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| ID | Type | Description | Link |
|---|---|---|---|
| IN-US-989-5752 | Other Grant/Funding Number | Gilead Sciences |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The purpose of this study is to promote the diagnosis and awareness of Non-Alcoholic Steatohepatitis (NASH) by linkage of care.
Nonalcoholic fatty liver disease (NAFLD) is an extremely common condition affecting 26% of the US general population but only 2% of the population has a more aggressive histological phenotype, nonalcoholic steatohepatitis (NASH) or evidence of liver fibrosis[1]. The American Association for the Study of Liver Diseases (AASLD) does not recommend routine screening of the general population for NAFLD[2] citing "uncertainties surrounding diagnostic tests and treatment options[3]", but does recommend referral to a hepatologist when there is a high index of suspicion for NASH and advanced fibrosis such as in patients with type 2 diabetes (T2D)[4-6], and in those with elevated fibrosis-4 index (FIB-4) [7, 8]. These aids are under-utilized by physicians that result in many patients who are at high risk for fibrosis and are not referred to hepatology[9]. Confusion regarding how to best define the population at risk is a major problem preventing the appropriate use of hepatology referral in the primary care setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Unit: | Experimental | Providers from internal medicine, family medicine and endocrinology clinics. |
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| Observation Unit: | Other | Patients from internal medicine, family medicine, and endocrinology clinics. Patients with an ICD 10 diagnosis of T2D E11.9. Patients have the most recent calculated FIB-4 Score of >3.25. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice Alert | Behavioral | To determine if rates of screening and referral to hepatology can be improved through an EMR-based BPA for an appropriate referral. |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine if rates of referral to hepatology can be improved through EMR-based Best Practice Alert (BPA) for an appropriate referral. Name of the specific primary outcome measure | Quantify the number of new referrals from providers who opt-in to have BPA notifications. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Winston Dunn, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25887357 | Background | Bazick J, Donithan M, Neuschwander-Tetri BA, Kleiner D, Brunt EM, Wilson L, Doo E, Lavine J, Tonascia J, Loomba R. Clinical Model for NASH and Advanced Fibrosis in Adult Patients With Diabetes and NAFLD: Guidelines for Referral in NAFLD. Diabetes Care. 2015 Jul;38(7):1347-55. doi: 10.2337/dc14-1239. Epub 2015 Apr 17. | |
| 25603789 |
| Label | URL |
|---|---|
| Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE). | View source |
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| No Intervention | Behavioral | The only intervention is the Best Practice Alert (BPA). Providers from three departments will be randomized to one of two groups: one that receives a BPA and one that does not. Thereafter, the study will observe patients who fit criteria for NASH referral, as defined by a diagnosis of T2DM and appropriate Fib4 score to determine if they have been referred to Hepatology for assessment. |
|
| Knight AM, Falade O, Maygers J, Sevransky JE. Factors associated with medication warning acceptance for hospitalized adults. J Hosp Med. 2015 Jan;10(1):19-25. doi: 10.1002/jhm.2258. |
| 31429887 | Background | Carroll AE. Averting Alert Fatigue to Prevent Adverse Drug Reactions. JAMA. 2019 Aug 20;322(7):601. doi: 10.1001/jama.2019.11710. No abstract available. |
| 27786365 | Background | Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available. |
| 28130846 | Background | Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available. |
| 24222016 | Background | Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available. |
| 25980762 | Background | Dongiovanni P, Petta S, Mannisto V, Mancina RM, Pipitone R, Karja V, Maggioni M, Kakela P, Wiklund O, Mozzi E, Grimaudo S, Kaminska D, Rametta R, Craxi A, Fargion S, Nobili V, Romeo S, Pihlajamaki J, Valenti L. Statin use and non-alcoholic steatohepatitis in at risk individuals. J Hepatol. 2015 Sep;63(3):705-12. doi: 10.1016/j.jhep.2015.05.006. Epub 2015 May 14. |
| 30708071 | Background | Scheen AJ. Beneficial effects of SGLT2 inhibitors on fatty liver in type 2 diabetes: A common comorbidity associated with severe complications. Diabetes Metab. 2019 Jun;45(3):213-223. doi: 10.1016/j.diabet.2019.01.008. Epub 2019 Jan 29. |
| 26608256 | Background | Armstrong MJ, Gaunt P, Aithal GP, Barton D, Hull D, Parker R, Hazlehurst JM, Guo K; LEAN trial team; Abouda G, Aldersley MA, Stocken D, Gough SC, Tomlinson JW, Brown RM, Hubscher SG, Newsome PN. Liraglutide safety and efficacy in patients with non-alcoholic steatohepatitis (LEAN): a multicentre, double-blind, randomised, placebo-controlled phase 2 study. Lancet. 2016 Feb 13;387(10019):679-690. doi: 10.1016/S0140-6736(15)00803-X. Epub 2015 Nov 20. |
| 20427778 | Background | Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-85. doi: 10.1056/NEJMoa0907929. Epub 2010 Apr 28. |
| 25865049 | Background | Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, Torres-Gonzalez A, Gra-Oramas B, Gonzalez-Fabian L, Friedman SL, Diago M, Romero-Gomez M. Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis. Gastroenterology. 2015 Aug;149(2):367-78.e5; quiz e14-5. doi: 10.1053/j.gastro.2015.04.005. Epub 2015 Apr 10. |
| 22278337 | Background | Musso G, Cassader M, Rosina F, Gambino R. Impact of current treatments on liver disease, glucose metabolism and cardiovascular risk in non-alcoholic fatty liver disease (NAFLD): a systematic review and meta-analysis of randomised trials. Diabetologia. 2012 Apr;55(4):885-904. doi: 10.1007/s00125-011-2446-4. Epub 2012 Jan 27. |
| Background | A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis (MAESTRO-NASH). |
| 29209663 | Background | Al-Hihi E, Shankweiler C, Stricklen D, Gibson C, Dunn W. Electronic medical record alert improves HCV testing for baby boomers in primary care setting: adults born during 1945-1965. BMJ Open Qual. 2017 Oct 21;6(2):e000084. doi: 10.1136/bmjoq-2017-000084. eCollection 2017. |
| 27578967 | Background | Oertel MJ, Graves L, Al-Hihi E, Leonardo V, Hopkins C, DeSouza K, Bhattacharya RK. Osteoporosis management in older patients who experienced a fracture. Clin Interv Aging. 2016 Aug 22;11:1111-6. doi: 10.2147/CIA.S107720. eCollection 2016. |
| 31520229 | Background | Philpot LM, Khokhar BA, Rosedahl JK, Sinclair TA, Chaudhry R, Ebbert JO. Variation in Patient Experience Across the Clinic Day: a Multilevel Assessment of Four Primary Care Practices. J Gen Intern Med. 2019 Nov;34(11):2536-2541. doi: 10.1007/s11606-019-05336-5. Epub 2019 Sep 13. |
| 25190263 | Background | Wright AP, Desai AP, Bajpai S, King LY, Sahani DV, Corey KE. Gaps in recognition and evaluation of incidentally identified hepatic steatosis. Dig Dis Sci. 2015 Feb;60(2):333-8. doi: 10.1007/s10620-014-3346-5. Epub 2014 Sep 5. |
| 26677985 | Background | Imajo K, Kessoku T, Honda Y, Tomeno W, Ogawa Y, Mawatari H, Fujita K, Yoneda M, Taguri M, Hyogo H, Sumida Y, Ono M, Eguchi Y, Inoue T, Yamanaka T, Wada K, Saito S, Nakajima A. Magnetic Resonance Imaging More Accurately Classifies Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease Than Transient Elastography. Gastroenterology. 2016 Mar;150(3):626-637.e7. doi: 10.1053/j.gastro.2015.11.048. Epub 2015 Dec 8. |
| 27017224 | Background | Kaswala DH, Lai M, Afdhal NH. Fibrosis Assessment in Nonalcoholic Fatty Liver Disease (NAFLD) in 2016. Dig Dis Sci. 2016 May;61(5):1356-64. doi: 10.1007/s10620-016-4079-4. Epub 2016 Mar 26. |
| 25873639 | Background | Kwok R, Choi KC, Wong GL, Zhang Y, Chan HL, Luk AO, Shu SS, Chan AW, Yeung MW, Chan JC, Kong AP, Wong VW. Screening diabetic patients for non-alcoholic fatty liver disease with controlled attenuation parameter and liver stiffness measurements: a prospective cohort study. Gut. 2016 Aug;65(8):1359-68. doi: 10.1136/gutjnl-2015-309265. Epub 2015 Apr 14. |
| 26171685 | Background | Koehler EM, Plompen EP, Schouten JN, Hansen BE, Darwish Murad S, Taimr P, Leebeek FW, Hofman A, Stricker BH, Castera L, Janssen HL. Presence of diabetes mellitus and steatosis is associated with liver stiffness in a general population: The Rotterdam study. Hepatology. 2016 Jan;63(1):138-47. doi: 10.1002/hep.27981. Epub 2015 Oct 1. |
| 25885947 | Background | Portillo-Sanchez P, Bril F, Maximos M, Lomonaco R, Biernacki D, Orsak B, Subbarayan S, Webb A, Hecht J, Cusi K. High Prevalence of Nonalcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus and Normal Plasma Aminotransferase Levels. J Clin Endocrinol Metab. 2015 Jun;100(6):2231-8. doi: 10.1210/jc.2015-1966. Epub 2015 Apr 17. |
| 26825843 | Background | Corey KE, Klebanoff MJ, Tramontano AC, Chung RT, Hur C. Screening for Nonalcoholic Steatohepatitis in Individuals with Type 2 Diabetes: A Cost-Effectiveness Analysis. Dig Dis Sci. 2016 Jul;61(7):2108-17. doi: 10.1007/s10620-016-4044-2. Epub 2016 Jan 29. |
| 28714183 | Background | Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available. |
| 29886156 | Background | Estes C, Anstee QM, Arias-Loste MT, Bantel H, Bellentani S, Caballeria J, Colombo M, Craxi A, Crespo J, Day CP, Eguchi Y, Geier A, Kondili LA, Kroy DC, Lazarus JV, Loomba R, Manns MP, Marchesini G, Nakajima A, Negro F, Petta S, Ratziu V, Romero-Gomez M, Sanyal A, Schattenberg JM, Tacke F, Tanaka J, Trautwein C, Wei L, Zeuzem S, Razavi H. Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030. J Hepatol. 2018 Oct;69(4):896-904. doi: 10.1016/j.jhep.2018.05.036. Epub 2018 Jun 8. |
| Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE). | View source |
| AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH. | View source |
| Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (STELLAR 4). | View source |
| Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (ATLAS). | View source |
| Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis (STELLAR 3). | View source |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D005234 | Fatty Liver |
| D003924 | Diabetes Mellitus, Type 2 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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