STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

University of Texas Southwestern Medical Center12,386 enrolled

Overview

Aim 1: The investigators will conduct a randomized controlled trial comparing two strategies to promote HCV screening, follow-up testing, and treatment among baby-boomers (i.e. persons born between 1945-1965): inreach with electronic medical record alerts and provider education vs. combination of inreach and provider education plus mailed outreach and patient navigation. Aim 2: The investigators will evaluate patient navigation strategies to promote follow-up testing and treatment evaluation among non-baby boomer Parkland patients (i.e. born before 1945 or after 1965) who are either: a) HCV antibody positive but have not completed follow-up viral load testing or b) HCV viral load positive and who have not completed in-clinic treatment evaluation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Enrollment

12,386

Conditions

Hepatitis C HepatoCellular Carcinoma

Interventions

The investigators will randomize all baby boomer 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).

Eligibility

Sex: ALLMin age: 53 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * born between 1945 and 1965 * ≥ 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 end stage CHF, end stage COPD, 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

Outcomes

Primary Outcomes

Hepatitis C Screening

Proportion with HCV Ab within 3 months of randomization

Time frame: 3 months

Secondary Outcomes

Hepatitis C Screening

Proportion with HCV Ab within 12 months of randomization

Time frame: 12 months

Hepatitis C Confirmation

Proportion with HCV Viral Load within 3 months of positive antibody result

Time frame: 3 months

Hepatitis C Linkage to care

Proportion with clinic visit within 6 months of positive HCV Viral Load

Time frame: 6 months

Cost: Cost-per patient screened

The primary measure of costs will be the cost per Ab completion.

Time frame: 3 months

Cost: Cost per-HCV diagnosis

The primary measure of costs will be the cost per-patient diagnosed with HCV.

Time frame: 12 months

STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes