Results from a clinical trial designed to evaluate the effectiveness of a hepatitis C educational program delivered by the Hepatology Centers of Educational Expertise, a hepatologist-led working group dedicated to educating healthcare professionals on the latest developments in the management of chronic liver disease.
Hepatitis C treatment can be a challenge for both patient and physician due to long and complex treatment regimens that are associated with frequent adverse events. Historically, treatment response rates have been lower in community settings, where more patients discontinue treatment compared to patients who receive treatment in academic centers. An educational initiative that improves community physicians’ access to knowledge and insight provided by experts in the management of patients with hepatitis C may help improve treatment adherence and lead to better outcomes in patients.
During a poster session at the 2013 American College of Gastroenterology annual meeting in San Diego, CA, lead author Kimberly A. Brown, MD, provided an update on a study that looked at an educational program aimed at improving treatment compliance among patients with hepatitis C in community settings.
Brown reviewed design details of the OPTIMAL study, a phase IV trial designed to evaluate the effectiveness of an educational partnership between academic and community practices to improve therapeutic management of hepatitis c virus (HCV) and patient outcomes at community sites (CS).
Under the program, academic centers dedicated to educating health professionals about effective management of chronic liver disease work together through the Hepatology Centers of Educational Expertise (HCEE) developed by the Chronic Liver Disease Foundation. The network has clinicians who have experience in clinical trials involving the first HCV direct acting antiviral (DAA) therapies. The primary endpoint is treatment compliance rate for patients treated at CS versus HCEEs, with each CS required to have experience treating HCV, but no experience using DAAs.
The program, administered by the HCEE, calls for a team of educational providers to visit the community sites on four occasions, with the first visit dedicated to review of the protocol and safety and efficacy data for first-generation DAA therapies. Initially, the second visit was meant to occur before patient enrollment in order to formulate an education plan for the practice. However, before the start of the study, the first and second visits were combined to shorten time between visits. The third visit required on-site review of patient records involved in the OPTIMAL study. The fourth visit was conducted via teleconference and involved review of patient laboratory and treatment response data, as well as feedback on managing side effects. Ad hoc support was also offered via e-mail and phone consultations with the CS staff.
There were 33 of 35 sites asked to participate from December 2011 to July 2012 that agreed and completed the combined first and second visits. Four sites then dropped out, one each from four different HCEE sites. The average time from the combined first and second visit to enrollment of the first patient was 75 days among the 29 CS that had patients enrolled. The average time from the first patient enrolled to the third visit was 45 days. The teleconference of the fourth visit took place on average 69 days from the third visit, and occurred within a 60-day protocol-defined window 66 percent of the time.
A review of the program concluded that complex treatment regimens warrant an education bridging program between HCEE and CS to increase the pool of knowledgeable HCV providers by pairing them with experienced mentors. Study authors said the connection is needed in anticipation of more broadly applied future HCV therapies. The findings focused on design and implementation of the program and results on efficacy are planned in a separate report.