Hepatitis CNCT04525690
Improving Inpatient Screening for Hepatitis C
A study testing Nudge in people with Hepatitis C, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will use a stepped-wedge cluster randomized clinical trial to evaluate a health system initiative to set defaults in the electronic health record admission order set to nudge inpatient hepatitis C (HCV) screening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Nudge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,634 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 10 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be admitted to the Hospital of the University of Pennsylvania (HUP) or Penn Presbyterian Medical Center (PPMC)
- Born between 1945 and 1965
Who cannot join
- Patients will be excluded if they have already received Hepatitis C screening or have been previously diagnosed with Hepatitis C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Inpatient Screening for Hepatitis C: A Stepped-Wedge Randomized Clinical Trial
This study will use a stepped-wedge cluster randomized clinical trial to evaluate a health system initiative to set defaults in the electronic health record admission order set to nudge inpatient hepatitis C (HCV) screening.
Read the detailed description
The hepatitis C virus (HCV) is the leading cause of liver transplant and hepatocellular carcinoma in the United States, but direct-acting antiviral medications are now available and can cure the disease in over 95% of those that are treated. The Centers for Disease Control and Prevention (CDC) estimate that 75% of all chronic HCV infections in the United States are among adults born between 1945 and 1965. The CDC and US Preventive Services Task Force (USPTF) therefore recommends birth cohort screening for all adults born in this time period. In 2016, the Commonwealth of Pennsylvania signed into law a requirement that all hospitalized patients born during this time period be offered HCV screening. In this study, a stepped-wedge cluster randomized clinical trial will be conducted to test the effect of defaulting HCV screening into the admission order set to improve screening rates.
- Conditions
- Hepatitis C
- Being tested
- Nudge
- Keywords
- Hepatitis C, HCV screening, nudge, defaults
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NudgeBehavioural
Clinicians will receive a default order upon entering the the admission order set. They will have the opportunity to opt-out and not order screening. Clinicians will receive the nudge each time they enter the admission order set for a new, eligible patient.
| Study group | Role | What they receive |
|---|---|---|
| HCV Screening Default-1 Hospital Crossed Over | Experimental | Upon entering the admission order set in the EHR clinicians will receive a default order for HCV screening for eligible patients. Clinicians will have the opportunity to opt-out and not order screening Receives: Behavioral: Nudge |
| HCV Screening Default-2 Hospitals Crossed Over | Experimental | Upon entering the admission order set in the EHR clinicians will receive a default order for HCV screening for eligible patients. Clinicians will have the opportunity to opt-out and not order screening. Receives: Behavioral: Nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of eligible patients that receive HCV antibody screening
The change in the percentage of eligible hospitalized patients that receive HCV antibody screening
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start21 Sep 2020
- Primary completion10 Apr 2021
- Study completion10 Apr 2021
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Hospital sites will be cluster randomized to the intervention in 3 month blocks over 6 months, after which both sites will receive the default intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 7,634 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitesh S Patel, MD, Principal investigator, University of PennsylvaniaShivan J Mehta, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525690
- Sponsor's protocol ID
- 842718
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2020
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta SJ, Torgersen J, Small DS, Mallozzi CP, McGreevey JD 3rd, Rareshide CAL, Evans CN, Epps M, Stabile D, Snider CK, Patel MS. Effect of a Default Order vs an Alert in the Electronic Health Record on Hepatitis C Virus Screening Among Hospitalized Patients: A Stepped-Wedge Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e222427. doi: 10.1001/jamanetworkopen.2022.2427.
PubMed 35297973
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Inpatient Screening for Hepatitis C: A Stepped-Wedge Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04525690
- Acronym / sponsor ID
- 842718
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, HCV screening, nudge, defaults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,634 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 25 Aug 2020 (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 study will use a stepped-wedge cluster randomized clinical trial to evaluate a health system initiative to set defaults in the electronic health record admission order set to nudge inpatient hepatitis C (HCV) screening.
Detailed description
The hepatitis C virus (HCV) is the leading cause of liver transplant and hepatocellular carcinoma in the United States, but direct-acting antiviral medications are now available and can cure the disease in over 95% of those that are treated. The Centers for Disease Control and Prevention (CDC) estimate that 75% of all chronic HCV infections in the United States are among adults born between 1945 and 1965. The CDC and US Preventive Services Task Force (USPTF) therefore recommends birth cohort screening for all adults born in this time period. In 2016, the Commonwealth of Pennsylvania signed into law a requirement that all hospitalized patients born during this time period be offered HCV screening. In this study, a stepped-wedge cluster randomized clinical trial will be conducted to test the effect of defaulting HCV screening into the admission order set to improve screening rates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Hospital sites will be cluster randomized to the intervention in 3 month blocks over 6 months, after which both sites will receive the default intervention.
| Arm | Type | Receives |
|---|---|---|
| HCV Screening Default-1 Hospital Crossed Over | Experimental | Behavioral: NudgeUpon entering the admission order set in the EHR clinicians will receive a default order for HCV screening for eligible patients. Clinicians will have the opportunity to opt-out and not order screening |
| HCV Screening Default-2 Hospitals Crossed Over | Experimental | Behavioral: NudgeUpon entering the admission order set in the EHR clinicians will receive a default order for HCV screening for eligible patients. Clinicians will have the opportunity to opt-out and not order screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be admitted to the Hospital of the University of Pennsylvania (HUP) or Penn Presbyterian Medical Center (PPMC)
- Born between 1945 and 1965
Key exclusion criteria (1 listed)
- Patients will be excluded if they have already received Hepatitis C screening or have been previously diagnosed with Hepatitis C.
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 |
|---|---|---|
| NudgeClinicians will receive a default order upon entering the the admission order set. They will have the opportunity to opt-out and not order screening. Clinicians will receive the nudge each time they enter the admission order set for a new, eligible patient. | Behavioural | HCV Screening Default-1 Hospital Crossed Over, HCV Screening Default-2 Hospitals Crossed Over |
Primary outcome
Change in percentage of eligible patients that receive HCV antibody screening
Time frame: 6 months
The change in the percentage of eligible hospitalized patients that receive HCV antibody screening
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 17 Aug 2021.
- Derived from this study: PubMed 35297973Mehta SJ, Torgersen J, Small DS, Mallozzi CP, McGreevey JD 3rd, Rareshide CAL, Evans CN, Epps M, Stabile D, Snider CK, Patel MS. Effect of a Default Order vs an Alert in the Electronic Health Record on Hepatitis C Virus Screening Among Hospitalized Patients: A Stepped-Wedge Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e222427. doi: 10.1001/jamanetworkopen.2022.2427.
- 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.
Mitesh S Patel, MD principal investigator
University of Pennsylvania
Shivan J Mehta, MD 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 Nudge 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 17 Aug 2021. 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?
Change in percentage of eligible patients that receive HCV antibody screening (time frame: 6 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 NCT04525690, 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 17 Aug 2021.