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Rural Expanded Access to OUD Care & Linkage Using Toxicologists for Telehealth Initiated Treatment (REAL TTIME)

Primary Purpose

Opioid Use, Opioid Abuse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sociobehavioral Intervention
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use focused on measuring Opioid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Georgia Poison CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sociobehavioral program Group

Control Group

Arm Description

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.

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

Outcomes

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)
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)
Change in number of patients evaluated for MOUD will be collected
Change in number of patients started on MOUD
Change in number of patients started on MOUD will be collected
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
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
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

Secondary Outcome Measures

Full Information

First Posted
January 18, 2023
Last Updated
September 18, 2023
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT05711056
Brief Title
Rural Expanded Access to OUD Care & Linkage Using Toxicologists for Telehealth Initiated Treatment
Acronym
REAL TTIME
Official Title
Expanding Rural Access to Opioid Use Disorder Treatment Utilizing Medical Toxicologists and the Georgia Poison Center to Facilitate Emergency Department- and Telehealth-Based Medication Initiation and Linkage to Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Over the past two decades, death from opioid overdose has dramatically increased. Opioid use disorder (OUD) is a complex and debilitating chronic illness associated with serious medical complications. Effective treatment of OUD often requires long-term treatment with multiple therapies. Medications for opioid use disorder (MOUD), are the gold standard for OUD treatment, including buprenorphine. MOUD is underutilized, and treatment programs are in short supply, particularly in rural areas. Psychosocial and behavioral health interventions are also key factors in maintaining sobriety. The use of trained peer recovery coaches (PRCs) has been shown to increase both MOUD initiation and 30-day treatment retention. The goal of this project is to increase the availability of OUD treatment in rural counties Georgia by using ED-based telehealth strategies to initiate MOUD and connect patients to treatment by implementing a novel collaboration between rural EDs, medical toxicologists at the Georgia Poison Center (GPC), PRCs, and Recovery Community Organizations (RCOs). The study population will include patients with OUD or opioid withdrawal that are 18 years or older, English speaking, clinically sober, and medically and psychiatrically stable, that present to a preselected rural ED in Candler, Carroll, Jefferson, Laurens, and Washington County. Pregnant patients are included as MOUD is standard of care and the sociobehavioral intervention is considered minimal risk. This sociobehavioral intervention will utilize 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 and linkage to outpatient care. An ED provider will evaluate the patient and if identified as someone with OUD or opioid withdrawal, the ED provider will call the GPC and be connected to the medical toxicologist on call. The toxicologist will assist the ED provider with initiation of MOUD. After the medical evaluation is complete, the ED provider will contact the virtual PRC. Once the PRC and the patient are introduced, the PRC will obtain verbal consent to participate in the study and allow for chart review and to follow up with the patient at 30-days to determine if they are still engaged with the outpatient program and/or maintained on MOUD. Before consent is obtained, this will be a no-contact study. The research team will perform a retrospective chart review to identify demographic and historical information about patients that present to each rural ED with OUD or opioid withdrawal. The investigators will request this data from hospitals monthly and continuously over the study period. One the patient has been consented by the PRC, the investigators will request additional data to follow up with them and obtain information from the RCO and Prescription Drug Monitoring Program (PDMP). Data will be made publicly available through HRSA and will be submitted for publication in a peer reviewed journal. Data will not be identifiable. Research team members will have access to the data but will be required to complete HIPPA and CITI training. The research team will request a HIPPA waiver to access existing data from hospital systems about the patients who present to the ED with OUD or acute opioid withdrawal. The ED provider will interact with the patient and perform standard of care. They will contact the poison center to help with MOUD initiation. Then, the patient will be introduced to the virtual PRC, who will review the consent document. Regardless of consent, the patient will still be offered the intervention. The participant burden is minimal (time required to obtain consent). Data will be kept confidential, and deidentified when it is stored in ToxSentry (GPC electronic medical record) and in Emory One Drive (HIPPA complaint and secure).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid Abuse
Keywords
Opioid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sociobehavioral program Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients who are seen at a participating hospital prior to the initiation of the intervention will be considered controls.
Intervention Type
Behavioral
Intervention Name(s)
Sociobehavioral Intervention
Intervention Description
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 Measure Information:
Title
Change in number of patients who present with acute opioid withdrawal, acute opioid overdose, or requesting treatment for OUD (Opioid Use Disorder)
Description
Change in number of patients who present with acute opioid withdrawal, acute opioid overdose, or requesting treatment for OUD will be collected
Time Frame
Baseline, 3 months post intervention, and 1 year post intervention
Title
Change in number of patients evaluated for MOUD (Medication for Opioid Use Disorder)
Description
Change in number of patients evaluated for MOUD will be collected
Time Frame
Baseline, 3 months post intervention, and 1 year post intervention
Title
Change in number of patients started on MOUD
Description
Change in number of patients started on MOUD will be collected
Time Frame
Baseline, 3 months post intervention, and 1 year post intervention
Title
Change in number of patients discharged with a prescription for MOUD
Description
Change in number of patients discharged with a prescription for MOUD will be collected
Time Frame
Baseline, 3 months post intervention, and 1 year post intervention
Title
Change in number of patients linked to a local RCO (Recovery Community Organization)
Description
Change in number of patients linked to a local RCO will be collected
Time Frame
Baseline, 3 months post intervention, and 1 year post intervention
Title
Change in number of patients seen at local RCO after ED discharge
Description
Change in number of patients seen at local RCO after ED discharge will be collected
Time Frame
Baseline, 3 months post intervention, and 1 year post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Kiernan, DO
Phone
412-519-4944
Email
emily.anne.kiernan@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Kiernan, DO
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Poison Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Kiernan, DO
Email
emily.anne.kiernan@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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