1. Clinical Assessment of Capacity to Consent Robert J. Gardella, MD Assistant Professor of Clinical Psychiatric Medicine, UVa robert.gardella@DBHDS.virginia.gov @DBHDS.virginia.gov Page # (540) 887-9474

2. All Capacities are NOT equal Voluntary admission Voluntary admission Medication (varies) Medication (varies) Non-medication treatments Non-medication treatments Disclosure of information/release of information Disclosure of information/release of information Testamentary capacity Custody Marriage Contracts Money management Testify Stand trial

3. Capacities derived from Rights Right to refuse treatment Right to refuse treatment Extensions of rights to: Extensions of rights to: Die Die Refuse to participate in research study Refuse to participate in research study Refuse transfusion, any treatment based on religious belief or basic values Refuse transfusion, any treatment based on religious belief or basic values preponderance preponderance of the evidence Can still be ordered to prevent death or serious irreversible condition

4. Informed Consent- Why ? Treatment without consent = without consent = BATTERY ABUSE Criminal action and/or civil tort wrong Criminal action and/or civil tort wrong without adequate information = without adequate information = NEGLIGENCE NEGLIGENCE MALPRACTICE MALPRACTICE Civil tort wrong Civil tort wrong ASSENT is NOT CONSENT

5. Basic Elements of Malpractice Claim There is a breach of Duty of care, There is a breach of Duty of care, writing a prescription, supervising another, having lengthy phone call with or giving advice to a prospective patient, giving a patient an appointment, providing treatment during consultation… writing a prescription, supervising another, having lengthy phone call with or giving advice to a prospective patient, giving a patient an appointment, providing treatment during consultation… A Deviation (dereliction) from the standard of care A Deviation (dereliction) from the standard of care Skill and care ordinarily employed by the average psychiatrist or a respected minority Skill and care ordinarily employed by the average psychiatrist or a respected minority Determined by expert testimony, practice guidelines, literature, hospital policies and procedures Determined by expert testimony, practice guidelines, literature, hospital policies and procedures Practice guidelines: less than 90% valid at 3.6 years; 50% outdated at 5.8 years Practice guidelines: less than 90% valid at 3.6 years; 50% outdated at 5.8 years Damage to patient is a… The Damage to patient is a… Direct result of the action or omission Direct result of the action or omission

6. Relationships Alliance- medical treatment model Alliance- medical treatment model Cooperation Cooperation Collaboration Collaboration Synergy Synergy Adversarial- legal model Adversarial- legal model Critogenic harms- judge caused harms- eg. adversarialization of the relationship which inevitably occurs when conflicts resolved/decisions made by the legal system Recovery model

7. Whos Interest ? Sell Criteria CompetentInformedConsent

8. Incorporating Recovery Concepts Disease Centered Model to Person Centered Model Disease Centered Model to Person Centered Model Restore hope, self-esteem, and self-value Restore hope, self-esteem, and self-value A connection to helpful others A connection to helpful others Self-control over illness Self-control over illness Responsibility for CHOICES Responsibility for CHOICES including consequences of the choices including consequences of the choices Restore purpose to ones life, and day to day activities Restore purpose to ones life, and day to day activities I am not my illness; manage the illness for persons sake to accomplish something or feel better I am not my illness; manage the illness for persons sake to accomplish something or feel better - Barber, MD et al, WSH CME 3/9/05

9. Informed Consent: 3 Basic Elements Voluntary Voluntary Not coerced Not coerced Expressed Expressed Information exchange Information exchange Competence/capacity Competence/capacity *The provider of the proposed treatment obtains informed consent from the individual or surrogate; the psychiatrist may comment/consult on patients capacity to give that consent

10. Sliding Scale Approach Patients consenting to low risk, high-benefit treatment should be allowed to do so even if fairly impaired on most measures of competence, because their autonomy, interests and physical well being will benefit from therapy. They might be considered competent if they can merely communicate a choice. In contrast, patients refusing such treatment might be held to a higher standard, because they run the risk of serious physical harm. The standards for competence in their case might require understanding, appreciation and rational manipulation. Patients consenting to low risk, high-benefit treatment should be allowed to do so even if fairly impaired on most measures of competence, because their autonomy, interests and physical well being will benefit from therapy. They might be considered competent if they can merely communicate a choice. In contrast, patients refusing such treatment might be held to a higher standard, because they run the risk of serious physical harm. The standards for competence in their case might require understanding, appreciation and rational manipulation. Guthiel & Applebaum. Clinical Handbook of Psychiatry and the Law 2000, p 224

11. Information Component How much ? How much ? What a reasonable patient needs to know to make an informed decision What a reasonable patient needs to know to make an informed decision What THIS patient would want/need to know… What THIS patient would want/need to know… to make this decision now to make this decision now changes with individual circumstances & situation over time changes with individual circumstances & situation over time The 1% rule The 1% rule ongoing process; initial agreement with progressive increase of information component as ability to incorporate such information improves and the context changes (risk/benefit ratio also changes over time). ongoing process; initial agreement with progressive increase of information component as ability to incorporate such information improves and the context changes (risk/benefit ratio also changes over time).

12. What Information ? Target symptom/problem (Diagnosis) Target symptom/problem (Diagnosis) Treatment alternatives-nature and purpose Treatment alternatives-nature and purpose Consequences (risks and benefits) of treatment Consequences (risks and benefits) of treatment Consequences of no treatment Consequences of no treatment Prognosis +/- treatment Prognosis +/- treatment Alternatives (including relative risk benefit ratios) Alternatives (including relative risk benefit ratios) off label use and dosages exceeding FDA approval off label use and dosages exceeding FDA approval suboptimal choices/ patient preferences suboptimal choices/ patient preferences

13. PRACTICAL APPLICATION Identify target symptoms Identify target symptoms Prioritize list of target symptoms Prioritize list of target symptoms Subjective: most distressing; self identified Subjective: most distressing; self identified Objectively: most likely to improve patient function Objectively: most likely to improve patient function Define achievable objectives/goals Define achievable objectives/goals Treat the most symptoms with the least possible number and frequency of doses of meds Treat the most symptoms with the least possible number and frequency of doses of meds The win-win The win-win When objective needs=subjective wants When objective needs=subjective wants Collaboration; mutual goals Collaboration; mutual goals Patient owns their treatment=insight Patient owns their treatment=insight

14. Capacity: Documentation Rationally understand the risks, benefits and alternatives to the proposed treatment Rationally understand the risks, benefits and alternatives to the proposed treatment Clarify and document rationale for any off label use Clarify and document rationale for any off label use Document discussion of information exchange Document discussion of information exchange As specifically as possible As specifically as possible Information sheet given (and on file) Information sheet given (and on file) Gradation of agreement proportionate to risk: Gradation of agreement proportionate to risk: agree < understanding < appreciation agree < understanding < appreciation

15. Continuum of Consent Capacity to: ….depending on risks Capacity to: ….depending on risks Agree Agree Understand Understand Appreciate Appreciate Able to assess risks in context of potential benefits Able to assess risks in context of potential benefits Capacity for consistency and reliability Capacity for consistency and reliability Capacity (competency) depends on the specific issue at hand (meds, hospitalization, money, contracts) Capacity (competency) depends on the specific issue at hand (meds, hospitalization, money, contracts)

16. MEDIUM threshold for capacity HIGH threshold for capacity MEDIUM threshold for capacity LOW threshold for capacity MEDIUM threshold for capacity HIGH threshold for capacity MEDIUM threshold for capacity AGREE Treatment Risk TREATMENTTREATMENTBENEFITBENEFITTREATMENTTREATMENTBENEFITBENEFIT Adapted from: Magid et al; Current Psychiatry Vol 5, No2, 3/06 LOW HIGH LOWLOW HIGHHIGH REFUSE

17. EXCEPTIONS to patient informed consent EMERGENCY TREATMENT EMERGENCY TREATMENT Emergency medical treatment order Emergency medical treatment order Over objection in absence of another alternative to patient consent Over objection in absence of another alternative to patient consent (VA Human Rights Regulations) Limited to 24 hrs; requires daily re-evaluation and order every 24 hrs (VA Human Rights Regulations) Limited to 24 hrs; requires daily re-evaluation and order every 24 hrs Individual lacks capacity Individual lacks capacity Seek surrogate decision maker Seek surrogate decision maker

18. Other Exceptions Waiver Waiver Patient states choice to NOT know side effects/risks Patient states choice to NOT know side effects/risks DOCUMENT DOCUMENT Therapeutic Privilege – if the information itself would be directly damaging it may be withheld but not if the damage would be mediated by the decision of a well informed patient to refuse treatment Therapeutic Privilege – if the information itself would be directly damaging it may be withheld but not if the damage would be mediated by the decision of a well informed patient to refuse treatment Guthiel & Applebaum. Clinical Handbook of Psychiatry and the Law 2000, p 158

19. Clinical Risk Management Patient centered with goal of achieving maximum function, autonomy and quality of life Patient centered with goal of achieving maximum function, autonomy and quality of life Clinically appropriate care with clear documentation Clinically appropriate care with clear documentation competence and consent issues competence and consent issues Why you did what you did Why you did what you did What other options were considered and why rejected What other options were considered and why rejected Consultation with colleague can provide biopsy of standard of care Consultation with colleague can provide biopsy of standard of care Debriefing of family/survivors (4.4 million; est. 1 in 62) Debriefing of family/survivors (4.4 million; est. 1 in 62) Defensive practices- an inappropriate response Defensive practices- an inappropriate response Actions or omissions solely for legal defensive reasons undermine the therapeutic alliance and interfere with treatment Actions or omissions solely for legal defensive reasons undermine the therapeutic alliance and interfere with treatment The Best Defense is clear documentation of competent care The Best Defense is clear documentation of competent care

20. Ethical Application Interferences with clients liberty of action are justified only when: The client lacks the capacity for autonomous choice regarding the relevant issue The client lacks the capacity for autonomous choice regarding the relevant issue There is a clearly demonstrated clinical indication for the treatment or restriction under consideration There is a clearly demonstrated clinical indication for the treatment or restriction under consideration The treatment or restriction under consideration is the least restrictive alternative that is reasonably available and capable of meeting the clients needs The treatment or restriction under consideration is the least restrictive alternative that is reasonably available and capable of meeting the clients needs The benefits of the treatment under consideration outweigh the harms of the interference itself The benefits of the treatment under consideration outweigh the harms of the interference itself Gillette, PhD; Bioethical Services of Virginia Inc.