Hepatitis C Testing in VA Community-Based Outpatient Clinics (HCVCBOC)

May 30, 2018 updated by: VA Office of Research and Development

Hepatitis C Testing in VA Community-Based Outpatient Clinics (QUE 15-284)

The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in vulnerable, high-risk groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to: (1) increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in vulnerable, high-risk groups, (2) Increase linkage to specialized HCV care among VISN 1 VA Veterans diagnosed with HCV infection, and (3) Evaluate whether race, ethnicity, gender, or other markers of social disparity influence completion of HCV testing and linkage to specialty care, and whether disparities are reduced by the planned VISN 1 VA HCV Quality Improvement (QI) program. The central focus is to reduce delays in diagnosis and linkage to treatment evaluation, management of comorbidities and contraindications, and subsequent initiation.

Study Type

Interventional

Enrollment (Actual)

2209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730
        • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Veterans
  • Born in the period of 1945-1965 ("birth cohort")
  • With an outpatient visit in primary care at a VISN1 facility in FY 2016

Exclusion Criteria:

  • N/A

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: quality improvement intervention
The intervention activities included: assessment, planning, stakeholder engagement, education, ongoing process monitoring, program adaptation, problem identification and problem solving, data audit/feedback, program marketing, network development, among others.
Other: quality improvement intervention
The intervention activities included: assessment, planning, stakeholder engagement, education, ongoing process monitoring, program adaptation, problem identification and problem solving, data audit/feedback, program marketing, network development, among others.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV Antibody Test
Time Frame: within 30 days of outpatient primary care visit
Number of Participants with HCV Antibody Test
within 30 days of outpatient primary care visit

Collaborators and Investigators

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

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Allen L. Gifford, MD, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
  • Principal Investigator: Mari-Lynn Drainoni, PhD, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUX 16-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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