Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,871
- 试验地点
- 2
- 主要终点
- Completion of HCC surveillance process
研究概览
简要总结
Project 5 of the Texas HCC Consortium (THCCC) is a comparative effectiveness pragmatic randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer (HCC) surveillance process completion among a socioeconomically and racially diverse cohort of Texans with cirrhosis. Through this project the investigators will implement and evaluate system-level mailed outreach interventions to identity at-risk patients with cirrhosis, promote HCC surveillance, and ensure timely follow-up of tests at UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. The study population will include adult patients with documented or unrecognized cirrhosis and at least one outpatient clinic visit in year prior to randomization. Patients will be identified using an EMR-enabled case identification algorithm. The investigators will randomize 3000 patients (1500 per arm) identified by this algorithm to: usual care, with opportunistic visit-based HCC surveillance (Group 1); or, mailed HCC surveillance outreach with patient education and patient navigation services (Group 2).
详细描述
Hepatocellular cancer (HCC) is the most common (≥ 95%) of liver cancers. HCC is also the fastest rising cause of cancer-related deaths in the U.S. HCC is particularly important for Texas residents. Texas has the second highest death rate from HCC in the nation. The 5-year HCC survival remains low (10-15%) and most patients get diagnosed at late stages. Texas residents notably Hispanics and African Americans are greatly affected with established HCC risk factors including hepatitis C virus, hepatitis B virus and alcoholic liver disease. Furthermore, emerging HCC risk factors, specifically the metabolic syndrome and non-alcoholic fatty liver disease (NAFLD), are exceptionally common in Texans.
The goal of the Texas Hepatocellular Carcinoma Consortium (THCCC) is to reduce the death and suffering related to liver cancer in Texas and the world through five research projects.
This protocol outlines Project 5 of the THCCC which is a comparative effectiveness randomized controlled trial of strategies to increase HCC surveillance. This is the first multi-center outreach intervention aimed at improving surveillance process completion among at-risk patients with cirrhosis.
This study is based at 3 health systems in Texas: UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. Across these 3 sites, we will implement and evaluate system-level mailed outreach interventions to identity at-risk patients with cirrhosis, promote HCC surveillance, and ensure timely follow-up of tests. This study uses an EMR-enabled case-finding algorithm to identify patients with documented cirrhosis, using ICD-9 codes, and those with unrecognized cirrhosis, using laboratory data.
Over 3000 patients identified by this algorithm will be randomized to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>21 years old)
- •Documented cirrhosis
- •Unrecognized cirrhosis
- •An outpatient visit in year prior to randomization
- •English or Spanish speaking
排除标准
- •History of HCC
- •History of liver transplantation
- •Child Pugh C cirrhosis
- •Significant comorbid conditions with life expectancy < 1 year, (e.g., extrahepatic malignancy)
结局指标
主要结局
Completion of HCC surveillance process
时间窗: 3 years post randomization
Ascertained through EMR. HCC surveillance process completion will be defined as: * normal ultrasound and AFP every 6 ± 1 months for two consecutive years, * abnormal ultrasound or AFP ≥20 ng/mL and follow-up diagnostic CT or MRI without HCC, then appropriate surveillance as indicated for total of 2 years, or * abnormal ultrasound or AFP, HCC detected on CT/MRI, and timely HCC treatment consultation. Effective surveillance requires repeat testing every 6 months in patients with normal tests to maximize sensitivity while minimizing patient burden. Patients with abnormal surveillance tests (i.e. liver mass on ultrasound or AFP ≥20 ng/mL) require 4-phase CT or MRI within 3 months, with a 3-month cut-off based on HCC tumor doubling time. Patients with non-contrast imaging, two-phase CT, or imaging \> 3 months after abnormal tests will be coded as failure. Likewise, patients with HCC confirmed on CT/MRI will need HCC-directed treatment within 3 months.
Patient satisfaction and acceptability
时间窗: 3 years post randomization
Assessed by 15-20 minute telephone semi-structured interviews. Patients will be called \>24 months post-randomization to ensure interviews do not interfere with likelihood of surveillance process completion. The investigators will interview 30 completers and 30 non-completers from each group at each site (540 total). The investigators will stratify sampling to include both patients with documented cirrhosis and unrecognized cirrhosis. Likert scale items will assess reactions: * Participants were confused why they were referred for HCC screening * Participants were not given enough information to make a decision * Participants don't want to know if they have HCC * Information about HCC was new and items assessing if invitations included more, right amount, or not enough information as the participants would like. Interviews will also assess what HCC testing (if any) patients think they should have.
次要结局
- One-time Screening(Outcomes will be adjudicated 6 months after randomization.)
- Early HCC(3 years post randomization)
- Repeat Screening(Outcomes will be adjudicated 12 months after randomization.)
研究者
Amit Singal
Professor of Medicine
University of Texas Southwestern Medical Center