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STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention for Elevated LFTs (STOP-HCC)

Primary Purpose

Hepatitis C, Hepatocellular Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mailed Outreach
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ages 18 or older
  • elevated liver functioning tests (AST or ALT >35 that are separated by at least one month)
  • ≥ 1 outpatient visit during 12 months prior to randomization at Parkland
  • no prior HCV screening (prior HCV antibody, viral load, or genotype).
  • any active medical coverage
  • speaks Spanish or English

Exclusion Criteria:

  • a life expectancy less than one year including any history of metastatic cancer, and those who received a palliative care or hospice referral in the past year
  • history of HCC.
  • non-English or Spanish speakers
  • no address or phone number on file

Sites / Locations

  • Parkland Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

Mailed Outreach

Arm Description

Patients randomized to Group 1 will receive visit-based HCV screening, as offered by clinic providers as part of usual care. Providers must identify at-risk patients who are eligible for HCV screening, understand the benefits of screening in this population, and enter orders for HCV Ab testing. If the HCV antibody is abnormal, providers must order appropriate follow-up tests including HCV viral load to confirm HCV infection. Once HCV is confirmed, providers must refer the patients for fibrosis assessment and treatment evaluation. These efforts are augmented by an established best practice alert and health maintenance reminders.

Patients randomized to Group 2 will receive low literacy, written materials about HCV screening in English and Spanish. The invitation will include patient-centered educational materials that discuss the risk of HCV in patients with elevated LFTs and the benefits and risks of HCV screening. The invitation will include a phone number to schedule the HCV antibody test. Once a potential subject is identified and randomized in Group 2, an outreach invitation will be mailed out. Shortly after the letter, a bilingual patient navigator will call to this potential subject. Patients will also receive centralized patient navigation to facilitate screening completion and appropriate test follow-up. He/she will help patients schedule HCV antibody testing and will assume responsibility for tracking results. Patients referred to the Hepatitis C clinic for treatment evaluation will receive reminder calls from trained and credentialed study staff 5-7 business days for scheduled appointments.

Outcomes

Primary Outcome Measures

Hepatitis C Screening
Proportion with HCV Ab or HCV VL within 6 months of randomization

Secondary Outcome Measures

Hepatitis C Screening
Proportion with HCV Ab within 12 months of randomization
Hepatitis C Confirmation
Proportion with HCV Viral Load within 3 months of positive antibody result
Hepatitis C Linkage to Care
Proportion with clinic visit within 6 months of positive HCV Viral Load
Cost Per Patient Screened
The primary measure of costs will be the cost per Ab completion.
Cost Per HCV Diagnosis
The primary measure of costs will be the cost per-patient diagnosed with HCV.

Full Information

First Posted
May 15, 2020
Last Updated
June 30, 2020
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04395118
Brief Title
STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention for Elevated LFTs
Acronym
STOP-HCC
Official Title
STOP-HCC Evidence-Based Hepatocellular Cancer Prevention Through Treatment of Hepatitis C Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study will not be conducted as a RCT due to limited project timeline.
Study Start Date
August 15, 2020 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will conduct a randomized controlled trial comparing two strategies to promote HCV screening, follow-up testing, and treatment among Parkland patients who are 18 years or older who have elevated liver functioning test (LFT) results: in reach with electronic medical record alerts and provider education vs. combination of in reach and provider education plus mailed outreach and patient navigation.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients randomized to Group 1 will receive visit-based HCV screening, as offered by clinic providers as part of usual care. Providers must identify at-risk patients who are eligible for HCV screening, understand the benefits of screening in this population, and enter orders for HCV Ab testing. If the HCV antibody is abnormal, providers must order appropriate follow-up tests including HCV viral load to confirm HCV infection. Once HCV is confirmed, providers must refer the patients for fibrosis assessment and treatment evaluation. These efforts are augmented by an established best practice alert and health maintenance reminders.
Arm Title
Mailed Outreach
Arm Type
Active Comparator
Arm Description
Patients randomized to Group 2 will receive low literacy, written materials about HCV screening in English and Spanish. The invitation will include patient-centered educational materials that discuss the risk of HCV in patients with elevated LFTs and the benefits and risks of HCV screening. The invitation will include a phone number to schedule the HCV antibody test. Once a potential subject is identified and randomized in Group 2, an outreach invitation will be mailed out. Shortly after the letter, a bilingual patient navigator will call to this potential subject. Patients will also receive centralized patient navigation to facilitate screening completion and appropriate test follow-up. He/she will help patients schedule HCV antibody testing and will assume responsibility for tracking results. Patients referred to the Hepatitis C clinic for treatment evaluation will receive reminder calls from trained and credentialed study staff 5-7 business days for scheduled appointments.
Intervention Type
Behavioral
Intervention Name(s)
Mailed Outreach
Intervention Description
The investigators will randomize elevated LFT patients (~12,000 patients) using a centrally maintained computer-generated list. Patients will be randomly assigned to one of two HCV screening strategies including: visit-based screening as part of usual care (Group 1) or mailed screening invitation outreach and centralized patient navigation (Group 2).
Primary Outcome Measure Information:
Title
Hepatitis C Screening
Description
Proportion with HCV Ab or HCV VL within 6 months of randomization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hepatitis C Screening
Description
Proportion with HCV Ab within 12 months of randomization
Time Frame
12 months
Title
Hepatitis C Confirmation
Description
Proportion with HCV Viral Load within 3 months of positive antibody result
Time Frame
3 months
Title
Hepatitis C Linkage to Care
Description
Proportion with clinic visit within 6 months of positive HCV Viral Load
Time Frame
6 months
Title
Cost Per Patient Screened
Description
The primary measure of costs will be the cost per Ab completion.
Time Frame
3 months
Title
Cost Per HCV Diagnosis
Description
The primary measure of costs will be the cost per-patient diagnosed with HCV.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ages 18 or older elevated liver functioning tests (AST or ALT >35 that are separated by at least one month) ≥ 1 outpatient visit during 12 months prior to randomization at Parkland no prior HCV screening (prior HCV antibody, viral load, or genotype). any active medical coverage speaks Spanish or English Exclusion Criteria: a life expectancy less than one year including any history of metastatic cancer, and those who received a palliative care or hospice referral in the past year history of HCC. non-English or Spanish speakers no address or phone number on file
Facility Information:
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention for Elevated LFTs

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