Behavioral Science and Hepatitis C Screening Outreach
1 other identifier
interventional
21,493
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedStudy Start
First participant enrolled
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2020
CompletedDecember 1, 2020
November 1, 2020
1.6 years
October 16, 2018
November 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HCV Antibody Completion within 4 Months
Percentage of patients who complete HCV antibody testing within 4 months of initial outreach
4 months
Secondary Outcomes (4)
HCV Antibody Completion within 12 Months
12 months
HCV Antibody Positive
12 months
HCV Antibody Positive with Viral Loads
12 months
Referred to Specialist
12 months
Study Arms (8)
A1: Opt-In, UC Letter
ACTIVE COMPARATORBehavioral: 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.
A2: Opt-Out, UC Letter
EXPERIMENTALBehavioral: 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.
B1: Active MPM User, UC Letter
EXPERIMENTALBehavioral: 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.
B2: Active MPM User, BE Letter
EXPERIMENTALBehavioral: 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.
B3: Active MPM User, UC MPM Message
ACTIVE COMPARATORBehavioral: 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.
B4: Active MPM User, BE MPM Message
EXPERIMENTALBehavioral: 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.
B5: Non-MPM User, UC Letter
ACTIVE COMPARATORBehavioral: 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.
B6: Non-MPM User, BE Letter
EXPERIMENTALBehavioral: 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.
Interventions
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.
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.
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.
Participants receive standard messaging about HCV and ways to get screening.
Eligibility Criteria
You may qualify if:
- at least 2 visits to primary care provider within 2 years
- born between 1945 and 1965
You may not qualify if:
- have had 1 HCV antibody test, viral load test or are considered up-to-date on HCV screening by health maintenance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 34006604DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shivan Mehta, MD, MBA
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
October 16, 2018
First Posted
October 19, 2018
Study Start
March 15, 2019
Primary Completion
October 15, 2020
Study Completion
October 15, 2020
Last Updated
December 1, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share