Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29,607
- 试验地点
- 5
- 主要终点
- Positive Hepatitis C Test
研究概览
简要总结
The Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C) compares the effectiveness of the birth cohort HCV screening strategy with the current risk-based screening approach to detect previous unidentified persons with viral hepatitis C who receive health care in primary systems.
The study involved three clinical sites, The University of Alabama, Birmingham; The Henry Ford Health System; and the Mount Sinai Medical Center, each of which developed an independent intervention to experimentally compare the number of positive Hepatitis C Virus (HCV) diagnoses found using the birth-cohort screening approach with that found using traditional risk-based screening, or standard of care strategies. Birth cohort testing is defined as the systematic recommendation of HCV antibody testing to any persons born during the years of 1945 to 1965 who do not have clinically documented evidence of a prior antibody test without regards to the patient's stated risk of exposure to the virus.
详细描述
The Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C) compares the effectiveness of the birth cohort HCV screening strategy with the current risk-based HCV screening approach to detect previously unidentified persons with viral hepatitis C who receive health care in primary care systems.
BEST-C funded sites to implement birth-cohort testing in a clinic sample of primary care patients using an experimental design to compare the effect of birth-cohort testing on testing rates and identified prevalence between a case and a control sample. Additional data will be collected to assess linkage to care for those testing positive, feasibility, and acceptance of the new strategy by medical staff, cost effectiveness, and patient impact. The sites used three models to measure the net effect of change:
One site used study coordinators to actively screen and recruit patients who met the inclusion criteria for birth-cohort screening. Study coordinators were located at two internal medicine clinics, where they approached eligible participants in person. A control group was pulled from an additional two internal medicine clinics, which screened using a risk-based strategy. A cluster randomized cross-over approach was used, so that the intervention and control clinics switched at the midpoint of data collection, allowing all four clinics to participate in both arms of the study.
A second site reached out directly to the patient using direct communication through the mail. Mailers contained HCV guidelines, the importance of screening, laboratory slips and locations for patients to act directly on their own behalf. This site used simple randomization of patients who used the health system in the past, met the definition of birth-cohort membership (born during 1945 to 1965) and had not previously tested positive for hepatitis C. The patients received up to 5 mailings including prepaid, lab registration forms that they were instructed to bring to an affiliated lab location for testing.
A third site implemented a physican best practice alert into the Epic electronic health record system of their clinic setting. This site had the pop-ups enabled for Medical Assistants (MAs) who were asked to pend the lab to the order in the chart for the clinician. When MAs open the chart of an arrived, untested patient, they are alerted to pend the Hepatitis C antibody test order when entering patient vitals prior to the patient seeing the physician. When the clinician subsequently opened the same patient chart, the lab order was present in the orders section of the chart for signature and execution or deletion depending on the circumstances of the patient encounter. As a back-up pathway alerted the physician directly in the event that the MA bypassed or did not open the prompt. This alert details the CDC recommendations for age-based screening and links to the proper Hepatitis C antibody test order and diagnosis code for them to address with the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 47 Years 至 69 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born 1945-1965
排除标准
- •Prior diagnosis of Hepatitis C
结局指标
主要结局
Positive Hepatitis C Test
时间窗: Up to 16 weeks
Positive diagnosis on a Hepatitis C test
次要结局
- Tested for Hepatitis C(Up to 16 weeks)
研究者
Dr. David Rein
Principal Research Scientist
National Opinion Research Center
