Improving Inpatient Screening for Hepatitis C

NCT04525690 | Completed

• 1 other identifier: 842718
• Study Type: interventional
• Target: 7,634
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

Hepatitis C; HCV screening; nudge; defaults

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Other Outcomes (3)

• Percentage of patients that are HCV antibody positive

  9 months

• Percentage of patients that have positive HCV testing who receive either linkage to care and/or treatment

  9 months

• Change in the percentage of eligible patients that are viral load positive for HCV

  9 months

Study Arms (2)

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

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.

Behavioral: Nudge

Interventions

Nudge BEHAVIORAL

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.

HCV Screening Default-1 Hospital Crossed Over; HCV Screening Default-2 Hospitals Crossed Over

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be admitted to the Hospital of the University of Pennsylvania (HUP) or Penn Presbyterian Medical Center (PPMC)
• Born between 1945 and 1965

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

• 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.

  PMID: 35297973 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Mitesh S Patel, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Shivan J Mehta, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal study investigator and data analyst will not have knowledge of when the hospital sites are randomized to the intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 25, 2020
• Study Start: September 21, 2020
• Primary Completion: April 10, 2021
• Study Completion: April 10, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)