R01AA029312

Impact of the COVID-19 Pandemic on Patient Outcomes, Telehealth Care Delivery, and Treatment for Unhealthy Alcohol Use in Vulnerable Patients with Advanced Liver Disease across Two Healthcare Systems - Project Summary

The COVID-19 pandemic has had a significant adverse impact on vulnerable populations with serious comorbid medical conditions. Individuals with advanced chronic liver disease (CLD) are among those most strongly affected by disruptions in care and are also highly susceptible to poor outcomes associated with SARS-CoV-2 infection. It is critical to understand how to effectively manage these patients during the course of the pandemic.

The rising prevalence of cirrhosis, an end-stage of CLD, is a significant contributor to morbidity and mortality in the United States, and alcohol use is a major risk factor. Thus, effective intervention for alcohol cessation is a high-priority need. In addition, high-quality advanced CLD with adherence to known quality indicators is associated with positive patient outcomes, critical to enhanced survival and quality of life.

Vulnerable populations, including veterans and those receiving care in safety net systems, are at significant risk for liver and COVID-19 related health disparities. They also have known barriers to healthcare access and are at high risk for disengagement from care. The COVID-19 pandemic has significantly disrupted the traditional healthcare delivery models, but the impact on outcomes of vulnerable patients with advanced CLD is currently unknown.

Moreover, the widespread use of telemedicine as a mitigation strategy within these health systems due to COVID-19 has provided an unprecedented opportunity for evaluation and innovation of care delivery models. Better understanding of patients' experience with telemedicine and impact on their outcomes is urgently needed to establish processes and policies that ensure equity in access, sustainability, and high-quality care delivery.

To address these critical issues, we propose to evaluate the care of patients with advanced CLD during the pandemic within hepatology practices in two generalizable health systems serving vulnerable populations, a public safety net system, and Veterans Affairs healthcare systems. Furthermore, we will examine the efficacy of a stepped care intervention (i.e., motivational interviewing and addiction physician management) via telemedicine to treat alcohol use as an adjunct to usual hepatology care. We will also examine COVID-19 outcomes.

We propose the following aims:
1) Evaluate the impact of the COVID-19 pandemic on clinical outcomes of vulnerable patients with advanced CLD receiving care in hepatology practices, in a natural experiment.
2) Evaluate patient-reported experiences with the use of telemedicine in response to the pandemic to deliver hepatology specialty care in those with advanced CLD.
3) Conduct a randomized controlled trial evaluating the efficacy and feasibility of a stepped alcohol treatment using telemedicine on unhealthy alcohol use in patients with alcohol-related CLD receiving care in hepatology practices, compared with usual care.

We hypothesize that we will observe an increase in adverse patient outcomes in the post-pandemic period, that the patient experience and satisfaction with telemedicine as a mitigation strategy to reduce COVID-19 risk will improve, and that patients receiving stepped care will be more likely to reduce or abstain from alcohol use.

San Francisco Regents Of The University Of California

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]

San Francisco, California 94110 United States

Single Zip Code

Community Interventions to Address the Consequences of the COVID-19 Pandemic among Health Disparity and Vulnerable Populations (R01- Clinical Trial Optional) (PAR-20-237)

Amendment Since initial award the total obligations have increased 396% from $708,716 to $3,517,747.