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CDA 07-221 – HSR&D Study

 
CDA 07-221
Preventing Long-term Adverse Drug Reactions: Glucocorticoids as a Model
Liron Caplan MD PhD
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, CO
Funding Period: July 2009 - June 2014

BACKGROUND/RATIONALE:
Adverse Drug Reactions (ADRs) represent a high-risk and high volume problem. Understanding and improving preventive measures for Adverse Drug Reactions of Long Latency (ADRLLs, toxicities that occur on prolonged exposure to a medication) would provide a model for avoiding numerous undesirable outcomes associated with medication use. Glucocorticoids are a classic example of medications that exhibit ADRLLs, insofar as prolonged exposure can result in Glucocorticoid Induced Osteoporosis (GIO) and Glucocorticoid Induced Diabetes (GID).

OBJECTIVE(S):
The objectives of this study are to:
AIM 1: Explore facilitators and barriers to ADRLL avoidance among health care providers, pharmacists, and administrators through the use of twenty semi-structured interviews.
AIM 2: Conduct a single site randomized controlled feasibility trial of a decisional support intervention to reduce ADRLLs by improving providers' adherence to glucocorticoid induced osteoporosis prevention measures.
AIM 3: Conduct a single site randomized controlled feasibility trial of a decisional support intervention to improve providers' adherence to glucocorticoid induced diabetes prevention measures.

METHODS:
SUBJECT POPULATION: Aim 1 will rely on 20 providers, pharmacists, and health administrators. Twenty primary care providers and approximately 100 veterans on chronic steroids are required in each of the feasibility trials (Aim 2 and Aim 3).
PROCEDURES:
Aim 1: Conduct semi-structured interviews to discuss facilitators and barriers to GIO and GID guideline concordance and ADRLL avoidance, and refine a decisional support tool.
Aim 2: Guided by Rogers' Diffusion of Innovation theory and Glasgow's RE-AIM framework, the intervention will exploit point-of-care decisional support systems capabilities (decision guides, prompts, reminders, feedback) within the VA's CPRS interface. Primary care providers randomly assigned to receive decisional support will be compared with providers not receiving decisional support, with regard to their management of GIO for veterans on chronic glucocorticoids.
Aim 3: Mirroring the structure for Aim 2, the intervention will exploit point-of-care decisional support systems capabilities (automatically generated orders for fasting plasma glucose sent to providers, notices to patients) designed to improve GID management.

FINDINGS/RESULTS:
Not yet available.

IMPACT:
1.As a result of publications such as our own (Caplan, et al Intl J Risk Saf Med 2012) there is growing awareness of "reminder fatigue" on the part of providers. This is influencing the approaches used in decisional support approaches to medication management.
2.Systematic methods of screening and ameliorating ADRLLs should be implemented. Our submitted MERIT capitalizes on the lessons learned by Aims 1 and 3 by incorporating a systematic screen procedure for medication adherence by patients and leverages new technology and clinical pharmacists (rather than reminders) to mediate an intervention. This can serve as a model for management of pharmacologic agents across many medical disciplines.
3.Dr. Caplan has assisted in drafting new more precise recommendations for Glucocorticoid Induced Osteoporosis. These will provide practitioners with better guidance for management of this condition and lessen the harm resulting from inappropriate prescribing ("over-prescription").


External Links for this Project

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PUBLICATIONS:

Journal Articles

  1. Ward MM, Deodhar A, Akl EA, Lui A, Ermann J, Gensler LS, Smith JA, Borenstein D, Hiratzka J, Weiss PF, Inman RD, Majithia V, Haroon N, Maksymowych WP, Joyce J, Clark BM, Colbert RA, Figgie MP, Hallegua DS, Prete PE, Rosenbaum JT, Stebulis JA, van den Bosch F, Yu DT, Miller AS, Reveille JD, Caplan L. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis & rheumatology (Hoboken, N.J.). 2016 Feb 1; 68(2):282-98. [view]
  2. Ward MM, Deodhar A, Akl EA, Lui A, Ermann J, Gensler LS, Smith JA, Borenstein D, Hiratzka J, Weiss PF, Inman RD, Majithia V, Haroon N, Maksymowych WP, Joyce J, Clark BM, Colbert RA, Figgie MP, Hallegua DS, Prete PE, Rosenbaum JT, Stebulis JA, Van Den Bosch F, Yu DT, Miller AS, Reveille JD, Caplan L. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis care & research. 2016 Feb 1; 68(2):151-66. [view]
  3. Caplan L, Clegg DO, Inman RD. Ankylosing spondylitis clinical registries: principles, practices and possibilities. The American journal of the medical sciences. 2013 Jun 1; 345(6):437-9. [view]
  4. England BR, Sokolove J, Robinson WH, Thiele GM, Ganti AK, Sayles H, Michaud K, Caplan L, Davis LA, Cannon GW, Sauer B, Singh N, Blair Solow E, Reimold AM, Kerr GS, Schwab P, Baker JF, Mikuls TR. Associations of Circulating Cytokines and Chemokines With Cancer Mortality in Men With Rheumatoid Arthritis. Arthritis & rheumatology (Hoboken, N.J.). 2016 Oct 1; 68(10):2394-402. [view]
  5. Kerr G, Aujero M, Richards J, Sayles H, Davis L, Cannon G, Caplan L, Michaud K, Mikuls T. Associations of hydroxychloroquine use with lipid profiles in rheumatoid arthritis: pharmacologic implications. Arthritis care & research. 2014 Nov 1; 66(11):1619-26. [view]
  6. Caplan L, Haverhals LM. Barriers and facilitators for preventing adverse drug reactions of long latency: a qualitative study. The International journal of risk & safety in medicine. 2012 Jan 1; 24(2):81-94. [view]
  7. Wood PR, Manning E, Baker JF, England B, Davis L, Cannon GW, Mikuls TR, Caplan L. Blood glucose changes surrounding initiation of tumor-necrosis factor inhibitors and conventional disease-modifying anti-rheumatic drugs in veterans with rheumatoid arthritis. World journal of diabetes. 2018 Feb 15; 9(2):53-58. [view]
  8. Caplan L, Davis LA, Bright CM, Kerr GS, Lazaro DM, Khan NA, Richards JS, Johnson DS, Cannon GW, Reimold AM, Mikuls TR. Body mass index and the rheumatoid arthritis swollen joint count: an observational study. Arthritis care & research. 2013 Jan 1; 65(1):101-6. [view]
  9. England BR, Baker JF, Sayles H, Michaud K, Caplan L, Davis LA, Cannon GW, Sauer BC, Solow EB, Reimold AM, Kerr GS, Mikuls TR. Body Mass Index, Weight Loss, and Cause-Specific Mortality in Rheumatoid Arthritis. Arthritis care & research. 2018 Jan 1; 70(1):11-18. [view]
  10. Davis LA, Cannon GW, Pointer LF, Haverhals LM, Wolff RK, Mikuls TR, Reimold AM, Kerr GS, Richards JS, Johnson DS, Valuck R, Prochazka A, Caplan L. Cardiovascular events are not associated with MTHFR polymorphisms, but are associated with methotrexate use and traditional risk factors in US veterans with rheumatoid arthritis. The Journal of rheumatology. 2013 Jun 1; 40(6):809-17. [view]
  11. England BR, Sayles H, Michaud K, Caplan L, Davis LA, Cannon GW, Sauer BC, Solow EB, Reimold AM, Kerr GS, Schwab P, Baker JF, Mikuls TR. Cause-Specific Mortality in Male US Veterans With Rheumatoid Arthritis. Arthritis care & research. 2016 Jan 1; 68(1):36-45. [view]
  12. Baker JF, Sauer BC, Cannon GW, Teng CC, Michaud K, Ibrahim S, Jorgenson E, Davis L, Caplan L, Cannella A, Mikuls TR. Changes in Body Mass Related to the Initiation of Disease-Modifying Therapies in Rheumatoid Arthritis. Arthritis & rheumatology (Hoboken, N.J.). 2016 Aug 1; 68(8):1818-27. [view]
  13. Cannon GW, DuVall SL, Haroldsen CL, Caplan L, Curtis JR, Michaud K, Mikuls TR, Reimold A, Collier DH, Joseph GJ, Harrison DJ, Sauer BC. Clinical Outcomes and Biologic Costs of Switching Between Tumor Necrosis Factor Inhibitors in US Veterans with Rheumatoid Arthritis. Advances in therapy. 2016 Aug 1; 33(8):1347-59. [view]
  14. Quinzanos I, Hirsh JM, Bright C, Caplan L. Cross-sectional correlation of single-item health literacy screening questions with established measures of health literacy in patients with rheumatoid arthritis. Rheumatology (Oxford, England). 2015 Sep 1; 35(9):1497-502. [view]
  15. Dischinger HR, Cheng E, Mann AD, Grueber TM, Hawk S, Davis LA, Prochazka AV, Hutt E, Caplan L. Decisional support to prevent adverse drug reactions of long latency: pilot randomized controlled intervention for glucocorticoid-induced diabetes. Journal of evaluation in clinical practice. 2015 Aug 1; 21(4):614-9. [view]
  16. Caplan L, Saag KG. Glucocorticoids and the risk of osteoporosis. Expert Opinion On Drug Safety. 2009 Jan 1; 8(1):33-47. [view]
  17. Lin CT, McKenzie M, Pell J, Caplan L. Health care provider satisfaction with a new electronic progress note format: SOAP vs APSO format. JAMA internal medicine. 2013 Jan 28; 173(2):160-2. [view]
  18. McDonald JR, Zeringue AL, Caplan L, Ranganathan P, Xian H, Burroughs TE, Fraser VJ, Cunningham F, Eisen SA. Herpes zoster risk factors in a national cohort of veterans with rheumatoid arthritis. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2009 May 15; 48(10):1364-71. [view]
  19. Pardeshi NN, Qi W, Dahl K, Caplan L, Carpenter JF. Microparticles and Nanoparticles Delivered in Intravenous Saline and in an Intravenous Solution of a Therapeutic Antibody Product. Journal of pharmaceutical sciences. 2017 Feb 1; 106(2):511-520. [view]
  20. Nhan DT, Caplan L. Patient-Reported Outcomes in Axial Spondyloarthritis. Rheumatic diseases clinics of North America. 2016 May 1; 42(2):285-99. [view]
  21. Cannon GW, DuVall SL, Haroldsen CL, Caplan L, Curtis JR, Michaud K, Mikuls TR, Reimold A, Collier DH, Harrison DJ, Joseph GJ, Sauer BC. Persistence and dose escalation of tumor necrosis factor inhibitors in US veterans with rheumatoid arthritis. The Journal of rheumatology. 2014 Oct 1; 41(10):1935-43. [view]
  22. Dischinger HR, Cheng E, Davis LA, Caplan L. Practices and preferences for detecting chronic medication toxicity: a pilot cross-sectional survey of health care providers focusing on decision support systems. Journal of evaluation in clinical practice. 2014 Dec 1; 20(6):1086-9. [view]
  23. Baker JF, Cannon GW, Ibrahim S, Haroldsen C, Caplan L, Mikuls TR. Predictors of longterm changes in body mass index in rheumatoid arthritis. The Journal of rheumatology. 2015 Jun 1; 42(6):920-7. [view]
  24. Ward MM, Deodhar A, Reveille JD, Caplan L. Reply. Arthritis care & research. 2016 Jun 1; 68(6):886-7. [view]
  25. Ward MM, Deodhar A, Reveille JD, Caplan L. Reply. 2016 Jun 1; 68(6):1563-4. [view]
  26. Baker JF, Ibrahim S, Billig E, Michaud K, Caplan L, Cannon GW, Stokes A, Majithia V, Mikuls TR. Reply. Arthritis & rheumatology (Hoboken, N.J.). 2016 Feb 1; 68(2):553-4. [view]
  27. Anderson J, Caplan L, Yazdany J, Robbins ML, Neogi T, Michaud K, Saag KG, O'Dell JR, Kazi S. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis care & research. 2012 May 1; 64(5):640-7. [view]
  28. Amari W, Zeringue AL, McDonald JR, Caplan L, Eisen SA, Ranganathan P. Risk of non-melanoma skin cancer in a national cohort of veterans with rheumatoid arthritis. Rheumatology (Oxford, England). 2011 Aug 1; 50(8):1431-9. [view]
  29. Caplan L, Wolfe F, Michaud K, Quinzanos I, Hirsh JM. Strong association of health literacy with functional status among rheumatoid arthritis patients: a cross-sectional study. Arthritis care & research. 2014 Apr 1; 66(4):508-14. [view]
  30. Deodhar A, Reveille JD, van den Bosch F, Braun J, Burgos-Vargas R, Caplan L, Clegg DO, Colbert RA, Gensler LS, van der Heijde D, van der Horst-Bruinsma IE, Inman RD, Maksymowych WP, Mease PJ, Raychaudhuri S, Reimold A, Rudwaleit M, Sieper J, Weisman MH, Landewé RB. The concept of axial spondyloarthritis: joint statement of the spondyloarthritis research and treatment network and the Assessment of SpondyloArthritis international Society in response to the US Food and Drug Administration's comments and concerns. Arthritis & rheumatology (Hoboken, N.J.). 2014 Oct 1; 66(10):2649-56. [view]
  31. Quinzanos I, Luong PT, Bobba S, Steuart Richards J, Majithia V, Davis LA, Caplan L. Validation of disease activity and functional status questionnaires in spondyloarthritis. Clinical and Experimental Rheumatology. 2015 Mar 1; 33(2):146-52. [view]
  32. Masri KR, Shaver TS, Shahouri SH, Wang S, Anderson JD, Busch RE, Michaud K, Mikuls TR, Caplan L, Wolfe F. Validity and reliability problems with patient global as a component of the ACR/EULAR remission criteria as used in clinical practice. The Journal of rheumatology. 2012 Jun 1; 39(6):1139-45. [view]
  33. Solow EB, Yu F, Thiele GM, Sokolove J, Robinson WH, Pruhs ZM, Michaud KD, Erickson AR, Sayles H, Kerr GS, Gaffo AL, Caplan L, Davis LA, Cannon GW, Reimold AM, Baker J, Schwab P, Anderson DR, Mikuls TR. Vascular calcifications on hand radiographs in rheumatoid arthritis and associations with autoantibodies, cardiovascular risk factors and mortality. Rheumatology (Oxford, England). 2015 Sep 1; 54(9):1587-95. [view]
  34. Baker JF, Billig E, Michaud K, Ibrahim S, Caplan L, Cannon GW, Stokes A, Majithia V, Mikuls TR. Weight Loss, the Obesity Paradox, and the Risk of Death in Rheumatoid Arthritis. Arthritis & rheumatology (Hoboken, N.J.). 2015 Jul 1; 67(7):1711-7. [view]
Journal Other

  1. Caplan L, Hansen KE, Saag KG. Response to the American College of Physicians Osteoporosis Guideline, 2017 Update. [Editorial]. 2017 Nov 1; 69(11):2097-2101. [view]
Conference Presentations

  1. Miriovsky BJ, Michaud K, Thiele G, O'Dell J, Cannon G, Kerr G, Richards J, Johnson D, Caplan L, Reimold A, Hooker R, Mikuls TR. Associations of Anti-CCP and RF with Clinical Remission in US Veterans with Established RA [AB0114]. Poster session presented at: European League Against Rheumatism Annual European Congress of Rheumatology; 2009 Jun 10; Copenhagen, Denmark. [view]
  2. McDonald JR, Pittman C, Zeringue AL, Eisen SA, Cunningham F, Wehmeier K, Caplan L. Atrial Fibrillation in US Veteran Fracture Patients Treated with Bisphosphonates. Poster session presented at: Pharmacoepidemiology and Therapeutic Risk Management Annual International Conference; 2009 Aug 16; Providence, RI. [view]
  3. Mikuls TR, Michaud K, Thiele GM, O'Dell JR, Cannella AC, Reimold A, Hooker R, Caplan L, Johnson D, Richards JS, Kerr G, Cannon GW. Autoantibody Status in U.S. Veterans with Rheumatoid Arthritis: Implications of Discordance Between Anti-CCP Antibody and Rheumatoid Factor. Poster session presented at: American College of Rheumatology Annual Scientific Meeting; 2008 Oct 24; San Francisco, CA. [view]
  4. Cannon GW, Michaud KD, Call SE, Reimold AM, Hooker R, Kerr GS, Richards JS, Caplan L, Johnson DS, Mikuls TE. Discrepancies in Rheumatoid Arthritis Response Measures In Clinical Practice: Comparison of Difference in EULAR, ACR20, and Real Time Assessment of Disease Activity in Rheumatoid Arthritis (RADARA). Poster session presented at: American College of Rheumatology Annual Scientific Meeting; 2008 Oct 24; San Francisco, CA. [view]
  5. Hooker RS, Prescott K, Cipher D, Wauson M, Mikuls T, Kerr G, Richards SJ, Cannon G, Caplan L, Hines A, Johnson D, Reimold A. Fit for Study: Eligibility of Veterans with Rheumatoid Arthritis in Major Clinical Trials of Biological Therapies. Poster session presented at: American College of Rheumatology Annual Scientific Meeting; 2008 Oct 24; San Francisco, CA. [view]
  6. Caplan L, Pittman CB, Zeringue A, Scherrer JF, Cunningham FE, Eisen SA, McDonald JR. Musculoskeletal Pain Among Patients on Bisphosphonates: A Possible Adverse Drug Reaction. Poster session presented at: American College of Rheumatology Annual Scientific Meeting; 2008 Oct 24; San Francisco, CA. [view]
  7. Mikuls TR, Michaud K, Thiele GM, O'Dell JR, Cannella AC, Reimold A, Hooker R, Caplan L, Johnson D, Cannon GW, Kerr G, Richards JS. The Association of Cigarette Smoking with Disease Expression in U.S. Veterans with Rheumatoid Arthritis. Poster session presented at: American College of Rheumatology Annual Scientific Meeting; 2008 Oct 24; San Francisco, CA. [view]


DRA: Health Systems, Diabetes and Other Endocrine Disorders, Musculoskeletal Disorders
DRE: Prevention, Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Pharmaceuticals
MeSH Terms: none

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