Developing and Testing the Opioid Rapid Response System

January 25, 2022 updated by: Michael Hecht, Real Prevention, LLC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Bloomington, Indiana, United States, 47404
        • Indiana University
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • REAL Prevention LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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).
Behavioral: Naloxone training
The naloxone training will teach participants about how to appropriately use naloxone in the event of an opioid overdose.
EXPERIMENTAL: 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).
Behavioral: Naloxone training
The naloxone training will teach participants about how to appropriately use naloxone in the event of an opioid overdose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scale to measure perceptions of training program
Time Frame: 3 months
Self report survey scale to measure perceptions of training using agree-disagree scale that yields a composite score of rating that the training is worth the investment of their time and they would recommend it to others in their community.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scales to measure knowledge gained from training
Time Frame: 3 months
Self report on 10, multiple choice items to measure the knowledge about opioids and other information taught during training content. Scores reflect the amount of learning from training.
3 months
Scale to measure perceptions of efficacy in delivering naloxone.
Time Frame: 3 months
Self report scales will measure response efficacy (i.e., administering Naloxone is effective) and self efficacy (i.e., they can administer Naloxone) using agree-disagree scales. Each subscale will consist of at least 3 items and be modified from existing efficacy scales used in drug prevention research.
3 months
Scale to measure exposure to recruitment campaign
Time Frame: 3 months
Will be adapted from the evaluation of the ONCDP's substance use prevention campaigns to measure if participants recall receiving messages and the channel that they received it in. Response items will include "definitely seen", "might have seen" and "definitely not seen"
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Real Prevention, LLC

Collaborators

Indiana University

Investigators

  • Principal Investigator: Michael Hecht, PhD, Real Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2020

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

October 12, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (ACTUAL)

October 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R41DA053078-01 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Confidential data cannot be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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