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Informed Consent and Capacity PowerPoint Presentation

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Informed Consent and Capacity ACLP Resident Education Curriculum James Knowles Rustad, MD, Psychiatrist, White River Junction VA Medical Center, Burlington VA Lakeside Community Based Outpatient Clinic, Clinical Assistant Professor, Department of Psychiatry, Geisel School of Medicine at Dartmouth, Clinical Assistant Professor, Department of Psychiatry, The University of Vermont Larner College of Medicine Thomas W. Heinrich, MD, Associate Professor of Psychiatry & Family Medicine, Chief, Psychiatric Consult Service at Froedtert Hospital, Department of Psychiatry & Behavioral Medicine, Medical College of Wisconsin Version of March 15, 2019
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Learning Objectives Acquire knowledge of the process of obtaining informed consent for medical and surgical procedures Define the terms competence and capacity Learn the skills necessary to assess of capacity Apply the four abilities model of criteria for decision-making capacity List relevant questions to ask consultees and patients in a capacity evaluation for medical decision-making Explain the use of substitute decision-makers in medical and surgical settings 2
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Introduction Helping to decide whether a patient has the clarity of mind (i.e., capacity) to agree to or refuse a treatment or procedure is one of the most common reasons for a psychiatric consultation in the general hospital (Huffman and Stern, 2003) This presentation will review case scenarios commonly encountered in the practice of consultation-liaison psychiatrists and clarify key points in the determination of capacity 3
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Case Example Capacity to consent for a surgical procedure? Ms. W an 83 year old female with a history of cognitive impairment and known CAD was admitted with chest pain. EKGs and enzymes are abnormal and a cardiac catheterization is recommended. You are asked to see if you think the patient can consent to the procedure… What do you do now? 4
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Informed Consent A little bit of history… Prior to informed consent Objection to treatment usually respected However, consent was often inferred or evoked by incomplete or misleading information Formal Informed Consent Process (late 1960s/early 1970s) Goal is to allow an individual with decision-making capacity to exercise effective and informed self-decision-making 5
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Purpose and Basis of Informed Consent Purpose of informed consent To promote individual autonomy To foster rational decision-making Informed consent is founded on two distinct legal principles The right of self-determination The physician’s fiduciary responsibility to the patient 6
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Elements of Informed Consent 1) Disclosure of information 2) Voluntary choice 3) Capacity to decide 7
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Exceptions to Informed Consent Emergency Time required to obtain consent is not available without threatening the patient’s life Therapeutic privilege In some circumstances, in which disclosure itself may be harmful to the patient, physicians may withhold certain information Waiver Patients waive their rights to consent Lack of capacity 8
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Informed Consent: Disclosure of Information Accepted set of information to disclose The diagnosis and the nature of the condition being treated The reasonably expected benefits of the proposed treatment The nature and the likelihood of the risks involved The inability to precisely predict the results of the proposed treatment The expected risks, benefits, and results of alternative, or no, treatment Information provided in an accurate, balanced, and understandable manner How much to disclose Professional standard: What a reasonable member of the profession would discuss with a patient in a similar situation Reasonable patient standard: What a reasonable patient would find material in making a decision The standard for what information is required varies from state to state 9
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Informed Consent: Voluntariness The capacity to make a choice freely in the absence of coercion The use of coercion by medical professionals is unethical Represents the patient’s ability to act in accord to what is right for them in light of their… Situation Values History 10
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Important Definitions: Capacity vs. Competency Capacity The ability to accept or refuse treatment recommendations Determined by a clinician upon specific elements of a mental status exam Does not have to be psychiatrist or psychologist Competency A legal concept formally determined in a court of law Judges often rely on the clinician’s recommendations The law presumes competence until proven otherwise 11
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Definition of Lack of Capacity Lack of capacity constitutes a status onto the individual that is defined by… Functional deficits judged to be sufficiently great that the person currently can not meet the demands of a specific decision making situation and its inherent consequences 12
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Important Points About Capacity Determined on a situation-by-situation basis (Querques et al., 2010) Patient can have capacity to make some decisions, but not all Must clarify the specific capacity question “Sliding scale” is used to assess capacity (Roth et al., 1977): e.g., patient may have capacity to refuse phlebotomy (risk-to-benefit ratio is low, hence standard to declare patient incapacitated is high) but not capacity to refuse urgent cardiac surgery (risk-to-benefit ratio of refusal is high, hence standard to declare patient incapacitated is low). “Sliding scale” is attempt to honor patients’ autonomy while doing no harm Capacity can change over time (e.g., delirious patient may be able to make decision once sensorium clears) Capacity refers to the specific condition or current situation; not an enduring status Reassessment periodically recommended 13
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Assessment of Capacity: Who Should Assess and What Information is Needed in Advance of the Assessment? Who should assess capacity? Treating physician is often the best choice Consultation with psychiatry or neuropsychology is appropriate in difficult cases in which there is a high risk of reaching a faulty conclusion; some states require psychiatric assessment of capacity in individuals with psychiatric disorders What should the consultant know before seeing the patient? Why is the consult being requested? Why do you think the patient may lack capacity? What is the patient’s medical situation? What are the treatment choices faced? Risks and benefits of these choices? What has already been communicated to the patient? Capacity to make what specific decision? 14
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Assessment of Capacity: Important Considerations The question posed: Does this patient have sufficient ability to make a meaningful decision, given the current circumstances with which he/she is faced? There is no single threshold for the level of ability necessary The patient’s abilities (expressing, understanding, appreciating, and reasoning) are important, but influenced by… Demands of the situation Consequences of choices Being unable to demonstrate capacity is effectively the same as lacking it For example, if intense affect proves intractable and obstructive, it might (in sufficiently high-stakes medical situations) leave the patient unable to demonstrate capacity 15
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Assessment of Capacity: Important Considerations Lack of capacity depends on functional demands Determination of capacity or incapacity will depend in part on the demands of the specific tasks the patient faces Capacity is dependent on the match or mismatch of the patient’s Functional decision making abilities Demands of the situation the patient faces Therefore, there is no absolute level of ability that defines capacity or lack of capacity across all situations It depends on how much is demanded Lack of capacity depends on the consequences of abiding by the patient’s choices The degree of disability required to categorize a patient as lacking capacity is adjusted upward or downward depending on the degree of harm associated with the patient’s choice 16
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How to Assess Capacity: Four Abilities Model Appelbaum, 2007 Communicate a (consistent) choice Understand the Relevant information Appreciate the circumstances and consequences Rationally Manipulate the information 17 Mnemonic: CRAM
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Functional Abilities of Capacity: Understanding Appelbaum, 2007 Ability to understand Understanding should be assessed in all cases in which the patient expresses a choice Can the patient assimilate the information disclosed regarding the nature of the illness, the treatment options, the prognosis (with and without treatment), and the risks/benefits of treatment? Suggested questions to ask: Tell me in your own words… The nature of your condition The recommended treatment along with possible benefits and risks The possible benefits and risks of alternative treatment or no treatment 19
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Functional Abilities of Capacity (Understanding): Case Example Capacity to accept treatment with psychotropic medication? Ms. V is a 92 year old female with a history of mild-moderate dementia with significant depressive symptoms on whom you would like to start a selective serotonin reuptake inhibitor to help moderate these symptoms. The patient initially consents to the medication but, when handed the prescription, she politely thanks you for these vitamin pills. When you query her further about what she understands this new medication is for, she happily responds that it “lowers my sugars.” 20
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Functional Abilities of Capacity (Appreciation) Appelbaum, 2007 Ability to Appreciate Appreciation relates to the patient’s ability to apply the information to his/her own situation. The focus is on the patient’s beliefs rather than knowledge Belief of illness Belief of treatments Suggested questions: What do you believe is wrong with you now? Do you think that you need some type of treatment? What do you believe will happen to you if you do not get treated? 21
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Functional Abilities of Capacity (Appreciation): Case Example Capacity to refuse surgical procedure? Mr. K is a 60 year old male alcoholic with a known history of cirrhosis admitted with hematemesis. The patient continues to have several bouts of bloody emesis now complicated by emerging hypotension and worsening anemia despite aggressive supportive care. When approached about the need to perform an EGD to band the likely bleeding varices the patient refuses. He states that he has a bad case of “heartburn” and that no one has ever died of heartburn so he will “be fine.” 22
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Functional Abilities of Capacity (Reasoning) Appelbaum, 2007 Ability to reason Does the patient use the information disclosed to engage in a rationale process of options? Is there a “reasonable reason” for the patient’s choice? Takes into account the patient’s past preferences and life decisions Suggested questions: Tell me how you reached this decision? How did you weigh the information provided? 23
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Functional Abilities of Capacity (Reasoning) Capacity to refuse surgical procedure? A 52 year old man suffering from chronic paranoid schizophrenia presented to the emergency department after he jumped of a bridge in an attempt to escape the “feds” who were chasing him because of his ability to communicate with aliens. The patient has suffered extensive fractures and requires surgery. The patient quickly identifies the fact that he has suffered numerous orthopedic injuries and that the orthopedic trauma service would like to perform surgery in an attempt to repair his injuries. He, however, flatly refuses surgery because he is convinced that the surgeon will implant a device that will block his impressive ability to communicate with “those not from this world” and allow the FBI to track him. 24
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Functional Abilities of Capacity Appelbaum, 2007 Summary of functional abilities Expressing a choice Ability to state a preference Understanding Ability to comprehend the information provided in the treatment disclosure required for informed consent Appreciation The patient’s beliefs about the disorder and proposed treatments and to apply it realistically to their own situation Reasoning Ability to process information and one’s preference in a logical manner 25
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When Should Decision-Making Capacity Be Assessed? It is often done at every patient encounter, but unrecognized Abrupt changes in mental status When patients refuse treatment recommendations, including AMA discharges When patients consent to especially risky treatment When patients have a risk factor for impaired decision-making 26
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Documentation of the Capacity Assessment Careful documentation in the medical record is imperative An appropriate note should include A description of the information disclosed A description of the potential consequences of the patient's choice A brief note on the patient’s mental status A statement on the patient’s performance on the four abilities Documentation of opinion of capacity Impression of why patient lacks capacity and what might be done to restore capacity (if possible) 27
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What Types of Conditions Can Diminish Capacity? Psychological factors/Cognitive Biases Psychiatric diagnoses Neurocognitive disorders 28
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Cognitive Biases Can Diminish Capacity Brock and Wartman, 1990 Myopic approaches to problem-solving Downplaying of risk Optimistic framing of problems Blindness to the effects of one’s decisions on others 29
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Psychiatric Diagnoses Can Diminish Capacity Kontos et al. (2015) suggest that every incapacity determination, with the exception of those associated with devastating neurological conditions (e.g., coma), be backed up by a psychiatric diagnosis Suspicion or presence of incapacity should trigger pursuit of mental illness-based explanations for it (Appelbaum, 1994) Diagnoses say what is incapacitating the patient and how: “If this patient is incapacitated, what is he incapacitated by?” (Kontos et al., 2015) Would optimally provide recommendations for treating the psychiatric illness in hope of restoring capacity 30
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Cognitive Impairment Can Diminish Capacity Kontos et al., 2015 Clinical assessment of incapacity due to cognitive impairment should be supported by cognitive screening that includes a standardized instrument such as the Montreal Cognitive Assessment (Nasreddine et al., 2005) 31
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Substitute Decision Making Once deem patient to lack capacity, need substitute decision maker Options for substitute decision making: Advanced directives Decision directives (living will) Documents the patient’s choice(s) of treatment under specific circumstances Proxy directives (POA)/Healthcare proxy Patients designate persons they desire to make decisions for them when they are incapacitated Effectiveness depends on patient sharing their choices with the proxy Family/Close friend/Partner If there is no advanced directive, families are usually asked to make decisions Some states have laws which specify which family members have priority 32
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Substitute Decision Making if no Proxy/Family Available Courts Decision makers of last resort Many hospitals turn to the courts to adjudicate incompetence and appoint a decision-maker in the absence of an advanced directive Patients can challenge findings of incapacity in court May go to court for treatment order or for guardianship Consider guardianship when: No substitute decision maker Capacity not likely to be restored in near future Ongoing medical decisions will likely need to be made 33
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Ethical Issues in Capacity Assessment Many capacity consults are not about capacity at all, but rather ethical dilemmas (Kontos et al., 2013) Psychiatrist’s role = elucidate the “real” issue, relay that finding to the consultee, and be one among many, albeit oftentimes the first person, to broach it with the patient (Kontos et al., 2013) 34
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References Appelbaum PS: Assessment of patients’ competence to consent to treatment. N Engl J Med 2007; 357: 1834-1840. Appelbaum PS: Almost a Revolution: Mental Health Law and the Limits of Change. New York, NY: Oxford University Press; 1994. Appelbaum PS, Grisso T: Capacities of hospitalized, medically ill patients to consent to treatment. Psychosomatics. 1997; 38: 119-125. Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 6th ed. New York, NY: Oxford University Press, 2009. 35
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References Brendel RW, Schouten R: Legal concerns in Psychosomatic Medicine. Psychiatr Clin N Am 2007;30:663-676. Brock DW, Wartman SA: When competent patients make irrational choices. N Engl J Med 1990; 322: 1595-1599. Grisso T, Appelbaum PS: Assessing competence to consent to treatment: a guide for physicians and other health professionals. New York: Oxford University Press, 1998. Huffman JC, Stern TA: Capacity Decisions in the General Hospital: When Can You Refuse to Follow a Person’s Wishes? Primary Care Companion J Clin Psychiatry 2003; 5(4). 36
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References Kontos N, Freudenreich O, Querques J. Beyond Capacity: Identifying Ethical Dilemmas Underlying Capacity Evaluation Requests. Psychosomatics 2013; 54: 103-110. Kontos N, Querques J, Freudenreich O: Fighting the good fight: responsibility and rationale in the confrontation of patients. Mayo Clin Proc 2012; 87: 63-66. Kontos N, Querques J, Freudenreich O: Capable of More: Some Underemphasized Aspects of Capacity Assessment. Psychosomatics 2015; 56: 217-226. Nasreddine ZS, Phillips NA, Bedririan V, et al: The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc 2005; 53: 695-699. 37
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References Pellegrino ED, Thomasma DC. For the Patient’s Good: The Restoration of Beneficence in Health Care. New York, NY: Oxford University Press, 1988, pp 7. Pellegrino ED: Patient and physician autonomy: conflicted rights and obligations in the physician-patient relationship. J Contemp Health Law Policy 1994; 10: 47-68. Querques J, Kontos N, Freudenreich O: Determination of decision-making capacity: A first step (Letter to the Editor). Crit Care Med 2010; 38: 1614-1615. Roth LH, Meisel A, Lidz CW: Tests of competency to consent to treatment. Am J Psychiatry 1977; 134: 279-284. Tauber AI: Sick autonomy. Perspect Biol Med 2003; 46: 484-495. 38