Ethics Surrounding Advanced Therapies. Leslie Macho CNP, RNFA
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1 Ethics Surrounding Advanced Therapies. Leslie Macho CNP, RNFA There are no conflicts of interest or relevant financial interests in making this presentation and have indicated that my presentation does not include discussion of an unlabeled use of a commercial product, or an investigational use not yet approved for any purpose. Palliative Care Abbott-Northwestern Hospital Allina Objectives Examples of Current Advanced Therapies: 1. To define common ethical challenges of advanced therapies upon society, patients, families and medical staff. 2. What is a medical futility dispute? 3. Explore the role of palliative care and ethics in advanced therapies 4. Case study 5. How do we keep our minds open to new technological advancements in therapy? ECMO: Extracoporial membrane oxygenator venous or arterial. Artificial Ventricular Assist Devices: Left and right sided devices, multiple manufacturers Total Artificial Heart TAVR: Transaortic Valve replacement TMVR-Trans-mitral Valve replacement Experimental Chemotherapies for Cancers Deep Brain Stimulation: Epilepsy, Parkinson s, nonessential tremor, chronic pain, obsessive compulsive disorder. Deep brain stimulation is also being studied as an experimental treatment for major depression, stroke recovery, addiction and dementia. Kidney Dialysis Long Term Ventilator Support New Therapies Beginning Clinical Trials: ELAD Bio-Artificial Liver: The ELAD device works by withdrawing blood from a central venous line and filtering it through a system that has four, 1-foot long tubes. Each tube contains human liver cells that process the blood, clean the blood, and make proteins all while performing other critical organ-related processes. Trial starting at Mayo Clinic as a bridge to liver transplant. Wearable Artificial Kidney: Approved by the FDA for human clinical trials, which are currently underway. Cell Cloning and Replacement Therapy: Using cell therapy to make replacement esophagus, and other organs with the patient s own cells in the lab. Ethical Challenges to Society with Advanced Therapies. Most Advanced Therapies Involve ICU Care. One in 5 citizens in the United States receive ICU care at the end of life (1). This contributes to the statistic that more than a quarter of Medicare dollars are spent on patients during the last year of life (2). The rate of ICU use in the United States is among the highest of all countries, with no clear benefit in terms of life expectancy (3). Thus, how do we as a society help to prevent end of life care that appears unwanted, expensive, and futile?
2 Dartmouth Atlas of Health Care Deaths Per State in the Hospital 2012 (4) State Hospital Deaths Average 22.8% Minnesota 20.7% New York (highest state) 32.6% Utah (lowest state) 15.1% Wisconsin 18.8% North Dakota 23.0% Challenges for Family/Medical Staff Surrounding Advanced Medical Therapies Loss of Control Anxiety Hopelessness Seeing their loved one/patient having physical suffering on artificial machines If I don t do or do this procedure will we be hastening death? Weighing benefits and burdens Trying to achieve consensus with broken family dynamics. Are we approaching or have we approached medical futility? Distress on medical staff coding a patient with stage 4 cancer or end stage disease with or without advanced therapies. How Do We Bring Humanity, Dignity Back Into this Room? Bioethical Principles Patient Autonomy Substituted Judgement -Advanced directive -Surrogate Best interests Professional Beneficence -Best interest Non-Maleficence -Do no harm Defining a Dispute in Medical Futility. There are 3 Main Attributes (5) Surrogate Driven Overtreatment A. Disputed treatment may keep patient alive. B. There could be a miracle! Value Laden A. Dialysis for a patient with end stage heart failure or stage four cancer. Is the Burden Worth the Benefit? A. Is the palliative chemotherapy going to make me to ill to enjoy my last days? B. Should I be admitted to the ICU for my stage 4 heart failure for tune up again?
3 Abbott-Northwestern Futility Procedure, Conflict Resolution and Response (Brief Version) Notify the hospital Risk Manager Ethics consultation is recommended. Team review with Critical Review Committee, Palliative Care team to review the decisions about Medical Futility or Harmfulness, identify the available options an develop a plan. Obtain a second opinion on the Medically Futile of Harmful Intervention. From a physician who has the greatest independence from the case. Discussions with the patient and the family. The treatment team should also seek input from the patient or substitute decision-maker before making its decision about the recommended plan If a conclusion cannot be met regarding discontinuing medically futile or harmful care. Transfer will be offered to a health care provider willing to provide life sustaining intervention. If there is inability to locate another provider to accept transfer of the patient s care and the request by the patient or family is to continue the care the hospital president will be notified with Allina Health Chief clinical Officer to determine a plan of action. Role of Palliative Care in Ethical Decision Surrounding Advanced Therapies. Establish patient goals of care. Effective communication is the key. Work toward establishing a consensus between family, patient and medical staff. Noted reduction in number of ethics consultations at ANW with a stronger presence of palliative care providers. Palliative care providers see pre-operative LVAD consultations at ANW. At most large ECMO facilities palliative care is consulted. The Difference Between Palliative Care and Hospice. Palliative care works in partnership with curative care to control symptoms, establish goals and plans of care. Hospice works on holistic care at end of life. How to Practice Preventative Versus Crisis End of Life Discussions:
4 Primary Care Role Grass roots of many ethical discussions with patients: Primary care physicians have an established relationship with the patients. It is always more difficult to have the conversations in a crisis situation. Resources allocating to Health Care directives. Health Care Directives. POLST forms for patient s with more advanced diseases Serious Illness Conversation Guide: Ariande Labs, discussed by Atwal Gwande and Harvard Palliative Care. (There is a skill set!) Understanding: What is your understanding now of where you are with you illness? Information Preferences: How much information about what is likely to be ahead with your illness would you like from me? Prognosis: Share prognosis as a range, tailored to information preferences. Goals: If your health situation worsens, what are your most important goals. Fears/Worries: What are your biggest fears and worries about the future with your health? Function: What abilities are so critical to your life that you can t imagine living without them? Trade-offs: If you become sicker, how much are you willing to go through for the possibility o gaining more time? Family: How much does your family know about your wishes? Case Study: 82 year old patient 11 years s/p LVAD. Now with progressing right sided failure and severe dementia. Mr. Jones has had a LVAD for over 10 years, in the last 9 months he has developed severe right sided heart failure and renal insufficiency with a creatinine of 3.5 baseline and worsening dementia. He is taking the key to the car and driving and getting lost. Patient and his wife are stating that his quality of life has dramatically declined and patient is stating that he is ready to go home to God. How do we proceed from here? Patient and his wife would like to discuss their options with his declining quality of life. DNR/DNI status is address and changed in his chart. 2. Family conference held so members could discuss options and let his children and siblings absorb the decision that the patient with his wife s blessing wished to discontinue therapy. 3. Patient passed peacefully within 24 hours of LVAD therapy discontinuation. Case Study: 78 year old Somali Muslim patient on hemodialysis with dementia, and a fractured hip who is agitated and disconnecting himself on dialysis causing large amounts of blood loss putting himself staff and other patients at risk. Providers need to start on the same page. Difficulties in this case included: 1. Language barrier 2. The families belief that their interpretation of Muslim religion included that all treatments should continue to be offered independent of quality of life. 3. That suffering is the pathway to heaven so the family did not want to treat his pain or agitation. 4. Lack of understanding of western medicine and distrust that providers are taking away medical therapy and not providing a cure for their father. 5. His father lived to 145 and sister to 131. (122 years , documented oldest) 6. How do we proceed from here?...
5 It s About Putting the Pieces Together Palliative consulted for goals of care and symptom management Depakote given prior to dialysis to relax patient and prevent blood exposure to other patients and staff. Care conference with nephrology, orthopedics, hospitalist, palliative care and family to decide goals of care. Family decided to try continuing to take care of him at home and if his quality of life continued to decline transition to hospice. Dialysis was stopped after 2 months and home hospice care was initiated. How Do We Continue to Keep an Open Mind Regarding Advanced Therapies? We should be exceedingly proud in Minnesota for our medical accomplishments. Many have taken place at the University of Minnesota. Transplantation. Kidney/heart Cardiopulmonary bypass Pacemaker Artificial heart valve Starting initial REMATCH clinical trial for LVAD Seat Belts ANW initial clinical Trials for the TAVR, TMVR ECMO, LVADs continue to improve. References Thank you! (1), (2), (3) Curtis, RJ, Engleberg RA, Bensink MA, Ramsey SD, End-of Life Care in the Intensive Care Unit: Can We Simultaneously Increase Quality and Reduce Costs? 10(1) AM J Respir Crit Care Med (2012). (4) Dartmouth Atlas of Health Care 2012, (5) White DB & Pope TM, The Courts, Futility, and the Ends of Medicine. 307(2) JAMA (2012). Leslie Macho CNP, RNFA Palliative Care Abbott-Northwestern Hospital Leslie.macho@allina.com
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