NCT06479681

Brief Summary

The project objective is to rigorously evaluate the effectiveness of a peer recovery coaching intervention (called RC-Link) in patients hospitalized with medical complications from alcohol use on recovery outcomes guided by the new NIAAA definition of recovery, examine mechanisms of heavy drinking using daily ecological momentary assessment (EMA), and determine the program's cost-effectiveness using an randomized controlled trial (RCT) design. The primary outcomes are frequency of heavy drinking, biopsychosocial functioning, and remission from AUD.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress50%
Apr 2024Jun 2028

Study Start

First participant enrolled

April 25, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2028

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

3.8 years

First QC Date

June 24, 2024

Last Update Submit

August 21, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Percentage of Heavy Drinking Days Per Month

    This outcome will be measured using the Alcohol Timeline Follow Back (TLFB), a calendar-based, self-report survey. The TLFB is the most widely used measure of alcohol use frequency in treatment trials for AUD and has strong reliability and validity in diverse populations.

    one-month, 3-months, 6-months

  • Remission from Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) AUD Diagnosis

    The DSM-5 checklist for AUD will be used to assess AUD diagnosis. Remission is defined as meeting 0 of the 11 criteria for AUD diagnosis, excluding craving. According to the NIAAA recovery definition, cessation of heavy drinking and AUD remission are classified as the following durations: initial (0-3 months), early (3-12 months), sustained (1-5 years), and stable (\>5 years). Using this definition, primary study endpoints will be 1-month post-baseline (initial recovery; past 1 month symptoms), 3-month post-baseline (early recovery; past 3-month symptoms), 6-month post-baseline (end of intervention period), and 1-year post-baseline (sustained recovery; past 12-month symptoms)

    one-month, 3-months, 6-months, 12-months

  • Change in Biopsychosocial Functioning

    The self-report World Health Organization (WHO) Quality of Life brief version (WHOQoL-BREF) will measure biopsychosocial functioning. There are subscales for physical functioning, psychological functioning, level of independence, social relationships, environment, and spirituality. Items are scored on a 1 - 5 scale with higher scores reflecting higher levels of that subscale domain. These items are them transformed so that the raw scale score for each domain is converted to a 0-100 scale with higher scores reflecting greater quality of life on that domain.

    one-month, 3-months, 6-months

  • Cost Effectiveness

    The intervention cost will be determined by gauging recovery coach salaries and additional medical provider and support staff time required, and applying this cost to each interaction. We will examine the cost of hospital services (hospital charges), including emergency department visits, hospitalizations, psychiatric inpatient stay, medical outpatient costs, and physician professional fee costs.

    6-months

Secondary Outcomes (7)

  • Change in Coping

    one-month, 3-months, 6-months, 12-months

  • Change in linkage to and engagement in Evidence-Based Practices

    one-month, 3-months, 6-months, 12-months

  • Change in linkage to and engagement in Social Determinants of Health (SDoH) resources

    one-month, 3-months, 6-months, 12-months

  • Hospital Utilization

    6-months

  • EMA: Heavy Drinking

    6-months

  • +2 more secondary outcomes

Study Arms (2)

Long-term peer recovery coaching intervention

EXPERIMENTAL

bedside peer recovery coaching + 6-months long-term engagement

Behavioral: Peer recovery coaching (PRC)

SBIRT Intervention

ACTIVE COMPARATOR

The control will receive a brief intervention, usual care (a referral list), contact information for the study team and hospital case management, and a follow-up contact at the end of the study period.

Behavioral: Brief Intervention (SBIRT)

Interventions

The RC-Link peer recovery coaching intervention provides participants with an introduction to an RC-Link coach during their hospitalization. The RC-Link coach delivers coaching and support services for a 6-month period using a standardized PRC Checklist. During the baseline visit, the RC-Link coach first develops a personalized recovery plan with the participant that emphasizes multiple pathways to recovery, including different types of mutual aid groups, counseling, and alternative recovery tools. The approach empowers the participant with an actionable recovery plan that can be initiated upon discharge, but the plan can be modified as changes arise. After the initial baseline encounter, the RC-Link coach initiates phone, virtual, and/or in-person contact with the participant a minimum of twice weekly using the PRC Checklist to standardize service delivery.

Long-term peer recovery coaching intervention

The control will receive a brief intervention, usual care (a referral list), contact information for the study team and hospital case management, and a follow-up contact at the end of the study period. The brief intervention entails (a) using motivational interviewing to gauge the individual's perspective of drinking, how it influences their life, and readiness for change; (b) provide information about the risks of hazardous drinking and potential ways to reduce drinking; (c) elicit their feedback; listen to their concerns; offer encouragement; encourage them to establish goals for behavior change; and (d) provide resources for change (e.g., the referral list). The referral list includes contact information for no-cost peer recovery coach through FAVOR that the participant could choose to call via self-referral. Thus, control participants are able to be linked to PRC, but they must initiate the call and initial visit outside the hospital setting.

SBIRT Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Live within 50 miles of the recruitment and plan to stay in the area for at least 6 months
  • Current DSM-V criteria for moderate or severe AUD (measured by a score of ≥4 on the DSM-V Checklist)
  • Hospitalized with a principal, primary, or secondary AUD-related diagnosis

You may not qualify if:

  • Unable to provide informed consent
  • Patients referred to hospice during hospitalization
  • Women who are pregnant
  • Comorbid diagnosis or at-risk for methamphetamine, cocaine, or opioid use disorder as determined by a score of ≥4 on the National Institute on Drug Abuse (NIDA) Modified Assist v3.0
  • Current suicidal ideation
  • Incarcerated at time of hospitalization
  • Currently has a peer recovery coach
  • Toxicology screen positive for opiates, cocaine, or methamphetamine
  • Experiencing moderate/severe alcohol withdrawal based on physician assessment
  • Psychotic disorders or bipolar disorder documented in chart

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

RECRUITING

Oconee Memorial Hospital

Seneca, South Carolina, 29672, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Kaileigh Byrne, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

April 25, 2024

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

June 2, 2028

Last Updated

August 27, 2025

Record last verified: 2025-08

Locations