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

NCT ID: NCT01405027

Last Updated: 2015-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-07-31

Brief Summary

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.

Detailed 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.

Conditions

Chronic Hepatitis C; Genotype 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A - HCEE

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.

Group Type: OTHER

Patient education and management skills training

Intervention Type: OTHER

Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.

Group B - Community Sites

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.

Group Type: OTHER

Educational Intervention

Intervention Type: PROCEDURE

Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.

Interventions

Educational Intervention

Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.

Intervention Type: PROCEDURE

Patient education and management skills training

Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.

Intervention Type: OTHER

Other Intervention Names

Peg-Intron; Pegasys; Victrelis; Pegylated interferon alfa 2B; Pegylated interferon alfa 2A; Boceprevir; Ribavirin; Peg-Intron; Pegasys; Victrelis; Pegylated interferon alfa 2B; Pegylated interferon alfa 2A; Boceprevir; Ribavirin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SCRI Development Innovations, LLC

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Chronic Liver Disease Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fred Poordad, MD

Role: PRINCIPAL_INVESTIGATOR

Chronic Liver Disease Foundation

Locations

California Liver Institute

Beverly Hills, California, United States

Samuel Burstein, MD

Calabasas, California, United States

William Katkov, MD

Santa Monica, California, United States

Sutha Sachar, MD

Torrance, California, United States

Harbor UCLA Medical Professional Group

Torrance, California, United States

Associates in Gastroenterology

Colorado Springs, Colorado, United States

South Denver Gastroenterology

Englewood, Colorado, United States

Bay Area Gastroenterology

Clearwater, Florida, United States

Digestive Medicine Associates

Hialeah, Florida, United States

James Johnson, MD

Lakeland, Florida, United States

Florida Center for Gastroenterology

Largo, Florida, United States

Marwan Iskandarani, MD

North Miami Beach, Florida, United States

Advanced Gastro and Liver Disease

Pinellas Park, Florida, United States

Lee S. Mitchel, MD

Sarasota, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Digestive Disease Consultants

Bourbonnais, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Consultants in Gastroenerology

Munster, Indiana, United States

Consultants in Gastroenterology

Munster, Indiana, United States

Wabash Valley Infectious Disease

Terre Haute, Indiana, United States

University of Iowa Health Center

Iowa City, Iowa, United States

Metropolitan Gastroenterology Associates

Metairie, Louisiana, United States

Henry Ford Health System

Detroit, Michigan, United States

South Oakland Gastroenterology

Farmington Hills, Michigan, United States

Union Lake Clinic

Madison Heights, Michigan, United States

GI Medicine Associates

Saint Clair Shores, Michigan, United States

Saint Luke's Health Center

Kansas City, Missouri, United States

Saint Luke's Hospital

Kansas City, Missouri, United States

Michael Fedotin, MD

Kansas City, Missouri, United States

St. Louis University Liver Center

St Louis, Missouri, United States

Mercy Digestive Disease

St Louis, Missouri, United States

North Shore Gastroenterology Associates

Great Neck, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Columbia University Medical Center

New York, New York, United States

NY Associates in Gastroenterology

The Bronx, New York, United States

Temple Physicians

Philadelphia, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

Dr. Glenn S. Freed, DO

Pottsville, Pennsylvania, United States

Main Line Gastroenterology

Wynnewood, Pennsylvania, United States

Gastroenterology Consultants

Live Oak, Texas, United States

Brooke Army Medical Center

San Antonio, Texas, United States

Metropolitan Research

Fairfax, Virginia, United States

Medical Associates of Central Virginia

Lynchburg, Virginia, United States

Countries

United States

References

Poordad F, Rustgi V, Brown RS Jr, Patel V, Kugelmas M, Regenstein F, Balart L, LaBrecque D, Brown K, Avila M, Biederman M, Freed G, Smith R, Bernstein M, Arnold H, Cahan J, Fink S, Katkov W, Massoumi H, Harrison S. The impact of an educational program on HCV patient outcomes using boceprevir in community practices (OPTIMAL trial). Therap Adv Gastroenterol. 2015 Sep;8(5):263-9. doi: 10.1177/1756283X15588876.

Reference Type: DERIVED

PMID: 26327916 (View on PubMed)

Related Links

http://www.chronicliverdisease.org

Click here for more information about the Chronic Liver Disease Foundation and Hepatology Centers of Educational Expertise

Other Identifiers

20111013

Identifier Type: OTHER

Identifier Source: secondary_id

CLDF-MER-001-00

Identifier Type: -

Identifier Source: org_study_id