STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention
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|ClinicalTrials.gov Identifier: NCT03706742|
Recruitment Status : Active, not recruiting
First Posted : October 16, 2018
Last Update Posted : March 17, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C HepatoCellular Carcinoma||Behavioral: Mailed outreach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||STOP-HCC Evidence-Based Hepatocellular Cancer Prevention Through Treatment of Hepatitis C Virus Infection|
|Actual Study Start Date :||September 10, 2018|
|Actual Primary Completion Date :||August 18, 2019|
|Estimated Study Completion Date :||March 31, 2021|
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 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
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).
- Hepatitis C Screening [ Time Frame: 3 months ]Proportion with HCV Ab within 3 months of randomization
- Hepatitis C Screening [ Time Frame: 12 months ]Proportion with HCV Ab within 12 months of randomization
- Hepatitis C Confirmation [ Time Frame: 3 months ]Proportion with HCV Viral Load within 3 months of positive antibody result
- Hepatitis C Linkage to care [ Time Frame: 6 months ]Proportion with clinic visit within 6 months of positive HCV Viral Load
- Cost: Cost-per patient screened [ Time Frame: 3 months ]The primary measure of costs will be the cost per Ab completion.
- Cost: Cost per-HCV diagnosis [ Time Frame: 12 months ]The primary measure of costs will be the cost per-patient diagnosed with HCV.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706742
|United States, Texas|
|Dallas, Texas, United States, 75235|