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Improving Inpatient Screening for Hepatitis C

Primary Purpose

Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nudge
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hepatitis C focused on measuring Hepatitis C, HCV screening, nudge, defaults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Penn Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HCV Screening Default-1 Hospital Crossed Over

HCV Screening Default-2 Hospitals Crossed Over

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 20, 2020
Last Updated
August 16, 2021
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04525690
Brief Title
Improving Inpatient Screening for Hepatitis C
Official Title
Improving Inpatient Screening for Hepatitis C: A Stepped-Wedge Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
April 10, 2021 (Actual)
Study Completion Date
April 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, HCV screening, nudge, defaults

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The principal study investigator and data analyst will not have knowledge of when the hospital sites are randomized to the intervention.
Allocation
Randomized
Enrollment
7634 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCV Screening Default-1 Hospital Crossed Over
Arm Type
Experimental
Arm Description
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
Arm Title
HCV Screening Default-2 Hospitals Crossed Over
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nudge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in percentage of eligible patients that receive HCV antibody screening
Description
The change in the percentage of eligible hospitalized patients that receive HCV antibody screening
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Percentage of patients that are HCV antibody positive
Description
The percentage of eligible hospitalized patients that are HCV antibody positive
Time Frame
9 months
Title
Percentage of patients that have positive HCV testing who receive either linkage to care and/or treatment
Description
The percentage of eligible hospitalized patients that have positive HCV testing who receive either linkage to care and/or treatment
Time Frame
9 months
Title
Change in the percentage of eligible patients that are viral load positive for HCV
Description
The change in the percentage of eligible hospitalized patients that are viral load positive for HCV
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitesh S Patel, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shivan J Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35297973
Citation
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.
Results Reference
derived

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Improving Inpatient Screening for Hepatitis C

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