impact.

Will I have to stop taking my current medications?

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

What prior data suggests that the PulsePoint-OD procedures are safe for opioid overdose response?

Research shows no specific safety information for the PulsePoint program regarding opioid overdoses. However, PulsePoint, a popular app connecting people to emergencies like heart attacks, is now adapting to assist with opioid overdoses. It has been used in various situations without safety issues.

This study tests new messages and procedures, not a new drug or medical device. The focus is on effectiveness, not physical safety. The goal is to improve responses to opioid overdoses and ensure more people know how to use naloxone, a medication that can save lives by reversing opioid overdoses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PulsePoint approach for opioid overdose because it aims to enhance public engagement and awareness through innovative messaging. Unlike traditional methods that rely on standard public service announcements or medical training, PulsePoint uses customized push notifications to educate laypeople, particularly focusing on correcting misconceptions about overdoses and naloxone. This method could potentially increase the number of individuals trained to administer naloxone, a life-saving medication in overdose situations, by making information more accessible and relatable. The trial's goal is to see if these personalized messages can motivate more people to get involved in overdose prevention efforts, potentially saving more lives.

What evidence suggests that this trial's treatments could be effective for opioid overdose?

Research has shown that many deadly opioid overdoses occur without the use of naloxone, highlighting a gap in emergency response that PulsePoint aims to address by improving naloxone distribution. Previous efforts that combined overdose education with naloxone distribution for home use have not significantly reduced overdose risks. In this trial, participants will be divided into different arms to test PulsePoint's strategy. One arm will receive standard layperson messaging, while another will receive customized messaging designed to counteract misperceptions about overdoses and naloxone. Tailored messages may help clarify misunderstandings about overdoses and naloxone, potentially leading to more community involvement and better management of overdoses. ^{1 2 3 4 6}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11015366/

The Feasibility of Using the National PulsePoint ... Data from 2019 indicate that in the majority of fatal opioid-involved overdoses, there is no evidence of naloxone administration [17]. Given the current ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06523985

NCT06523985 | The Feasibility of Using the PulsePoint to ... This study is a feasibility trial to assess whether, in a random sample of 180 agencies where PulsePoint is already active, revised procedures (hereinafter ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714425000291

Protocol for a national randomized controlled trial ... The training should focus on improving efficacy in managing opioid overdose events and administering naloxone. It is also critical to recruit citizen responders ...

4. withpower.com withpower.com/trial/pulsepoint-for-opioid-overdose-88739

PulsePoint for Opioid Overdose (PP-OD 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9427328/

Development of Opioid Rapid Response System: Protocol for ... Outcomes and Measurements: Primary outcome of this study is self-efficacy in overdose management. This study utilized three survey instruments on RED Cap ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06238128?cond=%22Opiate%20Overdose%22&viewType=Table&rank=9

Opioid Rapid Response System: Naloxone Training in ... Leveraging the PulsePoint health app, which connects citizens to cardiac events, the ORRS project will extend its capabilities to respond to overdose incidents.