Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial

Taylor L Stallings, Jennifer S Temel, Tamar A Klaiman, Michael K Paasche-Orlow, Margarita Alegria, Ann O'Hare, Nina O'Connor, Laura M Dember, Scott D Halpern, Nwamaka D Eneanya, Taylor L Stallings, Jennifer S Temel, Tamar A Klaiman, Michael K Paasche-Orlow, Margarita Alegria, Ann O'Hare, Nina O'Connor, Laura M Dember, Scott D Halpern, Nwamaka D Eneanya

Abstract

Introduction: Predialysis education for patients with advanced chronic kidney disease (CKD) typically focuses narrowly on haemodialysis and peritoneal dialysis as future treatment options. However, patients who are older or seriously ill may not want to pursue dialysis and/or may not benefit from this treatment. Conservative kidney management, a reasonable alternative treatment, and advance care planning (ACP) are often left out of patient education and shared decision-making. In this study, we will pilot an educational intervention (Conservative Kidney Management Options and Advance Care Planning Education-COPE) to improve knowledge of conservative kidney management and ACP among patients with advanced CKD who are older and/or have poor functional status.

Methods and analysis: This is a single-centre pilot randomised controlled trial at an academic centre in Philadelphia, PA. Eligible patients will have: age ≥70 years and/or poor functional status (as defined by Karnofsky Performance Index Score <70), advanced CKD (estimated glomerular filtration rate<20 mL/min/1.73 m2), prefer to speak English during clinical encounters and self-report as black or white race. Enrolled patients will be randomised 1:1, with stratification by race, to receive enhanced usual care or usual care and in-person education about conservative kidney management and ACP (COPE). The primary outcome is change in knowledge of CKM and ACP. We will also explore intervention feasibility and acceptability, change in communication of preferences and differences in the intervention's effects on knowledge and communication of preferences by race. We will assess outcomes at baseline, immediately post-education and at 2 and 12 weeks.

Ethics and dissemination: This protocol has been approved by the Institutional Review Board at the University of Pennsylvania. We will obtain written informed consent from all participants. The results from this work will be presented at academic conferences and disseminated through peer-reviewed journals.

Trial registration number: This trial is registered at ClinicalTrials.gov under NCT03229811.

Keywords: adult palliative care; chronic renal failure; end stage renal failure; geriatric medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Health belief model (adapted for COPE). ACP, advance are planning; CKM, conservative kidney management; COPE, Conservative Kidney Management Options and Advance Care Planning Education; KF, kidney failure.
Figure 2
Figure 2
Study flow chart. ACP, advance care planning; CKM, conservative kidney management; COPE, Conservative Kidney Management Options and Advance Care Planning Education; EOL, end-of-life;FACIT-SP-12, Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being; KF, kidney failure; KPS, Karnofsky Performance Index Score; MSPSS, Multidimensional Scale of Perceived Social Support; PAM, Patient Activation Measure; PSS-4, Perceived Stress Scale; QOL, McGill Quality of Life Questionnaire-Part A; REALM, Rapid Estimate of Adult Literacy in Medicine; SPMSQ, Short Portable Mental Status Questionnaire; YoDDA, Modified Yorkshire Dialysis Decision Aid.

References

    1. United States Renal Data System 2018 USRDS annual data report: epidemiology of kidney disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2018.
    1. Kurella M, Covinsky KE, Collins AJ, et al. . Octogenarians and nonagenarians starting dialysis in the United States. Ann Intern Med 2007;146:177–83. 10.7326/0003-4819-146-3-200702060-00006
    1. Kurella Tamura M, Covinsky KE, Chertow GM, et al. . Functional status of elderly adults before and after initiation of dialysis. N Engl J Med 2009;361:1539–47. 10.1056/NEJMoa0904655
    1. Weisbord SD, Fried LF, Arnold RM, et al. . Prevalence, severity, and importance of physical and emotional symptoms in chronic hemodialysis patients. J Am Soc Nephrol 2005;16:2487–94. 10.1681/ASN.2005020157
    1. McAdams-DeMarco MA, Law A, Salter ML. Frailty as a novel predictor of mortality and hospitalization in hemodialysis patients of all ages. J Am Geriatr Soc 2013;61:896–901.
    1. Verberne WR, Geers ABMT, Jellema WT, et al. . Comparative survival among older adults with advanced kidney disease managed conservatively versus with dialysis. Clin J Am Soc Nephrol 2016;11:633–40. 10.2215/CJN.07510715
    1. Pugh J, Aggett J, Goodland A, et al. . Frailty and comorbidity are independent predictors of outcome in patients referred for pre-dialysis education. Clin Kidney J 2016;9:324–9. 10.1093/ckj/sfv150
    1. Song M-K Quality of life of patients with advanced chronic kidney disease receiving conservative care without dialysis. Semin Dial 2016;29:165–9. 10.1111/sdi.12472
    1. Da Silva-Gane M, Wellsted D, Greenshields H, et al. . Quality of life and survival in patients with advanced kidney failure managed conservatively or by dialysis. Clin J Am Soc Nephrol 2012;7:2002–9. 10.2215/CJN.01130112
    1. Roshanravan B, Khatri M, Robinson-Cohen C, et al. . A prospective study of frailty in nephrology-referred patients with CKD. Am J Kidney Dis 2012;60:912–21. 10.1053/j.ajkd.2012.05.017
    1. Schmidt RJ, Landry DL, Cohen L, et al. . Derivation and validation of a prognostic model to predict mortality in patients with advanced chronic kidney disease. Nephrol Dial Transplant 2019;34:1517–25. 10.1093/ndt/gfy305
    1. Morton RL, Snelling P, Webster AC, et al. . Factors influencing patient choice of dialysis versus conservative care to treat end-stage kidney disease. CMAJ 2012;184:E277–83. 10.1503/cmaj.111355
    1. Foote C, Morton RL, Jardine M, et al. . Considerations of nephrologists when suggesting dialysis in elderly patients with renal failure (consider): a discrete choice experiment. Nephrol Dial Transplant 2014;29:2302–9. 10.1093/ndt/gfu257
    1. Tonkin-Crine S, Okamoto I, Leydon GM, et al. . Understanding by older patients of dialysis and conservative management for chronic kidney failure. Am J Kidney Dis 2015;65:443–50. 10.1053/j.ajkd.2014.08.011
    1. Eneanya ND, Paasche-Orlow MK, Volandes A. Palliative and end-of-life care in nephrology: moving from observations to interventions. Curr Opin Nephrol Hypertens 2017;26:327–34. 10.1097/MNH.0000000000000337
    1. Kurella Tamura M, Goldstein MK, Pérez-Stable EJ. Preferences for dialysis withdrawal and engagement in advance care planning within a diverse sample of dialysis patients. Nephrol Dial Transplant 2010;25:237–42. 10.1093/ndt/gfp430
    1. Fried TR, Redding CA, Robbins ML, et al. . Development of personalized health messages to promote engagement in advance care planning. J Am Geriatr Soc 2016;64:359–64. 10.1111/jgs.13934
    1. Eneanya ND, Wenger JB, Waite K, et al. . Racial disparities in end-of-life communication and preferences among chronic kidney disease patients. Am J Nephrol 2016;44:46–53. 10.1159/000447097
    1. Goff SL, Eneanya ND, Feinberg R, et al. . Advance care planning: a qualitative study of dialysis patients and families. Clin J Am Soc Nephrol 2015;10:390–400. 10.2215/CJN.07490714
    1. Sudore RL, Schickedanz AD, Landefeld CS, et al. . Engagement in multiple steps of the advance care planning process: a descriptive study of diverse older adults. J Am Geriatr Soc 2008;56:1006–13. 10.1111/j.1532-5415.2008.01701.x
    1. Detering KM, Hancock AD, Reade MC, et al. . The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ 2010;340:c1345. 10.1136/bmj.c1345
    1. Douglas C, Sloan J, Cathcart S. The impact of a renal supportive care service on symptom control, advance care planning and place of death for patients with advanced chronic kidney disease managed without dialysis. BJRM 2019;24:60–5.
    1. Greer JA, Pirl WF, Jackson VA, et al. . Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol 2012;30:394–400. 10.1200/JCO.2011.35.7996
    1. Temel JS, Greer JA, Admane S, et al. . Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol 2011;29:2319–26. 10.1200/JCO.2010.32.4459
    1. Braddock CH, Edwards KA, Hasenberg NM, et al. . Informed decision making in outpatient practice: time to get back to basics. JAMA 1999;282:2313–20. 10.1001/jama.282.24.2313
    1. Mack JW, Cronin A, Taback N, et al. . End-Of-Life care discussions among patients with advanced cancer: a cohort study. Ann Intern Med 2012;156:204–10. 10.7326/0003-4819-156-3-201202070-00008
    1. Davison SN End-Of-Life care preferences and needs: perceptions of patients with chronic kidney disease. Clin J Am Soc Nephrol 2010;5:195–204. 10.2215/CJN.05960809
    1. Moss AH Revised dialysis clinical practice guideline promotes more informed decision-making. Clin J Am Soc Nephrol 2010;5:2380–3. 10.2215/CJN.07170810
    1. Moss AH Ethical principles and processes guiding dialysis decision-making. Clin J Am Soc Nephrol 2011;6:2313–7. 10.2215/CJN.03960411
    1. Kurella Tamura M, Meier DE. Five policies to promote palliative care for patients with ESRD. Clin J Am Soc Nephrol 2013;8:1783–90. 10.2215/CJN.02180213
    1. Song M-K, Ward SE, Lin F-C, et al. . Racial differences in outcomes of an advance care planning intervention for dialysis patients and their surrogates. J Palliat Med 2016;19:134–42. 10.1089/jpm.2015.0232
    1. Thomas BA, Rodriguez RA, Boyko EJ, et al. . Geographic variation in black-white differences in end-of-life care for patients with ESRD. Clin J Am Soc Nephrol 2013;8:1171–8. 10.2215/CJN.06780712
    1. Eneanya ND, Olaniran K, Xu D, et al. . Health literacy mediates racial disparities in cardiopulmonary resuscitation knowledge among chronic kidney disease patients. J Health Care Poor Underserved 2018;29:1069–82. 10.1353/hpu.2018.0080
    1. Rosenstock IM, Strecher VJ, Becker MH. Social learning theory and the health belief model. Health Educ Q 1988;15:175–83. 10.1177/109019818801500203
    1. Eneanya ND, Labbe AK, Stallings TL, et al. . Caring for older patients with advanced chronic kidney disease and considering their needs: a qualitative study. BMC Nephrol 2020;21:213. 10.1186/s12882-020-01870-1
    1. Institute of Medicine (US) Committee on Health Literacy Nielsen-Bohlman L, Panzer AM, Kindig DA, Health literacy: a prescription to end confusion. US: National Academies Press, 2004.
    1. Levey AS, Bosch JP, Lewis JB, et al. . 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;130:461–70. 10.7326/0003-4819-130-6-199903160-00002
    1. Pfeiffer E A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc 1975;23:433–41. 10.1111/j.1532-5415.1975.tb00927.x
    1. Winterbottom AE, Gavaruzzi T, Mooney A, et al. . Patient acceptability of the Yorkshire dialysis decision aid (YODDA) booklet: a prospective Non-Randomized comparison study across 6 predialysis services. Perit Dial Int 2016;36:374–81. 10.3747/pdi.2014.00274
    1. The National Kidney Foundation If you choose not to start dialysis treatment, 2008. Available: [Accessed 15 Apr 2020].
    1. Connors AF, Dawson NV, Desbiens NA. A controlled trial to improve care for seriously ill hospitalized patients. the study to understand prognoses and preferences for outcomes and risks of treatments (support). The support principal Investigators. JAMA 1995;274:1591–8.
    1. Cavanaugh KL, Wingard RL, Hakim RM, et al. . Low health literacy associates with increased mortality in ESRD. J Am Soc Nephrol 2010;21:1979–85. 10.1681/ASN.2009111163
    1. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. conceptual framework and item selection. Med Care 1992;30:473–83.
    1. Wight JP, Edwards L, Brazier J, et al. . The SF36 as an outcome measure of services for end stage renal failure. Qual Health Care 1998;7:209–21. 10.1136/qshc.7.4.209
    1. Peterman AH, Fitchett G, Brady MJ, et al. . Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy--Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med 2002;24:49–58. 10.1207/S15324796ABM2401_06
    1. Taylor JM Psychometric analysis of the Ten-Item perceived stress scale. Psychol Assess 2015;27:90–101. 10.1037/a0038100
    1. Cohen SR, Mount BM, Bruera E, et al. . Validity of the McGill quality of life questionnaire in the palliative care setting: a multi-centre Canadian study demonstrating the importance of the existential domain. Palliat Med 1997;11:3–20. 10.1177/026921639701100102
    1. Prakash S, McGrail A, Lewis SA, et al. . Behavioral stage of change and dialysis decision-making. Clin J Am Soc Nephrol 2015;10:197–204. 10.2215/CJN.05560614
    1. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003;41:582–92. 10.1097/01.MLR.0000062554.74615.4C
    1. Cohen J Statistical power analysis for the behavioral sciences. Taylor and Francis, 2013.
    1. Saeed F, Adams H, Epstein RM. Matters of life and death: why do older patients choose conservative management? Am J Nephrol 2020;51:35–42. 10.1159/000504692
    1. Saeed F, Sardar M, Rasheed K, et al. . Dialysis decision making and preferences for end-of-life care: perspectives of Pakistani patients receiving maintenance dialysis. J Pain Symptom Manage 2020;60:336–45. 10.1016/j.jpainsymman.2020.03.009
    1. Verberne WR, Konijn WS, Prantl K, et al. . Older patients' experiences with a shared decision-making process on choosing dialysis or conservative care for advanced chronic kidney disease: a survey study. BMC Nephrol 2019;20:264. 10.1186/s12882-019-1423-x
    1. Saeed F, Sardar MA, Davison SN, et al. . Patients' perspectives on dialysis decision-making and end-of-life care. Clin Nephrol 2019;91:294–300. 10.5414/CN109608
    1. Kazley AS, Johnson E, Simpson K, et al. . African American patient knowledge of kidney disease: a qualitative study of those with advanced chronic kidney disease. Chronic Illn 2015;11:245–55. 10.1177/1742395314556658
    1. Grubbs V, Gregorich SE, Perez-Stable EJ, et al. . Health literacy and access to kidney transplantation. Clin J Am Soc Nephrol 2009;4:195–200. 10.2215/CJN.03290708
    1. Song M-K, Ward SE, Fine JP, et al. . Advance care planning and end-of-life decision making in dialysis: a randomized controlled trial targeting patients and their surrogates. Am J Kidney Dis 2015;66:813–22. 10.1053/j.ajkd.2015.05.018

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