Behavioral Science and Hepatitis C Screening Outreach

Hepatitis C Clinical Trial

Official title:

Behavioral Science and Hepatitis C Screening Outreach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712553
• Other study ID #: 831526
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: November 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21493
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 53 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Behavioral:
• Opt-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.
• Letter
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.
• Behavioral 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.
• Usual Care Messaging
Participants receive standard messaging about HCV and ways to get screening.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV Antibody Completion within 4 Months	Percentage of patients who complete HCV antibody testing within 4 months of initial outreach	4 months
Secondary	HCV Antibody Completion within 12 Months	Percentage of patients who complete HCV antibody testing within 12 months of initial outreach	12 months
Secondary	HCV Antibody Positive	Percentage of tests that are positive	12 months
Secondary	HCV Antibody Positive with Viral Loads	Percentage of test that are positive with detectable viral loads	12 months
Secondary	Referred to Specialist	Percentage of patients referred to specialist and receive HCV treatment and cure	12 months