Preventing Opioid Overdose Mortality in the United States

NCT ID: NCT03924505

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2022-03-14

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).'

Conditions

Opioid Overdose

Keywords

Implementation Science; Harm Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Organize and Mobilize for Implementation Effectiveness

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.

Group Type: EXPERIMENTAL

Organize and Mobilize for Implementation Effectiveness

Intervention Type: OTHER

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

Dissemination of Best Practice Recommendations

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

Group Type: ACTIVE_COMPARATOR

Dissemination

Intervention Type: OTHER

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

Interventions

Organize and Mobilize for Implementation Effectiveness

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

Intervention Type: OTHER

Dissemination

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: lead

Responsible Party

Barrot Lambdin

Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barrot Lambdin, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

RTI International

Berkeley, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38419058 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DA046867

Identifier Type: NIH

Identifier Source: secondary_id

View Link

INOD

Identifier Type: -

Identifier Source: org_study_id