The Kidney Awareness Registry and Education (KARE) study: protocol of a randomized controlled trial to enhance provider and patient engagement with chronic kidney disease

Delphine S Tuot, Alexandra Velasquez, Charles E McCulloch, Tanushree Banerjee, Yunnuo Zhu, Chi-yuan Hsu, Margaret Handley, Dean Schillinger, Neil R Powe, Delphine S Tuot, Alexandra Velasquez, Charles E McCulloch, Tanushree Banerjee, Yunnuo Zhu, Chi-yuan Hsu, Margaret Handley, Dean Schillinger, Neil R Powe

Abstract

Background: Chronic kidney disease (CKD) is common and is associated with excess mortality and morbidity. Better management could slow progression of disease, prevent metabolic complications, and reduce cardiovascular outcomes. Low patient awareness of CKD and ineffective patient-provider communication can impede such efforts. We developed provider and patient-directed interventions that harness health information technology to enhance provider recognition of CKD and delivery of guideline concordant care and augment patient understanding and engagement in CKD care.

Methods/design: We report the design and protocol of the Kidney Awareness Registry and Education (KARE) Study, a 2x2 factorial randomized controlled trial that examines the impact of a multi-level intervention on health outcomes among low-income English, Spanish and Cantonese-speaking patients with CKD in a safety net system. The intervention includes: (1) implementation of a primary care electronic CKD registry that notifies practice teams of patients' CKD status and employs a patient profile and quarterly feedback to encourage provision of guideline-concordant care at point-of-care and via outreach; and (2) a language-concordant, culturally-sensitive self-management support program that consists of automated telephone modules, provision of low-literacy written patient-educational materials and telephone health coaching. The primary outcomes of the trial are changes in systolic blood pressure (BP) and the proportion of patients with BP control (≤ 140/90 mmHg) after one year. Secondary outcomes include patient understanding of CKD, participation in healthy behaviors, and practice team delivery of guideline-concordant CKD care.

Discussion: Results from the KARE study will provide data on the feasibility, effectiveness, and acceptability of technology-based interventions that support primary care efforts at improving health outcomes among vulnerable patients with CKD.

Trial registration: ClinicalTrials.gov, number: NCT01530958.

Figures

Fig. 1
Fig. 1
KARE incorporates components of the Chronic Care Model and integrates with a patient-centered medical home to enhance health outcomes
Fig. 2
Fig. 2
KARE 2x2 factorial clinical randomized trial design
Fig. 3
Fig. 3
CKD-ATSM blends health technology with personalized education and counseling

References

    1. Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF, 3rd, Feldman HI, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604–12. doi: 10.7326/0003-4819-150-9-200905050-00006.
    1. Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004;351(13):1296–305. doi: 10.1056/NEJMoa041031.
    1. Merkin SS, Roux AV, Coresh J, Fried LF, Jackson SA, Powe NR. Individual and neighborhood socioeconomic status and progressive chronic kidney disease in an elderly population: the cardiovascular health study. Soc Sci Med. 2007;65(4):809–21. doi: 10.1016/j.socscimed.2007.04.011.
    1. McClellan WM, Newsome BB, McClure LA, Howard G, Volkova N, Audhya P, et al. Poverty and racial disparities in kidney disease: the REGARDS study. Am J Nephrol. 2010;32(1):38–46. doi: 10.1159/000313883.
    1. Tarver-Carr ME, Powe NR, Eberhardt MS, LaVeist TA, Kington RS, Coresh J, et al. Excess risk of chronic kidney disease among African-American versus white subjects in the United States: a population-based study of potential explanatory factors. J Am Soc Nephrol. 2002;13(9):2363–70. doi: 10.1097/01.ASN.0000026493.18542.6A.
    1. Hall YN, Choi AI, Chertow GM, Bindman AB. Chronic kidney disease in the urban poor. Clin J Am Soc Nephrol. 2010;5(5):828–35. doi: 10.2215/CJN.09011209.
    1. Hall YN, Rodriguez RA, Boyko EJ, Chertow GM, O’Hare AM. Characteristics of uninsured Americans with chronic kidney disease. J Gen Intern Med. 2009;24(8):917–22. doi: 10.1007/s11606-009-1028-3.
    1. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group. BMJ 1998, 317(7160):703–713.
    1. Brenner BM, Cooper ME, de Zeeuw D, Keane WF, Mitch WE, Parving HH, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001;345(12):861–9. doi: 10.1056/NEJMoa011161.
    1. Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345(12):851–60. doi: 10.1056/NEJMoa011303.
    1. Randomised placebo-controlled trial of effect of ramipril on decline in glomerular filtration rate and risk of terminal renal failure in proteinuric, non-diabetic nephropathy. The GISEN Group (Gruppo Italiano di Studi Epidemiologici in Nefrologia). Lancet 1997, 349(9069):1857–1863.
    1. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993, 329(14):977–986.
    1. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998, 352(9131):837–853.
    1. KDIGO Clinical practice guideline for the evaluation and management of chronic kidney disease. Summary of recommendation statements. Kidney Int Suppl 2013. 2012;3(1):5–14.
    1. Plantinga LC, Tuot DS, Powe NR. Awareness of chronic kidney disease among patients and providers. Adv Chronic Kidney Dis. 2010;17(3):225–36. doi: 10.1053/j.ackd.2010.03.002.
    1. Tuot D, Plantinga L, Judd S, Muntner P, Hsu C, Warnock DG, et al.. Health behaviors, risk factor control and awareness of chronic kidney disease. Am J Nephrol. In press. 2013.
    1. Tuot DS, Plantinga LC, Hsu CY, Jordan R, Burrows NR, Hedgeman E, et al. Chronic kidney disease awareness among individuals with clinical markers of kidney dysfunction. Clin J Am Soc Nephrol. 2011;6(8):1838–44. doi: 10.2215/CJN.00730111.
    1. Tahir MA, Dmitrieva O, de Lusignan S, van Vlymen J, Chan T, Golmohamad R, et al. Confidence and quality in managing CKD compared with other cardiovascular diseases and diabetes mellitus: a linked study of questionnaire and routine primary care data. BMC Fam Pract. 2011;12:83. doi: 10.1186/1471-2296-12-83.
    1. Costantini L, Beanlands H, McCay E, Cattran D, Hladunewich M, Francis D. The self-management experience of people with mild to moderate chronic kidney disease. Nephrol Nurs J. 2008;35(2):147–55.
    1. Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002;288(19):2469–75. doi: 10.1001/jama.288.19.2469.
    1. Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood) 2001;20(6):64–78. doi: 10.1377/hlthaff.20.6.64.
    1. American College of Physicians . The Patient-Centered Medical Home Neighbod: The Interface of the Patient Centered Medical Home With Specialty/Subspecialty Practices. Philadelphia, PA: American College of Physicians; 2010.
    1. Rich MW, Beckham V, Wittenberg C, Leven CL, Freedland KE, Carney RM. A multidisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. N Engl J Med. 1995;333(18):1190–5. doi: 10.1056/NEJM199511023331806.
    1. Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002;288(15):1909–14. doi: 10.1001/jama.288.15.1909.
    1. Halladay JR, Dewalt DA, Wise A, Qaqish B, Reiter K, Lee SY, et al. More extensive implementation of the chronic care model is associated with better lipid control in diabetes. J Am Board Fam Med. 2014;27(1):34–41. doi: 10.3122/jabfm.2014.01.130070.
    1. Volkova N, McClellan W, Klein M, Flanders D, Kleinbaum D, Soucie JM, et al. Neighborhood poverty and racial differences in ESRD incidence. J Am Soc Nephrol. 2008;19(2):356–64. doi: 10.1681/ASN.2006080934.
    1. Schillinger D. Literacy and health communication: reversing the ‘inverse care law’. Am J Bioeth. 2007;7(11):15–8. doi: 10.1080/15265160701638553.
    1. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of diet in renal disease study group. Ann Intern Med. 1999;130(6):461–70. doi: 10.7326/0003-4819-130-6-199903160-00002.
    1. McBride D, Dohan D, Handley MA, Powe NR, Tuot DS. Developing a CKD registry in primary care: provider attitudes and input. Am J Kidney Dis. 2013.
    1. Painter JE, Borba CP, Hynes M, Mays D, Glanz K. The use of theory in health behavior research from 2000 to 2005: a systematic review. Ann Behav Med. 2008;35(3):358–62. doi: 10.1007/s12160-008-9042-y.
    1. Glanz K, Rimer BK, Viswanath K. Health behavior and health education : theory, research, and practice. 4. San Francisco, CA: Jossey-Bass; 2008.
    1. Schillinger D, Handley M, Wang F, Hammer H. Effects of self-management support on structure, process, and outcomes among vulnerable patients with diabetes: a three-arm practical clinical trial. Diabetes Care. 2009;32(4):559–66. doi: 10.2337/dc08-0787.
    1. Tuot DS, Davis E, Velasquez A, Banerjee T, Powe NR. Assessment of printed patient-educational materials for chronic kidney disease. Am J Nephrol. 2013;38(3):184–94. doi: 10.1159/000354314.
    1. Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, et al. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the subcommittee of professional and public education of the american heart association council on high blood pressure research. Circulation. 2005;111(5):697–716. doi: 10.1161/01.CIR.0000154900.76284.F6.
    1. Boulware LE, Troll MU, Jaar BG, Myers DI, Powe NR. Identification and referral of patients with progressive CKD: a national study. Am J Kidney Dis. 2006;48(2):192–204. doi: 10.1053/j.ajkd.2006.04.073.
    1. Campbell C, Lockyer J, Laidlaw T, Macleod H. Assessment of a matched-pair instrument to examine doctor-patient communication skills in practising doctors. Med Educ. 2007;41(2):123–9. doi: 10.1111/j.1365-2929.2006.02657.x.
    1. Ware J, Jr, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–33. doi: 10.1097/00005650-199603000-00003.
    1. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24(1):67–74. doi: 10.1097/00005650-198601000-00007.
    1. Lorig K, Stewart AF, Ritter P, Gonzalez V, Laurent D, Lynch J. Outcome Measures for Health Education and Other Health Care Intervensions. Thousand Oaks, CA: Sage Publications; 1996.
    1. Behavioral Risk Factor Surveillance System Survey Questionnaire. In. Atlanta, Ceorgia: The U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC); 2011.
    1. Glasgow RE, Nelson CC, Strycker LA, King DK. Using RE-AIM metrics to evaluate diabetes self-management support interventions. Am J Prev Med. 2006;30(1):67–73. doi: 10.1016/j.amepre.2005.08.037.
    1. Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. 2009;169(19):1748–55. doi: 10.1001/archinternmed.2009.316.
    1. Inker LA, Astor BC, Fox CH, Isakova T, Lash JP, Peralta CA, et al. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for the evaluation and management of CKD. Am J Kidney Dis. 2014;63(5):713–35. doi: 10.1053/j.ajkd.2014.01.416.
    1. KDIGO Clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int. 2012;2013:3(1).
    1. Tuot DS, Plantinga LC, Hsu CY, Powe NR. Is awareness of chronic kidney disease associated with evidence-based guideline-concordant outcomes? Am J Nephrol. 2012;35(2):191–7. doi: 10.1159/000335935.
    1. Tuot DS, Powe NR. Chronic kidney disease in primary care: an opportunity for generalists. J Gen Intern Med. 2011;26(4):356–8. doi: 10.1007/s11606-011-1650-8.
    1. Tuot DS, Grubbs V. Chronic kidney disease care in the US safety Net. Adv Chronic Kidney Dis. 2015;22(1):66–73. doi: 10.1053/j.ackd.2014.05.006.
    1. Willard-Grace R, Chen EH, Hessler D, DeVore D, Prado C, Bodenheimer T, et al. Health coaching by medical assistants to improve control of diabetes, hypertension, and hyperlipidemia in low-income patients: a randomized controlled trial. Ann Fam Med. 2015;13(2):130–8. doi: 10.1370/afm.1768.

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