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临床试验/NCT03706742
NCT03706742已完成不适用

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 个国家目标入组 12,386 人开始时间: 2018年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12,386
试验地点
1
主要终点
Hepatitis C Screening

研究概览

简要总结

Aim 1: The investigators will conduct a randomized controlled trial comparing two strategies to promote HCV screening, follow-up testing, and treatment among baby-boomers (i.e. persons born between 1945-1965): inreach with electronic medical record alerts and provider education vs. combination of inreach and provider education plus mailed outreach and patient navigation.

Aim 2: The investigators will evaluate patient navigation strategies to promote follow-up testing and treatment evaluation among non-baby boomer Parkland patients (i.e. born before 1945 or after 1965) who are either: a) HCV antibody positive but have not completed follow-up viral load testing or b) HCV viral load positive and who have not completed in-clinic treatment evaluation.

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
53 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •born between 1945 and 1965
  • •≥ 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 end stage CHF, end stage COPD, 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 among baby-boomers in English and Spanish. The invitation will include patient-centered educational materials that discuss the risk of HCV in baby boomers and the benefits and risks of HCV screening. The invitation will include a phone number to schedule the HCV antibody blood test. Written materials will be developed and validated in Spanish using the Spanish Language Translation Resource. 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 place a follow-up call to this potential subject. These follow-up calls will occur in the 2nd - 4th week after mailing invitations; up to three attempts in total will be made to reach the patient to facilitate HCC screening completion.

干预措施: Mailed outreach (Behavioral)

结局指标

主要结局

Hepatitis C Screening

时间窗: 3 months

Proportion with HCV Ab within 3 months of randomization

次要结局

  • Hepatitis C Linkage to care(6 months)
  • Cost: Cost-per patient screened(3 months)
  • Cost: Cost per-HCV diagnosis(12 months)
  • Hepatitis C Confirmation(3 months)
  • Hepatitis C Screening(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amit Singal

Principal Investigator

University of Texas Southwestern Medical Center

研究点 (1)

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