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Behavioral Science and Hepatitis C Screening Outreach

Behavioral Science and Hepatitis C Screening Outreach

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03712553
Enrollment
21493
Registered
2018-10-19
Start date
2019-03-15
Completion date
2020-10-15
Last updated
2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Behavioral Economics, Screening, Outreach

Brief summary

This project aims to evaluate different approaches to increase Hepatitis C screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, we will evaluate different approaches to increase completion of screening among eligible patients, including changing the default from opt-in to opt-out and incorporating behavioral science principles into the outreach communication.

Detailed description

The hepatitis C virus (HCV) is the leading cause of liver transplant and hepatocellular carcinoma in the US. New direct-acting antivirals are available that can eradicate the disease in over 95% of those that are treated, with minimal side effects. As a result of new therapies and a five-fold higher risk among baby boomers, the US Preventive Services Task Force and CDC now recommend HCV screening for all patients born between 1945 and 1965. Of the estimated 3.2 million people chronically infected with HCV, about 75% were born during this time frame. Despite this, national rates of screening among this group remain low at less than 30%. If more people could get screened, we could potentially identify more undiagnosed disease and help navigate to treatment. At Penn Medicine primary care practices, HCV screening rates have risen from 37% in 2014 to 61% in 2017, likely from a combination of provider educational efforts and EHR alerts. There is also significant practice variation ranging from 4% to 99% screening rates. While EHR alerts have been shown to increase HCV screening rates, there is potential to complement this with direct outreach to patients homes, as has been incorporated into cancer screening initiatives. Additionally, there is a mandate from the state of Pennsylvania requiring health care providers to offer HCV testing to all primary care patients. There is an opportunity to provide direct outreach to all eligible primary care patients at Penn Medicine, while also evaluating different approaches to increasing HCV screening rates. Insights from behavioral science have been shown to increase participation in health promoting behaviors in a variety of ways. Switching from opt-in to opt-out framing has been shown to triple patient participation in remote monitoring and CRC screening. Additionally, messaging that incorporates social norms, reciprocity, and precommitment have also been shown to increase participation. However, it is not clear how these approaches would translate to HCV screening.

Interventions

BEHAVIORALBehavioral Economic Messaging

Participants receive standard messaging about HCV and ways to get screened and messaging that incorporates behavioral economic principles such as norms, reciprocity, anticipated regret, and pre-commitment to get screening.

BEHAVIORALOpt-Out

Opt-In messaging prompts participants to contact their primary care provider to receive Hepatitis C screening whereas Opt-Out messaging includes a signed laboratory order for Hepatitis C screening.

BEHAVIORALLetter

Participants receive messaging prompting them to contact their primary care provider to receive Hepatitis C screening, either as a letter or an electronic message on the MyPennMedicine patient portal.

BEHAVIORALUsual Care Messaging

Participants receive standard messaging about HCV and ways to get screening.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
53 Years to 73 Years
Healthy volunteers
No

Inclusion criteria

* at least 2 visits to primary care provider within 2 years * born between 1945 and 1965

Exclusion criteria

* have had 1 HCV antibody test, viral load test or are considered up-to-date on HCV screening by health maintenance

Design outcomes

Primary

MeasureTime frameDescription
HCV Antibody Completion within 4 Months4 monthsPercentage of patients who complete HCV antibody testing within 4 months of initial outreach

Secondary

MeasureTime frameDescription
HCV Antibody Completion within 12 Months12 monthsPercentage of patients who complete HCV antibody testing within 12 months of initial outreach
HCV Antibody Positive12 monthsPercentage of tests that are positive
HCV Antibody Positive with Viral Loads12 monthsPercentage of test that are positive with detectable viral loads
Referred to Specialist12 monthsPercentage of patients referred to specialist and receive HCV treatment and cure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026