A Peer Recovery Coaching Intervention for Hospitalized Alcohol Use Disorder Patients (RC-Link)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Kaileigh Byrne, PhD
- Phone Number: 864-656-3935
- Email: kaileib@clemson.edu
Study Contact Backup
- Name: Alain Litwin, MD
- Phone Number: 864-430-0911
- Email: alain.litwin@prismahealth.org
Study Locations
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South Carolina
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Greenville, South Carolina, United States, 29605
- Recruiting
- Greenville Memorial Hospital
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Contact:
- Kaileigh Byrne, PhD
- Phone Number: 864-656-3935
- Email: kaileib@clemson.edu
-
Contact:
- Alain Litwin, MD
- Phone Number: 864-430-0911
- Email: alain.litwin@prismahealth.org
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Seneca, South Carolina, United States, 29672
- Recruiting
- Oconee Memorial Hospital
-
Contact:
- Kaileigh Byrne, PhD
- Phone Number: 3153504368
- Email: kaileib@clemson.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Long-term peer recovery coaching intervention
bedside peer recovery coaching + 6-months long-term engagement
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Percentage of Heavy Drinking Days Per Month
Time Frame: one-month, 3-months, 6-months
|
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.
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one-month, 3-months, 6-months
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Remission from Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) AUD Diagnosis
Time Frame: one-month, 3-months, 6-months, 12-months
|
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)
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one-month, 3-months, 6-months, 12-months
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Change in Biopsychosocial Functioning
Time Frame: one-month, 3-months, 6-months
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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.
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one-month, 3-months, 6-months
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Cost Effectiveness
Time Frame: 6-months
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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.
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6-months
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Coping
Time Frame: one-month, 3-months, 6-months, 12-months
|
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.
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one-month, 3-months, 6-months, 12-months
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Change in linkage to and engagement in Evidence-Based Practices
Time Frame: one-month, 3-months, 6-months, 12-months
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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.).
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one-month, 3-months, 6-months, 12-months
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Change in linkage to and engagement in Social Determinants of Health (SDoH) resources
Time Frame: one-month, 3-months, 6-months, 12-months
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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.
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one-month, 3-months, 6-months, 12-months
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Hospital Utilization
Time Frame: 6-months
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Hospital utilization refers to the number of overall and alcohol-specific inpatient admission and emergency visits.
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6-months
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EMA: Heavy Drinking
Time Frame: 6-months
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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
|
6-months
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EMA: Breath Alcohol Content (BrAC) Levels
Time Frame: 6-months
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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.
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6-months
|
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EMA: Change in Craving
Time Frame: 6-months
|
This will be measured using a single-item questionnaire administered via EMA
|
6-months
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2089000(Prisma),2024-0110(CU)
- 1R01AA030815 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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