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Developing and Testing the Opioid Rapid Response System

Primary Purpose

Opioid Overdose

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Naloxone training
Sponsored by
Real Prevention, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Overdose focused on measuring Naloxone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Indiana University
  • REAL Prevention LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Personal recruitment

Online training

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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"

Full Information

First Posted
October 12, 2020
Last Updated
January 25, 2022
Sponsor
Real Prevention, LLC
Collaborators
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT04589676
Brief Title
Developing and Testing the Opioid Rapid Response System
Official Title
Developing and Testing the Opioid Rapid Response System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Real Prevention, LLC
Collaborators
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Overdose
Keywords
Naloxone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personal recruitment
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Online training
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Naloxone training
Intervention Description
The naloxone training will teach participants about how to appropriately use naloxone in the event of an opioid overdose.
Primary Outcome Measure Information:
Title
Scale to measure perceptions of training program
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Scales to measure knowledge gained from training
Description
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.
Time Frame
3 months
Title
Scale to measure perceptions of efficacy in delivering naloxone.
Description
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.
Time Frame
3 months
Title
Scale to measure exposure to recruitment campaign
Description
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"
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hecht, PhD
Organizational Affiliation
REAL Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47404
Country
United States
Facility Name
REAL Prevention LLC
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07013
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Confidential data cannot be shared.
Citations:
PubMed Identifier
32106355
Citation
Boslett AJ, Denham A, Hill EL. Using contributing causes of death improves prediction of opioid involvement in unclassified drug overdoses in US death records. Addiction. 2020 Jul;115(7):1308-1317. doi: 10.1111/add.14943. Epub 2020 Feb 27.
Results Reference
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PubMed Identifier
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Citation
Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.
Results Reference
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PubMed Identifier
31573628
Citation
Joudrey PJ, Edelman EJ, Wang EA. Drive Times to Opioid Treatment Programs in Urban and Rural Counties in 5 US States. JAMA. 2019 Oct 1;322(13):1310-1312. doi: 10.1001/jama.2019.12562.
Results Reference
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PubMed Identifier
30496008
Citation
Cosby AG, McDoom-Echebiri MM, James W, Khandekar H, Brown W, Hanna HL. Growth and Persistence of Place-Based Mortality in the United States: The Rural Mortality Penalty. Am J Public Health. 2019 Jan;109(1):155-162. doi: 10.2105/AJPH.2018.304787. Epub 2018 Nov 29.
Results Reference
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PubMed Identifier
26760086
Citation
Compton WM, Jones CM, Baldwin GT. Relationship between Nonmedical Prescription-Opioid Use and Heroin Use. N Engl J Med. 2016 Jan 14;374(2):154-63. doi: 10.1056/NEJMra1508490. No abstract available.
Results Reference
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PubMed Identifier
30707224
Citation
Chen Q, Larochelle MR, Weaver DT, Lietz AP, Mueller PP, Mercaldo S, Wakeman SE, Freedberg KA, Raphel TJ, Knudsen AB, Pandharipande PV, Chhatwal J. Prevention of Prescription Opioid Misuse and Projected Overdose Deaths in the United States. JAMA Netw Open. 2019 Feb 1;2(2):e187621. doi: 10.1001/jamanetworkopen.2018.7621.
Results Reference
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PubMed Identifier
29503877
Citation
Flood-Grady E, Clark VC, Bauer A, Morelli L, Horne P, Krieger JL, Nelson DR. Evaluating the Efficacy of a Registry linked to a Consent to Re-Contact Program and Communication Strategies for Recruiting and Enrolling Participants into Clinical Trials. Contemp Clin Trials Commun. 2017 Dec;8:62-66. doi: 10.1016/j.conctc.2017.08.005. Epub 2017 Aug 24.
Results Reference
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PubMed Identifier
29066940
Citation
Lewis CR, Vo HT, Fishman M. Intranasal naloxone and related strategies for opioid overdose intervention by nonmedical personnel: a review. Subst Abuse Rehabil. 2017 Oct 11;8:79-95. doi: 10.2147/SAR.S101700. eCollection 2017.
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PubMed Identifier
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Citation
Krieger JL, Palmer-Wackerly A, Dailey PM, Krok-Schoen JL, Schoenberg NE, Paskett ED. Comprehension of Randomization and Uncertainty in Cancer Clinical Trials Decision Making Among Rural, Appalachian Patients. J Cancer Educ. 2015 Dec;30(4):743-8. doi: 10.1007/s13187-015-0789-0.
Results Reference
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PubMed Identifier
31094328
Citation
Ray AE, Greene K, Hecht ML, Barriage SC, Miller-Day M, Glenn SD, Banerjee SC. An E-Learning Adaptation of an Evidence-Based Media Literacy Curriculum to Prevent Youth Substance Use in Community Groups: Development and Feasibility of REAL Media. JMIR Form Res. 2019 May 9;3(2):e12132. doi: 10.2196/12132.
Results Reference
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PubMed Identifier
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Citation
Hecht ML, Marsiglia FF, Elek E, Wagstaff DA, Kulis S, Dustman P, Miller-Day M. Culturally grounded substance use prevention: an evaluation of the keepin' it R.E.A.L. curriculum. Prev Sci. 2003 Dec;4(4):233-48. doi: 10.1023/a:1026016131401.
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Citation
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PubMed Identifier
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Citation
Jayawardene W, Pezalla A, Henderson C, Hecht M. Development of opioid rapid response system: Protocol for a randomized controlled trial. Contemp Clin Trials. 2022 Apr;115:106727. doi: 10.1016/j.cct.2022.106727. Epub 2022 Mar 13.
Results Reference
derived
Links:
URL
https://www.cdc.gov/drugoverdose/index.html
Description
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Developing and Testing the Opioid Rapid Response System

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