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

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04395118

Collaborator

(none)

Enrollment

Location

Arms

16.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Hepatocellular Carcinoma	Behavioral: Mailed Outreach	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

STOP-HCC Evidence-Based Hepatocellular Cancer Prevention Through Treatment of Hepatitis C Virus Infection

Anticipated Study Start Date :

Aug 15, 2020

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care 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.
Active Comparator: Mailed Outreach 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.	Behavioral: Mailed 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).

Arm

Intervention/Treatment

No Intervention: Usual Care

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.

Active Comparator: Mailed Outreach

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.

Behavioral: Mailed 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).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkland Hospital	Dallas	Texas	United States	75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT04395118

Other Study ID Numbers:

STU 072015-022

First Posted:

May 20, 2020

Last Update Posted:

Jul 2, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis C

Hepatitis

Study Results

No Results Posted as of Jul 2, 2020