Preventing Opioid Overdose Mortality in the United States

Preventing Opioid Overdose Mortality in the United States

Sponsors

Lead sponsor: RTI International

Collaborator: National Institute on Drug Abuse (NIDA)

Source RTI International
Brief Summary

This study aims to generate knowledge regarding the process of implementing naloxone within syringe service programs (SSPs), and to test whether external facilitation can improve implementation of naloxone within SSPs throughout the country. 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

The purpose of this study is to understand and improve naloxone implementation within Syringe Service Programs (SSPs) to reduce opioid overdose mortality in the United States. To achieve this goal, we will implement an external facilitation intervention that has been shown to improve implementation in HIV service settings. The intervention will leverage a naloxone implementation expert who will work with SSP organizational directors to identify barriers to and facilitators of achieving naloxone implementation quality and maximizing reach. We propose to assess the effectiveness of external facilitation, compared to dissemination of an implementation manual, in a national sample of SSPs in a randomized controlled trial (RCT). Our proposed specific aims are as follows:

Aim 1: To characterize United States syringe service programs along the exploration, preparation, implementation and sustainment (EPIS) continuum for delivering naloxone.

Aim 2: To test the effectiveness of external facilitation + dissemination of the naloxone implementation manual, compared with dissemination of the naloxone implementation manual alone, to improve the advancement of naloxone along the EPIS continuum among United States syringe service programs.

Hypothesis. The dissemination and external facilitation arm will be more effective in advancing naloxone implementation along the EPIS continuum between baseline and 12-month follow-up, than the dissemination-only arm.

To achieve these aims, 425 SSPs that are registered with the North American Syringe Exchange Network (NASEN) and /or receive information from harm reduction related web-based forums (e.g., online discussion groups, newsletters and listservs)will be asked to participate in an on-line cross-sectional survey and will be sent a hyperlink to the initial screening survey. We will use the on-line survey results to characterize the SSPs along the exploration, preparation, implementation and sustainment (EPIS) continuum for delivering the naloxone intervention (AIM 1).

The on-line survey includes a set of questions designed to collect information to evaluate where the SSP falls along the EPIS continuum for naloxone delivery. SSPs in the Implementation (I) phase of the EPIS continuum (estimated n = 100) will be contacted by research staff and offered the opportunity to participate in the RCT. SSPs that are interested in participating in the RCT will be enrolled in the study. For those SSPs who agree to participate, study staff will confirm eligibility by reviewing and documenting responses to the screening survey.

Following informed consent procedures, the study staff will administer the baseline survey to the SSP representative. The baseline survey will include questions about programmatic capacity, organizational culture, potential for internal champion or leader, perceived need for naloxone distribution within their community, and community acceptance of peer naloxone distribution programming. The study staff will then randomize SSPs into one of the one of the two study arms: (1) dissemination of the implementation manual and external facilitation for 12 months (experimental arm; n=50) and (2) dissemination of the implementation manual only (control arm; n=50).

All SSPs enrolled in the RCT will be sent a copy of the naloxone implementation manual either via email, hyperlink or the U.S. postal service depending on the preference of the participant. Those SSPs in the experimental arm will be enrolled in the EF intervention during which they will work directly with an OC to advance naloxone delivery as far along the EPIS continuum as possible during a 12-month period. The intervention will be delivered via phone calls, web-enabled audio and screen-sharing technology, and site visits. The key activities of the EF intervention include, initial SSP engagement, knowledge enhancement, capacity assessment, information gathering, identification of barriers and facilitators, development of action plans and provision of feedback, identification of funding and linkage to resources, and training of SSP staff.

At the end of the 12-month intervention period, SSPs in both study arms will participate in a follow-up survey, conducted by study staff, to evaluate advancement of naloxone implementation along the EPIS continuum.

Overall Status Recruiting
Start Date September 3, 2019
Completion Date September 2021
Primary Completion Date September 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Adoption of Best Practices Baseline
Adoption of Best Practices 12 months
Naloxone Coverage Baseline
Naloxone Coverage 12 months
Number of Naloxone Doses Distributed to SSP participants Baseline
Number of Naloxone Doses Distributed to SSP participants 12 months
Enrollment 100
Condition
Intervention

Intervention type: Behavioral

Intervention name: Implementation Manual with External Facilitation Intervention

Description: 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).

Arm group label: Implementation Manual and External Facilitation

Intervention type: Behavioral

Intervention name: Implementation Manual only

Description: Participating organizations will receive the implementation manual.The manual provides instructions for organizations wanting to implement a high quality naloxone program.

Arm group label: Implementation Manual - only

Eligibility

Criteria:

Inclusion Criteria:

- SSPs that participate in the on-line screening survey and fall into the implementation phase of the EPIS continuum will be recruited into the study.

Exclusion Criteria:

-

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Barrot Lambdin, PhD, MPH Principal Investigator RTI International
Overall Contact

Last name: Barrot Lambdin, PhD, MPH

Phone: 415-848-1334

Email: [email protected]

Location
facility status contact contact_backup RTI International Barrot Lambdin, PhD, MPH 415-848-1334 [email protected]
Location Countries

United States

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Implementation Manual and External Facilitation

Arm group type: Experimental

Description: 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.

Arm group label: Implementation Manual - only

Arm group type: Active Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov