An interventional study of Organize and Mobilize for Implementation Effectiveness and Dissemination in Opioid Overdose, sponsored by RTI International. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by RTI International · Not applicable, Interventional, and Prevention
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.
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).'
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
This study's enrollment of 105 is below the median of 184 across 48 interventional studies indexed under Opiate Overdose.
Browse Opiate Overdose studies →RTI International is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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
This arm will receive the best practice recommendations for implementing overdose education and naloxone distribution within syringe services programs.
Other: Dissemination
Our trial is trying to understand how a multi-faceted, facilitation-based implementation strategy advances effective implementation of naloxone within syringe services programs
Our comparison group receives dissemination of best practice recommendations for naloxone implementation.
Naloxone Coverage (Consistency)
Mean number of syringe services program participants receiving naloxone per total number of syringe services program participants
Time frame: 3 months
Naloxone Doses Distributed (Consistency)
The mean number of naloxone doses distributed per total number of SSP participants
Time frame: 3 months
Best Practice Adoption (Implementation Quality)
The mean number of best practices adopted by the SSP
Time frame: 12 months
| Milestone | Organize and Mobilize for Implementation Effectiveness | Implementation Manual - Only |
|---|---|---|
| Started | 53 | 52 |
| Completed | 51 | 51 |
| Not completed | 2 | 1 |
Mean number of syringe services program participants receiving naloxone per total number of syringe services program participants
| proportion of participants | Organize and Mobilize for Implementation Effectiveness | Dissemination of Best Practice Recommendations |
|---|---|---|
| Naloxone Coverage (Consistency) | 0.9 ± 1.4 | 0.4 ± 0.3 |
The mean number of naloxone doses distributed per total number of SSP participants
| naloxone doses | Organize and Mobilize for Implementation Effectiveness | Dissemination of Best Practice Recommendations |
|---|---|---|
| Naloxone Doses Distributed (Consistency) | 2.5 ± 2.6 | 1.3 ± 1.2 |
The mean number of best practices adopted by the SSP
| number of best practices | Organize and Mobilize for Implementation Effectiveness | Implementation Manual - Only |
|---|---|---|
| Best Practice Adoption (Implementation Quality) | 13.1 (8 to 18) | 12.9 (8 to 17) |
Collected over 12 months of the intervention period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Organize and Mobilize for Implementation Effectiveness | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Dissemination of Best Practice Recommendations | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
Our trial enrolled syringe services programs and randomized them to two arms. This was a study of organizations, not individuals.
| Age, Customized(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Unknown | 53 | 52 | 105 |
| Sex/Gender, Customized(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Female | 35 | 31 | 66 |
| Male | 16 | 16 | 32 |
| Unknown/Not reported | 2 | 5 | 7 |
| Race (NIH/OMB)(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 45 | 38 | 83 |
| More than one race | 3 | 4 | 7 |
| Unknown or Not Reported | 1 | 8 | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2019 to primary completion in Mar 2022, 30 months.
Results were first posted in Dec 2024, 2 years 8 months after primary completion.
Of 28 interventional studies with no phase under Opiate Overdose, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's 30 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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