Clinical trial NCT04589676: Developing and Testing the Opioid Rapid Response System
Official title: Developing and Testing the Opioid Rapid Response System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Overdose
Keywords: Naloxone
Lead sponsor: Real Prevention, LLC
Sponsor class: INDUSTRY
Collaborators: name: Indiana University
First posted: 2020-10-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Scale to measure perceptions of training program
timeFrame: 3 months
Secondary outcomes:
measure: Scales to measure knowledge gained from training
timeFrame: 3 months
measure: Scale to measure perceptions of efficacy in delivering naloxone.
timeFrame: 3 months
measure: Scale to measure exposure to recruitment campaign
timeFrame: 3 months
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Clifton
country: United States
facility: REAL Prevention LLC
state: New Jersey
Study officials:
affiliation: REAL Prevention
name: Michael Hecht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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