Design and rationale of a randomized controlled trial to reduce cardiovascular disease risk for patients with bipolar disorder

Contemporary Clinical Trials

Volumn 33, Issue 4, 2012, Pages 666-678

  Goodrich, David E ^a,b   Kilbourne, Amy M ^a,b   Lai, Zongshan ^a,b   Post, Edward P ^a,b   Bowersox, Nicholas W ^a   Mezuk, Briana ^c   Schumacher, Karen ^a   Bramlet, Margretta ^a   Welsh, Deborah E ^a   Bauer, Mark S ^d,e  

^a VA Ann Arbor Center for Clinical Management Research   (United States)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^c VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^d VA BOSTON HEALTHCARE SYSTEM   (United States)

^e HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Bipolar disorder; Cardiovascular disease; Collaborative care; Nutrition; Physical activity; Serious mental illness

Indexed keywords

ADULT; AGED; ARTICLE; BIPOLAR DISORDER; CARDIOVASCULAR RISK; CLINICAL EFFECTIVENESS; COLLABORATIVE CARE; CONTROLLED STUDY; FEMALE; HEALTH BEHAVIOR; HEALTH CARE SYSTEM; HUMAN; IMMOBILIZATION; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; QUALITY OF LIFE; QUESTIONNAIRE; RISK REDUCTION; SELF CARE; SHORT FORM 12; SMOKING; STUDY DESIGN;

ADULT; AGED; AGED, 80 AND OVER; BEHAVIOR THERAPY; BIPOLAR DISORDER; CARDIOVASCULAR DISEASES; CLINICAL PROTOCOLS; FEMALE; HUMANS; MALE; MIDDLE AGED; PATIENT SELECTION; PROSPECTIVE STUDIES; QUALITY OF LIFE; RESEARCH DESIGN; RISK FACTORS; RISK REDUCTION BEHAVIOR; SINGLE-BLIND METHOD; TREATMENT OUTCOME;

EID: 84861527243     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2012.02.010     Document Type: Article

References (83)

1. Judd L.L., Akiskal H.S. The prevalence and disability of bipolar spectrum disorders in the US population: re-analysis of the ECA database taking into account subthreshold cases. J Affect Disord 2003, 73:123-131.
2. Merikangas K.R., Akiskal H.S., Angst J., Greenberg P.E., Hirschfeld R.M., Petukhova M., et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry 2007, 64:543-552.
3. Murray C.J., Lopez A.D. Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet 1997, 349:1436-1442.
4. Kilbourne A.M., Cornelius J.R., Han X., Haas G.L., Salloum I., Conigliaro J., et al. General-medical conditions in older patients with serious mental illness. Am J Geriatr Psychiatry 2005, 13:250-254.
5. Perron B.E., Howard M.O., Nienhuis J.K., Bauer M.S., Woodward A.T., Kilbourne A.M. Prevalence and burden of general medical conditions among adults with bipolar I disorder: results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry 2009, 70:1407-1415.
6. Goldstein B.I., Fagiolini A., Houck P., Kupfer D. Cardiovascular disease and hypertension among adults with bipolar I disorder in the United States. Bipolar Disord 2009, 11:657-662.
7. Kilbourne A.M., Cornelius J.R., Han X., Pincus H.A., Shad M., Salloum I., et al. Burden of general medical conditions among individuals with bipolar disorder. Bipolar Disord 2004, 6:368-373.
8. Fiedorowicz J.G., Palagummi N.M., Forman-Hoffman V.L., Miller del D., Haynes W.G. Elevated prevalence of obesity, metabolic syndrome, and cardiovascular risk factors in bipolar disorder. Ann Clin Psychiatry 2008, 20:131-137.
9. Ramsey C.M., Leoutsakos J.M., Mayer L.S., Eaton W.W., Lee H.B. History of manic and hypomanic episodes and risk of incident cardiovascular disease: 11.5year follow-up from the Baltimore Epidemiologic Catchment Area Study. J Affect Disord 2010, 125:35-41.
10. Roshanaei-Moghaddam B., Katon W. Premature mortality from general medical illnesses among persons with bipolar disorder: a review. Psychiatr Serv 2009, 60:147-156.
11. Angst F., Stassen H.H., Clayton P.J., Angst J. Mortality of patients with mood disorders: follow-up over 34-38years. J Affect Disord 2002, 68:167-181.
12. Fagiolini A., Chengappa K.N., Soreca I., Chang J. Bipolar disorder and the metabolic syndrome: causal factors, psychiatric outcomes and economic burden. CNS Drugs 2008, 22:655-669.
13. De Hert M., Dekker J.M., Wood D., Kahl K.G., Holt R.I., Moller H.J. Cardiovascular disease and diabetes in people with severe mental illness position statement from the European Psychiatric Association (EPA), supported by the European Association for the Study of Diabetes (EASD) and the European Society of Cardiology (ESC). Eur Psychiatry 2009, 24:412-424.
14. Kilbourne A.M., Brar J.S., Drayer R.A., Xu X., Post E.P. Cardiovascular disease and metabolic risk factors in male patients with schizophrenia, schizoaffective disorder, and bipolar disorder. Psychosomatics 2007, 48:412-417.
15. Sharma R., Markar H.R. Mortality in affective disorder. J Affect Disord 1994, 31:91-96.
16. Fiedorowicz J.G., Solomon D.A., Endicott J., Leon A.C., Li C., Rice J.P., et al. Manic/hypomanic symptom burden and cardiovascular mortality in bipolar disorder. Psychosom Med 2009, 71:598-606.
17. Goldstein B.I., Kemp D.E., Soczynska J.K., McIntyre R.S. Inflammation and the phenomenology, pathophysiology, comorbidity, and treatment of bipolar disorder: a systematic review of the literature. J Clin Psychiatry 2009, 70:1078-1090.
18. Keck P.E. Long-term management strategies to achieve optimal function in patients with bipolar disorder. J Clin Psychiatry 2006, 67:e17.
19. McElroy S.L. Diagnosing and treating comorbid (complicated) bipolar disorder. J Clin Psychiatry 2004, 65(Suppl 15):35-44.
20. Keck P.E., McIntyre R.S., Shelton R.C. Bipolar depression: best practices for the outpatient. CNS Spectr 2007, 12:1-14.
21. Sajatovic M., Biswas K., Kilbourne A.K., Fenn H., Williford W., Bauer M.S. Factors associated with prospective long-term treatment adherence among individuals with bipolar disorder. Psychiatr Serv 2008, 59:753-759.
22. Druss B.G., Rosenheck R.A. Locus of mental health treatment in an integrated service system. Psychiatr Serv 2000, 51:890-892.
23. Morden N.E., Mistler L.A., Weeks W.B., Bartels S.J. Health care for patients with serious mental illness: family medicine's role. J Am Board Fam Med 2009, 22:187-195.
24. Kilbourne A.M., Welsh D., McCarthy J.F., Post E.P., Blow F.C. Quality of care for cardiovascular disease-related conditions in patients with and without mental disorders. J Gen Intern Med 2008, 23:1628-1633.
25. Fagiolini A., Goracci A. The effects of undertreated chronic medical illnesses in patients with severe mental disorders. J Clin Psychiatry 2009, 70(Suppl 3):22-29.
26. Morrato E.H., Newcomer J.W., Kamat S., Baser O., Harnett J., Cuffel B. Metabolic screening after the American Diabetes Association's consensus statement on antipsychotic drugs and diabetes. Diabetes Care 2009, 32:1037-1042.
27. Kilbourne A.M., Post E.P., Bauer M.S., Zeber J.E., Copeland L.A., Good C.B., et al. Therapeutic drug and cardiovascular disease risk monitoring in patients with bipolar disorder. J Affect Disord 2007, 102:145-151.
28. Morrato E.H., Druss B., Hartung D.M., Valuck R.J., Allen R., Campagna E., et al. Metabolic testing rates in 3 state Medicaid programs after FDA warnings and ADA/APA recommendations for second-generation antipsychotic drugs. Arch Gen Psychiatry 2010, 67:17-24.
29. Newcomer J.W. Comparing the safety and efficacy of atypical antipsychotics in psychiatric patients with comorbid medical illnesses. J Clin Psychiatry 2009, 70(Suppl 3):30-36.
30. Ray W.A., Chung C.P., Murray K.T., Hall K., Stein C.M. Atypical antipsychotic drugs and the risk of sudden cardiac death. N Engl J Med 2009, 360:225-235.
31. Wagner E.H., Austin B.T., Von Korff M. Organizing care for patients with chronic illness. Milbank Q 1996, 74:511-544.
32. Bodenheimer T., Wagner E.H., Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA 2002, 288:1909-1914.
33. Coleman K., Mattke S., Perrault P.J., Wagner E.H. Untangling practice redesign from disease management: how do we best care for the chronically ill?. Annu Rev Public Health 2009, 30:385-408.
34. Bauer M.S., McBride L., Williford W.O., Glick H., Kinosian B., Altshuler L., et al. Collaborative care for bipolar disorder: Part II. Impact on clinical outcome, function, and costs. Psychiatr Serv 2006, 57:937-945.
35. Simon G.E., Ludman E.J., Bauer M.S., Unutzer J., Operskalski B. Long-term effectiveness and cost of a systematic care program for bipolar disorder. Arch Gen Psychiatry 2006, 63:500-508.
36. Kilbourne A.M., Post E.P., Nossek A., Drill L., Cooley S., Bauer M.S. Improving medical and psychiatric outcomes among individuals with bipolar disorder: a randomized controlled trial. Psychiatr Serv 2008, 59:760-768.
37. Simon G.E., Katon W.J., VonKorff M., Unutzer J., Lin E.H., Walker E.A., et al. Cost-effectiveness of a collaborative care program for primary care patients with persistent depression. Am J Psychiatry 2001, 158:1638-1644.
38. Kilbourne A.M., Neumann M.S., Pincus H.A., Bauer M.S., Stall R. Implementing evidence-based interventions in health care: application of the replicating effective programs framework. Implement Sci 2007, 2:42.
39. Bauer M.S., McBride L. Structured group psychotherapy for bipolar disorder: the Life Goals Program 2003, Springer Publishing Co., New York, NY. 2nd ed.
40. Bauer M.S., Kilbourne A.M., Greenwald D.E., Ludman E.J., McBride L. Overcoming bipolar disorder: a comprehensive workbook for managing your symptoms & achieving your life goals 2008, New Harbinger Publications, Inc., Oakland, CA.
41. Pearson M.L., Mattke S., Shaw R., Ridgely M.S., Wiseman S.H. Patient self-management support programs: an evalation. Final Contract Report (Prepared by RAND Health under Contract No. 282-00-0005) November 2007, Agency for Healthcare Research and Quality, Rockville, MD, AHRQ Publication No. 08-0011.
42. Bandura A. Social foundations of thought and action: a social cognitive theory 1996, Prentice Hall, Englewood Cliffs, NJ.
43. Rollnick S., Miller W.R., Butler C.C. Motivational interviewing in health care: helping patients change behavior 2008, The Guilford Press, New York.
44. Michie S., Fixsen D., Grimshaw J.M., Eccles M.P. Specifying and reporting complex behaviour change interventions: the need for a scientific method. Implement Sci 2009, 4:40.
45. Bandura A. The primacy of self-regulation in health promotion. Appl Psychol Int Rev 2005, 245-254.
46. Kilbourne A.M., Post E.P., Nossek A., Sonel E., Drill L.J., Cooley S., et al. Service delivery in older patients with bipolar disorder: a review and development of a medical care model. Bipolar Disord 2008, 10:672-683.
47. U.S. Department of Health and Human Services Physical Activity Guidelines for Americans. Washington, D.C October 2008, ODPHP Publication No. U0036.
48. U.S. Department of Health and Human Services and U.S. Department of Agriculture Dietary Guidelines for Adult Americans, 2005 January 2005, U.S. Government Printing Office, Washington, D.C. 6th ed.
49. Khot U.N., Khot M.B., Bajzer C.T., Sapp S.K., Ohman E.M., Brener S.J., et al. Prevalence of conventional risk factors in patients with coronary heart disease. JAMA 2003, 290:898-904.
50. Rubins H.B., Robins S.J., Collins D., Fye C.L., Anderson J.W., Elam M.B., et al. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. N Engl J Med 1999, 341:410-418.
51. Folsom A.R., Chambless L.E., Ballantyne C.M., Coresh J., Heiss G., Wu K.K., et al. An assessment of incremental coronary risk prediction using C-reactive protein and other novel risk markers: the atherosclerosis risk in communities study. Arch Intern Med 2006, 166:1368-1373.
52. Chambless L.E., Folsom A.R., Sharrett A.R., Sorlie P., Couper D., Szklo M., et al. Coronary heart disease risk prediction in the Atherosclerosis Risk in Communities (ARIC) study. J Clin Epidemiol 2003, 56:880-890.
53. Norris S.L., Zhang X., Avenell A., Gregg E., Bowman B., Schmid C.H., et al. Long-term effectiveness of weight-loss interventions in adults with pre-diabetes: a review. Am J Prev Med 2005, 28:126-139.
54. Guyatt G.H. A taxonomy of health status instruments. J Rheumatol 1995, 22:1188-1190.
55. Hays R.D., Hahn H., Marshall G. Use of the SF-36 and other health-related quality of life measures to assess persons with disabilities. Arch Phys Med Rehabil 2002, 83:S4-S9.
56. Ware J., Kosinski M., Keller S.D. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996, 34:220-233.
57. Wyrwich K.W., Nienaber N.A., Tierney W.M., Wolinsky F.D. Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care 1999, 37:469-478.
58. Bosworth H.B., Siegler I.C., Brummett B.H., Barefoot J.C., Williams R.B., Clapp-Channing N.E., et al. The association between self-rated health and mortality in a well-characterized sample of coronary artery disease patients. Med Care 1999, 37:1226-1236.
59. Chyba M.M., Washington L.R. Questionnaires from the National Health Interview Survey, 1985-89. Vital Health Stat 1993, 1:1-412.
60. Kraemer H.C., Wilson G.T., Fairburn C.G., Agras W.S. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry 2002, 59:877-883.
61. Bauer M.S., Vojta C., Kinosian B., Altshuler L., Glick H. The Internal State Scale: replication of its discriminating abilities in a multisite, public sector sample. Bipolar Disord 2000, 2:340-346.
62. Morisky D.E., Green L.W., Levine D.M. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986, 24:67-74.
63. Kilbourne A.M., Good C.B., Sereika S.M., Justice A.C., Fine M.J. Algorithm for assessing patients' adherence to oral hypoglycemic medication. Am J Health Syst Pharm 2005, 62:198-204.
64. Guidelines for data processing and analysis of the International Physical Activity Questionnaire (IPAQ)-short and long forms 2005, IPAQ Research Committee, Available at. http://www.ipaq.ki.se/ipaq.htm.
65. Craig C.L., Marshall A.L., Sjostrom M., Bauman A.E., Booth M.L., Ainsworth B.E., et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003, 35:1381-1395.
66. National Center for Health Statistics Data File Documentation, National Health Interview Survey, 2005 2006, Centers for Disease Control and Prevention, Hyattsville, Maryland.
67. National Cancer Institute The Five-Factor screener: scoring procedures 2005, U.S. National Institutes of Health, Bethesda, Maryland.
68. Lorig K.R., Sobel D.S., Ritter P.L., Laurent D., Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract 2001, 4:256-262.
69. Kilbourne A.M., Farmer Teh C., Welsh D., Pincus H.A., Lasky E., Perron B., et al. Implementing composite quality metrics for bipolar disorder: towards a more comprehensive approach to quality measurement. Gen Hosp Psychiatry 2010, 32:636-643.
70. Gordon A.J., Maisto S.A., McNeil M., Kraemer K.L., Conigliaro R.L., Kelley M.E., et al. Three questions can detect hazardous drinkers. J Fam Pract 2001, 50:313-320.
71. Kessler R.C., Andrews G., Mroczek D., Üstün T.B., Wittchen H.U. The World Health Organization Composite International Diagnostic Interview Short Form (CIDI-SF). Int J Methods Psychiatr Res 1998, 7:171-185.
72. Fenn H.H., Bauer M.S., Altshuler L., Evans D.R., Williford W.O., Kilbourne A.M., et al. Medical comorbidity and health-related quality of life in bipolar disorder across the adult age span. J Affect Disord 2005, 86:47-60.
73. Bauer M.S., McBride L., Williford W.O., Glick H., Kinosian B., Altshuler L., et al. Collaborative care for bipolar disorder: part I. Intervention and implementation in a randomized effectiveness trial. Psychiatr Serv 2006, 57:927-936.
74. Dilsaver S.C. An estimate of the minimum economic burden of bipolar I and II disorders in the United States: 2009. J Affect Disord 2011, 129:79-83.
75. Kilbourne A.M., Ignacio R.V., Kim H.M., Blow F.C. Datapoints: are VA patients with serious mental illness dying younger?. Psychiatr Serv 2009, 60:589.
76. Colton C.W., Manderscheid R.W. Congruencies in increased mortality rates, years of potential life lost, and causes of death among public mental health clients in eight states. Prev Chronic Dis 2006, 3:A42.
77. van der Voort T.Y., van Meijel B., Goossens P.J., Renes J., Beekman A.T., Kupka R.W. Collaborative care for patients with bipolar disorder: a randomised controlled trial. BMC Psychiatry 2011, 11:133.
78. Fagiolini A., Frank E., Axelson D.A., Birmaher B., Cheng Y., Curet D.E., et al. Enhancing outcomes in patients with bipolar disorder: results from the Bipolar Disorder Center for Pennsylvanians Study. Bipolar Disord 2009, 11:382-390.
79. Katon W.J., Lin E.H., Von Korff M., Ciechanowski P., Ludman E.J., Young B., et al. Collaborative care for patients with depression and chronic illnesses. N Engl J Med 2010, 363:2611-2620.
80. Druss B.G., von Esenwein S.A., Compton M.T., Rask K.J., Zhao L., Parker R.M. A randomized trial of medical care management for community mental health settings: the Primary Care Access, Referral, and Evaluation (PCARE) study. Am J Psychiatry 2010, 167:151-159.
81. Druss B.G., Zhao L., von Esenwein S.A., Bona J.R., Fricks L., Jenkins-Tucker S., et al. The Health and Recovery Peer (HARP) Program: a peer-led intervention to improve medical self-management for persons with serious mental illness. Schizophr Res 2010, 118:264-270.
82. Daumit G.L., Dalcin A.T., Jerome G.J., Young D.R., Charleston J., Crum R.M., et al. A behavioral weight-loss intervention for persons with serious mental illness in psychiatric rehabilitation centers. Int J Obes (Lond) 2011, 35:1114-1123.
83. Gillhoff K., Gaab J., Emini L., Maroni C., Tholuck J., Greil W. Effects of a multimodal lifestyle intervention on body mass index in patients with bipolar disorder: a randomized controlled trial. Prim Care Companion J Clin Psychiatry 2010, 12.