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

Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C; Genotype 1
• Intervention / Treatment: Other: Patient education and management skills training; Procedure: Educational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • California Liver Institute
    • Calabasas, California, United States, 91302
      • Samuel Burstein, MD
    • Santa Monica, California, United States, 90404
      • William Katkov, MD
    • Torrance, California, United States, 90277
      • Sutha Sachar, MD
    • Torrance, California, United States, 90509
      • Harbor UCLA Medical Professional Group
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Associates in Gastroenterology
    • Englewood, Colorado, United States, 80113
      • South Denver Gastroenterology
  • Florida
    • Clearwater, Florida, United States, 33756
      • Bay Area Gastroenterology
    • Hialeah, Florida, United States, 33016
      • Digestive Medicine Associates
    • Lakeland, Florida, United States, 33805
      • James Johnson, MD
    • Largo, Florida, United States, 33777
      • Florida Center for Gastroenterology
    • North Miami Beach, Florida, United States, 33169
      • Marwan Iskandarani, MD
    • Pinellas Park, Florida, United States, 33781
      • Advanced Gastro and Liver Disease
    • Sarasota, Florida, United States, 34239
      • Lee S. Mitchel, MD
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Bourbonnais, Illinois, United States, 60914
      • Digestive Disease Consultants
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
    • Munster, Indiana, United States, 46321
      • Consultants in Gastroenerology
    • Munster, Indiana, United States, 46321
      • Consultants in Gastroenterology
    • Terre Haute, Indiana, United States, 47802
      • Wabash Valley Infectious Disease
  • Iowa
    • Iowa City, Iowa, United States, 53342
      • University of Iowa Health Center
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Metropolitan Gastroenterology Associates
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Farmington Hills, Michigan, United States, 48336
      • South Oakland Gastroenterology
    • Madison Heights, Michigan, United States, 48071
      • Union Lake Clinic
    • St Clair Shores, Michigan, United States, 48081
      • GI Medicine Associates
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Health Center
    • Kansas City, Missouri, United States, 64132
      • Michael Fedotin, MD
    • St. Louis, Missouri, United States, 63110
      • St. Louis University Liver Center
    • St. Louis, Missouri, United States, 63141
      • Mercy Digestive Disease
  • New York
    • Bronx, New York, United States, 10461
      • NY Associates in Gastroenterology
    • Great Neck, New York, United States, 11203
      • North Shore Gastroenterology Associates
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
    • Philadelphia, Pennsylvania, United States, 19134
      • Temple Physicians
    • Pottsville, Pennsylvania, United States, 17901
      • Dr. Glenn S. Freed, DO
    • Wynnewood, Pennsylvania, United States, 19096
      • Main Line Gastroenterology
  • Texas
    • Live Oak, Texas, United States, 78233
      • Gastroenterology Consultants
    • San Antonio, Texas, United States, 78234
      • Brooke Army Medical Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Metropolitan Research
    • Lynchburg, Virginia, United States, 24501
      • Medical Associates of Central Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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.; Other Names: Pegasys; Ribavirin; Peg-Intron; Victrelis; Pegylated interferon alfa 2B; Pegylated interferon alfa 2A; Boceprevir
Other: 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.	Procedure: 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.; Other Names: Pegasys; Ribavirin; Peg-Intron; Victrelis; Pegylated interferon alfa 2B; Pegylated interferon alfa 2A; Boceprevir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Duration Compliance Rate	The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B).	End of treatment up to treatment week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Exposure	Total number of patients receiving treatment over specified time intervals.	End of treatment up to treatment week 48
Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.	Rate of SVR was defined as the percentage of participants with HCV-RNA undetectable at follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.	Follow-up week 24
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)	Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs. Patient scores per subscale (8) were obtained by subtracting the lowest possible raw score from the actual raw score x 100, divided by the lowest possible raw score subtracted from the highest possible raw score. Subscale scores were averaged (with standard deviation) for Group A and Group B. Composite Scores are standardized to the general US population having a mean of 50 and a standard deviation of 10. Higher score = improved quality of life.	Baseline, end of treatment, follow-up week 24
Number of Participants With Adverse Events	Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs	Throughout entire study, at end of treatment and follow up week 24

Collaborators and Investigators

• Sponsor: Chronic Liver Disease Foundation
• Collaborators: Merck Sharp & Dohme LLC; SCRI Development Innovations, LLC
• Investigators: Principal Investigator: Fred Poordad, MD, Chronic Liver Disease Foundation

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 27, 2011
• First Posted (Estimate): July 29, 2011

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: December 22, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: HCV; Naive; Partial responder; Genotype1; Relapser
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Ribavirin; Peginterferon alfa-2a; Interferon alpha-2; Peginterferon alfa-2b
• Other Study ID Numbers: CLDF-MER-001-00; 20111013 (Other Identifier: Western Institutional Review Board)