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Improving Inpatient Screening for Hepatitis C

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT04525690
Collaborator
(none)
7,634
Enrollment
1
Location
2
Arms
6.6
Actual Duration (Months)
1156
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nudge
 N/A

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

Study Type:
Interventional
Actual Enrollment :
7634 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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 (Investigator, Outcomes Assessor)
Masking Description:
The principal study investigator and data analyst will not have knowledge of when the hospital sites are randomized to the intervention.
Primary Purpose:
Health Services Research
Official Title:
Improving Inpatient Screening for Hepatitis C: A Stepped-Wedge Randomized Clinical Trial
Actual Study Start Date :
Sep 21, 2020
Actual Primary Completion Date :
Apr 10, 2021
Actual Study Completion Date :
Apr 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: HCV Screening Default-1 Hospital Crossed Over

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

Behavioral: Nudge
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.
Experimental: HCV Screening Default-2 Hospitals Crossed Over

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.

Behavioral: Nudge
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.

Outcome Measures

Primary Outcome Measures

  1. Change in percentage of eligible patients that receive HCV antibody screening [6 months]

    The change in the percentage of eligible hospitalized patients that receive HCV antibody screening

Other Outcome Measures

  1. Percentage of patients that are HCV antibody positive [9 months]

    The percentage of eligible hospitalized patients that are HCV antibody positive

  2. Percentage of patients that have positive HCV testing who receive either linkage to care and/or treatment [9 months]

    The percentage of eligible hospitalized patients that have positive HCV testing who receive either linkage to care and/or treatment

  3. Change in the percentage of eligible patients that are viral load positive for HCV [9 months]

    The change in the percentage of eligible hospitalized patients that are viral load positive for HCV

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Be admitted to the Hospital of the University of Pennsylvania (HUP) or Penn Presbyterian Medical Center (PPMC)

  • Born between 1945 and 1965

Exclusion Criteria:
  • Patients will be excluded if they have already received Hepatitis C screening or have been previously diagnosed with Hepatitis C.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Penn Medicine Philadelphia Pennsylvania United States 19103

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

  • Principal Investigator: Mitesh S Patel, MD, University of Pennsylvania
  • Principal Investigator: Shivan J Mehta, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04525690
Other Study ID Numbers:
  • 842718
First Posted:
Aug 25, 2020
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pennsylvania
Hepatitis C
HCV screening
nudge
defaults
Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis

Study Results

No Results Posted as of Aug 17, 2021