Alvin H. Moss, MD, FACP, FAAHPM Nephrology Care at the End of Life: New Guideline on Withholding and Withdrawing Dialysis Alvin H. Moss, MD, FACP, FAAHPM Section of Nephrology West Virginia University School of Medicine amoss@hsc.wvu.edu

Alvin H. Moss, MD has disclosed no relevant financial relationships.

Objectives Employ appropriate goals and management strategies for patients who are unable to proceed with rehabilitative renal replacement therapy Describe the 2nd edition of the Shared Decision-Making in the Appropriate Initiation of and Withdrawal from Dialysis guideline Apply the guideline recommendations to cases Explain an evidence-based approach to prognostication in dialysis patients

Differing Goals for Care Mr. Higgins (not his real name) is a 67 year-old man who has been on CCPD for several years for ESRD from diabetic nephropathy. His long-standing diabetes has been complicated by severe autonomic and peripheral neuropathy, gastroparesis, blindness, and peripheral vascular disease. Over the past two years he has had multiple prolonged hospitalizations. He is severally malnourished with a serum albumin of 2.0. He is bedridden due to the diabetic involvement of his nervous system. He becomes lightheaded on sitting and cannot stand. Multiple interventions have been tried to improve his appetite and energy level with no success.

He has been offered TPN and hospitalization for rehabilitation, but the patient has declined most interventions. He wants to stay at home. His care is exhausting to his wife. The home health agency feels they have little to offer him. He has stopped coming for patient dialysis visits because transportation is so difficult. The patient, his wife, and the nephrology team all know that the patient is slowly dying. He wants to die at home. He does not want to stop dialysis even though he knows his health is rapidly declining. What can be done to help Mr. Higgins and family?

Three Points Mr. Higgins’ goals for care are different than those of most dialysis patients. Patient-centered care for him would look different than for another dialysis patient. There is an available approach to achieve his goals for treatment, but it is not yet widely used in dialysis units.

Evidence-based 10 adult recommendations 9 pediatric recommendations Rationales and strategies for implementation for each Tool kit of validated instruments Available from RPA online store www.renalmd.org

Different Treatment Goals for ESRD Patients New in the guideline is the identification of distinctly different treatment goals for ESRD patients based on their overall condition and preferences: Patients who choose aggressive therapy with dialysis w/o limitations on other treatments-rehabilitative RRT Patients with a poor prognosis who choose dialysis but with limitations on other treatments such as CPR, intubation, and mechanical ventilation because they want to balance life prolongation and comfort Patients who decline dialysis and prefer that the primary goal of care be their comfort-active medical management

Providing Effective Palliative Care Recommendation No. 9 To improve patient-centered outcomes, offer palliative care services and interventions to all AKI, CKD, and ESRD patients who suffer from burdens of their disease. Recommendation No. 10 Use a systematic approach to communicate about diagnosis, prognosis, treatment options, and goals of care.

End-of-Life/ Hospice Care Alvin H. Moss, MD April 8, 2009 Relationship between Palliative Care and EOLC Palliative Care Hospice is a subset of palliative care – Palliative care is the discipline, hospice is a way of delivering palliative care to patients who are acknowledged to be dying and to their families. In the US, hospice care is most often delivered in the home. End-of-Life/ Hospice Care End-of-Life Care

What’s New in the Guideline The poor prognosis of some elderly stage 4 & stage 5 chronic kidney disease patients, many of whom are likely to die prior to initiation of dialysis or for whom dialysis may not provide a survival advantage over medical management without dialysis An online calculator to estimate prognosis in ESRD patients http://touchcalc.com/calculators/sq The identification of distinctly different treatment goals for ESRD patients based on their overall condition and preferences The frequent prevalence of cognitive impairment in dialysis patients

What’s New in the Guideline Recognition of advance care planning as the preferred approach for decision-making for patients who lose decision-making capacity The under treatment of pain in dialysis patients The underutilization of hospice in dialysis patients Strategies to assist nephrologists with communication challenges regarding prognosis and treatment options Recommendations with regard to pediatric dialysis decision-making

10 GUIDELINE STATEMENTS: 6 TOPICS #1 Establishing a shared decision-making relationship #2,#3 Informing patients #4 Facilitating advance care planning #5,#6 Making decisions about initiating and discontinuing dialysis #7,#8 Resolving conflicts about which dialysis decisions to make #9,#10 Providing effective palliative care

A 40 year-old woman with ESRD from diabetic nephropathy who had started dialysis 3 months earlier was found down and unresponsive at home. EMS was called. They noted a blood sugar of zero. The patient was given D50 but did not respond. She was transported to the local ED where a repeat blood sugar was undetectable. The patient was again given an amp of D50 and started on a D10W drip. Despite the drip, over the next 24 hours the patient required additional boluses of D50 to raise her low blood sugar. The patient did not awaken. Neurology consultants diagnosed an anoxic encephalopathy from prolonged hypoglycemia.

Workup for the patient’s coma included a CT scan which did not show an acute intracranial process and an EEG which showed diffuse generalized slowing with no response to photic, auditory, and tactile stimuli. EEG findings were suggestive of a diffuse encephalopathic pattern due to hypoxia, hypoglycemia, metabolic disturbance, or a toxic or infectious etiology. Despite her mother’s coma, the daughter who was appointed her healthcare surrogate continued to request all possible treatment including dialysis and wound care for large necrotic ulcers on both legs from calciphylaxis.

The patient’s exam did not change over the subsequent six weeks nor did the EEG findings. The neurology service thought the patient had a very poor prognosis but said it could take up to six months or longer to be sure that patient would not wake up. The treating nephrologist did not think that dialysis should be continued because of the patient’s “profound neurologic impairment such that she lacked signs of thought, sensation, purposeful behavior, and awareness of self and environment.”

Despite a series of meetings in which the patient’s diagnosis and prognosis were explained in complete detail to the daughter and family by the nephrologist and the palliative care consultant, the daughter insisted that her mother continue to be dialyzed. Other family members thought that the patient would not want to continue on dialysis in her present condition, but the daughter became quite emotional and said that it was up to her to fight for her mother. No other nephrologist in the hospital was willing to assume care of the patient and continue dialysis.

Audience Response Slide Should you… Continue dialysis as the daughter requests Stop dialysis because the patient is comatose Request an ethics consultation Seek a court order to stop dialysis

An ethics consultation was requested, and the ethics committee agreed with the recommendation to discontinue dialysis. When the daughter was given a week’s notice and informed that the dialysis would be discontinued at the end of the seventh week of hospitalization because the patient remained in a coma, she contacted an attorney. What should the treating nephrologist do?

PATIENT SAYS “NO” DIRECTLY PATIENT SAYS “NO” INDIRECTLY Recommendation No. 5 If appropriate, forgo (withhold initiation or withdraw ongoing) dialysis for patients with AKI, CKD, or ESRD in certain, well-defined situations: APPROPRIATE TO SAY “NO” PATIENT SAYS “NO” DIRECTLY Patients with decision-making capacity, who being fully informed and making voluntary choices, refuse dialysis or request that dialysis be discontinued PATIENT SAYS “NO” INDIRECTLY Patients who no longer possess decision-making capacity who have previously indicated refusal of dialysis in an oral or written advance directive PROXY SAYS “NO” Patients who no longer possess decision-making capacity and whose properly appointed legal agents/surrogates refuse dialysis or request that it be discontinued PROVIDERS SAY “NO” Patients with irreversible, profound neurological impairment such that they lack signs of thought, sensation, purposeful behavior, and awareness of self and environment.1,2 1J Am Soc Nephrol 1994;4(11):1879-83. 2N Engl J Med 1990;322(14):1012-5.

Resolving Conflicts about Which Dialysis Decisions to Make Recommendation No. 8 Establish a systematic due process approach for conflict resolution if there is disagreement about what decision should be made with regard to dialysis.

Systematic Approach to Resolving Conflict between Patient/Family and Kidney Care Team RPA guideline for Shared Decision-Making , 2nd ed. 2010

Systematic Approach to Resolving Conflict between Patient/Family and Kidney Care Team RPA guideline for Shared Decision-Making , 2nd ed. 2010

Audience Response Slide What should the nephrologist do now? Just keep dialyzing the patient Attempt to transfer care within the hospital Attempt to transfer care to another hospital Stop dialysis without further discussion

Conflict Resolution In following the process, the treating nephrologist contacted nephrologists throughout the state. No other nephrologist and hospital was willing to accept the patient and dialyze her. The daughter’s attorney sought a court order to force the hospital to continue dialyzing the patient. The judge ruled that the hospital only needed to continue dialysis for one more week to see if the family could find a nephrologist to dialyze the patient. He was influenced in his ruling by 1) the clinical practice guideline recommending against dialysis for a person in the patient’s condition, and 2) there was no other nephrologist who could be found who was willing to dialyze the patient.

Predictors of Poor Prognosis for ESRD Patients Age Functional ability Nutritional status Comorbid Illnesses–eg, DM, PVD RPA. Shared Decision-Making in the Appropriate Initiation of and Withdrawal from Dialysis. 2nd. 2010.

“Would I be surprised if this patient died in the next year?” The “Surprise” Question: A Trigger for Palliative Care Evaluation and Advance Care Planning “Would I be surprised if this patient died in the next year?” Moss A., et. al. Utility of the “Surprise” Question to Identify Dialysis Patients with High Mortality. Clin J Am Soc Nephrol 2008;3:1379-1384

http://touchcalc.com/calculators/sq Mortality Prediction for Mr. Higgins Cohen LM, Ruthazer R, Moss AH, Germain MJ. Predicting six-month mortality for patients who are on maintenance hemodialysis. Clin J Am Soc Nephrol. 2010 Jan;5(1):72-9. http://touchcalc.com/calculators/sq

French Renal Epidemiology and Information Network 6 Month Mortality Score Prediction Risk Factors Points BMI ≥ 18.5 < 18.5 2 Diabetes Absence Presence 1 CHF III/IV PVD III/IV Dysrhythmia Risk Factors Points Active malignancy Absence Presence 1 Severe behavioral disorder 2 Totally dependent for transfers 3 Initial context Planned Unplanned Couchoud C., et. al. Renal Epidemiology and information Network (REIN) registry. A clinical score to predict 6-month prognosis in elderly patients starting dialysis for end-stage renal disease. Nephrol Dial Transplant 2009; 24(5): 1553-61.

French REIN Six-Month Mortality Rates by Risk Score in the Derivation and Validation Samples Derivation Sample % Validation Sample % 0 Point 8 1 Point 10 2 Points 14 17 3-4 Points 26 21 5-6 Points 35 33 7-8 Points 51 50 ≥ 9 Points 62 70 All 19 Mr. Higgins’ score was 6 points! Couchoud C., et. al. Renal Epidemiology and information Network (REIN) registry. A clinical score to predict 6-month prognosis in elderly patients starting dialysis for end-stage renal disease. Nephrol Dial Transplant 2009; 24(5): 1553-61.

High Mortality Score 6 or 7 27% 1-yr http://www.ncbi.nlm.nih.gov/pmc/articles/PMC545968/

Reason to Consider Age > 75 “Most older members of this cohort [209,622 VA patients with stage 3 to 5 CKD], especially those ≥ 75 years, were far more likely to die than develop ESRD, even when their eGFR was severely reduced (15 to 29 ml/min per 1.73 m2).” O’Hare AM, et al. Age affects outcome in chronic kidney disease. J Am Soc Nephrol 2007;18:2758-2765.

Incident counts & adjusted rates, by age Figure 2.5 (Volume 2) Incident ESRD patients; rates adjusted for gender & race. 33

Comparative Survival of CKD Patients over 75 Years With and Without Dialysis Retrospective survival comparison N=129 > 75 1st and 2nd year survival better in dialysis group except in those with greatest comorbidity score Kaplan-Meier survival curves for those with high comorbidity (score=2), comparing 5 dialysis and conservative groups (log rank statistics <0.001, df 1, P=0.98). Murtagh. Nephrol Dial Transplant. 2007; 22(7):1955-62

Independent Predictors Study N Dialysis MM* Median survival Independent Predictors Age (yrs) GFR (ml/min) Smith 2003 321 258 63 RRT MM 8.3 vs. 6.3 mo=NS Age KPS Diabetes Mean 61.5 < 15 CG Joly 2003 144 107 37 RRT MM 28.9 vs. 8.9 months P<.001 KPS Social Isolation Late Referral Diabetes Low BMI Mean 83 Cut off ≥ 80 <10 CG Carson 2009 202 173 29 RRT MM 37.8 vs. 13.9 months P<.001 Age ≥70 Cut off ≤30 Murtagh 2007 129 52 77 RRT MM MM 18 months No survival advantage for RRT patients with high comorbidity score or ischemic heart disease. Age Comorbidity Ischemic Heart Disease >75 yrs < 15 Stage 5 Wong 2007 73 -- MM 23.4 months 1-yr survival 65% Comorbidity Median 79 yrs Median 12 Range (4-31) Ellam 2009 69 MM 21 months Serum albumin ≤3.5 g/dL Late referral Median 80 <15 MDRD *MM indicates active medical management without dialysis. Yrs indicates years. GFR indicates estimated glomerular filtration rate in milliliters per minute. RRT indicates renal replacement therapy. KPS indicates Karnofsky Performance Status score. CG indicates Cockcroft-Gault estimate. BMI indicates body mass index. MDRD indicates Modified Diet in Renal Disease study estimate. In the Smith 2003 study, survival of 10 patients who chose dialysis over medical management was not statistically significantly better than that of the 26 patients who chose medical management .

2 or more  Poor prognosis1,2,3 Recommendation No. 3: Informing patients All patients with AKI, stage 5 CKD or ESRD should receive patient-specific estimates of prognosis. 2 or more  Poor prognosis1,2,3 > 75 years High comorbidity scores (“No” to “Surprise” Question) (e.g., modified Charlson Comorbidity score > 8) Marked functional impairment (e.g., Karnofsky performance status score < 40) Severe chronic malnutrition (e.g., serum albumin level < 2.5 g/dL using the bromcresol green method). Diagnosis Options prognosis Patients in this population should be informed: Dialysis may not confer a survival advantage or improve functional status over medical management without dialysis Dialysis entails significant burdens which may detract from their quality of life. 1 Arnold RM, Zeidel ML. Dialysis in frail elders--a role for palliative care. N Engl J Med 2009;361(16):1597-8. 2 Murtagh FE, Marsh JE, Donohoe P, Ekbal NJ, Sheerin NS, Harris FE. Dialysis or not? A comparative survival study of patients over 75 years with chronic kidney disease stage 5. Nephrol Dial Transplant 2007;22(7):1955-62. 3 Halstenberg WK, Goormastic M, Paganini EP. Validity of four models for predicting outcome in critically ill acute renal failure patients. Clin Nephrol 1997;47(2):81-6.

Informed Consent for Elderly CKD Patients SHOULD INCLUDE: Dialysis may not confer a survival advantage Patients with this level of illness more likely to die than live long enough to progress to ESRD 1 The majority of patients in their condition die or succumb to significant functional decline during their first year on dialysis 2 Life on dialysis entails burdens likely to detract from their quality of life Surgery and complications for vascular access or peritoneal access placement Adverse physical symptoms on dialysis --dizziness, fatigue, and cramping, and a feeling of “unwellness” after dialysis. Travel time and expense to and from dialysis Long hours spent on dialysis  reduction in the time available for physical activity. Unnecessary “medicalization of death” Invasive and costly tests, procedures, and hospitalizations. 1 J Am Soc Nephrol 2007;18(10):2758-2765. 2J Am Soc Nephrol 2003;14(4):1012-21.

Think Mr. Higgins 50.6.1.4 – Coverage Under the Hospice Benefit Alvin H. Moss, MD April 8, 2009 50.6.1.4 – Coverage Under the Hospice Benefit (Rev. 1, 10-01-03) If the patient’s terminal condition is not related to ESRD, the patient may receive covered services under both the ESRD benefit and the hospice benefit. A patient does not need to stop dialysis treatment to receive care under the hospice benefit. Consequently, hospice agencies can provide hospice services to patients who wish to continue dialysis treatment. Think Mr. Higgins End-of-Life Care

Underutilization of Hospice in ESRD 2009 Dialysis Deaths Patients Number (%) Number (%) Using Hospice Withdrew from Dialysis 20,854 (26) 13,502 (65) Continued Dialysis 59,032 (74) 3,410 (6) TOTAL 79,886 (100) 16,912 (21) As this chart shows, 65% of patients who withdrew from dialysis in 2009 used hospice, compared to just 6% of patients who continued dialysis through death and used hospice. Overall, only 21% of all dialysis patients who died in 2009 used hospice. Standard Information Management System [Network database]. Midlothian, VA: Mid-Atlantic Renal Coalition; 2010.

Pain and ESRD A common and severe symptom Impairs quality of life Undertreated in 75% of ESRD patients* Lack of knowledge in nephrology community *Davison SN. Am J Kidney Dis, 42:1239-1247, 2003 *Barakzoy & Moss. J Am Soc Nephrol. 2006;17:3198-3203 *Bailie GR, et al. Kidney Int 2004:65:2419-2425

www.kidneyeol.org/painbrochure9.09.pdf

Alvin H. Moss, MD April 8, 2009 8.1 7.4 P < .001 P=0.110 1.5 1.8 Barakzoy & Moss. Efficacy of the WHO Analgesic Ladder to Treat Pain in ESRD. J Am Soc Nephrol 2006;17:3198-3203. End-of-Life Care

Tool kit in guideline with a number of validated instruments 30 symptoms Weisbord SD, et al. J Pain Symptom Manage 2004;27:226-240.

Contact the Kidney End of Life Coalition at kidneyeol@nw5.esrd.net For additional information, including resources for patients and families, visit www.kidneyeol.org Advance care planning information Do not resuscitate orders in the dialysis unit Access to hospice Clinician educational resources Contact the Kidney End of Life Coalition at kidneyeol@nw5.esrd.net

Conclusions There is a new 2nd edition of the RPA guideline on initiation and withdrawal of dialysis The guideline contains recommendations for adult and pediatric dialysis decision-making There is accumulating evidence to assist in prognosis prediction for ESRD patients There is a recognition that patients’ goals for care may differ and that palliative care and hospice may assist clinicians treating some AKI, CKD and ESRD patients Pain and symptoms can be adequately treated in dialysis patients but many nephrologists lack knowledge