Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy (OPTIMAL)

Chronic Liver Disease Foundation

Status and phase: Completed; Phase 4

Conditions: Genotype 1; Chronic Hepatitis C

Treatments: Procedure: Educational Intervention; Other: Patient education and management skills training

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01405027

CLDF-MER-001-00

20111013 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated interferon, ribavirin and boceprevir.

Full description

The new treatment paradigm for HCV in the era of protease inhibitors will add a level of complexity that was previously not seen with pegylated interferon and ribavirin. In addition to new concepts such as utilization of a lead-in period, compliance with a TID dosing regimen of a third agent, development of resistance, and futility rules and decision points have yet to be assessed in a real life practice setting. The OPTIMAL trial is designed to evaluate the impact of an education program for community sites participating in a CLDF study treating chronic HCV genotype 1 patients. Group A will be comprised of approximately 30 CLDF designated Hepatology Centers of Educational Expertise (HCEE) and Group B will be comprised of approximately 60 community sites. Group A will also deliver the educational program regarding the use of HCV protease inhibitors, and the overall treatment of HCV to approximately two (2) community sites in it's geographic region. Group B will be comprised of community sites that have no previous clinical trial experience with boceprevir or an HCV protease inhibitor. For the purpose of this study, each community site in Group B will be assigned to an HCEE.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Hepatitis C (HCV) genotype 1
• Detectable HCV-RNA within 180 days of screening
• Age ≥ 18 years
• Weight > 40 kg
• Patient and partner(s) must agree to use acceptable methods of contraception
• Written informed consent

Exclusion criteria

• Known co-infection with HIV or HBV
• Previous interferon or ribavirin regimen requiring discontinuation for an adverse event considered related to ribavirin and/or interferon
• Currently taking or planning on taking any prohibited medications
• Evidence of decompensated liver disease including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
• Diabetes and/or hypertension with clinically significant ocular examination findings
• Pre-existing psychiatric condition(s)
• History of severe and uncontrolled psychiatric disorders
• Active alcohol or drug abuse (not including marijuana)
• Pre-existing medical condition that could interfere with the patient's participation in the study
• Chronic obstructive pulmonary disease
• Abnormal lab values

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 2 patient groups

Group A - HCEE

Other group

Description:

Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor. HCEE investigators provided patient education and management skills training during four (4) educational interventions to Community Site investigators.

Treatment:

Other: Patient education and management skills training

Group B - Community Sites

Other group

Description:

Group B - community physicians treating HCV but without clinical trial experience with an HCV protease inhibitor received patient education and management skills training from Hepatology Centers of Educational Expertise (HCEEs) during four (4) educational interventions.

Treatment:

Procedure: Educational Intervention