- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06320015
Emergency Medicine Peer Outreach Worker Engagement for Recovery (EMPOWER)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ashley Gaipo
- Phone Number: (401) 444-3374
- Email: agaipo@lifespan.org
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Recruiting
- Rhode Island Hospital
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Principal Investigator:
- Taneisha Wilson, MD
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Contact:
- Ashley Gaipo
- Phone Number: (401) 444-3374
- Email: agaipo@lifespan.org
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study will enroll 400 people with a substance-used related visit. Individuals will be approached after receipt of ED services.
200 people who have received SMART services.
- Participants will be approached for study participation after they have already received SMART services.
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Unable to provide informed consent
- In police custody, incarcerated, or have a court ordered treatment enrollment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
SMART Participant
Emergency department patients at with a substance use disorder who have received SMART services
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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.
|
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Usual Care
Emergency department patients with a substance use disorder who have not received SMART services
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Patient not seen by a SMART community health worker in the emergency department.
Care and treatment referral at discretion of emergency department treating team.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Will compare differences in treatment engagement between study arms 3 and 6 months after study enrollment.
|
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Recovery Capital
Time Frame: Will compare differences in treatment engagement between study arms 3 and 6 months after study enrollment.
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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
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Will compare differences in treatment engagement between study arms 3 and 6 months after study enrollment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency Department Utilization
Time Frame: Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
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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.
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Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
|
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Repeat Hospitalization
Time Frame: Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
|
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.
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Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
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Repeat Overdose
Time Frame: Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
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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.
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Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.
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Mortality
Time Frame: Will compare differences in mortality between study arms 3 and 6 months after study enrollment.
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Through linkage to the state vital records database, investigators will compare differences in mortality between study arms.
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Will compare differences in mortality between study arms 3 and 6 months after study enrollment.
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Social Services Engagement
Time Frame: Will compare differences in health related social needs between study arms 3 and 6 months after study enrollment.
|
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.
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Will compare differences in health related social needs between study arms 3 and 6 months after study enrollment.
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Housing Services Engagement
Time Frame: Will compare differences in housing services engagement between study arms 3 and 6 months after study enrollment.
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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.
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Will compare differences in housing services engagement between study arms 3 and 6 months after study enrollment.
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Employment
Time Frame: compare differences in changes in employment between study arms 3 and 6 months after study enrollment.
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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.
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compare differences in changes in employment between study arms 3 and 6 months after study enrollment.
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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.
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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.
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Will compare differences in changes in incarceration and encounters with the criminal justice system between study arms 3 and 6 months after study enrollment.
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Collaborators and Investigators
Investigators
- Principal Investigator: Elizabeth Samuels, MD, MPH, MHS, UCLA Emergency Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01CE003632-01-00
- R01CE003632 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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