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Behavioral Science and Hepatitis C Screening Outreach

NCT ID: NCT03712553

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21493 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2020-10-15

Brief Summary

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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

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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.

Conditions

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Hepatitis C

Keywords

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Behavioral Economics Screening Outreach

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Letter

Intervention Type BEHAVIORAL

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.

Usual Care Messaging

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Opt-Out

Intervention Type BEHAVIORAL

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.

Usual Care Messaging

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Letter

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Letter

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Usual Care Messaging

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Behavioral Economic Messaging

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Letter

Intervention Type BEHAVIORAL

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.

Usual Care Messaging

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Letter

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Usual Care Messaging

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

53 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Shivan J Mehta

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shivan Mehta, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34006604 (View on PubMed)

Other Identifiers

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831526

Identifier Type: -

Identifier Source: org_study_id