Hepatitis CNCT03712553
Behavioral Science and Hepatitis C Screening Outreach
A study testing Opt-Out, Letter and Behavioral Economic Messaging in people with Hepatitis C, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 53 to 73 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Opt-Out, Letter and Behavioral Economic Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,493 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2019to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 53 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 2 visits to primary care provider within 2 years
- born between 1945 and 1965
Who cannot join
- have had 1 HCV antibody test, viral load test or are considered up-to-date on HCV screening by health maintenance
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Opt-Out, Letter, Behavioral Economic Messaging, Usual Care Messaging
- Keywords
- Behavioral Economics, Screening, Outreach
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opt-OutBehavioural
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.
LetterBehavioural
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 MessagingBehavioural
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.
Usual Care MessagingBehavioural
Participants receive standard messaging about HCV and ways to get screening.
| Study group | Role | What they receive |
|---|---|---|
| A1: Opt-In, UC Letter | Active comparator | 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. Receives: Behavioral: Letter; Behavioral: Usual Care Messaging |
| A2: Opt-Out, UC Letter | Experimental | 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. Receives: Behavioral: Opt-Out; Behavioral: Usual Care Messaging |
| B1: Active MPM User, UC Letter | Experimental | 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. Receives: Behavioral: Letter |
| B2: Active MPM User, BE Letter | Experimental | 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. Receives: Behavioral: Letter; Behavioral: Behavioral Economic Messaging |
| B3: Active MPM User, UC MPM Message | Active comparator | 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. Receives: Behavioral: Usual Care Messaging |
| B4: Active MPM User, BE MPM Message | Experimental | 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. Receives: Behavioral: Behavioral Economic Messaging |
| B5: Non-MPM User, UC Letter | Active comparator | 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. Receives: Behavioral: Letter; Behavioral: Usual Care Messaging |
| B6: Non-MPM User, BE Letter | Experimental | 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. Receives: Behavioral: Letter; Behavioral: Behavioral Economic Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV Antibody Completion within 4 Months
Percentage of patients who complete HCV antibody testing within 4 months of initial outreach
Measured: 4 months
Secondary outcomes (4)
HCV Antibody Completion within 12 Months
Percentage of patients who complete HCV antibody testing within 12 months of initial outreach
Measured: 12 months
HCV Antibody Positive
Percentage of tests that are positive
Measured: 12 months
HCV Antibody Positive with Viral Loads
Percentage of test that are positive with detectable viral loads
Measured: 12 months
Referred to Specialist
Percentage of patients referred to specialist and receive HCV treatment and cure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start15 Mar 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 21,493 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shivan J Mehta, University of Pennsylvania
- Investigators
- Shivan Mehta, MD, MBA, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712553
- Sponsor's protocol ID
- 831526
- Status last verified
- Nov 2020
- First submitted
- 16 Oct 2018
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34006604
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Science and Hepatitis C Screening Outreach
- ClinicalTrials.gov ID
- NCT03712553
- Acronym / sponsor ID
- 831526
- Conditions
- Hepatitis C
- Keywords
- Behavioral Economics, Screening, Outreach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,493 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A1: Opt-In, UC Letter | Active comparator | Behavioral: Letter, Behavioral: Usual Care MessagingBehavioral: 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 | Experimental | Behavioral: Opt-Out, Behavioral: Usual Care MessagingBehavioral: 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 | Experimental | Behavioral: LetterBehavioral: 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 | Experimental | Behavioral: Letter, Behavioral: Behavioral Economic MessagingBehavioral: 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 comparator | Behavioral: Usual Care MessagingBehavioral: 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 | Experimental | Behavioral: Behavioral Economic MessagingBehavioral: 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 comparator | Behavioral: Letter, Behavioral: Usual Care MessagingBehavioral: 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 | Experimental | Behavioral: Letter, Behavioral: Behavioral Economic MessagingBehavioral: 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. |
Who may qualify
- Ages
- 53 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 2 visits to primary care provider within 2 years
- born between 1945 and 1965
Key exclusion criteria (1 listed)
- have had 1 HCV antibody test, viral load test or are considered up-to-date on HCV screening by health maintenance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opt-OutOpt-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. | Behavioural | A2: Opt-Out, UC Letter |
| LetterParticipants 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. | Behavioural | A1: Opt-In, UC Letter, B1: Active MPM User, UC Letter, B2: Active MPM User, BE Letter, B5: Non-MPM User, UC Letter, B6: Non-MPM User, BE Letter |
| Behavioral Economic MessagingParticipants 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. | Behavioural | B2: Active MPM User, BE Letter, B4: Active MPM User, BE MPM Message, B6: Non-MPM User, BE Letter |
| Usual Care MessagingParticipants receive standard messaging about HCV and ways to get screening. | Behavioural | A1: Opt-In, UC Letter, A2: Opt-Out, UC Letter, B3: Active MPM User, UC MPM Message, B5: Non-MPM User, UC Letter |
Primary outcome
HCV Antibody Completion within 4 Months
Time frame: 4 months
Percentage of patients who complete HCV antibody testing within 4 months of initial outreach
4 secondary outcomes
HCV Antibody Completion within 12 Months
Time frame: 12 months
HCV Antibody Positive
Time frame: 12 months
HCV Antibody Positive with Viral Loads
Time frame: 12 months
Referred to Specialist
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Derived from this study: PubMed 34006604Mehta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shivan Mehta, MD, MBA principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opt-Out, Letter and Behavioral Economic Messaging in people with Hepatitis C, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV Antibody Completion within 4 Months (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03712553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.