STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

NCT03706742 | Completed

• 1 other identifier: STU 072015-022
• Study Type: interventional
• Target: 12,386
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C; HepatoCellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Hepatitis C Screening

  Proportion with HCV Ab within 3 months of randomization

  3 months

Secondary Outcomes (5)

• Hepatitis C Screening

  12 months

• Hepatitis C Confirmation

  3 months

• Hepatitis C Linkage to care

  6 months

• Cost: Cost-per patient screened

  3 months

• Cost: Cost per-HCV diagnosis

  12 months

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Mailed outreach

ACTIVE COMPARATOR

Patients randomized to Group 2 will receive low literacy, written materials about HCV screening among baby-boomers in English and Spanish. The invitation will include patient-centered educational materials that discuss the risk of HCV in baby boomers and the benefits and risks of HCV screening. The invitation will include a phone number to schedule the HCV antibody blood test. Written materials will be developed and validated in Spanish using the Spanish Language Translation Resource. 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 place a follow-up call to this potential subject. These follow-up calls will occur in the 2nd - 4th week after mailing invitations; up to three attempts in total will be made to reach the patient to facilitate HCC screening completion.

Behavioral: Mailed outreach

Interventions

Mailed outreach BEHAVIORAL

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).

Mailed outreach

Eligibility Criteria

• Age: 53 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Desai N, Rich NE, Jain MK, Blackwell JM, Murphy CC, Perryman P, McBryde J, Quirk L, Clark C, Villarreal D, Waljee AK, Gopal P, Singal AG. Randomized Clinical Trial of Inreach With or Without Mailed Outreach to Promote Hepatitis C Screening in a Difficult-to-Reach Patient Population. Am J Gastroenterol. 2021 May 1;116(5):976-983. doi: 10.14309/ajg.0000000000001085.

  PMID: 33337657 DERIVED

MeSH Terms

Conditions

Hepatitis C; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: September 10, 2018
• Primary Completion: August 18, 2019
• Study Completion: March 31, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)