Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Behavioral Science and Hepatitis C Screening Outreach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03712553
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Shivan J Mehta, University of Pennsylvania

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
Hepatitis C Behavioral: Opt-Out Behavioral: Letter Behavioral: Behavioral Economic Messaging Behavioral: Usual Care Messaging Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30022 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 : March 15, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. HCV Antibody Completion within 4 Months [ Time Frame: 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 [ Time Frame: 12 months ]
    Percentage of patients who complete HCV antibody testing within 12 months of initial outreach

  2. HCV Antibody Positive [ Time Frame: 12 months ]
    Percentage of tests that are positive

  3. HCV Antibody Positive with Viral Loads [ Time Frame: 12 months ]
    Percentage of test that are positive with detectable viral loads

  4. Referred to Specialist [ Time Frame: 12 months ]
    Percentage of patients referred to specialist and receive HCV treatment and cure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   53 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712553


Locations
Layout table for location information
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Shivan Mehta, MD, MBA University of Pennsylvania

Layout table for additonal information
Responsible Party: Shivan J Mehta, Assistant Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03712553     History of Changes
Other Study ID Numbers: 831526
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shivan J Mehta, University of Pennsylvania:
Behavioral Economics
Screening
Outreach

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections