Opioid Overdose
Conditions
Keywords
Implementation Science, Harm Reduction
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).'
Interventions
OTHEROrganize 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
OTHERDissemination
Our comparison group receives dissemination of best practice recommendations for naloxone implementation.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
RTI International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Study statistician was masked to which participants were in the intervention arm and which participants were in the control arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm 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). | 53 |
| Intervention Arm 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). | 53 |
| Control Arm 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. | 52 |
| Control Arm 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. | 52 |
| Total | 210 |
Baseline characteristics
| Characteristic | Control Arm | Total | Intervention Arm |
|---|---|---|---|
| Age, Customized Unknown | 52 Participants | 105 Participants | 53 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 9 Participants | 1 Participants |
| Race (NIH/OMB) White | 38 Participants | 83 Participants | 45 Participants |
| Sex/Gender, Customized Female | 31 Participants | 66 Participants | 35 Participants |
| Sex/Gender, Customized Male | 16 Participants | 32 Participants | 16 Participants |
| Sex/Gender, Customized Unknown/Not reported | 5 Participants | 7 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
Primary
Best Practice Adoption (Implementation Quality)
The mean number of best practices adopted by the SSP
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Organize and Mobilize for Implementation Effectiveness | Best Practice Adoption (Implementation Quality) | 13.1 number of best practices |
| Dissemination of Best Practice Recommendations | Best Practice Adoption (Implementation Quality) | 12.9 number of best practices |
p-value: 0.6895% CI: [-0.7, 1]t-test, 2 sided
Primary
Naloxone Coverage (Consistency)
Mean number of syringe services program participants receiving naloxone per total number of syringe services program participants
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Organize and Mobilize for Implementation Effectiveness | Naloxone Coverage (Consistency) | 0.9 proportion of participants | Standard Deviation 1.4 |
| Dissemination of Best Practice Recommendations | Naloxone Coverage (Consistency) | 0.4 proportion of participants | Standard Deviation 0.3 |
p-value: <0.0195% CI: [1.42, 2.35]Negative Binomial Regression
Primary
Naloxone Doses Distributed (Consistency)
The mean number of naloxone doses distributed per total number of SSP participants
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Organize and Mobilize for Implementation Effectiveness | Naloxone Doses Distributed (Consistency) | 2.5 naloxone doses | Standard Deviation 2.6 |
| Dissemination of Best Practice Recommendations | Naloxone Doses Distributed (Consistency) | 1.3 naloxone doses | Standard Deviation 1.2 |
p-value: 0.0195% CI: [1.18, 3.3]Negative Binomial Regression