Hepatitis CHCVCBOCNCT02936648
Hepatitis C Testing in VA Community-Based Outpatient Clinics
A study testing quality improvement intervention in people with Hepatitis C, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- quality improvement intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,209 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Veterans
- Born in the period of 1945-1965 ("birth cohort")
- With an outpatient visit in primary care at a VISN1 facility in FY 2016
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- quality improvement intervention
- Keywords
- Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality improvement interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: quality improvement intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV Antibody Test
Number of Participants with HCV Antibody Test
Measured: within 30 days of outpatient primary care visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,209 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Allen L. Gifford, MD, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MAMari-Lynn Drainoni, PhD, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936648
- Sponsor's protocol ID
- QUX 16-010
- Acronym
- HCVCBOC
- Status last verified
- May 2018
- First submitted
- 11 Oct 2016
- Last updated
- 20 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32930938
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Testing in VA Community-Based Outpatient Clinics (QUE 15-284)
- ClinicalTrials.gov ID
- NCT02936648
- Acronym / sponsor ID
- HCVCBOC / QUX 16-010
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,209 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 20 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quality improvement intervention | Experimental | Other: quality improvement interventionThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans
- Born in the period of 1945-1965 ("birth cohort")
- With an outpatient visit in primary care at a VISN1 facility in FY 2016
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality improvement interventionThe 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 |
Primary outcome
HCV Antibody Test
Time frame: within 30 days of outpatient primary care visit
Number of Participants with HCV Antibody Test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32930938Yakovchenko 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.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C
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Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
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Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen L. Gifford, MD principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Mari-Lynn Drainoni, PhD principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quality improvement intervention in people with Hepatitis C, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV Antibody Test (time frame: within 30 days of outpatient primary care visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02936648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.