Video Images about Decisions for Ethical Outcomes in Kidney Disease (VIDEO-KD): the study protocol for a multi-centre randomised controlled trial

Nwamaka D Eneanya, Joshua R Lakin, Michael K Paasche-Orlow, Charlotta Lindvall, Edward T Moseley, Lori Henault, Amresh D Hanchate, Ernest I Mandel, Susan P Y Wong, Sophia N Zupanc, Aretha Delight Davis, Areej El-Jawahri, Lisa M Quintiliani, Yuchiao Chang, Sushrut S Waikar, Amar D Bansal, Jane O Schell, Andrew L Lundquist, Manjula Kurella Tamura, Margaret K Yu, Mark L Unruh, Christos Argyropoulos, Michael J Germain, Angelo Volandes, Nwamaka D Eneanya, Joshua R Lakin, Michael K Paasche-Orlow, Charlotta Lindvall, Edward T Moseley, Lori Henault, Amresh D Hanchate, Ernest I Mandel, Susan P Y Wong, Sophia N Zupanc, Aretha Delight Davis, Areej El-Jawahri, Lisa M Quintiliani, Yuchiao Chang, Sushrut S Waikar, Amar D Bansal, Jane O Schell, Andrew L Lundquist, Manjula Kurella Tamura, Margaret K Yu, Mark L Unruh, Christos Argyropoulos, Michael J Germain, Angelo Volandes

Abstract

Introduction: Older patients with advanced chronic kidney disease (CKD) often are inadequately prepared to make informed decisions about treatments including dialysis and cardiopulmonary resuscitation. Further, evidence shows that patients with advanced CKD do not commonly engage in advance care planning (ACP), may suffer from poor quality of life, and may be exposed to end-of-life care that is not concordant with their goals. We aim to study the effectiveness of a video intervention on ACP, treatment preferences and other patient-reported outcomes.

Methods and analysis: The Video Images about Decisions for Ethical Outcomes in Kidney Disease trial is a multi-centre randomised controlled trial that will test the effectiveness of an intervention that includes a CKD-related video decision aid followed by recording personal video declarations about goals of care and treatment preferences in older adults with advancing CKD. We aim to enrol 600 patients over 5 years at 10 sites.

Ethics and dissemination: Regulatory and ethical aspects of this trial include a single Institutional Review Board mechanism for approval, data use agreements among sites, and a Data Safety and Monitoring Board. We intend to disseminate findings at national meetings and publish our results.

Trial registration number: NCT04347629.

Keywords: chronic renal failure; dialysis; end stage renal failure; geriatric medicine; nephrology.

Conflict of interest statement

Competing interests: NE is a scientific advisor for Somatus and Davita. MKT has received honoraria from the American Federation of Aging Research and serves as Associate Editor at CJASN. Views expressed are those of the authors and not necessarily those of the Department of Veterans Affairs. AV has a financial interest in ACP decisions, a non-profit organisation developing advance care planning video decision support tools. AV’s interests were reviewed and are managed by MGH and Mass General Brigham in accordance with their conflict-of-interest policies. No other disclosures to report.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Sample sizes needed to distinguish utility differences for quality of life.

References

    1. Sudore RL, Lum HD, You JJ, et al. . Defining advance care planning for adults: a consensus definition from a multidisciplinary Delphi panel. J Pain Symptom Manage 2017;53:821–32. 10.1016/j.jpainsymman.2016.12.331
    1. Sudore RL, Fried TR. Redefining the “planning” in advance care planning: preparing for end-of-life decision making. Ann Intern Med 2010;153:256–61. 10.7326/0003-4819-153-4-201008170-00008
    1. Mack JW, Weeks JC, Wright AA, et al. . End-Of-Life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol 2010;28:1203–8. 10.1200/JCO.2009.25.4672
    1. Wright AA, et al. . Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA 2008;300:1665–73. 10.1001/jama.300.14.1665
    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. Davison SN, Simpson C. Hope and advance care planning in patients with end stage renal disease: qualitative interview study. BMJ 2006;333:886. 10.1136/bmj.38965.626250.55
    1. Brinkman-Stoppelenburg A, Rietjens JAC, van der Heide A. The effects of advance care planning on end-of-life care: a systematic review. Palliat Med 2014;28:1000–25. 10.1177/0269216314526272
    1. Ahronheim JC, Morrison RS, Baskin SA. Treatment of the dying in the acute care hospital. advanced dementia and metastatic cancer. Arch Intern Med 1996;156:2094–100.
    1. Bernacki RE, Block SD, American College of Physicians High Value Care Task Force . Communication about serious illness care goals: a review and synthesis of best practices. JAMA Intern Med 2014;174:1994–2003. 10.1001/jamainternmed.2014.5271
    1. Mitchell SL, Kiely DK, Hamel MB. Dying with advanced dementia in the nursing home. Arch Intern Med 2004;164:321–6. 10.1001/archinte.164.3.321
    1. Mitchell SL, Teno JM, Kiely DK, et al. . The clinical course of advanced dementia. N Engl J Med 2009;361:1529–38. 10.1056/NEJMoa0902234
    1. Thorne SE, Bultz BD, Baile WF, et al. . Is there a cost to poor communication in cancer care?: a critical review of the literature. Psychooncology 2005;14:875–84. 10.1002/pon.947
    1. Advance directives and advance care planning: report to Congress 2008.
    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. Ladin K, Neckermann I, D'Arcangelo N, et al. . Advance care planning in older adults with CKD: patient, care partner, and clinician perspectives. J Am Soc Nephrol 2021;32:1527–35. 10.1681/ASN.2020091298
    1. Oskoui T, Pandya R, Weiner DE, et al. . Advance care planning among older adults with advanced non–dialysis-dependent CKD and their care partners: perceptions versus reality? Kidney Med 2020;2:116–24. 10.1016/j.xkme.2019.11.002
    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. Davison SN, Moss AH. Supportive care: meeting the needs of patients with advanced chronic kidney disease. Clin J Am Soc Nephrol 2016;11:1879–80. 10.2215/CJN.06800616
    1. Davison SN, Levin A, Moss AH, et al. . Executive summary of the KDIGO controversies conference on supportive care in chronic kidney disease: developing a roadmap to improving quality care. Kidney Int 2015;88:447–59. 10.1038/ki.2015.110
    1. Shah KK, Murtagh FEM, McGeechan K, et al. . Quality of life among caregivers of people with end-stage kidney disease managed with dialysis or comprehensive conservative care. BMC Nephrol 2020;21:160. 10.1186/s12882-020-01830-9
    1. USRDS . 2019 annual data report: atlas of chronic kidney disease and end-stage renal disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Disease, 2019.
    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. Wachterman MW, O'Hare AM, Rahman O-K, et al. . One-year mortality after dialysis initiation among older adults. JAMA Intern Med 2019;179:987. 10.1001/jamainternmed.2019.0125
    1. O'Hare AM, Choi AI, Bertenthal D, et al. . Age affects outcomes in chronic kidney disease. J Am Soc Nephrol 2007;18:2758–65. 10.1681/ASN.2007040422
    1. Al-Wahsh H, Tangri N, Quinn R, et al. . Accounting for the competing risk of death to predict kidney failure in adults with stage 4 chronic kidney disease. JAMA Netw Open 2021;4:e219225. 10.1001/jamanetworkopen.2021.9225
    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 Overseas Ed 2009;361:1539–47. 10.1056/NEJMoa0904655
    1. Brown MA, Collett GK, Josland EA, et al. . CKD in elderly patients managed without dialysis: survival, symptoms, and quality of life. Clin J Am Soc Nephrol 2015;10:260–8. 10.2215/CJN.03330414
    1. Carson RC, Juszczak M, Davenport A, et al. . Is maximum conservative management an equivalent treatment option to dialysis for elderly patients with significant comorbid disease? Clin J Am Soc Nephrol 2009;4:1611–9. 10.2215/CJN.00510109
    1. Wong SPY, Kreuter W, Curtis JR, et al. . Trends in in-hospital cardiopulmonary resuscitation and survival in adults receiving maintenance dialysis. JAMA Intern Med 2015;175:1028–35. 10.1001/jamainternmed.2015.0406
    1. Renal Physicians Association, American Society of Nephrology Working Group . A new clinical practice guideline on initiation and withdrawal of dialysis that makes explicit the role of palliative medicine. J Palliat Med 2000;3:253–60. 10.1089/jpm.2000.3.253
    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. Burns RB, Waikar SS, Wachterman MW, et al. . Management options for an older adult with advanced chronic kidney disease and dementia: grand rounds discussion from Beth Israel Deaconess medical center. Ann Intern Med 2020;173:217–25. 10.7326/M20-2640
    1. O'Hare AM, Song M-K, Kurella Tamura M, et al. . Research priorities for palliative care for older adults with advanced chronic kidney disease. J Palliat Med 2017;20:453–60. 10.1089/jpm.2016.0571
    1. Tulsky JA. Improving quality of care for serious illness: findings and recommendations of the Institute of medicine report on dying in America. JAMA Intern Med 2015;175:840–1. 10.1001/jamainternmed.2014.8425
    1. Wong SPY, McFarland LV, Liu C-F, et al. . Care practices for patients with advanced kidney disease who forgo maintenance dialysis. JAMA Intern Med 2019;179:305. 10.1001/jamainternmed.2018.6197
    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. Karlin J, Chesla CA, Grubbs V. Dialysis or death: a qualitative study of older patients' and their families' understanding of kidney failure treatment options in a US public hospital setting. Kidney Med 2019;1:124–30. 10.1016/j.xkme.2019.04.003
    1. Eneanya ND, Percy SG, Stallings TL, et al. . Use of a supportive kidney care video decision aid in older patients: a randomized controlled trial. Am J Nephrol 2020;51:736–44. 10.1159/000509711
    1. In: dying in America: improving quality and honoring individual preferences near the end of life. Washington DC: 2015 by the National Academy of sciences 2015.
    1. Tulsky JA. Interventions to enhance communication among patients, providers, and families. J Palliat Med 2005;8:s-95–s-101. 10.1089/jpm.2005.8.s-95
    1. Gillick MR. Advance care planning. N Engl J Med Overseas Ed 2004;350:7–8. 10.1056/NEJMp038202
    1. Moss AH, Hozayen O, King K, et al. . Attitudes of patients toward cardiopulmonary resuscitation in the dialysis unit. Am J Kidney Dis 2001;38:847–52. 10.1053/ajkd.2001.27705
    1. Volandes AE, Barry MJ, Chang Y, et al. . Improving decision making at the end of life with video images. Med Decis Making 2010;30:29–34. 10.1177/0272989X09341587
    1. Volandes AE, Kennedy WJ, Davis AD, et al. . The new tools: what 21st century education can teach us. Healthc 2013;1:79–81. 10.1016/j.hjdsi.2013.07.011
    1. Volandes AE, Paasche-Orlow M, Gillick MR, et al. . Health literacy not race predicts end-of-life care preferences. J Palliat Med 2008;11:754–62. 10.1089/jpm.2007.0224
    1. Periyakoil VS, Kraemer H, Neri E. Multi-Ethnic attitudes toward physician-assisted death in California and Hawaii. J Palliat Med 2016;19:1060–5. 10.1089/jpm.2016.0160
    1. El-Jawahri A, Mitchell SL, Paasche-Orlow MK, et al. . A randomized controlled trial of a CPR and intubation video decision support tool for hospitalized patients. J Gen Intern Med 2015;30:1071–80. 10.1007/s11606-015-3200-2
    1. Volandes AE, Paasche-Orlow MK, Mitchell SL, et al. . Randomized controlled trial of a video decision support tool for cardiopulmonary resuscitation decision making in advanced cancer. J Clin Oncol 2013;31:380–6. 10.1200/JCO.2012.43.9570
    1. El-Jawahri A, Paasche-Orlow MK, Matlock D, et al. . Randomized, controlled trial of an advance care planning video decision support tool for patients with advanced heart failure. Circulation 2016;134:52–60. 10.1161/CIRCULATIONAHA.116.021937
    1. El-Jawahri A, Podgurski LM, Eichler AF, et al. . Use of video to facilitate end-of-life discussions with patients with cancer: a randomized controlled trial. J Clin Oncol 2010;28:305–10. 10.1200/JCO.2009.24.7502
    1. Volandes AE, Ariza M, Abbo ED, et al. . Overcoming educational barriers for advance care planning in Latinos with video images. J Palliat Med 2008;11:700–6. 10.1089/jpm.2007.0172
    1. Volandes AE, Brandeis GH, Davis AD, et al. . A randomized controlled trial of a goals-of-care video for elderly patients admitted to skilled nursing facilities. J Palliat Med 2012;15:805–11. 10.1089/jpm.2011.0505
    1. Volandes AE, Ferguson LA, Davis AD, et al. . Assessing end-of-life preferences for advanced dementia in rural patients using an educational video: a randomized controlled trial. J Palliat Med 2011;14:169–77. 10.1089/jpm.2010.0299
    1. Volandes AE, Lehmann LS, Cook EF. Using video images of dementia in advance care planning. Arch Intern Med 2007;167:828–33. 10.1001/archinte.167.8.828
    1. Volandes AE, Levin TT, Slovin S, et al. . Augmenting advance care planning in poor prognosis cancer with a video decision aid: a preintervention-postintervention study. Cancer 2012;118:4331–8. 10.1002/cncr.27423
    1. Volandes AE, Paasche-Orlow MK, Barry MJ, et al. . Video decision support tool for advance care planning in dementia: randomised controlled trial. BMJ 2009;338:b2159. 10.1136/bmj.b2159
    1. Volandes AE, Paasche-Orlow MK, Davis AD, et al. . Use of Video Decision Aids to Promote Advance Care Planning in Hilo, Hawai‘i. J Gen Intern Med 2016;31:1035–40. 10.1007/s11606-016-3730-2
    1. Sudore RL, Boscardin J, Feuz MA, et al. . Effect of the prepare website vs an Easy-to-Read advance Directive on advance care planning documentation and engagement among veterans: a randomized clinical trial. JAMA Intern Med 2017;177:1102. 10.1001/jamainternmed.2017.1607
    1. Epstein AS, Volandes AE, Chen LY, et al. . A randomized controlled trial of a cardiopulmonary resuscitation video in advance care planning for progressive pancreas and hepatobiliary cancer patients. J Palliat Med 2013;16:623–31. 10.1089/jpm.2012.0524
    1. Quintiliani LM, Murphy JE, Buitron de la Vega P, et al. . Feasibility and patient perceptions of video Declarations regarding end-of-life decisions by hospitalized patients. J Palliat Med 2018;21:766–72. 10.1089/jpm.2017.0351
    1. Schell JO, Cohen RA. Communication strategies to address conflict about dialysis decision making for critically ill patients. Clin J Am Soc Nephrol 2018;13:1248–50. 10.2215/CJN.00010118
    1. Mandel EI, Bernacki RE, Block SD. Serious illness conversations in ESRD. Clin J Am Soc Nephrol 2017;12:854–63. 10.2215/CJN.05760516
    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. Parvez S, Abdel-Kader K, Pankratz VS, et al. . Provider knowledge, attitudes, and practices surrounding conservative management for patients with advanced CKD. Clin J Am Soc Nephrol 2016;11:812–20. 10.2215/CJN.07180715
    1. Bradshaw CL, Gale RC, Chettiar A, et al. . Medical record documentation of goals-of-care discussions among older veterans with incident kidney failure. Am J Kidney Dis 2020;75:744–52. 10.1053/j.ajkd.2019.07.024
    1. Oestreich T, Sayre G, O'Hare AM. Perspectives on conservative care in advanced kidney disease: a qualitative study of US patients and family members. Am J Kidney Dis 2021;77:355–64. 10.1053/j.ajkd.2020.07.026
    1. Gelfand SL, Mandel EI, Mendu ML, et al. . Palliative care in the advancing American kidney health Initiative: a call for inclusion in kidney care delivery models. Am J Kidney Dis 2020;76:877–82. 10.1053/j.ajkd.2020.07.022
    1. Lakin JR, Robinson MG, Bernacki RE, et al. . Estimating 1-year mortality for high-risk primary care patients using the surprise question. JAMA Intern Med 2016;176:1863–5. 10.1001/jamainternmed.2016.5928
    1. Lakin JR, Robinson MG, Obermeyer Z, et al. . Prioritizing primary care patients for a communication intervention using the “surprise question”: a prospective cohort study. J Gen Intern Med 2019;34:1467–74. 10.1007/s11606-019-05094-4
    1. Salat H, Javier A, Siew ED, et al. . Nephrology provider prognostic perceptions and care delivered to older adults with advanced kidney disease. Clinical J Am Soc Nephrol 2017;12:1762–70. 10.2215/CJN.03830417
    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. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Lakin JR, Brannen EN, Tulsky JA, et al. . Advance care planning: promoting effective and aligned communication in the elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer. BMJ Open 2020;10:e040999. 10.1136/bmjopen-2020-040999
    1. Volandes AE, Barry MJ, Wood F, et al. . Audio-video decision support for patients: the documentary genré as a basis for decision AIDS. Health Expect 2013;16:e80–8. 10.1111/j.1369-7625.2011.00727.x
    1. Sudore RL, Heyland DK, Barnes DE, et al. . Measuring advance care planning: optimizing the advance care planning engagement survey. J Pain Symptom Manage 2017;53:669–81. 10.1016/j.jpainsymman.2016.10.367
    1. Hays RD, Kallich JD, Mapes DL, et al. . Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res 1994;3:329–38. 10.1007/BF00451725
    1. Davis S, Mohan S. Managing patients with failing kidney allograft: many questions remain. Clin J Am Soc Nephrol 2022;17:444–51. 10.2215/CJN.14620920
    1. O'Connor AM. Validation of a decisional conflict scale. Med Decis Making 1995;15:25–30. 10.1177/0272989X9501500105
    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. Volandes AE, Mitchell SL, Gillick MR, et al. . Using video images to improve the accuracy of surrogate decision-making: a randomized controlled trial. J Am Med Dir Assoc 2009;10:575–80. 10.1016/j.jamda.2009.05.006
    1. Nichols GA, Ustyugova A, Déruaz-Luyet A, et al. . Health care costs by type of expenditure across eGFR stages among patients with and without diabetes, cardiovascular disease, and heart failure. J Am Soc Nephrol 2020;31:1594–601. 10.1681/ASN.2019121308
    1. Donner A, Klar N. Statistical considerations in the design and analysis of community intervention trials. J Clin Epidemiol 1996;49:435–9. 10.1016/0895-4356(95)00511-0
    1. Lindvall C, Lilley EJ, Zupanc SN, et al. . Natural language processing to assess end-of-life quality indicators in cancer patients receiving palliative surgery. J Palliat Med 2019;22:183–7. 10.1089/jpm.2018.0326
    1. Poort H, Zupanc SN, Leiter RE, et al. . Documentation of palliative and end-of-life care process measures among young adults who died of cancer: a natural language processing approach. J Adolesc Young Adult Oncol 2020;9:100–4. 10.1089/jayao.2019.0040
    1. Udelsman BV, Lilley EJ, Qadan M, et al. . Deficits in the palliative care process measures in patients with advanced pancreatic cancer undergoing operative and invasive Nonoperative palliative procedures. Ann Surg Oncol 2019;26:4204–12. 10.1245/s10434-019-07757-2
    1. Lindvall C, Deng CY, Moseley E. Natural language processing to identify advance care planning documentation in a multisite pragmatic clinical trial. J Pain Symptom Manage 2021.
    1. Lakin JR, Gundersen DA, Lindvall C, et al. . A yet Unrealized promise: structured advance care planning elements in the electronic health record. J Palliat Med 2021;24:1221–5. 10.1089/jpm.2020.0774
    1. Donner A, Klar N. Design and analysis of cluster randomization trials in health research. London: Arnold, 2000.
    1. Liem YS, Bosch JL, Hunink MGM. Preference-based quality of life of patients on renal replacement therapy: a systematic review and meta-analysis. Value Health 2008;11:733–41. 10.1111/j.1524-4733.2007.00308.x
    1. Briggs AH, Mooney CZ, Wonderling DE. Constructing confidence intervals for cost-effectiveness ratios: an evaluation of parametric and non-parametric techniques using Monte Carlo simulation. Stat Med 1999;18:3245–62. 10.1002/(SICI)1097-0258(19991215)18:23<3245::AID-SIM314>;2-2
    1. Drummond MF, Sculpher MJ, Claxton K. Methods for the economic evaluation of health care programmes. New York, NY: Oxford University Press, 2015.
    1. Lincoln Y, Guba E. Naturalistic inquiry. 117. SAGE Publications, 1985.
    1. Bradley EH, Curry LA, Devers KJ. Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res 2007;42:1758–72. 10.1111/j.1475-6773.2006.00684.x
    1. Creswell JW. Qualitative inquiry and research design: choosing among five approaches. SAGE Publications, 2012.

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