Icahn School of Medicine at Mount Sinai
New York, 10029, United States
NCT Number: NCT02833298
Approximately half of the patients receiving treatment for chronic hepatitis C virus (HCV) infection in the United States have advanced liver disease. Patients with advanced fibrosis/cirrhosis who achieve a sustained virological response (SVR) to treatment and are clinically cured of HCV continue to have an elevated risk of developing hepatocellular carcinoma (HCC). According to guidelines from several professional societies and from the American Association for the Study of Liver Diseases (AASLD), in particular, patients with advanced fibrosis/cirrhosis should undergo life-long bi-annual screening for incident HCC whether they achieve an SVR, or not. The number of patients who need post-SVR HCC screening has risen dramatically in recent years due to the confluence of three factors: Increased screening for HCV, which has allowed more people to realize that they have this often "silent" infection; the availability of safe and highly effective direct acting antiviral drugs (DAAs) for HCV, which has allowed a much higher percentage of treated patients to achieve an SVR; and the long duration of HCV infection in many patients, which has allowed enough time for advanced fibrosis/cirrhosis to develop. To investigate post-SVR patients in the era of DAAs and to promote HCC screening, the objective of this study is to conduct a randomized, unblinded, two-arm prospective intervention trial comparing rates of HCC screening between patients randomized to either personalized patient navigation or automated reminders (e.g. electronic or mailed). Both interventions represent improved care over current standard of care (no patient navigation or automated reminders). There is no evidence to suggest one intervention is better than the other. Healthcare providers who agree to participate in the study will be contacted to confirm the liver disease status of their patients and during the clinical trial the providers of patients in both arms of the trial will be sent reminders about the need to schedule patients for screening visits.
Looking for future studies?
Notify Me21 year and older
All sexes
Interventional
Not applicable
New York, 10029, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
At the time consent is obtained, members of the research team will collect data about how a subject prefers to be contacted for automated reminders (i.e. text messages, postcard, email, MyChart)
The patient navigator will attempt to provide a reminder to the subject one to three days before the scheduled imaging and also offer to accompany the subject to the test.
Time frame: every 6 months until death - average of 5 years
Ratio of Number of on-time screening visits to number of missed screening visits
Time frame: every 6 months until death - average of 5 years
Percentage for patients completing timely screening visit
Time frame: every 6 months until death - average of 5 years
New incidences of HCC
Time frame: every 6 months until death - average of 5 years
Incidence of death
Time frame: every 6 months until death - average of 5 years
Icahn School of Medicine at Mount Sinai
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04710641
Adenocarcinoma, Blood-Borne Infections
Duarte, California, United States
View Trial DetailsNCT05498779
Ablation, Adenocarcinoma
Copenhagen, Denmark
View Trial DetailsNCT03702998
Adenocarcinoma, Blood-Borne Infections
Shatin, Hong Kong
View Trial DetailsNCT04653818
Adenocarcinoma, Blood-Borne Infections
Alexandria, Egypt
View Trial Details