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临床试验/NCT04395118
NCT04395118撤回不适用

STOP-HCC Evidence-Based Hepatocellular Cancer Prevention Through Treatment of Hepatitis C Virus Infection

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家开始时间: 2020年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Hepatitis C Screening

研究概览

简要总结

The investigators will conduct a randomized controlled trial comparing two strategies to promote HCV screening, follow-up testing, and treatment among Parkland patients who are 18 years or older who have elevated liver functioning test (LFT) results: in reach with electronic medical record alerts and provider education vs. combination of in reach and provider education plus mailed outreach and patient navigation.

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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ages 18 or older
  • elevated liver functioning tests (AST or ALT >35 that are separated by at least one month)
  • ≥ 1 outpatient visit during 12 months prior to randomization at Parkland
  • no prior HCV screening (prior HCV antibody, viral load, or genotype).
  • any active medical coverage
  • speaks Spanish or English

排除标准

  • a life expectancy less than one year including any history of metastatic cancer, and those who received a palliative care or hospice referral in the past year
  • history of HCC.
  • non-English or Spanish speakers
  • no address or phone number on file

研究组 & 干预措施

Usual Care

No Intervention

Patients randomized to Group 1 will receive visit-based HCV screening, as offered by clinic providers as part of usual care. Providers must identify at-risk patients who are eligible for HCV screening, understand the benefits of screening in this population, and enter orders for HCV Ab testing. If the HCV antibody is abnormal, providers must order appropriate follow-up tests including HCV viral load to confirm HCV infection. Once HCV is confirmed, providers must refer the patients for fibrosis assessment and treatment evaluation. These efforts are augmented by an established best practice alert and health maintenance reminders.

Mailed Outreach

Active Comparator

Patients randomized to Group 2 will receive low literacy, written materials about HCV screening in English and Spanish. The invitation will include patient-centered educational materials that discuss the risk of HCV in patients with elevated LFTs and the benefits and risks of HCV screening. The invitation will include a phone number to schedule the HCV antibody test. Once a potential subject is identified and randomized in Group 2, an outreach invitation will be mailed out. Shortly after the letter, a bilingual patient navigator will call to this potential subject. Patients will also receive centralized patient navigation to facilitate screening completion and appropriate test follow-up. He/she will help patients schedule HCV antibody testing and will assume responsibility for tracking results. Patients referred to the Hepatitis C clinic for treatment evaluation will receive reminder calls from trained and credentialed study staff 5-7 business days for scheduled appointments.

干预措施: Mailed Outreach (Behavioral)

结局指标

主要结局

Hepatitis C Screening

时间窗: 6 months

Proportion with HCV Ab or HCV VL within 6 months of randomization

次要结局

  • Hepatitis C Screening(12 months)
  • Hepatitis C Confirmation(3 months)
  • Hepatitis C Linkage to Care(6 months)
  • Cost Per Patient Screened(3 months)
  • Cost Per HCV Diagnosis(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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