Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C

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.

Conditions

• Hepatitis C
• Chronic Hepatitis C

Interventions

OTHER

Mailer

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.

OTHER

In-person recruitment

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.

OTHER

EHR Alert

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.

Sponsors & Collaborators

• NORC at the University of Chicago

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Henry Ford Health System

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• National Opinion Research Center

  lead OTHER

Principal Investigators

• David B Rein, Ph.D. · NORC at the University of Chicago

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

47 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-02-28

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• United States

Study Locations