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Informed Consent, Assisted Consent, and Assent in Geriatric Health Care. Laurence B. McCullough, Ph.D. Professor of Medicine and Medical Ethics Associate Director for Education Center for Medical Ethics and Health Policy Baylor College of Medicine. Objectives -1.

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informed consent assisted consent and assent in geriatric health care

Informed Consent, Assisted Consent, and Assent in Geriatric Health Care

Laurence B. McCullough, Ph.D.

Professor of Medicine and Medical Ethics

Associate Director for Education

Center for Medical Ethics and Health Policy

Baylor College of Medicine

objectives 1
Objectives -1
  • Identify ethical and legal presumption that guides informed consent process and assessment of decision-making capacity
  • Identify capacities of patients required for participation in informed consent process
  • Identify appropriate role for consultation-liaison psychiatry in assessing decision-making capacity
objectives 2
Objectives -2
  • Identify concept of assisted consent and its goal of restoring capacity for decision making in patients with potentially reversible impairments of decision-making capacity
  • Identify concept of geriatric assent and its goal of making decisions with patients with irreversible but not complete impairments of decision-making capacity
ethical and legal presumption
Ethical and Legal Presumption
  • All adults patients are, as a matter of accepted ethical and legal practice and standards, assumed to have intact decision-making capacity
  • Burden of proof is therefore on physician to establish, according to accepted practice, that patient lacks decision-making capacity
  • Assessment of components of decision-making capacity mostly a matter of clinical judgment, aided by reliable measures
  • Assessment is task-specific, because decision-making capacity is task-specific
  • In emergencies, consent is not required.
    • Therefore assessment of decision-making capacity not required
capacities required for the informed consent process 1
Capacities Required for the Informed Consent Process -1
  • Pay attention to what one is being told, what one is reading, what one is watching (e.g., video education materials)
  • Absorb, retain, recall information
    • Importance of memory functions (which are not be equated with decision-making capacity)
  • Reason from present events to future likely consequences: Cognitive Understanding
capacities required for the informed consent process 2
Capacities Required for the Informed Consent Process -2
  • Believe that these future likely consequences could happen to oneself: Appreciation
    • Denial vs. something more serious, e.g., delusion
  • Assess those consequences for their value in one’s life: Evaluative Understanding
    • At this point in your care, what is important to you to protect? To achieve? To avoid?
  • When asked, express a decision and explain it in terms of cognitive understanding and evaluative understanding
involving consultation liaison psychiatry 1
Involving Consultation-Liaison Psychiatry -1
  • Do not ask consultation-liaison psychiatry to determine whether the patient is incompetent = lacks decision-making capacity
    • To implement ethical and legal presumption and in response to history of abuse of civil rights of the mentally ill, burden of proof for incompetence/lack of capacity is set very high
    • You will often(?) be left with an assessment that the patient is not incompetent but with no assessment of impairments nor plan to address them
involving consultation liaison psychiatry 2
Involving Consultation-Liaison Psychiatry -2
  • Instead, identify your concerns about diminished capacity in specific domains and ask for comprehensive assessment of decision-making capacity in all six domains
  • Ask for judgment about whether identified impairments are potentially reversible
  • Divide labor: Who will work on which impairments and how will divided work of treating impaired decision making be coordinated and assessed by primary physician/clinician?
assisted decision making 1
Assisted Decision Making -1
  • First goal should be to identify and treat impaired components of decision-making capacity with aim of returning patient to threshold of intact decision-making capacity
    • This is clinical ethical concept of assisted decision making
    • Assist patient to assess medically reasonable alternatives on basis of patient’s express values (not one’s own)
      • Sometimes we are conflicted in our values and so our values may support more than one alternative
assisted decision making 2
Assisted Decision Making -2
  • Should threshold for judgment of intact or impaired decision-making capacity be risk-adjusted?
    • Disabling problem with this approach: Uncontrolled variation of observer-dependent assessment of capacity
      • Uncontrolled variation in any component of the process of patient care violates intellectual integrity of clinical judgment and practice and is therefore ethically impermissible
assisted decision making 3
Assisted Decision Making -3
  • It is ethically permissible to risk-adjust weight to be given to patient’s decisions after process of assisted decision making returns the patient near to threshold of intact decision making?
    • Beneficence-based risk adjustment?
    • Beneficence-based risk adjustment directly connected to autonomy-based risk adjustment?
      • Connection between future functional status and future autonomy
    • Proceed with great care
geriatric assent 1
Geriatric Assent -1
  • Based on concept of pediatric assent
  • Concept and clinical practice of pediatric assent developed in pediatric oncology in the 1980s
    • Pioneering work of Sanford Leiken, M.D. (Children's Hospital/George Washington University, Washington, DC)
geriatric assent 2
Geriatric Assent -2
  • Some children are mature enough in their decision-making capacity that decisions should be made with them, even though as a matter of law decisions are made by and for them by their parents
    • Assent, rather than informed consent, is relevant to decision making with patients with irreversible impairments of decision-making capacity but who do not altogether lack decision-making capacity
    • Such patients may well be able to express their values, though with some impairments
    • Such patients may well be able to express their preferences, though with some impairments
    • It may well be possible to meaningfully make decisions with such patients
geriatric assent 3
Geriatric Assent -3
  • Concept of pediatric assent endorsed by American Academy of Pediatrics, Committee on Bioethics in 1995
    • “Patients should participate in decision-making commensurate with their development; they should assent to care whenever reasonable. Parents and physicians should not exclude children and adolescents from decision-making without persuasive reasons.”
      • Pediatrics 1995; 95: 314-317
      • And there are very few, if any, persuasive reasons
geriatric assent 4
Geriatric Assent -4
  • Components of pediatric assent:
    • Help patient achieve a developmentally appropriate awareness of his or her condition
    • Tell the patient what to expect with clinical management
    • Assess patient’s understanding and factors influencing how he or she is responding
    • Solicit an expression of the patient’s willingness to accept proposed clinical management
      • The patient’s response should be weighed seriously
      • If patient to be treated over patient’s objection, tell the patient; no deception
geriatric assent 5
Geriatric Assent -5
  • There are geriatric (and other adult) patients who, despite impaired decision-making capacity, do not altogether lack such capacity
    • Decisions cannot be made by such patients, because of irreversibly impaired decision-making capacity,
    • It may well be possible to meaningfully make decisions with them, even though others (duly constituted surrogate decision makers) will make decisions for them
geriatric assent 6
Geriatric Assent -6
  • Differences between geriatric and pediatric patients
    • Geriatric patients have a long history of independent living, responsibility for self and others, long-standing values, intact decision-making capacity, and often strong preferences about how they want to be treated
    • Geriatric patients usually have little or no expectation of deferring to anyone else, especially adult children
    • Geriatric patients can exhibit decreased capacity for self-care
    • Reduced decision-making capacity results from pathology
geriatric assent 7
Geriatric Assent -7
  • Clear, simple, jargon-free disclosure to patient commensurate with the patient’s cognitive level, mental status, and educational attainment
    • Patient’s current condition
    • Proposed management plans
    • Expected consequences
geriatric assent 8
Geriatric Assent -8
  • Explain care plan to patient in same manner
    • Care plans should be chosen on basis of preserving current functional status and slowing its decline (beneficence-based) and thus preserve functional status necessary for exercise of remaining, diminished, but not absent autonomy (autonomy-based)
    • Care plans should also be chosen on basis of supporting patient’s values consistent with protecting remaining autonomy
    • Explain bases of care plan in preserving future autonomy and patient’s values
    • Short-term questionable paternalism but long-term ethically justified paternalism
geriatric assent 9
Geriatric Assent -9
  • Assess capacity in first two steps
  • When first two steps cannot be completed, because of severely impaired capacity, care plans should be chosen to preserve remaining autonomy and, as much as possible, on basis of patient’s values
    • Unreasonable care burdens on family members (wife, daughters, daughters-in-law) providing long-term care are justifiably taken into account
      • Between the rock of doing everything and the hard place of thinking oneself selfish for doing anything less, there is the middle ground of setting reasonable limits on self-sacrifice
geriatric assent 10
Geriatric Assent -10
  • Soliciting patient’s preferences from those still capable of expressing them in some meaningful way
    • Patient’s ability to express values and detect when they are being violated may be more intact than cognitive functions such as memory
    • Risk-adjust weight to be given to preferences
      • Preserving future autonomy
      • Preserving biopsychosocial safety vs. preserving physical safety
      • Increased mortality risk of a care plan is not eo ipso paramount in selecting care plan to implement
geriatric assent 11
Geriatric Assent -11
  • Importance of professional virtues and clinician as role model of virtues
    • Respect
    • Compassion
    • Steadiness
informed consent assisted consent and assent in geriatric health care23

Informed Consent, Assisted Consent, and Assent in Geriatric Health Care

Laurence B. McCullough, Ph.D.

Professor of Medicine and Medical Ethics

Associate Director for Education

Center for Medical Ethics and Health Policy

Baylor College of Medicine