Developing and Testing the Opioid Rapid Response System

Study Overview
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Brief Summary
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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
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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).

Official Title
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Developing and Testing the Opioid Rapid Response System

Conditions
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Opioid Overdose

Intervention / Treatment
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* Behavioral: Naloxone training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Personal recruitment<br>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<br>* The naloxone training will teach participants about how to appropriately use naloxone in the event of an opioid overdose.<br>|
| Experimental: Online training<br>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<br>* The naloxone training will teach participants about how to appropriately use naloxone in the event of an opioid overdose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale to measure perceptions of training program | 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 | 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. | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Naloxone