Developing and Testing the Opioid Rapid Response System

NCT ID: NCT04589676

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-12-31

Brief Summary

This Phase I SBIR will develop and demonstrate the usability/feasibility of the Opioid Rapid Response System (OSSR) in order to reduce deaths and strain on emergency response systems from opioid overdoses.

Detailed Description

Opioid overdoses exact a tremendous cost in lives and expenditures due to incredible strain on emergency response systems. Naloxone has been developed to counteract overdoses. However, the nature of these events requires a rapid response, a situation that challenges emergency responders in both lightly populated rural areas as well as densely populated urban communities. PulsePoint has developed an app with the potential to obviate both concerns by linking responders to events through the 911 system. PulsePoint is already in place in 4,000 communities throughout the U.S. However, the app cannot accomplish these goals without being used by a large number of citizen responders who are both able to administer life-saving Naloxone and confident in their ability to do so. This project is designed to develop innovative and effective techniques for filling this gap. We build off of the Clark County Pilot Project conducted by members of our team that developed preliminary recruitment and training protocols for enabling citizen responders to utilize the PulsePoint App. Using communication theory, a technology-based recruitment protocol will be built around appeals to individuals (personal identity appeals) and others (communal appeals). Recruitment messages will be disseminated through diverse media channels, including social media, posters, radio announcement, and work-of-mouth. Social Cognitive Theory will be used to develop both online and face-to-face training to enable users to use the PulsePoint App, safely respond to calls, and administer Naloxone. An unblinded, two-arm, parallel group cluster-randomized trial with non-random cluster sampling will be conducted in two Indiana counties to establish the usability and feasibility of ORRS and its recruitment and training components. We anticipate recruiting and training 400 citizen responders. Pretest and posttest surveys will evaluate the training and as well as recruitment exposure through the various channels. County-level data on the number of events to which participant responded as well as lives saved also will be used to evaluate the intervention. A quasi-experimental design will compare the two recruitment strategies and the two training modalities. Project findings will be used to design and more extensive, two statewide evaluation studies (Indiana and Washington) that examine outcomes in numbers of lives saves as well as conducted a cost effectiveness analyses. The project has great promise for rapid and wide dissemination through the PulsePoint network of communities and has the potential to develop a model for community responses to similar public health events (e.g., coronavirus, stroke, heart failure).

Conditions

Opioid Overdose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Personal recruitment

Participants in this training condition will receive recruitment messages that appeal to their personal sense of identity (e.g., you could be a hero if you get trained with naloxone).

Group Type: ACTIVE_COMPARATOR

Naloxone training

Intervention Type: BEHAVIORAL

The naloxone training will teach participants about how to appropriately use naloxone in the event of an opioid overdose.

Online training

Participants in this training condition will receive recruitment messages that appeal to their communal sense of identity (e.g., your family and friends will thank you for getting trained with naloxone).

Group Type: EXPERIMENTAL

Naloxone training

Intervention Type: BEHAVIORAL

The naloxone training will teach participants about how to appropriately use naloxone in the event of an opioid overdose.

Interventions

Naloxone training

The naloxone training will teach participants about how to appropriately use naloxone in the event of an opioid overdose.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Overtly healthy citizen volunteers, aged 18 and over, living in Boone and Hancock Counties of Indiana.
• Able to understand/complete questionnaires, recruitment messages, and training procedures in English.

Exclusion Criteria

• Those who have a Boone or Hancock County residential address, but temporarily live in another county or State, so are unable to attend training if assigned to face-to-face naloxone training.
• Those who participate in other research studies which require activities that interfere with the measurements of the current study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: collaborator

Real Prevention, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Michael Hecht

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Hecht, PhD

Role: PRINCIPAL_INVESTIGATOR

REAL Prevention

Locations

Indiana University

Bloomington, Indiana, United States

REAL Prevention LLC

Clifton, New Jersey, United States

Countries

United States

References

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Reference Type: DERIVED

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Related Links

https://www.cdc.gov/drugoverdose/index.html

Related Info

Other Identifiers

1R41DA053078-01

Identifier Type: NIH

Identifier Source: org_study_id

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