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

Primary Purpose

Chronic Hepatitis C, Genotype 1

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Patient education and management skills training
Sponsored by
Chronic Liver Disease Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV, Genotype1, Naive, Partial responder, Relapser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • California Liver Institute
  • Samuel Burstein, MD
  • William Katkov, MD
  • Sutha Sachar, MD
  • Harbor UCLA Medical Professional Group
  • Associates in Gastroenterology
  • South Denver Gastroenterology
  • Bay Area Gastroenterology
  • Digestive Medicine Associates
  • James Johnson, MD
  • Florida Center for Gastroenterology
  • Marwan Iskandarani, MD
  • Advanced Gastro and Liver Disease
  • Lee S. Mitchel, MD
  • Tampa General Hospital
  • Digestive Disease Consultants
  • Indiana University
  • Consultants in Gastroenerology
  • Consultants in Gastroenterology
  • Wabash Valley Infectious Disease
  • University of Iowa Health Center
  • Metropolitan Gastroenterology Associates
  • Henry Ford Health System
  • South Oakland Gastroenterology
  • Union Lake Clinic
  • GI Medicine Associates
  • Saint Luke's Health Center
  • Saint Luke's Hospital
  • Michael Fedotin, MD
  • St. Louis University Liver Center
  • Mercy Digestive Disease
  • NY Associates in Gastroenterology
  • North Shore Gastroenterology Associates
  • North Shore University Hospital
  • Columbia University Medical Center
  • Temple Physicians
  • Temple University
  • Dr. Glenn S. Freed, DO
  • Main Line Gastroenterology
  • Gastroenterology Consultants
  • Brooke Army Medical Center
  • Metropolitan Research
  • Medical Associates of Central Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A - HCEE

Group B - Community Sites

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Drug Exposure
Total number of patients receiving treatment over specified time intervals.
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.
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.
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

Full Information

First Posted
July 25, 2011
Last Updated
December 22, 2014
Sponsor
Chronic Liver Disease Foundation
Collaborators
SCRI Development Innovations, LLC, Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01405027
Brief Title
Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy
Acronym
OPTIMAL
Official Title
Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chronic Liver Disease Foundation
Collaborators
SCRI Development Innovations, LLC, Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, Genotype 1
Keywords
HCV, Genotype1, Naive, Partial responder, Relapser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A - HCEE
Arm Type
Other
Arm 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.
Arm Title
Group B - Community Sites
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Peg-Intron, Pegasys, Victrelis, Pegylated interferon alfa 2B, Pegylated interferon alfa 2A, Boceprevir, Ribavirin
Intervention Description
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
Other
Intervention Name(s)
Patient education and management skills training
Other Intervention Name(s)
Peg-Intron, Pegasys, Victrelis, Pegylated interferon alfa 2B, Pegylated interferon alfa 2A, Boceprevir, Ribavirin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Duration Compliance Rate
Description
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).
Time Frame
End of treatment up to treatment week 48
Secondary Outcome Measure Information:
Title
Drug Exposure
Description
Total number of patients receiving treatment over specified time intervals.
Time Frame
End of treatment up to treatment week 48
Title
Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.
Description
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.
Time Frame
Follow-up week 24
Title
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Description
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.
Time Frame
Baseline, end of treatment, follow-up week 24
Title
Number of Participants With Adverse Events
Description
Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs
Time Frame
Throughout entire study, at end of treatment and follow up week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Poordad, MD
Organizational Affiliation
Chronic Liver Disease Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Liver Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Samuel Burstein, MD
City
Calabasas
State/Province
California
ZIP/Postal Code
91302
Country
United States
Facility Name
William Katkov, MD
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Sutha Sachar, MD
City
Torrance
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Harbor UCLA Medical Professional Group
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Associates in Gastroenterology
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
South Denver Gastroenterology
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Bay Area Gastroenterology
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Digestive Medicine Associates
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
James Johnson, MD
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Florida Center for Gastroenterology
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Marwan Iskandarani, MD
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Advanced Gastro and Liver Disease
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Lee S. Mitchel, MD
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Digestive Disease Consultants
City
Bourbonnais
State/Province
Illinois
ZIP/Postal Code
60914
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Consultants in Gastroenerology
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Consultants in Gastroenterology
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Wabash Valley Infectious Disease
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
University of Iowa Health Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
53342
Country
United States
Facility Name
Metropolitan Gastroenterology Associates
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
South Oakland Gastroenterology
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Union Lake Clinic
City
Madison Heights
State/Province
Michigan
ZIP/Postal Code
48071
Country
United States
Facility Name
GI Medicine Associates
City
St Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Saint Luke's Health Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Michael Fedotin, MD
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
St. Louis University Liver Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Digestive Disease
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
NY Associates in Gastroenterology
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
North Shore Gastroenterology Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Temple Physicians
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Dr. Glenn S. Freed, DO
City
Pottsville
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States
Facility Name
Main Line Gastroenterology
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Gastroenterology Consultants
City
Live Oak
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Medical Associates of Central Virginia
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26327916
Citation
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.
Results Reference
derived
Links:
URL
http://www.chronicliverdisease.org
Description
Click here for more information about the Chronic Liver Disease Foundation and Hepatology Centers of Educational Expertise

Learn more about this trial

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

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