NCT05847621

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 16, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

April 27, 2023

Last Update Submit

December 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in number of participants with successful linkage to at least one recovery resource

    Change in number of participants with successful linkage to at least one recovery resource (formal addiction treatment, Recovery Community Organization (RCO), or harm reduction organization) at 30 days and 90 days after enrollment.

    Baseline, 30 and 90 days after enrollment

Secondary Outcomes (11)

  • Change in Brief Assessment of Recovery Capital (BARC-10)

    Baseline, 7, 30, and 90 days after enrollment

  • Change in number of successful engagements with PRC after ED visit

    Baseline, 7, 30, and 90 days after enrollment

  • Change in number of episodes of re-linkage to recovery resources

    Baseline, 7, 30, and 90 days post intervention

  • Self-reported substance use in last 30 days

    Baseline, 30 and 90 days post intervention

  • Number of fatal overdose events

    90 days post intervention

  • +6 more secondary outcomes

Study Arms (3)

In-person peer recovery coaching with linkage to recovery resources

EXPERIMENTAL

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.

Behavioral: Peer recovery coaching with linkage to recovery resources

Telemedicine-based peer recovery coaching with linkage to recovery resources

EXPERIMENTAL

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.

Behavioral: Peer recovery coaching with linkage to recovery resources

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Interventions

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.

In-person peer recovery coaching with linkage to recovery resourcesTelemedicine-based peer recovery coaching with linkage to recovery resources
Usual CareBEHAVIORAL

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

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ED patient or hospitalized through the ED within last 24 hours
  • Age 18 years or older
  • Able to speak and understand English
  • Clinically sober, able to provide informed consent
  • 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)
  • Willing to follow study procedures and complete research follow-up calls
  • Have at least one reliable contact number

You may not qualify if:

  • Medically or psychiatrically unstable as determined by treating physician
  • Prisoner or in police custody
  • Prior participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Joseph E Carpenter, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 6, 2023

Study Start

August 16, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Data sharing will be initiated upon written request to the PI and would ultimately be shared via a secure portal such as Microsoft OneDrive. Deidentified data files, the data dictionary, and the final protocol will be uploaded to the Emory Dataverse, which is a long-term repository offered through a partnership between Emory and the Odum Institute at the University of North Carolina and Chapel Hill. This repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with federal data sharing policies and applicable laws and regulations. Datasets are uniquely named with a persistent digital object identifier (DOI), and are downloadable directly through a web-based interface. Additional data documentation and de-identified data will be deposited for sharing along with data consistent with applicable laws and regulations. Submitted data will confirm with relevant data and terminology standards.

Shared Documents
STUDY PROTOCOL
Time Frame
Data sharing will be initiated upon written request to the PI and would ultimately be shared via a secure portal such as Microsoft OneDrive. The investigators will make data publicly available within 30 months of completing data collection.
Access Criteria
Written request to the PI.

Locations