Interprofessional Webinar Series

Consent to Care:

When Patients Lack Capacity

Pauline Lesage, MD, LLM

Physician Educator

MJHS Institute for Innovation in Palliative Care

Disclosure Slide

Pauline Lesage, MD, LLM, has no financial

arrangements or affiliations with any commercial

entities whose products, research, or services may be

discussed in these materials. Any discussion of

investigational or unlabeled uses of a product will be

identified.

Russell K. Portenoy, MD, Planner, has indicated a

relationship with the following: Pfizer Inc. No other

Planning Committee Member has any disclosures.

Consent to Care

• Consent: General Concepts

• Context of decision-making

• Limitations of involved parties

• Models of decision-making

• Elements of consent

• Consent form

Consent to Care

• Consent: Patient with lack of capacity

• Definition

• Advance Directives

–Health Care Proxy

–Instructional Directives:

•Living Wills

•MOLST

Context of Decision-Making

• Relation to communication

• Influence by communication limitations (barriers) of

parties involved:

• Physician

• Patient

• Third party (family/friend)

Physician Limitations (Barriers)

• Technical language

• Medical uncertainty

• Concern not to alarm patient

• Time

• Denial/personal factors

• Liability

Patient Limitations (Barriers)

• Understanding

• Inattentiveness

• Fear, anxiety

• Effects of illness/medications

• Denial

• Trust

Limitations – Third Party (Barriers)

• Guilt

• Denial

• Trust

• Loss

DECISION-MAKING Model

•PATERNALISTIC

Underlying ethical principle: Beneficence

Person centered: Doctor

Information base: Medical

Decision-making: Unilateral

• INFORMED CHOICE MODEL

Underlying ethical principle: Autonomy

Person centered: Patient

Information base: Medical (personal info not shared

with MD)

Decision-making: Unilateral (patient)

DECISION-MAKING Model

DECISION-MAKING Model

•SHARED DECISION-MAKING

Underlying ethical principle: Autonomy/Beneficence

Relationship centered

Information base: Medical and Personal

Decision-making: Bilateral

Consent to Care

• Legal ground: Autodetermination

• Ethical ground: Principle of Autonomy

• Information

• Authorization

Consent to Care

Consent to Care

• Elements of information

Nature of illness

Nature of procedure or treatment

Probable, foreseeable risks

Results anticipated

Possible choices (risks/benefits)

Consequences of refusal

Answers to questions

Consent to Care

• Risks:

Probable, foreseeable

Rare, if serious and specific to patient

Known by everyone (specific to patient)

Significant (serious, % variable)

Increased (when choice possible)

ANY KNOWN RISK (research)

Consent to Care

• Qualities of the information

Objective

Concise

Understandable

Criteria: reasonable person

Consent to Care

• “fear of knowing”

• “therapeutic privilege”

Consent to Care

• Exceptions:

Emergency (if cannot be obtained in due time)

Exceptions stipulated in the law:

•Mandatory confinement

•Treatment for certain medical conditions

•Alcohol test…, etc.

Consent to Care

• Consent form:

Element of proof not a proof of valid consent

Added element to verbal disclosure

Addition, not a replacement

Consent to Care

• Right to refuse care:

Meets the same conditions required for consent

(information, form)

Patient has capacity

Consent to Care: Lack of Capacity

• Should be made by attending MD

• Confirmed by another MD in writing

• No mandatory need for psychiatric evaluation

• No legal standard criteria for evaluation

Advance Directives

BACKGROUND

• Most states: There is law providing for surrogate decision-making, and families are empowered to make decisions

• 1968 - Introduction of Living Will

• 1990 - United States Self-Determination Act

(existence of AD upon enrollment in HC facility)

• 2010 - New York Family Health Care Decisions Act (FHCDA)

Advance Directives

LEGAL BACKGROUND

• Federal Patient Self-Determination Act requires medical facilities to maintain a policy ensuring compliance with state laws governing advance directives

• Federal Omnibus Budget Reconciliation Act of 1990 requires facilities participating in Medicare and Medicaid to inform patients about advance directives

• New York law requires medical facilities to honor both written and oral directives

Consent to Care: Lack of Capacity

Advance Directives Modalities

• Health Care Proxy

• Instructional Directives (oral/written)

• DNR

• LIVING WILL

• MOLST

Advance Directives

Health Care Proxy

• Definition

A document that designates someone to be an

‘agent’ with authority to make decisions, ideally

representing preferences, but if preferences are

unknown, according to the best interest of the

patient

Advance Directives

Substituted Judgment (SJ)

• SJ refers to attempts to judge as the patient

would have if he/she could have

• Version of “prior preference” guided judgment

Advance Directives

Best Interest

•Based on balance of benefits/burdens

• Although easier conceptually, it involves highly

subjective value assessments

• Best guiding standard when prior preferences

are unknown

Consent to Care: Lack of Capacity

WHO

Health care agent

Surrogate:

• Guardian

• Spouse (if not separated) or domestic partner

• Son/daughter >18 y.o.

• Parent

• Brother/sister >18 y.o.

• Close friend

Advance Directives

Proxy Designation

• Important to understand proxy role

• Proxy often guesses prior wishes of patient inaccurately

• Close relationship with proxy is not a guarantee of better decision-making

• Friends, family members have their own interests and issues, which can conflict with their role (difficulty letting go)

• A physician who is appointed as agent should not be the attending MD

Advance Directives

Health Care Proxy

• Requirements:

Name of patient

Statement that principal intends the agent to have authority to make health care decisions on patient’s behalf

Must be signed and dated by patient

Must be signed and dated by two witnesses

Alternate agent can be designated

Statement as to patient wishes regarding artificial hydration and nutrition, or simply that my agent knows my wishes as to artificial nutrition and hydration

Advance Directives

Living Wills

• Definition

Instructions made by an adult—orally or in writing—

related to medical decisions in the event decisional

capacity is lost

• Supports ethical imperative of autonomy (surviving

interest)

• Ensures that patient’s preferences are considered

in medical decisions

• Can be oral or written

Advance Directives

Living Wills

•Legal aspects

No statute in New York that governs Living Wills

According to NY Supreme Court, a Living Will is valid

as long as it constitutes “clear and convincing evidence”

of your wishes

No standard form. LW will be subject to interpretation...

Advance Directives

Living Wills

• Introduced in 1968 by a lawyer (Kutner)

• Multiple efforts to increase their specificity

• Forms have been validated

• Completion by 25% (NHPCO, 2013)

Advance Directives

Living Wills

• Poor % completion:

Not enough knowledge about it

Reluctance to discuss it

Difficulty to execute

Question about their use

Incompatibility with cultural/ethical beliefs

• Terminology

• Inclusion of medical conditions

• Uncertainty about benefits

• Transmission to health care decision maker

MOLSTMedical Orders for Life-Sustaining Treatment

• Physician’s order signed after consulting with the patient/ surrogate

• Concise form containing specific medical instructions that can be carried out by health care staff

• It may include directives on: DNR

Antibiotics

IV fluids

Feeding tubes

Artificial hydration/nutrition

Mechanical ventilation

Any other medical interventions

• MOLST is legal in New York

Conclusion

• Consent is embedded in communication and subject to its barriers

• When patient lacks capacity, the rules of obtaining consent still apply through advance directives

• Consent does entail specific legal rules

Conclusion

• Clinicians must be comfortable that the agent or surrogate is acting appropriately and in the patient’s interest. If there is question about this, get help from Ethics or Administration

• Previously expressed wishes need to be contextualized. They do not apply to acute, potentially reversible situations

Consent to Care:

When Patients Lack Capacity

Q/A

Bibliography

• American College of Legal Medicine. Legal Medicine.

Philadelphia. Mosby/Elsevier 2007

• Beauchamp, TL. Principles of Biomedical Ethics. New York.

Oxford University Press, 2013

• Feely MA, Albright RC, Thorsteinsdottir B, Moss AH, Swetz KM.

Ethical challenges with hemodialysis patients who lack decision-

making capacity: Behavioral issues, surrogate decision-makers,

and end-of-life situations. Kidney Int 2014;86:474-480

• Miller, FG, Wertheimer A. The Ethics of Consent: Theory and

Practice. New York: Oxford University Press, 2010

• Rich BA. Prognosis terminal: Truth–telling in the context of end-

of-life care. Camb Q Healthc Ethics 2014;23:209-219

• Rozovsky FA. Consent to Treatment: A Practical Guide, 4th Ed.

Aspen Publishers, 2014

Bibliography

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Manage 2015 Jan 23 (Epub ahead of print)

• Triebel KL, Gerstenecker A, Meneses K, et al. Capacity of

patients with brain metastases to make treatment decisions.

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