Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C
Best-C
2 other identifiers
interventional
29,607
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 22, 2014
CompletedFirst Posted
Study publicly available on registry
April 25, 2014
CompletedMarch 26, 2015
March 1, 2015
1.1 years
April 22, 2014
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive Hepatitis C Test
Positive diagnosis on a Hepatitis C test
Up to 16 weeks
Secondary Outcomes (1)
Tested for Hepatitis C
Up to 16 weeks
Study Arms (3)
Mt. Sinai
EXPERIMENTALCluster randomization with EHR Alert intervention
Henry Ford Health System
EXPERIMENTALSimple randomization with mailer intervention
University of Alabama, Birmingham
EXPERIMENTALCrossover randomization with in-person recruitment intervention
Interventions
Henry Ford intentifies patients meeting birth cohort screening criteria and then sends mailers to those individuals. Mailers contained HCV guidelines, the importance of screening, laboratory slips and locations for patients to act directly on their own behalf. If patients do not respond to the initial mailer, Henry Ford sends additional mailers.
UAB 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 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.
EHR include a Best Practice Alert (BPA) prompting the Medical Assistant and/or clinican to order a Hepatitis C lab test for patients in the birth cohort.
Eligibility Criteria
You may qualify if:
- Born 1945-1965
You may not qualify if:
- Prior diagnosis of Hepatitis C
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Opinion Research Centerlead
- NORC at the University of Chicagocollaborator
- University of Alabama at Birminghamcollaborator
- Henry Ford Health Systemcollaborator
- Icahn School of Medicine at Mount Sinaicollaborator
- Centers for Disease Control and Preventioncollaborator
Study Sites (3)
University of Alabama, Birmingham
Birmingham, Alabama, 35294, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mt. Sinai Medical Center
New York, New York, 10029, United States
Related Publications (4)
Rein DB, Smith BD, Wittenborn JS, Lesesne SB, Wagner LD, Roblin DW, Patel N, Ward JW, Weinbaum CM. The cost-effectiveness of birth-cohort screening for hepatitis C antibody in U.S. primary care settings. Ann Intern Med. 2012 Feb 21;156(4):263-70. doi: 10.7326/0003-4819-156-4-201202210-00378. Epub 2011 Nov 4.
PMID: 22056542BACKGROUNDSmith BD, Yartel AK, Krauskopf K, Massoud OI, Brown KA, Fallon MB, Rein DB. Hepatitis C virus antibody positivity and predictors among previously undiagnosed adult primary care outpatients: cross-sectional analysis of a multisite retrospective cohort study. Clin Infect Dis. 2015 Apr 15;60(8):1145-52. doi: 10.1093/cid/civ002. Epub 2015 Jan 16.
PMID: 25595745BACKGROUNDJewett A, Garg A, Meyer K, Wagner LD, Krauskopf K, Brown KA, Pan JJ, Massoud O, Smith BD, Rein DB. Hepatitis C virus testing perspectives among primary care physicians in four large primary care settings. Health Promot Pract. 2015 Mar;16(2):256-63. doi: 10.1177/1524839914532291. Epub 2014 Apr 28.
PMID: 24776636BACKGROUNDFederman AD, Kil N, Kannry J, Andreopolous E, Toribio W, Lyons J, Singer M, Yartel A, Smith BD, Rein DB, Krauskopf K. An Electronic Health Record-based Intervention to Promote Hepatitis C Virus Testing Among Adults Born Between 1945 and 1965: A Cluster-randomized Trial. Med Care. 2017 Jun;55(6):590-597. doi: 10.1097/MLR.0000000000000715.
PMID: 28288075DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David B Rein, Ph.D.
NORC at the University of Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Research Scientist
Study Record Dates
First Submitted
April 22, 2014
First Posted
April 25, 2014
Study Start
February 1, 2013
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
March 26, 2015
Record last verified: 2015-03