Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: Methods and participant characteristics for the Heart to Health study

Contemporary Clinical Trials

Volumn 36, Issue 2, 2013, Pages 394-405

  Sheridan, Stacey L ^a,b   Draeger, Lindy B ^b   Pignone, Michael P ^a,b   Sloane, Philip D ^a,b   Samuel Hodge, Carmen ^b,c   Finkelstein, Eric A ^d   Gizlice, Ziya ^b   Vu, Maihan B ^b   Gitterman, Daniel P ^b   Bangdiwala, Shrikant I ^b,c   Donahue, Katrina E ^a,b   Evenson, Kelly ^c   Ammerman, Alice S ^b,c   Keyserling, Thomas C ^a,b  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF NORTH CAROLINA   (United States)

^c IL   (United States)

^d DUKE NUS MEDICAL SCHOOL   (Singapore)

Author keywords

Coronary heart disease; Counseling; Evidence based practice; Prevention; Therapy computer assisted

Indexed keywords

ADULT; AFRICAN AMERICAN; AGE DISTRIBUTION; ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; COLLEGE; COMPARATIVE EFFECTIVENESS; COST EFFECTIVENESS ANALYSIS; FAMILY MEDICINE; FEMALE; FOLLOW UP; HEALTH INSURANCE; HUMAN; ISCHEMIC HEART DISEASE; LIFESTYLE MODIFICATION; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; MEDICAL RESEARCH; MEDICATION COMPLIANCE; PREVENTIVE MEDICINE; QUALITY CONTROL; RISK ASSESSMENT; RISK FACTOR;

CORONARY HEART DISEASE; COUNSELING; EVIDENCE-BASED PRACTICE; PREVENTION; THERAPY/COMPUTER-ASSISTED;

ADULT; AGED; CLINICAL PROTOCOLS; COMPARATIVE EFFECTIVENESS RESEARCH; CORONARY DISEASE; COST-BENEFIT ANALYSIS; COUNSELING; DECISION SUPPORT TECHNIQUES; FEMALE; HUMANS; MALE; MIDDLE AGED; RISK FACTORS; RISK REDUCTION BEHAVIOR; TELEMEDICINE; TREATMENT OUTCOME;

EID: 84884515746     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2013.07.013     Document Type: Article

References (63)

1. Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, et al. Executive summary: heart disease and stroke statistics-2010 update: a report from the american heart association. Circulation.121:948-54.
2. Frieden T.R., Berwick D.M. The "Million Hearts" initiative-preventing heart attacks and strokes. N Engl J Med 2011, 365:e27.
3. Stampfer M.J., Hu F.B., Manson J.E., Rimm E.B., Willett W.C. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med 2000, 343:16-22.
4. Estruch R., Ros E., Salas-Salvado J., Covas M.I., Corella D., Aros F., et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med 2013, 368:1279-1290.
5. Gueyffier F., Froment A., Gouton M. New meta-analysis of treatment trials of hypertension: improving the estimate of therapeutic benefit. J Hum Hypertens 1996, 10:1-8.
6. Hall K.M., Luepker R.V. Is hypercholesterolemia a risk factor and should it be treated in the elderly?. Am J Health Promot 2000, 14:347-356.
7. Pignone M., Phillips C., Mulrow C. Use of lipid lowering drugs for primary prevention of coronary heart disease: meta-analysis of randomised trials. BMJ 2000, 321:983-986.
8. Ridker P.M., Danielson E., Fonseca F.A., Genest J., Gotto A.M., Kastelein J.J., et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008, 359:2195-2207.
9. Sheridan S., Pignone M., Donahue K. Screening for high blood pressure: a review of the evidence for the U.S. Preventive Services Task Force. Am J Prev Med 2003, 25:151-158.
10. Staessen J.A., Gasowski J., Wang J.G., Thijs L., Den Hond E., Boissel J.P., et al. Risks of untreated and treated isolated systolic hypertension in the elderly: meta-analysis of outcome trials. Lancet 2000, 355:865-872.
11. Walsh J.M. Lipids in women: screening and treatment. J Am Med Womens Assoc 2003, 58:240-247.
12. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001, 285:2486-2497.
13. Eriksson M.K., Franks P.W., Eliasson M. A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Bjorknas study. PLoS One 2009, 4:e5195.
14. Goldstein M.G., Whitlock E.P., DePue J. Multiple behavioral risk factor interventions in primary care. Summary of research evidence. Am J Prev Med 2004, 27:61-79.
15. Ma J., Berra K., Haskell W.L., Klieman L., Hyde S., Smith M.W., et al. Case management to reduce risk of cardiovascular disease in a county health care system. Arch Intern Med 2009, 169:1988-1995.
16. Glasgow R.E., Bull S.S., Piette J.D., Steiner J.F. Interactive behavior change technology. A partial solution to the competing demands of primary care. Am J Prev Med 2004, 27:80-87.
17. Noell J., Glasgow R.E. Interactive technology applications for behavioral counseling: issues and opportunities for health care settings. Am J Prev Med 1999, 17:269-274.
18. Holtrop J.S., Dosh S.A., Torres T., Thum Y.M. The community health educator referral liaison (CHERL): a primary care practice role for promoting healthy behaviors. Am J Prev Med 2008, 35:S365-S372.
19. Krist A.H., Woolf S.H., Frazier C.O., Johnson R.E., Rothemich S.F., Wilson D.B., et al. An electronic linkage system for health behavior counseling effect on delivery of the 5A's. Am J Prev Med 2008, 35:S350-S358.
20. Ebrahim S., Beswick A., Burke M., Davey Smith G. Multiple risk factor interventions for primary prevention of coronary heart disease. Cochrane Database Syst Rev 2006, CD001561.
21. Sheridan S.L., Viera A.J., Krantz M.J., Ice C.L., Steinman L.E., Peters K.E., et al. The effect of giving global coronary risk information to adults: a systematic review. Arch Intern Med 2010, 170:230-239.
22. Benner J.S., Morrison M.R., Karnes E.K., Kocot S.L., McClellan M. An evaluation of recent federal spending on comparative effectiveness research: priorities, gaps, and next steps. Health Aff (Millwood). 2010, 29:1768-1776.
23. Slutsky J.R., Clancy C.M. Patient-centered comparative effectiveness research: essential for high-quality care. Arch Intern Med 2010, 170:403-404.
24. Bodenheimer T., Laing B.Y. The teamlet model of primary care. Ann Fam Med 2007, 5:457-461.
25. Sloane P.D., Callahan L., Kahwati L., Mitchell C.M. Development of a practice-based patient cohort for primary care research. Fam Med 2006, 38:50-57.
26. Kraschnewski J.L., Keyserling T.C., Bangdiwala S.I., Gizlice Z., Garcia B.A., Johnston L.F., et al. Optimized probability sampling of study sites to improve generalizability in a multisite intervention trial. Prev Chronic Dis 2010, 7:A10.
27. Pignone M., Sheridan S.L., Lee Y.Z., Kuo J., Phillips C., Mulrow C., et al. Heart to heart: a computerized decision aid for assessment of coronary heart disease risk and the impact of risk-reduction interventions for primary prevention. Prev Cardiol 2004, 7:26-33.
28. Ammerman A.S., Keyserling T.C., Atwood J.R., Hosking J.D., Zayed H., Krasny C. A randomized controlled trial of a public health nurse directed treatment program for rural patients with high blood cholesterol. Prev Med 2003, 36:340-351.
29. Keyserling T.C., Ammerman A.S., Davis C.E., Chen Mok M., Garrett J., Simpson R.A. A randomized controlled trial of a physician-directed treatment program for low-income patients with high blood cholesterol: the southeast cholesterol project. Arch Fam Med 1997, 6:135-145.
30. Keyserling T.C., Samuel Hodge C.D., Jilcott S.B., Johnston L.F., Garcia B.A., Gizlice Z., et al. Randomized trial of a clinic-based, community-supported, lifestyle intervention to improve physical activity and diet: the North Carolina enhanced WISEWOMAN project. Prev Med 2008, 46:499-510.
31. Keyserling T.C., Samuel-Hodge C.D., Ammerman A.S., Ainsworth B.E., Henriquez-Roldan C.F., Elasy T.A., et al. A randomized trial of an intervention to improve self-care behaviors of African-American women with type 2 diabetes: impact on physical activity. Diabetes Care 2002, 25:1576-1583.
32. Hamer M., Chida Y. Active commuting and cardiovascular risk: a meta-analytic review. Prev Med 2008, 46:9-13.
33. Hu F.B., Willett W.C. Optimal diets for prevention of coronary heart disease. JAMA 2002, 288:2569-2578.
34. Mozaffarian D., Micha R., Wallace S. Effects on coronary heart disease of increasing polyunsaturated fat in place of saturated fat: a systematic review and meta-analysis of randomized controlled trials. PLoS Med 2010, 7:e1000252.
35. Mozaffarian D., Rimm E.B. Fish intake, contaminants, and human health: evaluating the risks and the benefits. JAMA 2006, 296:1885-1899.
36. Oh K., Hu F.B., Manson J.E., Stampfer M.J., Willett W.C. Dietary fat intake and risk of coronary heart disease in women: 20years of follow-up of the nurses' health study. Am J Epidemiol 2005, 161:672-679.
37. Pereira M.A., O'Reilly E., Augustsson K., Fraser G.E., Goldbourt U., Heitmann B.L., et al. Dietary fiber and risk of coronary heart disease: a pooled analysis of cohort studies. Arch Intern Med 2004, 164:370-376.
38. Zheng H., Orsini N., Amin J., Wolk A., Nguyen V.T., Ehrlich F. Quantifying the dose-response of walking in reducing coronary heart disease risk: meta-analysis. Eur J Epidemiol 2009, 24:181-192.
39. Sheridan S.L., Draeger L.B., Pignone M.P., Keyserling T.C., Simpson R.J., Rimer B., et al. A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies. BMC Health Serv Res 2011, 11:331.
40. Hernandez-Diaz S., Garcia Rodriguez L.A. Cardioprotective aspirin users and their excess risk of upper gastrointestinal complications. BMC Med 2006, 4:22.
41. Hippisley-Cox J., Coupland C. Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database. BMJ 2010, 340:c2197.
42. Baigent C., Blackwell L., Collins R., Emberson J., Godwin J., Peto R., et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009, 373:1849-1860.
43. Wolf P.A., D'Agostino R.B., Belanger A.J., Kannel W.B. Probability of stroke: a risk profile from the Framingham Study. Stroke 1991, 22:312-318.
44. Sheridan S.L., Shadle J., Simpson R.J.J., Pignone M.P. The impact of a decision aid about heart disease prevention on patients' discussions with their doctor and their plans for prevention: a pilot randomized trial. BMC Health Serv Res 2006, 6:121.
45. Anderson K.M., Odell P.M., Wilson P.W., Kannel W.B. Cardiovascular disease risk profiles. Am Heart J 1991, 121:293-298.
46. Pearson T.A. New tools for coronary risk assessment: what are their advantages and limitations?. Circulation 2002, 105:886-892.
47. Booth G.L., Kapral M.K., Fung K., Tu J.V. Relation between age and cardiovascular disease in men and women with diabetes compared with non-diabetic people: a population-based retrospective cohort study. Lancet 2006, 368:29-36.
48. Haffner S.M., Lehto S., Ronnemaa T., Pyorala K., Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med 1998, 339:229-234.
49. Antithrombotic Trialists C., Baigent C., Blackwell L., Collins R., Emberson J., Godwin J., et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009, 373:1849-1860.
50. Block G., Gillespie C., Rosenbaum E.H., Jenson C. A rapid food screener to assess fat and fruit and vegetable intake. Am J Prev Med 2000, 18:284-288.
51. Kraschnewski J.L., Gold A.D., Gizlice Z., Johnston L.F., Garcia B.A., Samuel-Hodge C.D., et al. Development and evaluation of a brief questionnaire to assess dietary fat quality in low-income overweight women in the Southern United States. J Nutr Educ Behav 2013, 45(4):355-361.
52. 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.
53. Giles-Corti B., Timperio A., Cutt H., Pikora T.J., Bull F.C., Knuiman M., et al. Development of a reliable measure of walking within and outside the local neighborhood: RESIDE's Neighborhood Physical Activity Questionnaire. Prev Med 2006, 42:455-459.
54. Morisky D.E., Ang A., Krousel-Wood M., Ward H.J. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich) 2008, 10:348-354.
55. Law M.R., Wald N.J., Morris J.K., Jordan R.E. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ 2003, 326:1427.
56. Law M.R., Wald N.J., Rudnicka A.R. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ 2003, 326:1423.
57. Appel L.J., Sacks F.M., Carey V.J., Obarzanek E., Swain J.F., ERr Miller, et al. Effects of protein, monounsaturated fat, and carbohydrate intake on blood pressure and serum lipids: results of the OmniHeart randomized trial. JAMA 2005, 294:2455-2464.
58. Edelman D., Oddone E.Z., Liebowitz R.S., Yancy W.S.J., Olsen M.K., Jeffreys A.S., et al. A multidimensional integrative medicine intervention to improve cardiovascular risk. J Gen Intern Med 2006, 21:728-734.
59. Grover S.A., Lowensteyn I., Joseph L., Kaouache M., Marchand S., Coupal L., et al. Patient knowledge of coronary risk profile improves the effectiveness of dyslipidemia therapy: the CHECK-UP study: a randomized controlled trial. Arch Intern Med 2007, 167:2296-2303.
60. Krones T., Keller H., Sonnichsen A., Sadowski E.M., Baum E., Wegscheider K., et al. Absolute cardiovascular disease risk and shared decision making in primary care: a randomized controlled trial. Ann Fam Med 2008, 6:218-227.
61. Vickers A.J., Altman D.G. Statistics notes: analysing controlled trials with baseline and follow up measurements. BMJ 2001, 323:1123-1124.
62. Frison L., Pocock S.J. Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design. Stat Med 1992, 11:1685-1704.
63. Sheridan S.L., Behrend L., Vu M.B., Meier A., Griffith J.M., Pignone M.P. Individuals' responses to global CHD risk: a focus group study. Patient Educ Couns 2009, 76(2):233-239.