CClinicalTrials.gg
RecruitingNCT06479681RC-LinkUpdated Aug 27, 2025

A Peer Recovery Coaching Intervention for Hospitalized Alcohol Use Disorder Patients

An interventional study of Peer recovery coaching (PRC) and Brief Intervention (SBIRT) in Alcohol Use Disorder, sponsored by Clemson University. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by Clemson University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Alcohol Use Disorder (AUD) is the third leading cause of preventable deaths in U.S. and accounts for over 10% of U.S. hospital admissions. Treatment for this population often fails to address the underlying cause of the hospitalization: the AUD. Patients hospitalized with alcohol-related medical complications tend to have high-risk for recurrence of alcohol-related medical problems, high rates of hospital readmissions, and poor recovery outcomes. Methods that promote long-term recovery care are needed. Inpatient linkage to peer recovery coaching may bridge this gap in care by providing a method of continued care for AUD recovery that offers flexibility in recovery pathways, peer modeling opportunities, and strong social support. Pilot study results demonstrated the feasibility of inpatient linkage to peer recovery coaching and showed evidence of decreased alcohol consumption, increased engagement in treatment and recovery support programs, and decreased emergency department visits. However, pilot study sample size, outcomes, and methods were limited. This proposal seeks to overcome these limitations and build on these preliminary results by: using ecological momentary assessments, measuring recovery using the new NIAAA definition, examining cost-effectiveness, assessing alcohol consumption using an additional objective measure (breath alcohol content levels), and examining social support and self-efficacy as potential mechanisms of effectiveness. This proposal will rigorously test the effectiveness of an inpatient peer recovery coaching service called the RC-Link program on recovery outcomes in patients hospitalized with medical complications from AUD. The program involves a bedside introduction to a peer recovery coach during the patient's hospitalization plus continued, recovery support for six-months. The RC-Link program provides standardized peer recovery service that is both personalized to the patients' needs and generalized to provide socioemotional, instrumental, and informational social support during every patient encounter. Aim 1 will determine the effect of the RC-Link program on frequency of heavy drinking, biopsychosocial functioning, and remission from AUD compared to controls. Aim 2 will examine how daily changes in perceived social support and self-efficacy influence alcohol consumption and determine whether such associations differ between the RC-Link and control groups. Aim 3 will examine the cost-effectiveness of the RC-Link program; hospital utilization rates will be examined as secondary outcomes. These aims will be evaluated using a two-arm randomized controlled trial that compares the RC-Link program intervention to a control group that receives a brief intervention and connection to a peer recovery coach after the study period. Outcomes will be assessed at baseline, monthly during the 6-month study period, and 6-months post- intervention. This study has potential to advance recovery care for AUD by providing a better understanding of how long-term, inpatient-initiated peer recovery coaching influences recovery outcomes over time in this population.

02

Conditions studied

  • Alcohol Use Disorder

Browse trials for

03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
750 participants (estimated)

Study arms

  • Experimental
    Long-term peer recovery coaching intervention

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

    Behavioral: Peer recovery coaching (PRC)

  • Active comparator
    SBIRT 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.

    Behavioral: Brief Intervention (SBIRT)

Interventions

  • BehavioralPeer recovery coaching (PRC)

    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.

  • BehavioralBrief Intervention (SBIRT)

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one-month, 3-months, 6-months

  2. 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)

    Time frame: one-month, 3-months, 6-months, 12-months

  3. 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.

    Time frame: one-month, 3-months, 6-months

  4. 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.

    Time frame: 6-months

Secondary outcomes

  1. Change in Coping

    The self-reported Brief Coping Orientation to Problems Experienced (COPE) Inventory 28-item scale will be used and administered. Items on this scale range from 1 (I haven't been doing this at all) to 4 (I have been doing this a lot). There are two items for 14 coping strategies, such as self-distraction, emotional support, humor, self-blame, and denial. Higher scores reflect a higher degree of engaging in a particular coping strategies.

    Time frame: one-month, 3-months, 6-months, 12-months

  2. Change in linkage to and engagement in Evidence-Based Practices

    Percentage of participants linked and percentage of participants engaged: Participants will indicate the types of evidence-based practices (EBPs) for AUD that they have been engaged in and the number of days they engaged in EBPs in the past month. EBPs for AUD are defined by the NIAAA as FDA-approved pharmacology for AUD (disulfiram, acamprosate \& naltrexone), inpatient/outpatient rehabilitation, therapy/counseling, and mutual aid programs (e.g., 12-step programs, SMART recovery, etc.).

    Time frame: one-month, 3-months, 6-months, 12-months

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

    Percentage of participants linked and percentage of participants utilizing resources: Participants will be asked if anyone (family/friend, recovery coach, social worker, etc.) helped provide them with housing, employment, education, food security, or transportation assistance in the past month, and if so, what services and who helped them.

    Time frame: one-month, 3-months, 6-months, 12-months

  4. Hospital Utilization

    Hospital utilization refers to the number of overall and alcohol-specific inpatient admission and emergency visits.

    Time frame: 6-months

  5. EMA: Heavy Drinking

    Two-items from the Daily Drinking Questionnaire will be used: one queries whether participants drank alcohol that day (yes/no) and the other assesses amount consumed

    Time frame: 6-months

  6. EMA: Breath Alcohol Content (BrAC) Levels

    Breath alcohol content levels will be measured using a breathalyzer (BACtrack) as an objective measure of alcohol consumption, which controls for the possibility that differences in self-reported consumption are due to inaccurate reporting.

    Time frame: 6-months

  7. EMA: Change in Craving

    This will be measured using a single-item questionnaire administered via EMA

    Time frame: 6-months

06

Study locations

2 of 2 sites recruiting
  • Greenville Memorial Hospital
    Greenville, South Carolina 29605, United States
    Recruiting
  • Oconee Memorial Hospital
    Seneca, South Carolina 29672, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT06479681
Lead sponsor
Clemson University
Collaborators
Prisma Health-Upstate, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Sponsor
First posted
Jun 28, 2024
Start date
Apr 25, 2024
Primary completion
Feb 1, 2028 (estimated)
Completion
Jun 2, 2028 (estimated)
Last update
Aug 27, 2025

Study contacts

Kaileigh Byrne, PhD
Contact
kaileib@clemson.edu
864-656-3935
Alain Litwin, MD
Contact
alain.litwin@prismahealth.org
864-430-0911

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion