NCT05711056 · Emory University
Rural Expanded Access to OUD Care & Linkage Using Toxicologists for Telehealth Initiated Treatment
(REAL TTIME)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Sociobehavioral Intervention
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.
Primary outcome measures
Change in number of patients who present with acute opioid withdrawal, acute opioid overdose, or requesting treatment for OUD (Opioid Use Disorder)
Time frame: Baseline, 3 months post intervention, and 1 year post intervention
Change in number of patients who present with acute opioid withdrawal, acute opioid overdose, or requesting treatment for OUD will be collected
Change in number of patients evaluated for MOUD (Medication for Opioid Use Disorder)
Time frame: Baseline, 3 months post intervention, and 1 year post intervention
Change in number of patients evaluated for MOUD will be collected
Change in number of patients started on MOUD
Time frame: Baseline, 3 months post intervention, and 1 year post intervention
Change in number of patients started on MOUD will be collected
Change in number of patients discharged with a prescription for MOUD
Time frame: Baseline, 3 months post intervention, and 1 year post intervention
Change in number of patients discharged with a prescription for MOUD will be collected
Change in number of patients linked to a local RCO (Recovery Community Organization)
Time frame: Baseline, 3 months post intervention, and 1 year post intervention
Change in number of patients linked to a local RCO will be collected
Change in number of patients seen at local RCO after ED discharge
Time frame: Baseline, 3 months post intervention, and 1 year post intervention
Change in number of patients seen at local RCO after ED discharge will be collected
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 years or older
- English speaking
- Clinically sober
- Medically and psychiatrically stable
Exclusion criteria
- 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
- 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
Where
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 20, 2025 · Source of record for eligibility and locations