Clinical Assessment of Capacity to Consent

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

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

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

4. “Informed” Consent- Why ? Treatment • without consent = • BATTERY • ABUSE • Criminal action and/or civil “tort” wrong • without adequate information = • NEGLIGENCE • MALPRACTICE • Civil “tort” wrong ASSENT is NOTCONSENT

5. Basic Elements of Malpractice Claim • 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… • ADeviation (dereliction) from the standard of care • Skill and care ordinarily employed by the “average” psychiatrist or a “respected minority” • 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guidelines, literature, hospital policies and procedures • Practice guidelines: less than 90% valid at 3.6 years; 50% outdated at 5.8 years • The Damageto patient is a… • Direct result of the action or omission

6. Relationships • Alliance- medical treatment model • Cooperation • Collaboration • Synergy • 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. Who’s Interest ? Competent Informed Consent “Sell” Criteria

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

9. Informed Consent: 3 Basic Elements • Voluntary • Not coerced • Expressed • Information exchange • 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 refusingsuch 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 ? • What a “reasonable patient” needs to know to make an informed decision • What THIS patient would want/need to know… • to make this decision now • changes with individual circumstances & situation over time • 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).

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

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

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

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

16. Treatment Risk HIGH LOW HIGH LOW TREATMENT BENEFIT LOW AGREE REFUSE HIGH Adapted from: Magid et al; Current Psychiatry Vol 5, No2, 3/06

17. EXCEPTIONSto patient informed consent • EMERGENCY TREATMENT • Emergency medical treatment order • 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 • Individual lacks capacity • Seek surrogate decision maker

18. Other Exceptions • Waiver • Patient states choice to NOT know side effects/risks • 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” 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 • Clinically appropriate care with clear documentation • competence and consent issues • Why you did what you did • What other options were considered and why rejected • Consultation with colleague can provide “biopsy” of standard of care • Debriefing of family/survivors (4.4 million; est. 1 in 62) • Defensive practices- an inappropriate response • 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

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 • 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 client’s needs • The benefits of the treatment under consideration outweigh the harms of the interference itself Gillette, PhD; Bioethical Services of Virginia Inc.