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

Chronic Hepatitis C Clinical Trial

— OPTIMAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405027
• Other study ID #: CLDF-MER-001-00
• Secondary ID: 20111013
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2011
• Last updated: December 22, 2014
• Start date: December 2011
• Est. completion date: July 2014

Study information

• Verified date: December 2014
• Source: Chronic Liver Disease Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Genotype 1
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	California Liver Institute	Beverly Hills	California
United States	Digestive Disease Consultants	Bourbonnais	Illinois
United States	NY Associates in Gastroenterology	Bronx	New York
United States	Samuel Burstein, MD	Calabasas	California
United States	Bay Area Gastroenterology	Clearwater	Florida
United States	Associates in Gastroenterology	Colorado Springs	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	South Denver Gastroenterology	Englewood	Colorado
United States	Metropolitan Research	Fairfax	Virginia
United States	South Oakland Gastroenterology	Farmington Hills	Michigan
United States	North Shore Gastroenterology Associates	Great Neck	New York
United States	Digestive Medicine Associates	Hialeah	Florida
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa Health Center	Iowa City	Iowa
United States	Michael Fedotin, MD	Kansas City	Missouri
United States	Saint Luke's Health Center	Kansas City	Missouri
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	James Johnson, MD	Lakeland	Florida
United States	Florida Center for Gastroenterology	Largo	Florida
United States	Gastroenterology Consultants	Live Oak	Texas
United States	Medical Associates of Central Virginia	Lynchburg	Virginia
United States	Union Lake Clinic	Madison Heights	Michigan
United States	North Shore University Hospital	Manhasset	New York
United States	Metropolitan Gastroenterology Associates	Metairie	Louisiana
United States	Consultants in Gastroenerology	Munster	Indiana
United States	Consultants in Gastroenterology	Munster	Indiana
United States	Columbia University Medical Center	New York	New York
United States	Marwan Iskandarani, MD	North Miami Beach	Florida
United States	Temple Physicians	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania
United States	Advanced Gastro and Liver Disease	Pinellas Park	Florida
United States	Dr. Glenn S. Freed, DO	Pottsville	Pennsylvania
United States	Brooke Army Medical Center	San Antonio	Texas
United States	William Katkov, MD	Santa Monica	California
United States	Lee S. Mitchel, MD	Sarasota	Florida
United States	GI Medicine Associates	St Clair Shores	Michigan
United States	Mercy Digestive Disease	St. Louis	Missouri
United States	St. Louis University Liver Center	St. Louis	Missouri
United States	Tampa General Hospital	Tampa	Florida
United States	Wabash Valley Infectious Disease	Terre Haute	Indiana
United States	Harbor UCLA Medical Professional Group	Torrance	California
United States	Sutha Sachar, MD	Torrance	California
United States	Main Line Gastroenterology	Wynnewood	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Chronic Liver Disease Foundation	Merck Sharp & Dohme Corp., SCRI Development Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Drug Exposure	Total number of patients receiving treatment over specified time intervals.	End of treatment up to treatment week 48	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes

External Links

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