Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Opioid Abuse
  • Opioid Dependence
  • Opioid Use
  • Opioid Related Disorders
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Opioid overdoses are a leading cause of death for Americans under 50 years old, with recent years recording the most opioid overdose deaths on record. US Emergency Departments (EDs) have seen a parallel increase in opioid-related visits (a 100% increase from 2005 - 2014). ED patients presenting for ...

Opioid overdoses are a leading cause of death for Americans under 50 years old, with recent years recording the most opioid overdose deaths on record. US Emergency Departments (EDs) have seen a parallel increase in opioid-related visits (a 100% increase from 2005 - 2014). ED patients presenting for an overdose are at greatly elevated risk for a repeat overdose and death. Thus, an overdose-related ED visit is both a critical and opportune time to prevent recurrent opioid overdose and overdose death through increased uptake in addiction treatment. The most effective means to promote engagement in treatment following an ED visit for opioid overdose remains unknown. To address this critical evidence gap, the investigators will compare the effectiveness of two ED-based behavioral interventions to increase treatment uptake and reduce the risk of future overdose among ED patients who are at greatest risk of accidental drug-related death. In response to RI's overdose crisis, in 2014, the state's largest ED (Rhode Island Hospital) began a proactive campaign to improve the care of overdose patients. The program includes an ED-based behavioral intervention either by in-house clinical social work staff or peer recovery support specialists ("peer navigators"). Following the introduction of these interventions in the ED, there was 10-fold increase in the proportion of patients engaging in addiction treatment within 30 days of the initial ED visit. While this preliminary data is promising, the effectiveness of the peer navigators versus the social work intervention is not known. The investigators propose a randomized controlled trial of early ED behavioral interventions following an opioid overdose. The investigators hypothesize that peer navigation will result in greater early treatment engagement and reduction in recurrent opioid overdose compared to a standard intervention delivered by a clinical social worker. The investigators will determine the effectiveness of peer navigation versus a standard behavioral intervention delivered in the ED to overdose patients and those at risk of recurrent opioid overdose. A total of 650 ED patients will be recruited (n=325 per arm) and followed for 18 months. Effectiveness will be measured objectively through linkage to administrative statewide databases, with two primary endpoints: (1) engagement in formal addiction treatment (e.g., inpatient services, outpatient services, medication assisted treatment (MAT)) from a licensed substance abuse treatment provider within 30 days following the ED visit, and (2) reduction in 18-month recurrent ED visits for an opioid overdose. Exploratory outcomes of interest are: overdose fatality, repeat ED visits related to opioids, and successful completion of an addiction treatment program and/or long-term retention in MAT. The investigators will explore if there is heterogeneity of treatment effect related to patient characteristics. The investigators anticipate that there will be individuals within each treatment arm who will vary in their response to the intervention. Specifically, the investigators will examine if the effects of the interventions are modified by baseline characteristics such as age, sex, race, type of opioid used, and history of comorbid chronic pain, depression or PTSD. Understanding these factors will allow us to further optimize subsequent interventions.

Tracking Information

NCT #
NCT03684681
Collaborators
Brown University
Investigators
Principal Investigator: Francesca Beaudoin, MD Brown Emergency Medicine