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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
quality improvement intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatitis C focused on measuring Hepatitis C

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

quality improvement intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

HCV Antibody Test
Number of Participants with HCV Antibody Test

Secondary Outcome Measures

Full Information

First Posted
October 11, 2016
Last Updated
May 30, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02936648
Brief Title
Hepatitis C Testing in VA Community-Based Outpatient Clinics
Acronym
HCVCBOC
Official Title
Hepatitis C Testing in VA Community-Based Outpatient Clinics (QUE 15-284)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
quality improvement intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
quality improvement intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
HCV Antibody Test
Description
Number of Participants with HCV Antibody Test
Time Frame
within 30 days of outpatient primary care visit

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen L. Gifford, MD
Organizational Affiliation
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mari-Lynn Drainoni, PhD
Organizational Affiliation
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32930938
Citation
Yakovchenko V, DeSotto K, Drainoni ML, Lukesh W, Miller DR, Park A, Shao Q, Thornton DJ, Gifford AL. Using Lean-Facilitation to Improve Quality of Hepatitis C Testing in Primary Care. J Gen Intern Med. 2021 Feb;36(2):349-357. doi: 10.1007/s11606-020-06210-5. Epub 2020 Sep 15.
Results Reference
derived

Learn more about this trial

Hepatitis C Testing in VA Community-Based Outpatient Clinics

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