Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06320015 |
Other study ID # |
R01CE003632-01-00 |
Secondary ID |
R01CE003632 |
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 1, 2024 |
Est. completion date |
September 2025 |
Study information
Verified date |
March 2024 |
Source |
University of California, Los Angeles |
Contact |
Ashley Gaipo |
Phone |
(401) 444-3374 |
Email |
agaipo[@]lifespan.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This is an observational, prospective case-control study evaluating the effects of an
emergency department community health worker-peer recovery specialist program (PCHW), the
Substance Misuse Assistance Response Team (SMART). Aims of this study are to 1) understand
participant experiences working with a SMART PCHW and identify possible mechanisms for
successful recovery linkage; 2) Evaluate SMART effectiveness on patient-centered outcomes,
building recovery capital, and recovery linkage; 3) Evaluate SMART implementation and
effectiveness on patient outcomes over time.
Using a combination of surveys and data linkages to state administrative databases, study
investigators will prospectively compare changes in addiction treatment engagement, recovery
capital, health related social needs, acute care utilization, and death between people
receiving a ED PCHW and those who do not. After consenting to study participation,
participants will complete surveys at time of study enrollment and 3 and 6 months after their
initial ED visit. Primary outcomes include engagement in addiction treatment, social services
engagement, acute care utilization, and mortality will be assessed through linkages to state
administrative databases.
Description:
The emergency department (ED) is on the front lines of the overdose epidemic, treating an
increasing number of people with substance use disorders (SUD). In the year after a substance
use-related ED visit, risk of death is six time higher than other patients, and for people
treated after an opioid overdose, more than one in twenty patients will die. Each substance
use-related ED visit represents a crucial opportunity to link patients to recovery services,
however there are significant gaps in service provision with less than one in three receiving
behavioral counseling and only one in five linked to addiction treatment. To improve linkage
to recovery and addiction treatment services from the ED, study investigators launched a
multidisciplinary, ED community health worker-peer recovery specialist program (PCHW), the
Substance Misuse Assistance Response Team (SMART), at a large, academic, urban medical center
which cares for the majority of patients with SUDs in Rhode Island. Drawing from models of
existing peer recovery specialist, CHW, and health promotion advocate programs, SMART is a
novel ED-based program that provides people with a substance-use related ED visit
individualized support, short term case management, navigation to social services, harm
reduction, recovery, and addiction treatment services in and out of the ED. SMART
distinguishes itself from other models of ED patient navigation and/or peer recovery
specialist programs by working in and out of the ED and focusing on social determinants of
recovery. In recent years there has been a proliferation of ED peer recovery programs, but
little is known about their effectiveness. Study investigators will conduct a pragmatic,
mixed methods study of an established ED PCHW program to evaluate program delivery, linkage
to evidence-based recovery services, and short- and long-term patient outcomes. Aims of this
study are to 1) understand participant experiences working with a SMART PCHW and identify
possible mechanisms for successful recovery linkage; 2) Evaluate SMART effectiveness on
patient-centered outcomes, building recovery capital, and recovery linkage; 3) Evaluate SMART
implementation and effectiveness on patient outcomes over time. Participant interviews will
examine participant experiences with SMART, recovery services engagement, and identify
potentially effective engagement strategies. A RE-AIM framework will be used to evaluate
program implementation (process outcomes) and effectiveness (patient outcomes). Surveys and
data linkage to hospital and state administrative databases will be used to measure changes
in recovery capital, social networks, receipt of social services, linkage to harm reduction,
recovery, and addiction treatment services, and changes in acute care utilization and
mortality among people receiving SMART. Results from this study will provide robust data
about ED peer recovery specialist program process and patient-level outcomes needed for a
subsequent multilevel, comprehensive study to identify and test effectiveness of ED peer
recovery program components and implementation strategies for program enhancement,
dissemination, and sustainability.