Hepatitis C Diagnosis to Treatment Management

Hepatitis C Clinical Trial

Official title:

Hepatitis C Disease Management: Diagnosis to Treatment Alerts in CHORUS™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05725109
• Other study ID #: COL2023-001
• Status: Completed
• Start date: January 16, 2023
• Est. completion date: October 17, 2023

Study information

• Verified date: February 2024
• Source: Epividian
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to evaluate whether sending alerts to healthcare providers and clinic staff to identify patients with untreated hepatitis C infection can increase the uptake of hepatitis C treatment. A period of time without alerts will be compared to a period of time with alerts.

Description:

The hepatitis C virus (HCV) is one of the most common bloodborne pathogens in the United States. A large proportion of people with HCV infection progress to chronic HCV infection despite the availability of effective treatment; chronic infection can result in cirrhosis, end-stage liver disease, liver cancer, and liver-related death. HCV infection can be cured most of the time with treatment. The objective of this before and after study is to evaluate whether sending alerts to healthcare providers and clinic staff to identify patients with untreated hepatitis C infection can increase the uptake of HCV treatment. A period of time without alerts will be compared to a period of time with alerts. Healthcare providers and clinic staff will not receive alerts during the before period of the study. Healthcare providers and clinic staff will receive alerts during the after period of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1063
• Est. completion date: October 17, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18+ years of age

• In care at an AIDS Healthcare Foundation Healthcare Center

• Active, untreated HCV infection

Exclusion Criteria:

• <18 years of age

• Patients with active HCV infection who have a current prescription for HCV treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Other:
• Hepatitis C Treatment Alerts in CHORUS™
Clinical Health Outcomes Reporting & Utilization Service (CHORUS™) is a web-based healthcare analytics and reporting solution that transforms electronic health record data into meaningful information for healthcare providers. CHORUS™ generates a weekly email report that alerts clinics to patients with certain conditions who have a scheduled appointment in the coming week and may require close attention. CHORUS™ is a service provided to participating clinics and has been used by AIDS Healthcare Foundation for normal healthcare operations for quality improvement and retention in care in recent years. In the after period of this study, the alert will identify patients with active hepatitis C infection.
• Standard of Care
CHORUS™ is a service provided to participating clinics and has been used by AIDS Healthcare Foundation for normal healthcare operations for quality improvement and retention in care in recent years. NO alerts identifying patients with active hepatitis C infection will be disseminated.

Locations

Country	Name	City	State
United States	AIDS Healthcare Foundation	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Epividian	AIDS Healthcare Foundation, Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prescriptions for HCV treatment	Proportion of patients who are prescribed HCV treatment over follow-up, out of patients with a completed visit over follow-up.	End of follow-up, up to 9 months
Secondary	HCV RNA viral load tests	Frequency of HCV RNA viral load tests that occur between the first visit over follow-up and the first censoring event	End of follow-up, up to 9 months