Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03684681 |
| Other study ID # |
Navigator |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 14, 2018 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Rhode Island Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, the investigators will investigate if there is a better intervention for
patients who present to the emergency department with an overdose or with symptoms consistent
with drug use. There are currently two interventions that are routinely used when a patient
comes to the Emergency Department with these criteria, and the investigators will compare the
two. The first is when hospital social workers uses their own previous training to help
people meet their goals. The second is when a person called a peer navigator, who is someone
that has been in long-term drug recovery for over two years and has completed a lot of
training to work with current drug users, delivers an intervention to current drug users and
uses their own training and real- life experiences to help people meet their goals. The
investigators hope to determine if patients have better outcomes if they work with one of
these two groups.
If a patient agrees to be in the study, the research staff will randomize them (like flipping
a coin) to see if they will work with a social worker or a peer navigator. The research staff
will distribute a survey in RedCap and the following information will be collected: age, sex,
race, type of opioid used, and history of chronic pain, depression or post-traumatic stress
disorder. Once the patient is assigned to a group, they will work with their assigned
interventionist for the duration of the study. After this, the research team will track the
patient to see if they joined an addiction-treatment program within 30 days of when the
joined the study. The study team will also track patients to see if they had additional
emergency department visits, additional overdoses, and if they successfully completed a
treatment program over an 18-month period.
650 patients will be enrolled into the study.
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 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.
