COACH trial: A randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: Rationale and design

Contemporary Clinical Trials

Volumn 32, Issue 3, 2011, Pages 403-411

  Allen, Jerilyn K ^a,b,c   Himmelfarb, Cheryl R Dennison ^a,b   Szanton, Sarah L ^a   Bone, Lee ^c   Hill, Martha N ^a,b,c   Levine, David M ^a,b,c  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF NURSING   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Cardiovascular disease; Case management; Diabetes; Prevention; Randomized trial; Translational research

Indexed keywords

CHOLESTEROL; HEMOGLOBIN A1C;

ADULT; AGED; ARTICLE; CARDIOVASCULAR DISEASE; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; FEMALE; HEALTH AUXILIARY; HUMAN; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; NURSE PRACTITIONER; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; STUDY DESIGN; TREATMENT OUTCOME; URBAN POPULATION;

ADULT; AGED; BALTIMORE; BLOOD PRESSURE; CARDIOVASCULAR DISEASES; COMMUNITY HEALTH AIDES; COMMUNITY HEALTH CENTERS; DIABETES MELLITUS, TYPE 2; FEMALE; HEALTH PROMOTION; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; INSURANCE, HEALTH; LIFE STYLE; LIPIDS; MALE; MEDICATION THERAPY MANAGEMENT; MIDDLE AGED; NURSE PRACTITIONERS; RESEARCH DESIGN; RISK REDUCTION BEHAVIOR; SOCIOECONOMIC FACTORS; URBAN POPULATION;

EID: 79953037630     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2011.01.001     Document Type: Article

References (71)

1. Adult Treatment Panel III 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.
2. Sacks F.M., Pfeffer M.A., Moye L.A., Rouleau J.L., Rutherford J.D., Cole T.G., et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and recurrent events trial investigators. N Engl J Med 1996, 335:1001-1009.
3. Scandinavian Simvastatin Survival Study Group Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994, 344:1383-1389.
4. Schectman G., Hiatt J. Drug therapy for hypercholesterolemia in patients with cardiovascular disease: factors limiting achievement of lipid goals. Am J Med 1996, 100:197-204.
5. Simes J., Furberg C.D., Braunwald E., Davis B.R., Ford I., Tonkin A., et al. Effects of pravastatin on mortality in patients with and without coronary heart disease across a broad range of cholesterol levels. The prospective pravastatin pooling project. Eur Heart J 2002, 23:207-215.
6. Burke L.E., Dunbar-Jacob J.M., Hill M.N. Compliance with cardiovascular disease prevention strategies: a review of the research. Ann Behav Med 1997, 19:239-263.
7. Dunbar-Jacob J, Puczynski S, Burke LE. Clinical assessment and management of adherence to medical regimens. In: Nicassio P, Smith T, editors. Managing Chronic Illness: A Biopsychosocial Perspective, San Diego: American Psychological Association; 1995, p. 313-349.
8. Ford E.S., Mokdad A.H., Giles W.H., Mensah G.A. Serum total cholesterol concentrations and awareness, treatment, and control of hypercholesterolemia among US adults: findings from the National Health and Nutrition Examination Survey, 1999 to 2000. Circulation 2003, 107:2185-2189.
9. Lemaitre R.N., Furberg C.D., Newman A.B., Hulley S.B., Gordon D.J., Gottdiener J.S., et al. Time trends in the use of cholesterol-lowering agents in older adults: the Cardiovascular Health Study. Arch Intern Med 1998, 158:1761-1768.
10. Burt V.L., Cutler J.A., Higgins M., Horan M.J., Labarthe D., Whelton P., et al. Trends in the prevalence, awareness, treatment, and control of hypertension in the adult US population. Data from the health examination surveys, 1960 to 1991. Hypertension 1995, 26:60-69.
11. Hajjar I., Kotchen T. Trends in prevalence, awareness, treatment, and control of hypertension in the United States population: 1988-2000. Am J Hypertens 2003, 16(Supplement-8A).
12. Chobanian A.V., Bakris G.L., Black H.R., Cushman W.C., Green L.A., Izzo J.L., et al. The Seventh Report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure: the JNC 7 report. JAMA 2003, 289:2560-2572.
13. Lloyd-Jones D., Adams R.J., Brown T.M., Carnethon M., Dai S., De Simone G., et al. Heart disease and stroke statistics - 2010 update: a report from the American Heart Association. Circulation 2010, 121:e46-e215.
14. Summary of revisions for the 2010 clinical practice recommendations. Diabetes Care 2010, 33(Suppl. 1):S3.
15. Raynor D.K., Booth T.G., Blenkinsopp A. Effects of computer generated reminder charts on patients' compliance with drug regimens. BMJ 1993, 306:1158-1161.
16. Cornwall A., Jewkes R. What is participatory research?. Soc Sci Med 1995, 41:1667-1676.
17. Green L., Daniel M., Novack L. Partnerships and coalitions for community-based research. 2001, 116(Suppl. 1):20-31.
18. Chrisman N.J., Senturia K., Tang G., Gheisar B. Qualitative process evaluation of urban community work: a preliminary view. Health Educ Behav 2002, 29:232-248.
19. Friedewald W.T., Levy R.I., Fredrickson D.S. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 1972, 18:499-502.
20. NHLBI Obesity Education Initiative Expert Panel Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: the evidence report 1998.
21. Blair S.N., Haskell W.L., Ho P., Paffenbarger R.S., Vranizan K.M., Farquhar J.W., et al. Assessment of habitual physical activity by a seven-day recall in a community survey and controlled experiments. Am J Epidemiol 1985, 122:794-804.
22. Sallis J.F., Haskell W.L., Wood P.D., Fortmann S.P., Rogers T., Blair S.N., et al. Physical activity assessment methodology in the Five-City Project. Am J Epidemiol 1985, 121:91-106.
23. Block G., Hartman A.M., Dresser C.M., Carroll M.D., Gannon J., Gardner L. A data-based approach to diet questionnaire design and testing. Am J Epidemiol 1986, 124:453-469.
24. Block G., Thompson F.E., Hartman A.M., Larkin F.A., Guire K.E. Comparison of two dietary questionnaires validated against multiple dietary records collected during a 1-year period. J Am Diet Assoc 1992, 92:686-693.
25. EuroQo - a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 1990, 199-208.
26. Glasgow R.E., Wagner E.H., Schaefer J., Mahoney L.D., Reid R.J., Greene S.M. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care 2005, 43:436-444.
27. Charlson M.E., Pompei P., Ales K.L., MacKenzie C.R. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chron Dis 1987, 40:373-383.
28. Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. Tenn Med 2000, 93:430-433.
29. Prochaska J.O., DiClemente C.C. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol 1983, 51:390-395.
30. Smith S.C., Allen J., Blair S.N., Bonow R.O., Brass L.M., Fonarow G.C., et al. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update endorsed by the National Heart, Lung, and Blood Institute. J Am Coll Cardiol 2006, 47:2130-2139.
31. Allen J.K. Cholesterol management: an opportunity for nurse case managers. J Cardiovasc Nurs 2000, 14:50-58.
32. Becker D.M., Raqueno J.V., Yook R.M., Kral B.G., Blumenthal R.S., Moy T.F., et al. Nurse-mediated cholesterol management compared with enhanced primary care in siblings of individuals with premature coronary disease. Arch Intern Med 1998, 158:1533-1539.
33. Blair T.P., Bryant F.J., Bocuzzi S. Treatment of hypercholesterolemia by a clinical nurse using a stepped-care protocol in a nonvolunteer population. Arch Intern Med 1988, 148:1046-1048.
34. Bond C.A., Monson R. Sustained improvement in drug documentation, compliance, and disease control. A four-year analysis of an ambulatory care model. Arch Intern Med 1984, 144:1159-1162.
35. DeBusk R.F., Miller N.H., Superko H.R., Dennis C.A., Thomas R.J., Lew H.T., et al. A case-management system for coronary risk factor modification after acute myocardial infarction [see comments]. Ann Intern Med 1994, 120:721-729.
36. Hill M.N., Reichgott M.J. Achievement of standards for quality care of hypertension by physicians and nurses. Clin Exp Hypertens 1979, 1:665-684.
37. Jewell D., Hope J. Evaluation of a nurse-run hypertension clinic in general practice. Practitioner 1988, 232:484-487.
38. Reichgott M.J., Pearson S., Hill M.N. The nurse practitioner's role in complex patient management: hypertension. J Natl Med Assoc 1983, 75:1197-1204.
39. Runyan J.W. The Memphis chronic disease program. Comparisons in outcome and the nurse's extended role. JAMA 1975, 231:264-267.
40. Sackett D.L., Spitzer W.O., Gent M., Roberts R.S. The Burlington randomized trial of the nurse practitioner: health outcomes of patients. Ann Intern Med 1974, 80:137-142.
41. Taylor C.B., Houston-Miller N., Killen J.D., DeBusk R.F. Smoking cessation after acute myocardial infarction: effects of a nurse-managed intervention. Ann Intern Med 1990, 113:118-123.
42. Allen J.K., Dennison C.R. Randomized trials of nursing interventions for secondary prevention in patients with coronary artery disease and heart failure: systematic review. J Cardiovasc Nurs 2010, 25:207-220.
43. Allen J.K., Blumenthal R.S., Margolis S., Young D.R., Miller E.R., Kelly K. Nurse case management of hypercholesterolemia in patients with coronary heart disease: results of a randomized clinical trial. Am Heart J 2002, 144:678-686.
44. Allison T.G., Squires R.W., Johnson B.D., Gau G.T. Achieving National Cholesterol Education Program goals for low-density lipoprotein cholesterol in cardiac patients: importance of diet, exercise, weight control, and drug therapy. Mayo Clin Proc 1999, 74:466-473.
45. Brown A.S., Cofer L.A. Lipid management in a private cardiology practice (the Midwest Heart experience). Am J Cardiol 2000, 85:18A-22A.
46. Hill M.N., Han H.R., Dennison C.R., Kim M.T., Roary M.C., Blumenthal R.S., et al. Hypertension care and control in underserved urban African American men: behavioral and physiologic outcomes at 36months. Am J Hypertens 2003, 16:906-913.
47. Hoogwerf B.J., Frolkis J.P., Pearce G.P., Vidt D, Pashkow F.J., Cross J.A., et al. Use of treatment algorithms by physician extenders in a preventive cardiology clinic for LDL-cholesterol, blood pressure, and HbA1c in diabetic patients. Circulation 1999, 100:I-100.
48. LaBresh K.A., Owen P., Alteri C., Reilly S., Albright P.S., Hordes A.R., et al. Secondary prevention in a cardiology group practice and hospital setting after a heart-care initiative. Am J Cardiol 2000, 85:23A-29A.
49. Stuart-Shor E., Skinner S.S., McCleary N.C., Clark S.J., Waldman H.M., Kemper A.J. A nurse-directed, community-based, integrated multiple cardiac risk-reduction program: physiologic and behavioral outcomes. Presented at the American Heart Association 72nd Scientific Session 1999.
50. West J.A., Miller N.H., Parker K.M., Senneca D., Ghandour G., Clark M., et al. A comprehensive management system for heart failure improves clinical outcomes and reduces medical resource utilization. Am J Cardiol 1997, 79:58-63.
51. WOSCOPS West of Scotland Coronary Prevention Study: implications for clinical practice. The WOSCOPS Study Group. Eur Heart J 1996, 17:163-164.
52. Cofer L.A. Aggressive cholesterol management: role of the lipid nurse specialist. Heart Lung 1997, 26:337-344.
53. Thomas T.S. Improving care with nurse case managers: practical aspects of designing lipid clinics. Am J Cardiol 1997, 80:62H-65H.
54. Shaffer J., Wexler L.F. Reducing low-density lipoprotein cholesterol levels in an ambulatory care system. Results of a multidisciplinary collaborative practice lipid clinic compared with traditional physician-based care. Arch Intern Med 1995, 155:2330-2335.
55. Sikka R., Waters J., Moore W., Sutton D.R., Herman W.H., Aubert R.E. Renal assessment practices and the effect of nurse case management of health maintenance organization patients with diabetes. Diab Care 1999, 22:1-6.
56. Ridgeway N.A., Harvill D.R., Harvill L.M., Falin T.M., Forester G.M., Gose O.D. Improved control of type 2 diabetes mellitus: a practical education/behavior modification program in a primary care clinic. S Med J 1999, 92:667-672.
57. Kirkman M.S., Weinberger M., Landsman P.B., Samsa G.P., Shortliffe E.A., Simel D.L., et al. A telephone-delivered intervention for patients with NIDDM. Effect on coronary risk factors. Diab Care 1994, 17:840-846.
58. Fedder D.O., Chang R.J., Curry S., Nichols G. The effectiveness of a community health worker outreach program on healthcare utilization of west Baltimore City Medicaid patients with diabetes, with or without hypertension. Ethn Dis 2003, 13:22-27.
59. National Center for Chronic Disease Prevention and Health Promotion Community Health Advisors/Workers: selected annotations and programs in the United States 1998, III.
60. Brownstein J.N., Bone L.R., Dennison C.R., Hill M.N., Levine D.M. Community health workers as interventionists in research and practice for the prevention of heart disease and stroke. Am J Preventative Med 2005, 29:128-133.
61. Batts M.L., Gary T.L., Huss K., Hill M.N., Bone L., Brancati F.L. Patient priorities and needs for diabetes care among urban African American adults. Diab Educ 2001, 27:405-412.
62. Hill M.N., Becker D.M. Roles of nurses and health workers in cardiovascular health promotion. Am J Med Sci 1995, 310(Suppl. 1):S123-S126.
63. Hill M.N., Bone L.R., Hilton S.C., Roary M.C., Kelen G.D., Levine D.M. A clinical trial to improve high blood pressure care in young urban black men: recruitment, follow-up, and outcomes. Am J Hypertens 1999, 12:548-554.
64. Bird J.A., Otero-Sabogal R., Ngoc-The H., McPhee S.J. Tailoring lay health worker interventions for diverse cultures: lessons learned from Vietnamese and Latina communities. Health Educ Behav 1996, 23:S105-S122.
65. Brownstein JH, Rosenthal EL. The challenge of evaluating CHA services. In: Rosenthal EL, Wiggins N, Brownstein JN, Johnson S, Miester J, editors. The final report of the National Advisor Study: Weaving the Future, Tuscon: University of Arizona; 1998, p. 50-74.
66. Love M.B., Gardner K. The emerging role of the community health worker in California: results of a statewide university survey and San Francisco Bay Area focus group on the Community Health Workers in California's public health system 1992.
67. Stone R.I., Wiener J.M. Who will care for us? Addressing the long-term care workforce crisis 2001.
68. Koch E., Thompson A., Keegan P. Community health workers: a leadership brief on preventive health programs 1998.
69. Levine D.M., Bone L.R., Hill M.N., Stallings R., Gelber A.C., Barker A., et al. The effectiveness of a community/academic health center partnership in decreasing the level of blood pressure in an urban African-American population. Ethn Dis 2003, 13:354-361.
70. Witmer A., Seifer S.D., Finocchio L., Leslie J., O'Neil E.H. Community health workers: integral members of the health care work force. Am J Public Health 1995, 85:1055-1058.
71. Hill M.N., Bone L.R., Butz A.M. Enhancing the role of community-health workers in research. Image J Nurs Sch 1996, 28:221-226.