Substance Use DisordersEMPOWERNCT06320015
Emergency Medicine Peer Outreach Worker Engagement for Recovery
An observational study of Substance Use Disorders and Overdose, run by University of California, Los Angeles at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Overdose, Opioid Use Disorder
- What is being tested?
- Substance Misuse Assistance Response Team (SMART)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll 400 people with a substance-used related visit. Individuals will be approached after receipt of ED services. 1. 200 people who have received SMART services. - Participants will be approached for study participation after they have already received SMART services. 2. 200 people who did NOT receive SMART services. * Participants will be approached for study enrollment in this study arm when they are seen and treated on a day and time or ED site where SMART is not available.
Who may be able to join
- Adults 18 years old or older
- Seen and treated at Rhode Island or The Miriam Hospital ED for a substance use-related concern including intoxication, withdrawal, opioid overdose, opioid withdrawal, or substance use-related infection
- Able to provide informed consent
- Able to provide at least two forms of contact (personal phone, social media, email, or contact information for family or friends)
- Participants may speak languages other than English but require use of interpreter services. Consents will be available in English, Spanish, and Portuguese, the three most spoken languages in the Providence metropolitan area.
Who cannot join
- Unable to provide informed consent
- In police custody, incarcerated, or have a court ordered treatment enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Ashley Gaipo, (401) 444-3374, agaipo@lifespan.org
Taneisha Wilson, MD
About this study
Official title: Emergency Department Community Health Worker-Peer Recovery Navigation for Linkage to Recovery: A Mixed Methods Evaluation
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.
Read the detailed 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.
- Being tested
- Substance Misuse Assistance Response Team (SMART), Usual Care Group
- Medical subject headings
- Substance-Related Disorders, Drug Overdose, Opioid-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substance Misuse Assistance Response Team (SMART)Behavioural
The study intervention is engagement with a Substance Misuse Assistance Response Team (SMART) community health worker-peer recovery specialist (PCHW). SMART PCHWs engage ED patients with substance use disorders and facilitates ED services provision and linkages to outpatient care. Services provided include supporting ED initiation of buprenorphine, harm reduction services, social services (transportation, housing assistance, etc.), and engagement in peer recovery, behavioral health services, and addiction treatment services. Services are provided at the time of the ED visit. A subgroup of patients is provided short term case management and outpatient services navigation depending on PCHW caseload availability and individual needs.
Usual Care GroupOther
Patient not seen by a SMART community health worker in the emergency department. Care and treatment referral at discretion of emergency department treating team.
| Study group | Role | What they receive |
|---|---|---|
| SMART Participant | Emergency department patients at with a substance use disorder who have received SMART services Receives: Behavioral: Substance Misuse Assistance Response Team (SMART) | |
| Usual Care | Emergency department patients with a substance use disorder who have not received SMART services Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment engagement
Investigators will measure engagement in formal addiction treatment at a state licensed addiction treatment facility and/or receipt of office-based buprenorphine through data linkages to the Rhode Island Prescription Drug Monitoring Program database and the Rhode Island Behavioral Health Online Database.
Measured: Will compare differences in treatment engagement between study arms 3 and 6 months after study enrollment.
Recovery Capital
Investigators will conduct surveys with study participants at time of enrollment, three months after enrollment, and six months after enrollment. Survey Changes in individual recovery capital as measured by reported self-efficacy, social networks, and quality of life
Measured: Will compare differences in treatment engagement between study arms 3 and 6 months after study enrollment.
Secondary outcomes (8)
Emergency Department Utilization
Investigators will measure emergency department utilization through review of health system electronic health records and data linkages to the Rhode Island Emergency Medical Services and Medicaid claims databases.
Measured: Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
Repeat Hospitalization
Investigators will measure hospitalizations review of health system electronic health records and data linkages to the Rhode Island Emergency Medical Services and Medicaid claims databases.
Measured: Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
Repeat Overdose
Investigators will measure overdose incidence review of health system electronic health records and data linkages to the Rhode Island Emergency Medical Services and Medicaid claims databases.
Measured: Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
Mortality
Through linkage to the state vital records database, investigators will compare differences in mortality between study arms.
Measured: Will compare differences in mortality between study arms 3 and 6 months after study enrollment.
Social Services Engagement
Investigators will compare changes in social services engagement needs through linkage to the Rhode Island Executive Office of Health and Human Services Data Ecosystem. Databases included in the Data Ecosystem include the Rhode Island Department of Labor and Training, Department of Health and Human Services, Department of Corrections, Department of Human Services, and the Rhode Island Coalition on Homelessness.
Measured: Will compare differences in health related social needs between study arms 3 and 6 months after study enrollment.
Housing Services Engagement
Investigators will compare changes in housing services engagement for participants unstably housed. Participants will be identified as unstably housed through study intake survey responses. Outcomes will be identified through linkage to the Rhode Island Coalition on Homelessness data housed in the Rhode Island Executive Office of Health and Human Services Data Ecosystem.
Measured: Will compare differences in housing services engagement between study arms 3 and 6 months after study enrollment.
Employment
Investigators will compare changes in employment through linkage to the Rhode Island Department of Labor and Training databased housed in the Rhode Island Executive Office of Health and Human Services Data Ecosystem.
Measured: compare differences in changes in employment between study arms 3 and 6 months after study enrollment.
Incarceration
Investigators will compare changes in incarceration and encounters with the criminal justice system through linkage to the Rhode Island Department of Corrections database which is housed in the Rhode Island Executive Office of Health and Human Services Data Ecosystem.
Measured: Will compare differences in changes in incarceration and encounters with the criminal justice system between study arms 3 and 6 months after study enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Jul 2024
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital, Brown University
- Responsible party
- Principal investigator, Elizabeth Samuels, University of California, Los Angeles
- Investigators
- Elizabeth Samuels, MD, MPH, MHS, Principal investigator, UCLA Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320015
- Sponsor's protocol ID
- R01CE003632-01-00
- Other IDs
- R01CE003632
- Acronym
- EMPOWER
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2023
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Community Health Worker-Peer Recovery Navigation for Linkage to Recovery: A Mixed Methods Evaluation
- ClinicalTrials.gov ID
- NCT06320015
- Acronym / sponsor ID
- EMPOWER / R01CE003632-01-00
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital, Brown University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART Participant | – | Behavioral: Substance Misuse Assistance Response Team (SMART)Emergency department patients at with a substance use disorder who have received SMART services |
| Usual Care | – | Other: Usual Care GroupEmergency department patients with a substance use disorder who have not received SMART services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll 400 people with a substance-used related visit. Individuals will be approached after receipt of ED services. 1. 200 people who have received SMART services. - Participants will be approached for study participation after they have already received SMART services. 2. 200 people who did NOT receive SMART services. * Participants will be approached for study enrollment in this study arm when they are seen and treated on a day and time or ED site where SMART is not available.
Key inclusion criteria (5 listed)
- Adults 18 years old or older
- Seen and treated at Rhode Island or The Miriam Hospital ED for a substance use-related concern including intoxication, withdrawal, opioid overdose, opioid withdrawal, or substance use-related infection
- Able to provide informed consent
- Able to provide at least two forms of contact (personal phone, social media, email, or contact information for family or friends)
- Participants may speak languages other than English but require use of interpreter services. Consents will be available in English, Spanish, and Portuguese, the three most spoken languages in the Providence metropolitan area.
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- In police custody, incarcerated, or have a court ordered treatment enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Substance Misuse Assistance Response Team (SMART)The study intervention is engagement with a Substance Misuse Assistance Response Team (SMART) community health worker-peer recovery specialist (PCHW). SMART PCHWs engage ED patients with substance use disorders and facilitates ED services provision and linkages to outpatient care. Services provided include supporting ED initiation of buprenorphine, harm reduction services, social services (transportation, housing assistance, etc.), and engagement in peer recovery, behavioral health services, and addiction treatment services. Services are provided at the time of the ED visit. A subgroup of patients is provided short term case management and outpatient services navigation depending on PCHW caseload availability and individual needs. | Behavioural | SMART Participant |
| Usual Care GroupPatient not seen by a SMART community health worker in the emergency department. Care and treatment referral at discretion of emergency department treating team. | Other | Usual Care |
Primary outcome
Treatment engagement
Time frame: Will compare differences in treatment engagement between study arms 3 and 6 months after study enrollment.
Investigators will measure engagement in formal addiction treatment at a state licensed addiction treatment facility and/or receipt of office-based buprenorphine through data linkages to the Rhode Island Prescription Drug Monitoring Program database and the Rhode Island Behavioral Health Online Database.
Recovery Capital
Time frame: Will compare differences in treatment engagement between study arms 3 and 6 months after study enrollment.
Investigators will conduct surveys with study participants at time of enrollment, three months after enrollment, and six months after enrollment. Survey Changes in individual recovery capital as measured by reported self-efficacy, social networks, and quality of life
8 secondary outcomes
Emergency Department Utilization
Time frame: Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
Repeat Hospitalization
Time frame: Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
Repeat Overdose
Time frame: Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
Mortality
Time frame: Will compare differences in mortality between study arms 3 and 6 months after study enrollment.
Social Services Engagement
Time frame: Will compare differences in health related social needs between study arms 3 and 6 months after study enrollment.
Housing Services Engagement
Time frame: Will compare differences in housing services engagement between study arms 3 and 6 months after study enrollment.
Employment
Time frame: compare differences in changes in employment between study arms 3 and 6 months after study enrollment.
Incarceration
Time frame: Will compare differences in changes in incarceration and encounters with the criminal justice system between study arms 3 and 6 months after study enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Samuels, MD, MPH, MHS principal investigator
UCLA Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders and Overdose, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Gaipo ((401) 444-3374, agaipo@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment engagement (time frame: Will compare differences in treatment engagement between study arms 3 and 6 months after study enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.