Preventing Opioid Overdose Mortality in the United States

Opioid Overdose Clinical Trial

Official title:

Preventing Opioid Overdose Mortality in the United States

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03924505
• Other study ID #: INOD
• Secondary ID: 1R01DA046867-01
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: September 2021

Study information

• Verified date: September 2020
• Source: RTI International
• Contact: Barrot Lambdin, PhD, MPH
• Phone: 510-665-8254
• Email: blambdin[@]rti.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Drug Overdose
• Opioid Overdose

Intervention

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

Locations

Country	Name	City	State
United States	RTI International	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adoption of Best Practices	Number of Best Practices adopted by the SSP	Baseline
Primary	Adoption of Best Practices	Number of Best Practices adopted by the SSP	12 months
Primary	Naloxone Coverage	Number of SSP participants receiving a dose of naloxone	Baseline
Primary	Naloxone Coverage	Number of SSP participants receiving a dose of naloxone	12 months
Primary	Number of Naloxone Doses Distributed to SSP participants	Naloxone Dispensed	Baseline
Primary	Number of Naloxone Doses Distributed to SSP participants	Naloxone Dispensed	12 months