R01AA029820

Promoting Alcohol Treatment Engagement Post-Hospitalization with Brief Intervention, Medications, and CBT4CBT: A Randomized Clinical Trial in a Diverse Patient Population - Abstract

Alcohol Use Disorder (AUD) is a major cause of morbidity and mortality, yet often goes untreated. This is particularly true among individuals of diverse racial and ethnic backgrounds. Acute medical hospitalization provides an untapped opportunity to address the AUD treatment gap. To date, AUD-related care has focused on treatment of acute withdrawal and addressing associated acute medical complications without addressing the underlying AUD. This overlooks an opportunity "treatable" moment.

There are a range of behavioral and medication treatments that may be initiated prior to hospital discharge to address AUD. However, we lack data on the optimal approach to enhance post-discharge AUD treatment engagement and alcohol reduction. Further, the influence of structural racism on more proximal social determinants of health (SDOH, e.g., housing instability, medical mistrust) among patients hospitalized with AUD and their resulting impact on treatment engagement and alcohol use post-discharge has not been well characterized.

We propose a 3-arm randomized trial to compare the impact of:

1) A specific brief intervention, the Brief Negotiated Interview with Referral and 2-week telephone booster (BNI) delivered by a health promotion advocate alone to the additional
2) Provision of medications for AUD (BNI+MAUD), and
3) The computer-based platform of Cognitive Behavioral Therapy (CBT4CBT; BNI+MAUD+CBT4CBT) among a diverse sample of 450 patients hospitalized with untreated AUD at a large, urban academic medical center.

The primary outcome is engagement in formal AUD treatment at 30 days post-hospital discharge. Secondary outcomes include formal AUD treatment engagement at 90 days, changes in alcohol use (by self-report and the alcohol biomarker, phosphatidylethanol), and the exploratory outcome of healthcare utilization (Aim 1). We will explore whether the effectiveness of the interventions differ across and within racial and ethnic groups and based on SDOH (Aim 2).

Consistent with a hybrid type 1 effectiveness-implementation design, we will conduct an implementation-focused process evaluation to inform future implementation, including process outcomes, perspectives from clinicians and staff, and cost (Aim 3). Building on new and longstanding collaborations, the study team includes individuals with expertise in addiction medicine in hospital settings; behavioral interventions, including brief interventions and technology-delivered cognitive behavioral therapy; health disparities research; clinical trials; longitudinal analysis; and implementation science.

Study components are readily-scalable and rooted in strong evidence. This proposal offers innovation given the 1) hospital focus for AUD treatment initiation; 2) evaluation of added benefit of medications and CBT4CBT to BNI; 3) focus on evaluation of differential effects by race, ethnicity and SDOH; 4) consideration of the impact of structural racism in all aspects of study design and implementation with a highly qualified team.

The study has potential for high impact by generating data on reproducible and scalable approaches to transform hospital-based AUD treatment initiation nationally.

Yale Univ

TO DEVELOP A SOUND FUNDAMENTAL KNOWLEDGE BASE WHICH CAN BE APPLIED TO THE DEVELOPMENT OF IMPROVED METHODS OF TREATMENT AND MORE EFFECTIVE STRATEGIES FOR PREVENTING ALCOHOLISM AND ALCOHOL-RELATED PROBLEMS. THE NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) SUPPORTS RESEARCH IN A BROAD RANGE OF DISCIPLINES AND SUBJECT AREAS RELATED TO BIOMEDICAL AND GENETIC FACTORS, PSYCHOLOGICAL AND ENVIRONMENTAL FACTORS, ALCOHOL-RELATED PROBLEMS AND MEDICAL DISORDERS, HEALTH SERVICES RESEARCH, AND PREVENTION AND TREATMENT RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION AND TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.273 - Alcohol Research Programs

National Institute on Alcohol Abuse and Alcoholism (NIAAA) [HHS - NIH]

New Haven, Connecticut 065208327 United States

Single Zip Code

Improving Health Disparities in Alcohol Health Services (R01 Clinical Trial Optional) (RFA-AA-21-001)

Amendment Since initial award the total obligations have increased 422% from $670,645 to $3,501,674.