MedPath

Preventing Opioid Overdose Mortality in the United States

Not Applicable
Completed
Conditions
Opioid Overdose
Interventions
Behavioral: Implementation Manual only
Behavioral: Implementation Manual with External Facilitation Intervention
Registration Number
NCT03924505
Lead Sponsor
RTI International
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.

Detailed Description

We conducted a randomized controlled trial of SSPs throughout the United States (US) and US Territories. Prior to the trial, 342 SSPs were known to be operating throughout the US and US Territories. Our team launched a national survey of syringe services programs (NSSSP) in February 2019 of all known SSPs operating throughout the United States and its Territories, receiving a response from 263 (77%) SSPs. Among the responding SSPs, 94% were implementing overdose education and naloxone distribution (OEND), and a total of 105 of SSPs implementing OEND were recruited into the trial. SSPs were randomized in a 1-to-1 fashion to either receive the OEND best practice recommendations (comparison SSPs) or the OEND best practice recommendations along with facilitation-based implementation strategies as detailed below (intervention SSPs).

We tested the effectiveness of a multifaceted, facilitation-based strategy at advancing OEND implementation effectiveness within SSPs. Implementation effectiveness is 'an organization-level construct that refers to the aggregated consistency, quality, and appropriateness of innovation use (OEND) within an organization (SSP).'

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
105
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Implementation Manual - onlyImplementation Manual onlyThis arm will receive the naloxone intervention implementation manual. The manual provides details for developing, implementing, and managing a naloxone intervention program within different types of organizations that serve people who use opioids, including SSPs.
Implementation Manual and External FacilitationImplementation Manual with External Facilitation InterventionThis arm will receive the naloxone intervention implementation manual and the External Facilitation (EF) intervention. The manual provides details for developing, implementing, and managing a naloxone intervention program within different types of organizations that serve people who use opioids, including SSPs. The EF intervention is a collaborative, organization-centered form of guiding to navigate barriers and leverage facilitators to advance an evidence-based intervention along the EPIS continuum. Guidance will be conducted by an External Facilitator.
Primary Outcome Measures
NameTimeMethod
Naloxone Coverage (Consistency)3 months

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

Naloxone Doses Distributed (Consistency)3 months

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

Best Practice Adoption (Implementation Quality)12 months

The mean number of best practices adopted by the SSP

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

RTI International

🇺🇸

Berkeley, California, United States

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