NCT06320015

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jul 2024Oct 2026

First Submitted

Initial submission to the registry

November 18, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

November 18, 2023

Last Update Submit

September 30, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    Will compare differences in treatment engagement between study arms 3 and 6 months after study enrollment.

Secondary Outcomes (8)

  • Emergency Department Utilization

    Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.

  • Repeat Hospitalization

    Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.

  • Repeat Overdose

    Will compare differences in acute care utilization between study arms 3 and 6 months after study enrollment.

  • Mortality

    Will compare differences in mortality between study arms 3 and 6 months after study enrollment.

  • Social Services Engagement

    Will compare differences in health related social needs between study arms 3 and 6 months after study enrollment.

  • +3 more secondary outcomes

Study Arms (2)

SMART Participant

Emergency department patients at with a substance use disorder who have received SMART services

Behavioral: Substance Misuse Assistance Response Team (SMART)

Usual Care

Emergency department patients with a substance use disorder who have not received SMART services

Other: Usual Care Group

Interventions

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.

SMART Participant

Patient not seen by a SMART community health worker in the emergency department. Care and treatment referral at discretion of emergency department treating team.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to provide informed consent
  • In police custody, incarcerated, or have a court ordered treatment enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersDrug OverdoseOpioid-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPrescription Drug MisuseDrug MisuseNarcotic-Related DisordersAlcohol-Related Disorders

Study Officials

  • Elizabeth Samuels, MD, MPH, MHS

    UCLA Emergency Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 18, 2023

First Posted

March 20, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations