Hypertension Improvement Project (HIP): study protocol and implementation challenges

Rowena J Dolor, William S Yancy Jr, William F Owen, David B Matchar, Gregory P Samsa, Kathryn I Pollak, Pao-Hwa Lin, Jamy D Ard, Maxwell Prempeh, Heather L McGuire, Bryan C Batch, William Fan, Laura P Svetkey, Rowena J Dolor, William S Yancy Jr, William F Owen, David B Matchar, Gregory P Samsa, Kathryn I Pollak, Pao-Hwa Lin, Jamy D Ard, Maxwell Prempeh, Heather L McGuire, Bryan C Batch, William Fan, Laura P Svetkey

Abstract

Background: Hypertension affects 29% of the adult U.S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goal blood pressure. The chronic care model suggests that blood pressure control can be achieved by improving how patients and physicians address patient self-care.

Methods and design: This paper describes the protocol of a nested 2 x 2 randomized controlled trial to test the separate and combined effects on systolic blood pressure of a behavioral intervention for patients and a quality improvement-type intervention for physicians. Primary care practices were randomly assigned to the physician intervention or to the physician control condition. Physician randomization occurred at the clinic level. The physician intervention included training and performance monitoring. The training comprised 2 internet-based modules detailing both the JNC-7 hypertension guidelines and lifestyle modifications for hypertension. Performance data were collected for 18 months, and feedback was provided to physicians every 3 months. Patient participants in both intervention and control clinics were individually randomized to the patient intervention or to usual care. The patient intervention consisted of a 6-month behavioral intervention conducted by trained interventionists in 20 group sessions, followed by 12 monthly phone contacts by community health advisors. Follow-up measurements were performed at 6 and 18 months. The primary outcome was the mean change in systolic blood pressure at 6 months. Secondary outcomes were diastolic blood pressure and the proportion of patients with adequate blood pressure control at 6 and 18 months.

Discussion: Overall, 8 practices (4 per treatment group), 32 physicians (4 per practice; 16 per treatment group), and 574 patients (289 control and 285 intervention) were enrolled. Baseline characteristics of patients and providers and the challenges faced during study implementation are presented. The HIP interventions may improve blood pressure control and lower cardiovascular disease risk in a primary care practice setting by addressing key components of the chronic care model. The study design allows an assessment of the effectiveness and cost of physician and patient interventions separately, so that health care organizations can make informed decisions about implementation of 1 or both interventions in the context of local resources.

Trial registration: ClinicalTrials.gov identifier NCT00201136.

Figures

Figure 1
Figure 1
Psychosocial mediators and systems factors that influence physician and patient adherence to JNC-7 guidelines. MD = physician.
Figure 2
Figure 2
Design of the HIP study. MD = physician.

References

    1. Burt VL, Whelton P, Roccella EJ, Brown C, Cutler JA, Higgins M, Horan MJ, Labarthe D. Prevalence of hypertension in the US adult population. Results from the Third National Health and Nutrition Examination Survey, 1988–1991. Hypertension. 1995;25:305–313.
    1. Hypertension Working Group of the National Institutes of Health Working Group Report on Primary Prevention of Hypertension National High Blood Pressure Education Program Bethesda, MD. 2000.
    1. Kannel W. Blood pressure as a cardiovascular risk factor: prevention and treatment. JAMA. 1996;275:1571–1576. doi: 10.1001/jama.275.20.1571.
    1. Psaty B, Smith N, Siscovick D, Koepsell TD, Weiss NS, Heckbert SR, Lemaitre RN, Wagner EH, Furberg CD. Health outcomes associated with antihypertensive therapies used as first-line agents: a systematic review and meta-analysis. JAMA. 1997;277:739–745. doi: 10.1001/jama.277.9.739.
    1. Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension: final results of the Systolic Hypertension in the Elderly Program (SHEP) JAMA. 1991;265:3255–3264. doi: 10.1001/jama.265.24.3255.
    1. 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.
    1. ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) JAMA. 2002;288:2981–2997. doi: 10.1001/jama.288.23.2981.
    1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, Jr, Jones DW, Materson BJ, Oparil S, Wright JT, Jr, Roccella EJ, National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee 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. doi: 10.1001/jama.289.19.2560.
    1. Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER, 3rd, Simons-Morton DG, Karanja N, Lin PH, for the DASH-Sodium Collaborative Research Group Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. N Engl J Med. 2001;344:3–10. doi: 10.1056/NEJM200101043440101.
    1. Cabana M, Rand C, Powe N, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999;282:1458–1465. doi: 10.1001/jama.282.15.1458.
    1. Walsh JM, McPhee SJ. A systems model of clinical preventive care: An analysis of factors influencing patient and physician. Health Educ Q. 1992;19:157–175.
    1. Bandura A. Social Foundations of Thought and Action: A Social Cognitive Theory. Englewood Cliffs, NJ: Prentice Hall; 1986.
    1. Prochaska J, DiClemente C. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983;51:390–395. doi: 10.1037/0022-006X.51.3.390.
    1. Ockene J, Zapka J. Changing provider behaviour: provider education and training. Tob Control. 1997;6:S63–S67. doi: 10.1136/tc.6.suppl_2.S49.
    1. Tamblyn R, Battista R. Changing clinical practice: which interventions work? J Contin Educ Health Prof. 1993;13:273–288. doi: 10.1002/chp.4750130403.
    1. Oxman A, Thomson M, Davis D, Haynes R. No magic bullets: a systematic review of 102 trials of interventions to improve professional practice. Can Med Assoc J. 1995;153:1423–1431.
    1. Wensing M, Weijden T Van Der, Grol R. Implementing guidelines and innovations in general practice: which interventions are effective? Br J Gen Pract. 1998;48:991–997.
    1. Watson DTR. Self-directed Behavior: Self-modification for Personal Adjustment. 5. Pacific Grove, CA: Brooks/Cole; 1989.
    1. Prochaska J, Velicer W, Rossi J, Goldstein MG, Marcus BH, Rakowski W, Fiore C, Harlow LL, Redding CA, Rosenbloom D. Stages of change and decisional balance for 12 problem behaviors. Health Psychol. 1994;13:39–46. doi: 10.1037/0278-6133.13.1.39.
    1. Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change. 2. New York, NY: The Guilford Press; 2002.
    1. Rollnick S, Miller W. What is motivational interviewing? Behav Cogn Psychother. 1995;23:325–334.
    1. Bandura A. Self-efficacy: The Exercise of Control. New York: W.H. Freeman; 1997.
    1. Svetkey L, Harsha D, Vollmer W, Stevens VJ, Obarzanek E, Elmer PJ, Lin PH, Champagne C, Simons-Morton DG, Aickin M, Proschan MA, Appel LJ. PREMIER: a clinical trial of comprehensive lifestyle modification for blood pressure control: rationale, design and baseline characteristics. Ann Epidemiol. 2003;13:462–471. doi: 10.1016/S1047-2797(03)00006-1.
    1. Elmer P, Grimm R, Jr, Laing B, Grandits G, Svendsen K, Van Heel N, Betz E, Raines J, Link M, Stamler J. Lifestyle intervention: results of the Treatment of Mild Hypertension Study (TOMHS) Prev Med. 1995;24:378–388. doi: 10.1006/pmed.1995.1062.
    1. Stampfer M, Hu F, Manson J, Rimm E, Willett W. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med. 2000;343:16–22. doi: 10.1056/NEJM200007063430103.
    1. Tuomilehto J, Lindstrom J, Eriksson J, Valle TT, Hämäläinen H, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M, Finnish Diabetes Prevention Study Group Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;344:1343–1350. doi: 10.1056/NEJM200105033441801.
    1. Block G, Hartman AM, Dresser CM, Carroll MD, Gannon J, Gardner L. A data-based approach to diet questionnaire design and testing. Am J Epidemiol. 1986;124:453–469.
    1. Westerterp KR. Assessment of physical activity level in relation to obesity: current evidence and research issues. Med Sci Sports Exerc. 1999;31:S522–S525.
    1. Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness. JAMA. 2002;288:1775–1779. doi: 10.1001/jama.288.14.1775.
    1. Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002;288:1909–1914. doi: 10.1001/jama.288.15.1909.
    1. Casalino L, Gillies RR, Shortell SM, Schmittdiel JA, Bodenheimer T, Robinson JC, Rundall T, Oswald N, Schauffler H, Wang MC. External incentives, information technology, and organized processes to improve health care quality for patients with chronic diseases. JAMA. 2003;289:434–441. doi: 10.1001/jama.289.4.434.
    1. Lenfant C. High blood pressure control: put the champagne away. J Clin Hypertens (Greenwich) 2002;4:391–392.
    1. Hyman D, Pavlik V. Characteristics of patients with uncontrolled hypertension in the United States. N Engl J Med. 2001;345:479–486. doi: 10.1056/NEJMoa010273.
    1. Hyman D, Pavlik V. Self-reported hypertension treatment practices among primary care physicians: blood pressure thresholds, drug choices, and the role of guidelines and evidence-based medicine. Arch Intern Med. 2000;160:2281–2286. doi: 10.1001/archinte.160.15.2281.
    1. Berlowitz D, Ash A, Hickey E, Friedman RH, Glickman M, Kader B, Moskowitz MA. Inadequate management of blood pressure in a hypertensive population. N Engl J Med. 1998;339:1957–1963. doi: 10.1056/NEJM199812313392701.
    1. Samsa G, Matchar D. Can continuous quality improvement be assessed using randomized trials? Health Serv Res. 2000;35:687–700.
    1. Matchar DB, Patwardhan MB, Samsa GP, Haley WE. Facilitated process improvement: an approach to the seamless linkage between evidence and practice in CKD. Am J Kidney Dis. 2006;47:528–538. doi: 10.1053/j.ajkd.2005.11.016.
    1. Appel LJ, Vollmer WM, Obarzanek E, Aicher KM, Conlin PR, Kennedy BM, Charleston JB, Reams PM. Recruitment and baseline characteristics of participants in the Dietary Approaches to Stop Hypertension trial. DASH Collaborative Research Group. J Am Diet Assoc. 1999;99:S69–S75. doi: 10.1016/S0002-8223(99)00419-8.
    1. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure The sixth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI) Arch Intern Med. 1997;157:2413–2446. doi: 10.1001/archinte.157.21.2413.
    1. Department of Veterans Administration, Department of Defense VA/DoD Clinical Practice Guideline for Diagnosis and Management of Hypertension in the Primary Care Setting Washington DC; 2004.
    1. National Kidney Foundation K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. Am J Kidney Dis. 2004;43:S1–S290.

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