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Patient-centered HCV care via telemedicine for individuals on opiate substitution therapy: a stepped-wedge cluster randomized controlled trial
Investigator (PI): Talal, Andrew
Performing Organization (PO): (Current): University at Buffalo, State University of New York, School of Medicine and Biomedical Sciences, Department of Medicine, Division of Gastroenterology, Hepatology and Nutrition / (716) 862-8634
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2022
Record Source/Award ID: PCORI/IHS-1507-31640
Funding: Total Award Amount: $7,004,591
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Hepatitis C virus (HCV) affects almost 5 million people in the United States and is a major cause of chronic liver disease, liver fibrosis, cirrhosis, liver cancer, and death. Drug users are most affected by HCV, with 30-70 percent being chronically infected. However, very few drug users with HCV receive treatment. Reasons include lack of knowledge about the infection, distrust of their doctors, and difficulty navigating the health care system. While HCV treatment of drug users in methadone treatment programs has been shown to be effective, only a small number of programs have the ability to treat HCV onsite. Telemedicine, a type of videoconferencing, permits the doctor and the patient to interact even if they are not in the same location. Our project aims to establish telemedicine as a treatment approach for HCV for drug users in the familiar environment of a methadone clinic. The primary aim of this project is to compare HCV treatment through telemedicine in a methadone clinic with usual care, which is referral to a liver specialist offsite. Our study will be conducted in 12 methadone clinics following the standard of care. At regular intervals, clinics will switch in a random order to the telemedicine approach. The study will be conducted over a five-year period. The primary outcome is the rate of viral eradication 12 weeks after completing HCV treatment. We will also measure patient satisfaction with the delivery of HCV care in both those treated via telemedicine and those treated by the liver specialist, differences in the number starting and completing treatment, and how much of the prescribed treatment is actually taken by the patient. As current approaches for HCV treatment of people recovering from addiction are highly unsuccessful, new models for HCV care in this population are needed. The major goal of our study is to provide such a model. All hepatitis C antibody-positive patients in the methadone clinics will be able to participate in the recruitment phase of the study. Patients who participate in the recruitment phase and are HCV-infected will be able to participate in the study. Those who are ineligible for HCV treatment, or who are currently being treated elsewhere, will be excluded. Patients who will be treated in the clinics by telemedicine will have their hepatitis C medications delivered at the same time as their methadone. The study will be conducted in a wide variety of methadone clinics located throughout New York State. We have partnered with clinics from urban and rural locations, which ensures a diverse patient population. We will recruit patients at each clinic to be part of a patient advisory committee. We will also recruit stakeholders from all domains relevant to HCV treatment at the federal, state, and local levels and from community-based organizations, and medical specialists from a diverse range of disciplines.
MeSH Terms:
  • Analgesics, Opioid /*therapeutic use
  • Cluster Analysis
  • Delivery of Health Care
  • Hepatitis C /*therapy
  • Humans
  • Mental Health Services /organization & administration
  • Methadone /*therapeutic use
  • New York
  • Patient Participation
  • Patient-Centered Care
  • Randomized Controlled Trials as Topic
  • Rural Population
  • Substance Abuse, Intravenous /complications
  • /*rehabilitation
  • Telemedicine /*methods
  • United States
  • Urban Population
Country: United States
State: New York
Zip Code: 14214
UI: 20163107
Project Status: Ongoing
Record History: ('2017: Project extended to 2022.',)