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Developing and Testing the Opioid Rapid Response System

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ClinicalTrials.gov Identifier: NCT04589676
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Indiana University
Information provided by (Responsible Party):
Michael Hecht, Real Prevention, LLC

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. 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).

Condition or disease Intervention/treatment Phase
Opioid Overdose Behavioral: Community identity recruitment Behavioral: Personal identity recruitment Behavioral: Face-to-face training Behavioral: Online training Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Developing and Testing the Opioid Rapid Response System
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Active Comparator: Face-to-face training
Participants in the face-to-face training condition will receive training in groups of 20. Standardized content will teach them to use the PulsePoint app, respond safely to calls, and administer Naloxone.
Behavioral: Community identity recruitment
Multiple communication channels will be used in targeted areas of Boone and Hancock counties to recruit citizen responders through messages that appeal to their communal identities (e.g., benefits as members of communities and other social groups).

Behavioral: Personal identity recruitment
Multiple communication channels will be used in targeted areas of Boone and Hancock counties to recruit citizen responders through messages that appeal to their personal identities (e.g., benefits to them as individuals).

Behavioral: Face-to-face training
Participants in the face-to-face training condition will receive training in groups of 20. Standardized content will teach them to use the PulsePoint app, respond safely to calls, and administer Naloxone.

Experimental: Online training
Participants in the online training condition will receive training in groups on Smartphones and other devices at their own pace. Standardized content will teach them to use the PulsePoint app, respond safely to calls, and administer Naloxone.
Behavioral: Community identity recruitment
Multiple communication channels will be used in targeted areas of Boone and Hancock counties to recruit citizen responders through messages that appeal to their communal identities (e.g., benefits as members of communities and other social groups).

Behavioral: Personal identity recruitment
Multiple communication channels will be used in targeted areas of Boone and Hancock counties to recruit citizen responders through messages that appeal to their personal identities (e.g., benefits to them as individuals).

Behavioral: Online training
Participants in the online training condition will receive training in groups on Smartphones and other devices at their own pace. Standardized content will teach them to use the PulsePoint app, respond safely to calls, and administer Naloxone.




Primary Outcome Measures :
  1. Reaction score [ Time Frame: 3 months ]
    Reaction to training is a self report measure 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.


Secondary Outcome Measures :
  1. Knowledge [ Time Frame: 3 months ]
    The knowledge scale will consists of up to 10, multiple-choice items generated from the training content. Scores reflect the amount of learning from training.

  2. Efficacy [ Time Frame: 3 months ]
    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. 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"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589676


Contacts
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Contact: Michael Hecht, PhD 814-360-1893 hechtpsu@gmail.com
Contact: Wasantha Jayawardene, PhD, MD 8128558534 wajayawa@indiana.edu

Sponsors and Collaborators
Real Prevention, LLC
Indiana University
Additional Information:
Publications:

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Responsible Party: Michael Hecht, President, Real Prevention, LLC
ClinicalTrials.gov Identifier: NCT04589676    
Other Study ID Numbers: 1R41DA053078-01 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Hecht, Real Prevention, LLC:
Naloxone
Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders