Behavioral Science and Hepatitis C Screening Outreach

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT03712553
Collaborator
(none)
21,493
1
8
19.1
1127.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Opt-Out
  • Behavioral: Letter
  • Behavioral: Behavioral Economic Messaging
  • Behavioral: Usual Care Messaging
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
21493 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Behavioral Science and Hepatitis C Screening Outreach
Actual Study Start Date :
Mar 15, 2019
Actual Primary Completion Date :
Oct 15, 2020
Actual Study Completion Date :
Oct 15, 2020

Arms and Interventions

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: 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.

Behavioral: Usual Care Messaging
Participants receive standard messaging about HCV and ways to get 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.

Outcome Measures

Primary Outcome Measures

  1. HCV Antibody Completion within 4 Months [4 months]

    Percentage of patients who complete HCV antibody testing within 4 months of initial outreach

Secondary Outcome Measures

  1. HCV Antibody Completion within 12 Months [12 months]

    Percentage of patients who complete HCV antibody testing within 12 months of initial outreach

  2. HCV Antibody Positive [12 months]

    Percentage of tests that are positive

  3. HCV Antibody Positive with Viral Loads [12 months]

    Percentage of test that are positive with detectable viral loads

  4. Referred to Specialist [12 months]

    Percentage of patients referred to specialist and receive HCV treatment and cure

Eligibility Criteria

Criteria

Ages Eligible for Study:
53 Years to 73 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

  • Principal Investigator: Shivan Mehta, MD, MBA, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shivan J Mehta, Assistant Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03712553
Other Study ID Numbers:
  • 831526
First Posted:
Oct 19, 2018
Last Update Posted:
Dec 1, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shivan J Mehta, Assistant Professor of Medicine, University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2020