NCT02936648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

November 20, 2018

Completed
Last Updated

November 20, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

October 11, 2016

Results QC Date

September 6, 2017

Last Update Submit

May 30, 2018

Conditions

Keywords

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • HCV Antibody Test

    Number of Participants with HCV Antibody Test

    within 30 days of outpatient primary care visit

Study Arms (1)

quality improvement intervention

EXPERIMENTAL

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

Interventions

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.

quality improvement intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Vera Yakovchenko
Organization
Department of Veterans Affairs, CHOIR and BridgeQUERI

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 18, 2016

Study Start

October 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 20, 2018

Results First Posted

November 20, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations