search
Back to results

Behavioral Science and Hepatitis C Screening Outreach

Primary Purpose

Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opt-Out
Letter
Behavioral Economic Messaging
Usual Care Messaging
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis C focused on measuring Behavioral Economics, Screening, Outreach

Eligibility Criteria

53 Years - 73 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

A1: Opt-In, UC Letter

A2: Opt-Out, UC Letter

B1: Active MPM User, UC Letter

B2: Active MPM User, BE Letter

B3: Active MPM User, UC MPM Message

B4: Active MPM User, BE MPM Message

B5: Non-MPM User, UC Letter

B6: Non-MPM User, BE Letter

Arm Description

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: 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: 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 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 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: 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: 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: 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2018
Last Updated
November 30, 2020
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT03712553
Brief Title
Behavioral Science and Hepatitis C Screening Outreach
Official Title
Behavioral Science and Hepatitis C Screening Outreach
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Behavioral Economics, Screening, Outreach

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21493 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1: Opt-In, UC Letter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
A2: Opt-Out, UC Letter
Arm Type
Experimental
Arm Description
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.
Arm Title
B1: Active MPM User, UC Letter
Arm Type
Experimental
Arm Description
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.
Arm Title
B2: Active MPM User, BE Letter
Arm Type
Experimental
Arm Description
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.
Arm Title
B3: Active MPM User, UC MPM Message
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B4: Active MPM User, BE MPM Message
Arm Type
Experimental
Arm Description
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.
Arm Title
B5: Non-MPM User, UC Letter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B6: Non-MPM User, BE Letter
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Opt-Out
Intervention Description
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
Intervention Name(s)
Letter
Intervention Description
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
Intervention Name(s)
Behavioral Economic Messaging
Intervention Description
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
Intervention Name(s)
Usual Care Messaging
Intervention Description
Participants receive standard messaging about HCV and ways to get screening.
Primary Outcome Measure Information:
Title
HCV Antibody Completion within 4 Months
Description
Percentage of patients who complete HCV antibody testing within 4 months of initial outreach
Time Frame
4 months
Secondary Outcome Measure Information:
Title
HCV Antibody Completion within 12 Months
Description
Percentage of patients who complete HCV antibody testing within 12 months of initial outreach
Time Frame
12 months
Title
HCV Antibody Positive
Description
Percentage of tests that are positive
Time Frame
12 months
Title
HCV Antibody Positive with Viral Loads
Description
Percentage of test that are positive with detectable viral loads
Time Frame
12 months
Title
Referred to Specialist
Description
Percentage of patients referred to specialist and receive HCV treatment and cure
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
53 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD, MBA
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34006604
Citation
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.
Results Reference
derived

Learn more about this trial

Behavioral Science and Hepatitis C Screening Outreach

We'll reach out to this number within 24 hrs