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IIR 16-072 – HSR&D Study

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IIR 16-072
Determining and targeting reasons for low statin use to improve guideline-concordant statin therapy in high-risk patients
Salim Virani MD
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, TX
Funding Period: July 2017 - June 2021

BACKGROUND/RATIONALE:
Optimal statin therapy reduces cardiovascular events. We have shown that optimal statin therapy is underused in Veterans with CVD. This can be due to clinical inertia or statin associated side effects which providers usually document in text notes and may not be well captured in structured datasets.

OBJECTIVE(S):
Our objectives are to (Aim 1) identify reasons for suboptimal statin use using structured data and provider text notes using NLP; (Aim 2) understand provider and patient perspectives on statin intolerance and refine a communication aid targeting providers to improve guideline-concordant statin use; and (Aim 3) pilot test an intervention to improve optimal statin use in Veterans with CVD using the communication aid refined in Aim 2.

METHODS:
For Aim 1, we will randomly identify VA patients with CVD on optimal, suboptimal and no statins, and partition them into training and test sets. We will train our NLP system to achieve sensitivity and specificity of >90%, compared with manual chart review to identify reason for suboptimal stain use. In Aim 2, we will conduct interviews with providers and patients to elicit their perspectives on clinical inertia and statin intolerance. These interviews will help refine the communication aid for Aim 3. In Aim 3, we will conduct a pilot trial with Houston and Nashville VAMC PACTs serving as intervention sites. PACTs at intervention sites will receive the communication aid to assist them with statin initiation and/or titration in CVD patients on suboptimal statins. At usual care sites, PACT providers will only receive a quarterly report of the proportion of their CVD patients on suboptimal statins. Our primary outcome is change in the proportion of CVD patients receiving optimal statin therapy.

FINDINGS/RESULTS:
We developed an initial corpus of 465 patients for training/testing the NLP system. We selected notes with standard titles that were most likely to contain documentation of adverse events related to statin usage. We used an iterative process to develop an annotation schema consisting of concepts of interest within the documents. Two nurse annotators identified an initial group of concepts within a small batch of 10-20 documents. Upon completion, annotation was discussed among the research team for further refinement and finalization.
To create document sets for annotation, we used one document from each patient. Documents were stratified so that each set of documents contained approximately 25% African Americans and 75% Non-African Americans, 25% females and 75% males, and 50% were on no statins, 25% on low statin, and 25% on moderate statin. Currently, a total of 171 documents (3 groups of 57) from 171 patients were selected for annotation. Within the first 57 documents, we identified 8 patients with statin-related adverse events, which corresponds to a prevalence rate of 14%.

IMPACT:
Our results identify the vast majority of high-risk Veterans not on optimal statin therapy due to intolerance versus clinical inertia. Our communication aid will identify strategies to initiate or titrate statins in high-risk Veterans. These results will be important for the VA Health Care System to identify patients with "true statin intolerance" who will be future candidates for expensive new drugs recently approved by the FDA.

PUBLICATIONS:

Journal Articles

  1. Nanna MG, Navar AM, Wang TY, Li S, Virani SS, Li Z, Robinson JG, Roger VL, Wilson PWF, Goldberg AC, Koren A, Louie MJ, Peterson ED. Practice-level variation in statin use and low-density lipoprotein cholesterol control in the United States: Results from the Patient and Provider Assessment of Lipid Management (PALM) registry. American heart journal. 2019 May 22; 214:113-124.
  2. Jia X, Al Rifai M, Ramsey DJ, Ahmed ST, Akeroyd JM, Nambi V, Ballantyne CM, Petersen LA, Stone NJ, Virani SS. Association Between Lipid Testing and Statin Adherence in the Veterans Affairs Health System. The American journal of medicine. 2019 May 17.
  3. Pokharel Y, Mouhanna F, Nambi V, Virani SS, Hoogeveen R, Alonso A, Heiss G, Coresh J, Mosley T, Gottesman RF, Ballantyne CM, Power MC. ApoB, small-dense LDL-C, Lp(a), LpPLA activity, and cognitive change. Neurology. 2019 May 28; 92(22):e2580-e2593.
  4. Trang A, Kampangkaew J, Fernandes R, Tiwana J, Misra A, Hamzeh I, Blaustein A, Aguilar D, Shah T, Ballantyne C, Quinones M, Nagueh SF, Dokanish H, Virani SS, Deswal A, Kirkpatrick JN, Nambi V. Understanding by General Providers of the Echocardiogram Report. The American journal of cardiology. 2019 Apr 24; 124(2):296-302.
  5. Shah NR, Ahmed ST, Winchester DE, Ramsey DJ, Akeroyd JM, Wu WC, Waldo SW, Schofield RS, Ballantyne CM, Petersen LA, Virani SS. Facility-Level Variation in Stress Test Utilization in Veterans With Ischemic Heart Disease. JACC. Cardiovascular imaging. 2019 Apr 10.
  6. Merchant AT, Virani SS. Childhood Oral Infections and Subclinical Atherosclerosis in Adulthood: Should We Wait for Causality or Just Treat? JAMA Network Open. 2019 Apr 5; 2(4):e192489.
  7. Jia X, Al Rifai M, Birnbaum Y, Smith SC, Virani SS. The 2018 Cholesterol Management Guidelines: Topics in Secondary ASCVD Prevention Clinicians Need to Know. Current Atherosclerosis Reports. 2019 Apr 2; 21(6):20.
  8. Jia X, Virani SS. CLEAR Serenity Trial: More Clarity for the Future of Bempedoic Acid in Patients Unable to Take Statins? Journal of the American Heart Association. 2019 Apr 2; 8(7):e012352.
  9. Sandesara PB, Virani SS, Fazio S, Shapiro MD. The Forgotten Lipids: Triglycerides, Remnant Cholesterol, and Atherosclerotic Cardiovascular Disease Risk. Endocrine reviews. 2019 Apr 1; 40(2):537-557.
  10. Jia X, Akeroyd JM, Nasir K, Nambi V, Ballantyne CM, Petersen LA, Virani SS. Eligibility and Cost for Icosapent Ethyl Based on the REDUCE-IT Trial. Circulation. 2019 Mar 5; 139(10):1341-1343.
  11. Okunrintemi V, Khera R, Spatz ES, Salami JA, Valero-Elizondo J, Warraich HJ, Virani SS, Blankstein R, Blaha MJ, Pawlik TM, Dharmarajan K, Krumholz HM, Nasir K. Association of Income Disparities with Patient-Reported Healthcare Experience. Journal of general internal medicine. 2019 Jun 1; 34(6):884-892.
  12. Valero-Elizondo J, Khera R, Saxena A, Grandhi GR, Virani SS, Butler J, Samad Z, Desai NR, Krumholz HM, Nasir K. Financial Hardship From Medical Bills Among Nonelderly U.S. Adults With Atherosclerotic Cardiovascular Disease. Journal of the American College of Cardiology. 2019 Feb 19; 73(6):727-732.
  13. Hyman DA, Siebert V, Jia X, Alam M, Levine GN, Virani SS, Birnbaum Y. Risk Assessment of Stroke in Patients with Atrial Fibrillation: Current Shortcomings and Future Directions. Cardiovascular drugs and therapy. 2019 Feb 1; 33(1):105-117.
  14. Mishra SR, Ghimire S, Shrestha N, Shrestha A, Virani SS. Socio-economic inequalities in hypertension burden and cascade of services: nationwide cross-sectional study in Nepal. Journal of Human Hypertension. 2019 Jan 18.
  15. Virani SS, Akeroyd JM, Nambi V, Michos ED, Morris PB, Nasir K, Smith SC, Stone NJ, Petersen LA, Ballantyne CM. Applicability and Cost Implications for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Based on the ODYSSEY Outcomes Trial. Circulation. 2019 Jan 15; 139(3):410-412.
  16. Hira RS, Kataruka A, Akeroyd JM, Ramsey DJ, Pokharel Y, Gurm HS, Nasir K, Deswal A, Jneid H, Alam M, Ballantyne CM, Petersen LA, Virani SS. Association of Body Mass Index With Risk Factor Optimization and Guideline-Directed Medical Therapy in US Veterans With Cardiovascular Disease. Circulation. Cardiovascular quality and outcomes. 2019 Jan 1; 12(1):e004817.
  17. Saeed A, Sun W, Agarwala A, Virani SS, Nambi V, Coresh J, Selvin E, Boerwinkle E, Jones PH, Ballantyne CM, Hoogeveen RC. Lipoprotein(a) levels and risk of cardiovascular disease events in individuals with diabetes mellitus or prediabetes: The Atherosclerosis Risk in Communities study. Atherosclerosis. 2019 Mar 1; 282:52-56.
  18. Kamal AK, Khalid W, Muqeet A, Jamil A, Farhat K, Gillani SRA, Zulfiqar M, Saif M, Muhammad AA, Zaidi F, Mustafa M, Gowani A, Sharif S, Bokhari SS, Tai J, Rahman N, Sultan FAT, Sayani S, Virani SS. Making prescriptions "talk" to stroke and heart attack survivors to improve adherence: Results of a randomized clinical trial (The Talking Rx Study). PLoS ONE. 2018 Dec 20; 13(12):e0197671.
  19. Lloyd-Jones DM, Braun LT, Ndumele CE, Smith SC, Sperling LS, Virani SS, Blumenthal RS. Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology. Circulation. 2019 Jun 18; 139(25):e1162-e1177.
  20. Lloyd-Jones DM, Braun LT, Ndumele CE, Smith SC, Sperling LS, Virani SS, Blumenthal RS. Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology. Journal of the American College of Cardiology. 2019 Jun 25; 73(24):3153-3167.
  21. Rodwin BA, Salami JA, Spatz ES, Valero-Elizondo J, Virani SS, Blankstein R, Blaha MJ, Nasir K, Desai NR. Variation in the Use of Warfarin and Direct Oral Anticoagulants in Atrial Fibrillation and Associated Cost Implications. The American journal of medicine. 2019 Jan 1; 132(1):61-70.e1.
  22. Saeed A, Virani SS, Jones PH, Ballantyne CM, Nambi V. Case reports of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition nonresponse. Journal of clinical lipidology. 2018 Sep 1; 12(5):1141-1145.
Journal Other

  1. Virani SS, Ballantyne CM. Low-Density Lipoprotein Cholesterol: Is 160 the New 190? [Editorial]. Circulation. 2018 Nov 20; 138(21):2326-2329.


DRA: Cardiovascular Disease
DRE: Prevention, Prognosis, Treatment - Implementation
Keywords: Best Practices, Care Management Tools, Implementation
MeSH Terms: none