Hepatitis C Screening in the Primary Care Setting

November 16, 2018 updated by: New York Institute of Technology

Prospective Cohort Study: Hepatitis C Screening in the Primary Care Setting

The purpose of this study is to determine whether patient education improves Hepatitis C screening in the primary care setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hepatitis C is a chronic, asymptomatic infection that progresses to liver cirrhosis and cancer in the later stages if left untreated. The Centers for Disease Control (CDC) recommends a one-time screening for high risk birth cohort between the years 1945-1965. Prior studies have evaluated methods to improve screening for hepatitis c with focus on increasing awareness in health professionals. Targets included nursing staff and electronic medical records. This study targets providing patients with education resources to see if screening rates improve.

Study Type

Observational

Enrollment (Actual)

503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Screening was performed at two locations with differing socioeconomic data per census reports.

Description

Inclusion Criteria:

  • All patients born between the years 1945 and 1965.

Exclusion Criteria:

  • Patients who had already received a prior screening test for Hepatitis C before the office visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Date of birth
Those people born within the years 1945-1965
Diagnostic test: Hepatitis C Antibody
Patients who received a blood test to screen for the Hepatitis C virus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Screened for Hepatitis C
Time Frame: June 2016 to October 2016.
Change from baseline in number of patients from high-risk birth cohort screened for Hepatitis C during intervention period.
June 2016 to October 2016.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (Actual)

October 20, 2017

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHS-1194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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