Rural Expanded Access to OUD Care & Linkage Using Toxicologists for Telehealth Initiated Treatment

NCT05711056 | Recruiting DMC

• 2 other identifiers: STUDY00005086G28RH46273-01-00
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this project is to increase the availability of OUD treatment in rural counties in the state of Georgia by using Emergency Department (ED)-based telehealth strategies to initiate MOUD and connect patients to treatment. The investigators will implement a novel collaboration between rural EDs, medical toxicologists at the Georgia Poison Center (GPC), peer recovery coaches (PRCs) and RCOs throughout Georgia to bridge the gap between OUD treatment need in rural EDs and specialty physician availability at the GPC. Research activities will be conducted during two broad phases, at three rural EDs in Georgia: planning and implementation. During the planning phase, aggregate data will be obtained to determine each ED's existing practices treating patients with OUD and opioid withdrawal. During the implementation phase, the researchers will prospectively study a poison center OUD consultation and PRC intervention as it is rolled out at each site, collecting participant-level data. Sites will be rolled into the implementation phase in a stepped-wedge fashion, so there will be times when some sites are in the planning phase while others are in the implementation phase.

Conditions

Opioid Use; Opioid Abuse

Keywords

Opioid

Outcome Measures

Primary Outcomes (6)

• Change in number of patients who present with acute opioid withdrawal, acute opioid overdose, or requesting treatment for OUD (Opioid Use Disorder)

  Change in number of patients who present with acute opioid withdrawal, acute opioid overdose, or requesting treatment for OUD will be collected

  Baseline, 3 months post intervention, and 1 year post intervention

• Change in number of patients evaluated for MOUD (Medication for Opioid Use Disorder)

  Change in number of patients evaluated for MOUD will be collected

  Baseline, 3 months post intervention, and 1 year post intervention

• Change in number of patients started on MOUD

  Change in number of patients started on MOUD will be collected

  Baseline, 3 months post intervention, and 1 year post intervention

• Change in number of patients discharged with a prescription for MOUD

  Change in number of patients discharged with a prescription for MOUD will be collected

  Baseline, 3 months post intervention, and 1 year post intervention

• Change in number of patients linked to a local RCO (Recovery Community Organization)

  Change in number of patients linked to a local RCO will be collected

  Baseline, 3 months post intervention, and 1 year post intervention

• Change in number of patients seen at local RCO after ED discharge

  Change in number of patients seen at local RCO after ED discharge will be collected

  Baseline, 3 months post intervention, and 1 year post intervention

Study Arms (2)

Sociobehavioral program Group

EXPERIMENTAL

A novel sociobehavioral collaborative program that will improve the health of individuals in rural areas by expanding access to MOUD through an ED- based telemedicine strategy. Researchers will prospectively study a poison center OUD consultation and peer recovery coach (PRC) intervention as it is rolled out at each site, collecting participant-level data at baseline, one week post intervention and 30 days post intervention.

Behavioral: Sociobehavioral Intervention

Control Group

NO INTERVENTION

Patients who are seen at a participating hospital prior to the initiation of the intervention will be considered controls.

Interventions

Sociobehavioral Intervention BEHAVIORAL

Utilizes two primary evidence-based strategies: * Delivering OUD consultation via telemedicine, which has been demonstrated to be a safe and effective means for initiating MOUD with buprenorphine; and, * Incorporating psychosocial support in the form of PRC, whose involvement in patient care is associated with increased treatment retention and MOUD initiation.

Sociobehavioral program Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• English speaking
• Clinically sober
• Medically and psychiatrically stable

You may not qualify if:

• Already receiving MAT or psychotherapy for OUD prior to ED arrival
• Prior participation in the study
• Unable to provide informed consent
• If their clinical condition worsens such that continued participation would be considered unsafe in the opinion of the PRC or ED staff
• Prisoners
• Individuals who are not yet adults (infants, children, teenagers)
• Cognitively impaired or Individuals with Impaired Decision-Making Capacity
• Individuals who are not able to clearly understand English

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Georgia Poison Center

Atlanta, Georgia, 30303, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Emily Kiernan, DO

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Kiernan, DO

CONTACT

412-519-4944; emily.anne.kiernan@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 2, 2023
• Study Start: August 30, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)