Trial Outcomes & Findings for Preventing Opioid Overdose Mortality in the United States (NCT NCT03924505)
NCT ID: NCT03924505
Last Updated: 2024-12-12
Results Overview
Mean number of syringe services program participants receiving naloxone per total number of syringe services program participants
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
3 months
Results posted on
2024-12-12
Participant Flow
Unit of analysis: syringe services programs
Participant milestones
| Measure |
Organize and Mobilize for Implementation Effectiveness
This 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.
Implementation Manual with External Facilitation Intervention: Participating organizations will receive the implementation manual and the external facilitation (EF) intervention. The manual provides instructions for organizations wanting to implement a high quality naloxone program. The EF will assist syringe service programs to integrate naloxone delivery within their organization. As part of these efforts, we will use a measurement framework to understand naloxone delivery within SSPs along the four phases of the implementation process-exploration, preparation, implementation and sustainment (EPIS).
|
Implementation Manual - Only
This 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 only: Participating organizations will receive the implementation manual.The manual provides instructions for organizations wanting to implement a high quality naloxone program.
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|---|---|---|
|
Overall Study
STARTED
|
53 53
|
52 52
|
|
Overall Study
COMPLETED
|
51 51
|
51 51
|
|
Overall Study
NOT COMPLETED
|
2 2
|
1 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preventing Opioid Overdose Mortality in the United States
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=53 Syringe Services Programs
This 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.
Implementation Manual with External Facilitation Intervention: Participating organizations will receive the implementation manual and the external facilitation (EF) intervention. The manual provides instructions for organizations wanting to implement a high quality naloxone program. The EF will assist syringe service programs to integrate naloxone delivery within their organization. As part of these efforts, we will use a measurement framework to understand naloxone delivery within SSPs along the four phases of the implementation process-exploration, preparation, implementation and sustainment (EPIS).
|
Control Arm
n=52 Syringe Services Programs
This 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 only: Participating organizations will receive the implementation manual.The manual provides instructions for organizations wanting to implement a high quality naloxone program.
|
Total
n=105 Syringe Services Programs
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Unknown
|
53 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown/Not reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsMean number of syringe services program participants receiving naloxone per total number of syringe services program participants
Outcome measures
| Measure |
Organize and Mobilize for Implementation Effectiveness
n=45 syringe services programs
Our approach was based on the Implementation Sustainment Facilitation (ISF) 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. These 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.
Regarding potential dose, SSP staff and organizational leadership were provided the opportunity to participate in 60-minute sessions once a month for up to 12 months. In addition to monthly sessions, facilitators were provided up to 2 hours to prepare for sessions and to identify and distribute resources to SSPs based on identified priorities. All sessions were offered virtually over audio-visual connections. Thus, the maximum possible dose for each SSP was 12 sessions or 36 hours.
|
Dissemination of Best Practice Recommendations
n=49 syringe services programs
Dissemination: Study staff disseminated best practice recommendations to all SSPs enrolled in the trial. To detail the OEND best practice recommendations, a Delphi study was carried out to develop a set of best practices for OEND implementation within SSPs. Experts for the Delphi study included people in paid and volunteer leadership and direct service positions in SSPs, OEND researchers, people who work in state or local health departments, and people who use drugs who deliver and access SSP/OEND services. All individuals had prior or current experience delivering OEND programming in community-based settings, and people with lived substance use experience were represented in each of the expert categories. Findings from this initiative were summarized into an organized best practices recommendations guide.
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|---|---|---|
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Naloxone Coverage (Consistency)
|
0.9 proportion of participants
Standard Deviation 1.4
|
0.4 proportion of participants
Standard Deviation 0.3
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PRIMARY outcome
Timeframe: 3 monthsThe mean number of naloxone doses distributed per total number of SSP participants
Outcome measures
| Measure |
Organize and Mobilize for Implementation Effectiveness
n=46 syringe services programs
Our approach was based on the Implementation Sustainment Facilitation (ISF) 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. These 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.
Regarding potential dose, SSP staff and organizational leadership were provided the opportunity to participate in 60-minute sessions once a month for up to 12 months. In addition to monthly sessions, facilitators were provided up to 2 hours to prepare for sessions and to identify and distribute resources to SSPs based on identified priorities. All sessions were offered virtually over audio-visual connections. Thus, the maximum possible dose for each SSP was 12 sessions or 36 hours.
|
Dissemination of Best Practice Recommendations
n=50 syringe services programs
Dissemination: Study staff disseminated best practice recommendations to all SSPs enrolled in the trial. To detail the OEND best practice recommendations, a Delphi study was carried out to develop a set of best practices for OEND implementation within SSPs. Experts for the Delphi study included people in paid and volunteer leadership and direct service positions in SSPs, OEND researchers, people who work in state or local health departments, and people who use drugs who deliver and access SSP/OEND services. All individuals had prior or current experience delivering OEND programming in community-based settings, and people with lived substance use experience were represented in each of the expert categories. Findings from this initiative were summarized into an organized best practices recommendations guide.
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|---|---|---|
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Naloxone Doses Distributed (Consistency)
|
2.5 naloxone doses
Standard Deviation 2.6
|
1.3 naloxone doses
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: 12 monthsThe mean number of best practices adopted by the SSP
Outcome measures
| Measure |
Organize and Mobilize for Implementation Effectiveness
n=51 syringe services programs
Our approach was based on the Implementation Sustainment Facilitation (ISF) 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. These 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.
Regarding potential dose, SSP staff and organizational leadership were provided the opportunity to participate in 60-minute sessions once a month for up to 12 months. In addition to monthly sessions, facilitators were provided up to 2 hours to prepare for sessions and to identify and distribute resources to SSPs based on identified priorities. All sessions were offered virtually over audio-visual connections. Thus, the maximum possible dose for each SSP was 12 sessions or 36 hours.
|
Dissemination of Best Practice Recommendations
n=51 syringe services programs
Dissemination: Study staff disseminated best practice recommendations to all SSPs enrolled in the trial. To detail the OEND best practice recommendations, a Delphi study was carried out to develop a set of best practices for OEND implementation within SSPs. Experts for the Delphi study included people in paid and volunteer leadership and direct service positions in SSPs, OEND researchers, people who work in state or local health departments, and people who use drugs who deliver and access SSP/OEND services. All individuals had prior or current experience delivering OEND programming in community-based settings, and people with lived substance use experience were represented in each of the expert categories. Findings from this initiative were summarized into an organized best practices recommendations guide.
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|---|---|---|
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Best Practice Adoption (Implementation Quality)
|
13.1 number of best practices
Interval 8.0 to 18.0
|
12.9 number of best practices
Interval 8.0 to 17.0
|
Adverse Events
Organize and Mobilize for Implementation Effectiveness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dissemination of Best Practice Recommendations
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place