Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT03712553
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.
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Notify Me53 year–73 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Participants receive standard messaging about HCV and ways to get screening.
Time frame: 4 months
Percentage of patients who complete HCV antibody testing within 4 months of initial outreach
Time frame: 12 months
Percentage of patients who complete HCV antibody testing within 12 months of initial outreach
Time frame: 12 months
Percentage of tests that are positive
Time frame: 12 months
Percentage of test that are positive with detectable viral loads
Time frame: 12 months
Percentage of patients referred to specialist and receive HCV treatment and cure
University of Pennsylvania
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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