Project Background/Rationale: Hepatocellular carcinoma (HCC) has become the fastest rising cause of cancer-related death in the United States (US) and its incidence has tripled over the past two decades. Patients at high-risk of developing HCC are recommended for surveillance, namely via liver ultrasound and serum alpha-fetoprotein (AFP). While AFP is used extensively in clinical practice, its performance has generally been low when used alone. As part of our current parent R01 study, we developed an algorithm using laboratory tests such as AFP along with patient factors to calculate the probability of developing HCC within 6 months. This algorithm has been validated and upon formalizing the procedures for its use, ready to be pilot-tested in a real-world clinical practice setting. Project Objectives: This study proposes to implement an intervention using a computerized tool, the Hepatocellular Estimation Software Program (HESP), to support healthcare providers in managing patients at risk for hepatocellular carcinoma (HCC). Our goal is to create and disseminate this tool as a useful, intuitive, and personalized aid for both patients and providers. Therefore, the specific aims of this project are: 1) To formalize procedures for using the Hepatocellular Estimation Software Program in a clinical setting among patients with cirrhosis. We will examine the usability and understandability of a software enabled decision support tool for both providers and patients at two clinical sites (VA, non-VA); 2) To conduct a pilot study to determine whether use of the Hepatocellular Estimation Software is associated with increased adherence to HCC surveillance in patients with cirrhosis. Outcomes will include a) physician referral for recommended HCC surveillance tests and b) application of recommended HCC surveillance tests in patients. Project Methods:
Aim 1 will consist of two phases: In phase 1, we will conduct patient and provider interviews to gather feedback about the visual aspects of the software as well as to identify other user issues. In phase 2, we will audio record clinic visits in which physicians will use the HESP as part of their evaluations and interactions with patients. We will also assess patient engagement during the clinic visit. After the clinic visit, we will ask the patients and providers to complete brief surveys about their interaction and use of the HESP. Data obtained from Aim 1 will directly inform the development of the intervention in Aim 2, which will be pilot tested in clinical practice.
Aim 2 will build the foundation for a subsequent grant submission proposing a large, randomized controlled trial of our intervention.
In our current parent R01-funded study, we developed and validated a robust statistical algorithm that determines the probability of developing HCC within 6-months. This algorithm serves as the foundation for a newly developed, web-tool, the Hepatocellular Estimation Software Program (HESP); designed to determine HCC risk within 6-months and provide personalized surveillance recommendations. For the proposed study, our goal is to refine via cognitive interviews and conduct a feasibility study of HESP?s usability in the clinical- setting and its impact on HCC surveillance receipt and adherence.
