Clinical trial NCT02123212: Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C
Official title: Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Chronic Hepatitis C
Keywords: Hepatitis C
Chronic Hepatitis C
Screening
Lead sponsor: National Opinion Research Center
Sponsor class: OTHER
Collaborators: name: NORC at the University of Chicago
name: University of Alabama at Birmingham
name: Henry Ford Health System
name: Icahn School of Medicine at Mount Sinai
name: Centers for Disease Control and Prevention
First posted: 2014-04-25
Enrollment: 29607
Sex: ALL
Minimum age (years): 47
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

Detailed description: 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.

This site used a cluster randomized experimental design in which physicians and MA's from specific primary care practices were consented into the study. Experimental clusters received an education about HCV testing and the implemented best practice alert. Control clusters received only education about HCV testing.

Eligibility criteria: Inclusion Criteria:

* Born 1945-1965

Exclusion Criteria:

* Prior diagnosis of Hepatitis C

Primary outcomes:
measure: Positive Hepatitis C Test
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Tested for Hepatitis C
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
Study officials:
affiliation: NORC at the University of Chicago
name: David B Rein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Smith 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.
citation: Jewett 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.
citation: Federman 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.