Linking Individuals Needing Care for Substance Use Disorders to Peer Coaches

NCT ID: NCT05847621

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-16

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a 3-arm randomized controlled trial. Participants will be randomized via a maximally tolerated imbalance randomization procedure using NCI's Clinical Trial Randomization Tool with 1:1:1 allocation to each group: in-person peer recovery coaching (PRC) with linkage to recovery resources, telemedicine-based peer recovery coaching with linkage to recovery resources, or usual care.

In the PRC arms, PRCs will meet patients at bedside (in person) or via a tablet-based video call (telemedicine). They will assess the participant's state of change, engage in motivational interviewing techniques, and link the participant to community-based recovery resources according to the needs of the participant. They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed.

Participants in the usual care arm will be provided with a list of community recovery resources, but there will be no PRC interaction or direct linkage to resources through the study.

Follow up visits will take place at 7, 30, and 90 days after enrollment. Most will take place via telephone, but participants will be given the option of an in-person visit if they so desire.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Deaths from drug overdose have risen to record levels since the onset of the COVID-19 pandemic, disproportionately impacting Black individuals and people experiencing homelessness. Fewer than one-third of the 8.3 million individuals living with an illicit drug use disorder in 2019 reported receiving treatment. Telemedicine services have increased access to care for many patients living with substance use disorders (SUD), but the long-term role of this treatment approach in SUD care is uncertain. Multifaceted strategies are needed to build recovery capital and link vulnerable individuals to recovery resources.

Emergency department (ED) visits are an opportunity to screen for SUDs, initiate treatment, and link to recovery resources. Observational studies have noted that consultation with a peer recovery coach (PRC) was well-received in EDs, with high rates of engagement and satisfaction. PRCs facilitate conversations allowing patients to express their ideal pathway to recovery, provide linkage to services across the social ecology, and follow up to support recovery, including re-linkage to resources as needed. Nonetheless, their role in ED screening and linkage to resources, including the potential role of telemedicine, has not been rigorously evaluated.

The investigators will conduct a randomized controlled trial enrolling 600 subjects across three arms: in-person peer coaching with linkage to recovery support services and callbacks, telemedicine-based peer coaching with linkage and callbacks, or usual care. Results will inform other EDs considering a peer recovery coach program for patients presenting with SUD-related conditions. By utilizing telemedicine, this model will be rapidly scalable and readily implemented at other facilities.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Substance Use Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

In-person peer recovery coaching with linkage to recovery resources

PRCs will meet patients at bedside (in person). They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed.

Follow-up data collection on day 7, 30, 90 post discharge.

Group Type EXPERIMENTAL

Peer recovery coaching with linkage to recovery resources

Intervention Type BEHAVIORAL

Peer recovery coach (PRC) assessment of the participant's state of change, engage in motivational interviewing techniques, and link the participant to community-based recovery resources according to the needs of the participant. They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed.

Telemedicine-based peer recovery coaching with linkage to recovery resources

PRCs will meet patients via a tablet-based video call (telemedicine). They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed.

Follow-up data collection on day 7, 30, 90 post discharge.

Group Type EXPERIMENTAL

Peer recovery coaching with linkage to recovery resources

Intervention Type BEHAVIORAL

Peer recovery coach (PRC) assessment of the participant's state of change, engage in motivational interviewing techniques, and link the participant to community-based recovery resources according to the needs of the participant. They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed.

Usual Care

Participants in the usual care arm will be provided with a list of community recovery resources. No callbacks or re-linkage to recovery resources.

Follow-up data collection on day 7, 30, 90 post discharge.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Participants will be provided with a list of community recovery resources.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peer recovery coaching with linkage to recovery resources

Peer recovery coach (PRC) assessment of the participant's state of change, engage in motivational interviewing techniques, and link the participant to community-based recovery resources according to the needs of the participant. They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed.

Intervention Type BEHAVIORAL

Usual Care

Participants will be provided with a list of community recovery resources.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. ED patient or hospitalized through the ED within last 24 hours
2. Age 18 years or older
3. Able to speak and understand English
4. Clinically sober, able to provide informed consent
5. Score of 3 or greater - "moderate level", "substantial level", or "severe level" of problems related to drug abuse - on Drug Abuse Screening Test (DAST-10).(103, 104)
6. Willing to follow study procedures and complete research follow-up calls
7. Have at least one reliable contact number

Exclusion Criteria

1. Medically or psychiatrically unstable as determined by treating physician
2. Prisoner or in police custody
3. Prior participation in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joseph Carpenter

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph E Carpenter, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01CE003509

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P009769

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00005553

Identifier Type: -

Identifier Source: org_study_id