A Peer Recovery Coaching Intervention for Hospitalized Alcohol Use Disorder Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 4
- 主要终点
- Remission from Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) AUD Diagnosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Remission from Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) AUD Diagnosis
时间窗: 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)
Change in Biopsychosocial Functioning
时间窗: one-month, 3-months, 6-months
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.
Change in Percentage of Heavy Drinking Days Per Month
时间窗: 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.
Cost Effectiveness
时间窗: 6-months
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.
次要结局
- EMA: Breath Alcohol Content (BrAC) Levels(6-months)
- EMA: Change in Craving(6-months)
- EMA: Heavy Drinking(6-months)
- Change in Coping(one-month, 3-months, 6-months, 12-months)
- Hospital Utilization(6-months)
- Change in linkage to and engagement in Social Determinants of Health (SDoH) resources(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)