Rae Jean Proeschold-Bell1, Donna M Evon2, Christina Makarushka3, John B Wong4, Santanu K Datta5, Jia Yao6, Ashwin A Patkar7, Paolo Mannelli8, Terra Hodge9, Susanna Naggie10, Julius M Wilder11, Michael W Fried12, Donna Niedzwiecki13, Andrew J Muir14. 1. Duke Global Health Institute, Duke University, Box 90392, Durham, NC 27708-0392, USA; Duke Center for Health Policy & Inequalities Research, Duke University, Box 90392, Durham, NC 27708-0392, USA. Electronic address: Rae.jean@duke.edu. 2. Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, CB# 7584, Chapel Hill, NC 27599-7584, United States. Electronic address: Donna_evon@med.unc.edu. 3. Duke Center for Health Policy & Inequalities Research, Duke University, Box 90392, Durham, NC 27708-0392, USA. Electronic address: Christina.makarushka@duke.edu. 4. Division of Clinical Decision Making, Tufts Medical Center, 800 Washington St #302, Boston, MA 02111, USA. Electronic address: JWong@TuftsMedicalCenter.org. 5. Department of Medicine, Duke University, 411 West Chapel Hill St, Suite 500, Durham, NC 27701, USA. Electronic address: santanu.datta@duke.edu. 6. Duke Center for Health Policy & Inequalities Research, Duke University, Box 90392, Durham, NC 27708-0392, USA. Electronic address: jia.yao@duke.edu. 7. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 2213 Elba Street, Suite 165, Durham, NC 27705, United States; Department of Community and Family Medicine, Duke University Medical Center, 2213 Elba Street, Suite 165, Durham, NC 27705, United States. Electronic address: Ashwin.patkar@duke.edu. 8. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 2213 Elba Street, Suite 165, Durham, NC 27705, United States. Electronic address: paolo.mannelli@duke.edu. 9. Division of Gastroenterology, Department of Medicine, Duke University School of Medicine, DUMC 3913, Durham, NC 27710, USA. Electronic address: Terra.hodge@duke.edu. 10. Duke University School of Medicine, Infectious Diseases, Durham, NC 27710, USA; Duke Clinical Research Institute, 2400 Pratt Street, Rm. 0311, Terrace Level, Durham, NC 27705, USA; Durham VA Medical Center, Durham, NC 27705, USA. Electronic address: susanna.naggie@duke.edu. 11. Division of Gastroenterology, Department of Medicine, Duke University School of Medicine, DUMC 3913, Durham, NC 27710, USA; Duke Clinical Research Institute, 2400 Pratt Street, Rm. 0311, Terrace Level, Durham, NC 27705, USA. Electronic address: julius.wilder@duke.edu. 12. Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, CB# 7584, Chapel Hill, NC 27599-7584, United States. Electronic address: mfried@med.unc.edu. 13. Department of Biostatistics and Bioinformatics, Duke University, Box 2721, Durham, NC 27710, United States. Electronic address: donna.niedzwiecki@duke.edu. 14. Division of Gastroenterology, Department of Medicine, Duke University School of Medicine, DUMC 3913, Durham, NC 27710, USA; Duke Clinical Research Institute, 2400 Pratt Street, Rm. 0311, Terrace Level, Durham, NC 27705, USA. Electronic address: Andrew.muir@duke.edu.
Abstract
INTRODUCTION: Among patients with hepatitis C virus (HCV) infection, alcohol synergistically increases the risk of cirrhosis, hepatocellular carcinoma, and death. Randomized controlled trials of integrated models of HCV-alcohol treatment have been recommended but only performed in patients with severe alcohol use disorders. OBJECTIVES: This pragmatic randomized controlled trial seeks to compare clinical effectiveness and cost-effectiveness of integrated alcohol treatment compared to enhanced treatment as usual (TAU) on alcohol consumption and economic outcomes among patients ever infected with HCV. METHODS:Patients recruited from three liver centers who had current or prior chronic HCV and qualifying alcohol screener scores were randomly assigned to enhanced TAU or the Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention. All patients received enhanced TAU, consisting of a patient-administered alcohol screener and care from medical providers who were trained in Screening, Brief Intervention and Referral to Treatment (SBIRT), including brief motivational interviewing counseling. The Hep ART intervention combined enhanced TAU with up to six months of integrated co-located individual and/or group therapy that provided motivational, cognitive, and behavioral strategies to reduce alcohol consumption. The Timeline Followback (TLFB) Method was used to evaluate alcohol use at baseline, 3, 6, and 12 months. Primary outcomes are alcohol abstinence and fewer heavy drinking days, and for the cost-effectiveness analysis, measures included grams of alcohol consumed. DISCUSSION: This study will determine whether Hep ART, a six-month integrated alcohol treatment, compared to enhanced TAU, is both clinically effective and cost-effective in patients with a history of comorbid HCV and alcohol use.
RCT Entities:
INTRODUCTION: Among patients with hepatitis C virus (HCV) infection, alcohol synergistically increases the risk of cirrhosis, hepatocellular carcinoma, and death. Randomized controlled trials of integrated models of HCV-alcohol treatment have been recommended but only performed in patients with severe alcohol use disorders. OBJECTIVES: This pragmatic randomized controlled trial seeks to compare clinical effectiveness and cost-effectiveness of integrated alcohol treatment compared to enhanced treatment as usual (TAU) on alcohol consumption and economic outcomes among patients ever infected with HCV. METHODS:Patients recruited from three liver centers who had current or prior chronic HCV and qualifying alcohol screener scores were randomly assigned to enhanced TAU or the Hepatitis C-Alcohol Reduction Treatment (HepART) intervention. All patients received enhanced TAU, consisting of a patient-administered alcohol screener and care from medical providers who were trained in Screening, Brief Intervention and Referral to Treatment (SBIRT), including brief motivational interviewing counseling. The HepART intervention combined enhanced TAU with up to six months of integrated co-located individual and/or group therapy that provided motivational, cognitive, and behavioral strategies to reduce alcohol consumption. The Timeline Followback (TLFB) Method was used to evaluate alcohol use at baseline, 3, 6, and 12 months. Primary outcomes are alcohol abstinence and fewer heavy drinking days, and for the cost-effectiveness analysis, measures included grams of alcohol consumed. DISCUSSION: This study will determine whether HepART, a six-month integrated alcohol treatment, compared to enhanced TAU, is both clinically effective and cost-effective in patients with a history of comorbid HCV and alcohol use.
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Authors: Jennifer R Mertens; Felicia W Chi; Constance M Weisner; Derek D Satre; Thekla B Ross; Steve Allen; David Pating; Cynthia I Campbell; Yun Wendy Lu; Stacy A Sterling Journal: Addict Sci Clin Pract Date: 2015-11-19
Authors: Rae Jean Proeschold-Bell; Donna M Evon; Jia Yao; Donna Niedzwiecki; Christina Makarushka; Kelly A Keefe; Ashwin A Patkar; Paolo Mannelli; James C Garbutt; John B Wong; Julius M Wilder; Santanu K Datta; Terra Hodge; Susanna Naggie; Michael W Fried; Andrew J Muir Journal: Hepatology Date: 2020-03-24 Impact factor: 17.425
Authors: E Jennifer Edelman; Stephen A Maisto; Nathan B Hansen; Christopher J Cutter; James Dziura; Yanhong Deng; Lynn E Fiellin; Patrick G O'Connor; Roger Bedimo; Cynthia L Gibert; Vincent C Marconi; David Rimland; Maria C Rodriguez-Barradas; Michael S Simberkoff; Janet P Tate; Amy C Justice; Kendall J Bryant; David A Fiellin Journal: J Subst Abuse Treat Date: 2019-08-17