Behavioral Science and Hepatitis C Screening Outreach

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Behavioral: Letter; Behavioral: Usual Care Messaging; Behavioral: Opt-Out; Behavioral: Behavioral Economic Messaging

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.

• Study Type: Interventional
• Enrollment (Actual): 21493
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A1: Opt-In, UC Letter; Behavioral: Opt-In vs. Opt-Out The usual care (UC) letter consists of an opt-in message encouraging participants to contact their primary care provider for Hepatitis C screening.	Behavioral: 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: Usual Care Messaging; Participants receive standard messaging about HCV and ways to get screening.
Experimental: A2: Opt-Out, UC Letter; Behavioral: Opt-In vs. Opt-Out The usual care (UC) letter consists of a message and a written laboratory order from primary care provider to complete Hepatitis C screening.	Behavioral: Usual Care Messaging; Participants receive standard messaging about HCV and ways to get screening.; 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.
Experimental: B1: Active MPM User, UC Letter; Behavioral: Letter vs. Electronic Messaging Behavioral: Usual Care Messaging vs. Behavioral Economic Messaging Participants who are active MyPennMedicine (MPM) users receive a usual care (UC) letter consisting of a message encouraging them to contact their primary care provider for Hepatitis C screening.	Behavioral: 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.
Experimental: B2: Active MPM User, BE Letter; Behavioral: Letter vs. Electronic Messaging Behavioral: Usual Care Messaging vs. Behavioral Economic Messaging Participants who are active MyPennMedicine (MPM) users receive a letter with behavioral economic (BE) principles encouraging them to contact their primary care provider for Hepatitis C screening.	Behavioral: 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: 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.
Active Comparator: B3: Active MPM User, UC MPM Message; Behavioral: Letter vs. Electronic Messaging Behavioral: Usual Care Messaging vs. Behavioral Economic Messaging Participants who are active MyPennMedicine (MPM) users receive an electronic usual care (UC) message on the MyPennMedicine patient portal encouraging them to contact their primary care provider for Hepatitis C screening.	Behavioral: Usual Care Messaging; Participants receive standard messaging about HCV and ways to get screening.
Experimental: B4: Active MPM User, BE MPM Message; Behavioral: Letter vs. Electronic Messaging Behavioral: Usual Care Messaging vs. Behavioral Economic Messaging Participants who are active MyPennMedicine (MPM) users receive an electronic message with behavioral economic principles on the MyPennMedicine patient portal encouraging them to contact their primary care provider for Hepatitis C screening.	Behavioral: 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.
Active Comparator: B5: Non-MPM User, UC Letter; Behavioral: Usual Care Messaging vs. Behavioral Economic Messaging Participants who are non-MyPennMedicine (non-MPM) users receive a usual care (UC) letter consisting of a message encouraging them to contact their primary care provider for Hepatitis C screening.	Behavioral: 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: Usual Care Messaging; Participants receive standard messaging about HCV and ways to get screening.
Experimental: B6: Non-MPM User, BE Letter; Behavioral: Usual Care Messaging vs. Behavioral Economic Messaging Participants who are non-MyPennMedicine (non-MPM) users receive a letter with behavioral economic principles (BE) encouraging them to contact their primary care provider for Hepatitis C screening.	Behavioral: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV Antibody Completion within 4 Months	Percentage of patients who complete HCV antibody testing within 4 months of initial outreach	4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Publications and helpful links

General Publications

• Mehta SJ, Day SC, Norris AH, Sung J, Reitz C, Wollack C, Snider CK, Shaw PA, Asch DA. Behavioral interventions to improve population health outreach for hepatitis C screening: randomized clinical trial. BMJ. 2021 May 18;373:n1022. doi: 10.1136/bmj.n1022.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Screening; Behavioral Economics; Outreach
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: 831526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No