Preventing Opioid Overdose Mortality in the United States

NCT03924505 | Completed Results

• 2 other identifiers: INODR01DA046867
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to conduct a randomized controlled trial of 105 syringe services programs (SSPs) throughout the United States to understand the effectiveness of a multifaceted, facilitation-based strategy at advancing naloxone implementation effectiveness within SSPs. Together, these efforts can improve access to naloxone for people at high risk of overdose, thereby improving our nation's response to the opioid overdose epidemic.

Conditions

Opioid Overdose

Keywords

Implementation Science; Harm Reduction

Outcome Measures

Primary Outcomes (3)

• Naloxone Coverage (Consistency)

  Mean number of syringe services program participants receiving naloxone per total number of syringe services program participants

  3 months

• Naloxone Doses Distributed (Consistency)

  The mean number of naloxone doses distributed per total number of SSP participants

  3 months

• Best Practice Adoption (Implementation Quality)

  The mean number of best practices adopted by the SSP

  12 months

Study Arms (2)

Organize and Mobilize for Implementation Effectiveness

EXPERIMENTAL

Our approach was based on the Implementation Sustainment Facilitation (ISF), which is grounded in the theory of implementation effectiveness, and added discrete strategies from the Addiction Technology Transfer Center (ATTC), which were considered necessary elements from the original ISF trial. In addition to receiving the OEND best practice recommendations, our multi-component approach used external facilitation as the overarching strategy, by which seven other strategies were leveraged to support SSP staff and leadership. In addition to external facilitation, the multi-faceted approach included: organize implementation team meetings, identify and prepare champions, develop and organize quality monitoring system, assess for readiness and identify barriers, distribute educational materials and resources, conduct educational meetings, and provide ongoing consultation.

Other: Organize and Mobilize for Implementation Effectiveness

Dissemination of Best Practice Recommendations

ACTIVE COMPARATOR

This arm will receive the best practice recommendations for implementing overdose education and naloxone distribution within syringe services programs.

Other: Dissemination

Interventions

Organize and Mobilize for Implementation Effectiveness OTHER

Our trial is trying to understand how a multi-faceted, facilitation-based implementation strategy advances effective implementation of naloxone within syringe services programs

Organize and Mobilize for Implementation Effectiveness

Dissemination OTHER

Our comparison group receives dissemination of best practice recommendations for naloxone implementation.

Dissemination of Best Practice Recommendations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

To be eligible, an organization must have: 1) met the definition of an SSP - an organization whose primary function is to distribute drug use supplies to participants to reduce harms associated with drug use, 2) implemented OEND for a minimum of 6 months, and 3) completed the national survey of syringe services programs fielded February-July 2019. We excluded organizations such as fire departments or emergency departments of hospitals that offered supply distribution since it would be an ancillary function of these organizations and OEND programs that were not part of a syringe services program.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• RTI International: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

RTI International

Berkeley, California, 94704, United States

Location

Related Publications (1)

• Lambdin BH, Bluthenthal RN, Garner BR, Wenger LD, Browne EN, Morris T, Ongais L, Megerian CE, Kral AH. Organize and mobilize for implementation effectiveness to improve overdose education and naloxone distribution from syringe services programs: a randomized controlled trial. Implement Sci. 2024 Feb 28;19(1):22. doi: 10.1186/s13012-024-01354-y.

  PMID: 38419058 DERIVED

MeSH Terms

Conditions

Opiate Overdose; Harm Reduction

Interventions

Organizations

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Limitations and Caveats

A noteworthy limitation with our trial is the reliance on self-report for the number of naloxone doses distributed, number of people receiving naloxone and best practice implementation. However, SSPs routinely report naloxone distribution metrics for funders. Generalizability of our study findings requires careful consideration. While we randomly selected SSPs to participate, it is possible that those that enrolled had different levels of resources than those that did not participate.

Results Point of Contact

• Title: Dr. Barrot H Lambdin
• Organization: RTI International

blambdin@rti.org

628-200-6707

Study Officials

• Barrot Lambdin, PhD, MPH

  RTI International

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study statistician was masked to which participants were in the intervention arm and which participants were in the control arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 23, 2019
• Study Start: September 3, 2019
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)