Hepatitis C, Hepatocellular Carcinoma
Conditions
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.
Interventions
BEHAVIORALMailed Outreach
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).
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis C Screening | 6 months | Proportion with HCV Ab or HCV VL within 6 months of randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis C Screening | 12 months | Proportion with HCV Ab within 12 months of randomization |
| Hepatitis C Confirmation | 3 months | Proportion with HCV Viral Load within 3 months of positive antibody result |
| Hepatitis C Linkage to Care | 6 months | Proportion with clinic visit within 6 months of positive HCV Viral Load |
| Cost Per Patient Screened | 3 months | The primary measure of costs will be the cost per Ab completion. |
| Cost Per HCV Diagnosis | 12 months | The primary measure of costs will be the cost per-patient diagnosed with HCV. |
Countries
United States
Outcome results
None listed