Preventing Opioid Overdose Mortality in the United States

RTI International

Status: Completed

Conditions: Opioid Overdose

Treatments: Other: Organize and Mobilize for Implementation Effectiveness; Other: Dissemination

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03924505

INOD

R01DA046867 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).'

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Organize and Mobilize for Implementation Effectiveness

Experimental group

Description:

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.

Treatment:

Other: Organize and Mobilize for Implementation Effectiveness

Dissemination of Best Practice Recommendations

Active Comparator group

Description:

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

Treatment:

Other: Dissemination