Developing and Testing the Opioid Rapid Response System

• ClinicalTrials.gov Identifier: NCT04589676
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Last Update Posted: February 7, 2022
• Sponsor: Real Prevention, LLC
• Collaborator: Indiana University
• Information provided by (Responsible Party): Michael Hecht, Real Prevention, LLC

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.

Condition or disease	Intervention/treatment	Phase
Opioid Overdose	Behavioral: Naloxone training	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Study Start Date: December 1, 2020
• Actual Primary Completion Date: December 31, 2021
• Actual Study Completion Date: December 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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. 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"

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Indiana

Indiana University

Bloomington, Indiana, United States, 47404

United States, New Jersey

REAL Prevention LLC

Clifton, New Jersey, United States, 07013

Sponsors and Collaborators

Real Prevention, LLC

Indiana University

Investigators

• Principal Investigator: Michael Hecht, PhD; REAL Prevention

More Information

Additional Information:

Related Info 

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Choi HJ, Krieger JL, Hecht ML. Reconceptualizing efficacy in substance use prevention research: refusal response efficacy and drug resistance self-efficacy in adolescent substance use. Health Commun. 2013;28(1):40-52. doi: 10.1080/10410236.2012.720245.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: February 7, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Confidential data cannot be shared.

• 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:

Opiate Overdose; Drug Overdose; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders; Naloxone; Narcotic Antagonists; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents