2. Assessment of Patients’ Competence to Consent to Treatment Leon Driss MD, MMM

3. The New England Journal of Medicine – November 1, 2007 – Assessment of Patients’ Competence to Consent to Treatment Competency

4. Capacity – The process of health care workers determining if a patient has the ability to make sound judgments concerning their health care Competency – A legal determination, usually by a judge – of the patient’s ability to make sound judgments concerning their medical care Competency: Definition

5. Prior to initiating treatment, physicians are required ethically and by law to obtain the informed consent of their patients Valid consent is obtained by providing appropriate information to the patient required to make a voluntary decision The patient must also be competent – must understand the disclosed information and must understand the ramifications of pursuing or choosing to refuse treatment Competency: Patient Consent

6. When patients lack competence – the ability to make the decision to pursue treatment – alternative decision makers must be obtained Competency: Alternative Decision Makers

7. The decision in determining patient competency is required so that that the patient’s autonomy in making their own decisions is respected It is also required to protect the cognitively impaired and all those unable to make their own treatment decisions Competency: Patient Autonomy

8. The determination of capacity is paramount in balancing the autonomy of patients who have the ability to make sound decisions and protecting those who are cognitively impaired Competency: Patient Autonomy

9. A patient’s competency is a legal status that can only be determined in a court of law However, the sheer number of patients whose competency must be determined is so immense that the responsibility to make this determination in almost all cases remains in the physician’s jurisdiction Competency: Legal Status

10. Obtaining consent from a patient to provide medical treatment who does not possess the capacity to give such consent places the physician at risk of a charge of treating the patient without informed consent The ramifications of such an action are formidable Thus the physician’s skill at determining a patient’s capacity to give informed consent is of paramount importance Competency: Legal Ramifications

11. Patient incapacity to make their own medical decisions is a common occurrence One study of medical inpatients found that 48% were incompetent to consent to their own treatment The clinical team caring for these patients only identified about a quarter of patients as lacking the capacity to make their own medical decisions Competency: Patient Incapacity

12. Any disease or treatment that compromises mentation may be associated with the patient’s incapacity to make medical decisions No specific diagnosis is invariable associated with incompetence Competency: Patient Incapacity

13. Patients with Alzheimer’s Disease and other dementias have high rates of incompetence More than half of patients with mild to moderate Alzheimer’s are incompetent to make medical decisions In patients with severe Alzheimer’s, incompetence is nearly universal Competency: Patient Incapacity – Alzheimer’s Disease

14. Patients hospitalized with a psychiatric diagnosis are commonly found to be incompetent: 20 to 25% of those with depression and up to 50% of those with schizophrenia or bipolar disease A lack of awareness of their diagnosis and their need for treatment is closely linked with their level of incompetence Competency: Patient Incapacity – Psychiatric Diagnosis

15. When cognitive dysfunction is lacking, a condition such as unstable angina, HIV, or diabetes mellitus is not associated with a deficit in capacity in medical decision-making However, in a study of cancer outpatients – a deficit in capacity to make medical decisions was linked to older age, fewer years of education and cognitive impairment Competency: Patient Incapacity – Cognitive Dysfunction

16. Patients with impaired capacity to make medical decisions are commonly found in ICU’s and nursing homes Health care workers need to be attentive to the potential limitations in capacity to make health care decisions in all patient locations and in all patient types and diagnoses Competency: Patient Incapacity

17. The patient’s diagnosis may be confused with the determination of capacity The diagnosis of Alzheimer’s or schizophrenia does not automatically indicate a patient’s incapacity in medical decision-making Competency: Patient Incapacity

18. Historically, physician ability to perform capacity assessments has been suboptimal Physicians are frequently unaware of a patient’s incapacity to make medical decisions When incapacity is suspected, physicians are often unaware how to confirm this suspicion The ability to correctly assess a patient’s capacity to make medical decisions requires a high index of suspicion of patient incapacity and the use of a systematic approach in assessing capacity Competency: Capacity Assessments

19. Legal determinations of competency vary across jurisdictions In general, they base determinations on: – a patient’s ability to communicate a choice – a patient’s ability to understand relevant information – a patient’s ability to appreciate the consequences of their choice – a patient’s ability to reason about treatment choices Competency: Capacity Assessments

20. Patient’s task: Clearly indicate preferred treatment option Physician’s task: Ask the patient to choose treatment option Questions: – Have you decided whether you will follow your doctor’s recommendation for treatment? – Can you tell me what the decision is? – (If no), What is making it hard to decide? Comments: Frequent reversals of choice may indicate lack of capacity (possibly due to psychiatric or neurologic condition) Communicate a Choice

21. Patient’s task: Understand the meaning of the information communicated by the physician Physician’s task: Request the patient paraphrase communicated information regarding their medical condition and treatment Understand the Relevant Information

22. Questions: – Please tell me in your own words: What is your health problem? What is the recommended treatment? What are the benefits and risks (or discomforts) of the treatment? Are their any alternative treatments? If yes, what are the benefits and risks? What are the benefits and risks of choosing to decline pursuing the recommended treatment? Understand the Relevant Information, cont.

23. Comments: – Information to be understood includes: Status of the patient’s condition Nature and purpose of proposed treatment Benefits and risks of proposed treatment Alternative options, including no treatment and its risks and benefits Understand the Relevant Information, cont.

24. Patient’s task: Acknowledge their medical condition and the likely consequences of treatment options Physician’s task: Ask the patient to describe their medical condition, proposed treatment and likely outcomes Understand the Situation and its Consequences

25. Questions: – What is wrong with your health? – Do you believe you require treatment? – What will the treatment do for you? – Why do you believe it will have this effect? – What will happen if you do not receive the treatment? – Why do you think the doctor has recommended this treatment? Understand the Situation and its Consequences, Cont.

26. Comments: – Courts have recognized that patients who do not acknowledge their illnesses, and have a lack of insight into their conditions, cannot make valid decisions about their treatment – Delusions or pathologic levels of distortion are the most common causes of impairment Understand the Situation and its Consequences, Cont.

27. Patient’s task: Engage in a rational process of discussing and evaluating the relevant information Physician’s task: – Ask the patient to compare treatment options and their consequences – Ask the patient to explain the reasons for their selection of a treatment option Reason About Treatment Options

28. Questions: – How did you make your decision to accept or reject the recommended treatment? – What makes the option you chose better than the alternative options? Reason About Treatment Options, cont.

29. Comments: – This task focuses on the process by which a decision is reached – Not the outcome of the patient’s choice – Patients have the right to make poor choices Reason About Treatment Options, cont.

30. The level of impairment that renders a patient incapacitated in making treatment decisions should be a balance between the patient’s autonomy and the consequences of making a bad decision Since the great majority of patients are competent in making their own treatment decisions, physicians should error towards patient autonomy and declare patients incapacitated in making treatment decisions only when their incapacity is most obvious Competency Evaluation

31. In practice, the aggressiveness in pursuing a patient’s capacity should be directly related to the seriousness of the patient’s medical condition and the severity of the consequence of a poor decision Competency Evaluation, cont.

32. In the absence of a reason to question a patient’s competence, each patient is assumed competent to make their own treatment decisions and have their wishes honored When patient competency is in question, physicians and other health care workers should use a structured protocol in evaluating patient capacity as previously discussed Competency Evaluation, cont.

33. When physicians and nurses were studied in making capacity decisions, those that were asked to use a systematic set of questions made decisions that correlated highly with expert judgments Competency Evaluation, cont.

34. Although a simple instrument to screen patients for impaired capacity would be valuable, no instruments designed to date have yielded consistent results Competency Evaluation, cont.

35. The MMSE exam has been found to correlate with clinical judgments of incapacity but its use is restricted mostly to those patients at the high and low range of capacity – especially among elderly patients with some degree of cognitive impairment No single cutoff score has been found to signify incapacity None the less, scores below 19 are associated with incapacity and scores above 23 to 26 more strongly indicate competence Competency Evaluation, cont.

36. In an effort to standardize and increase the reliability of competence evaluations, an instrument was developed named the “MacArthur Competence Assessment Tool for Treatment” It incorporates data specific to a patient’s situation Quantitative scores are generated for the four domains previously discussed in evaluating a patient’s capacity to make their own treatment decisions Competency Evaluation, cont.

37. An experienced clinician can administer the MacArthur test in 20 minutes Even this test result must be integrated with other patient data in order to reach a valid judgment of the patient’s competence This instrument is most valuable when an assessment is very difficult or when a case is most likely to be resolved in court Competency Evaluation, cont.

38. To ensure a valid assessment, each patient must be made aware of all relevant information, including: – Status of the patient’s condition – Nature and purpose of the proposed treatment – Alternative treatments, including no treatment An assumption cannot be made that such a disclosure has been made The evaluator must witness one of the patient’s clinicians sharing this information with the patient or disclose the relevant information himself Competency Evaluation, cont.

39. Given the possibility of a fluctuation in the patient’s mental capacity and the seriousness in depriving a patient of decision-making rights, the evaluation should be deferred until the patient’s mental status has improved or repeat the evaluation a second time or at a later date when possible Competency Evaluation, cont.

40. When possible, family members, nursing staff or other people familiar to the patient should be included in assessing the patient’s competence Although the patient should be informed of the purpose of the evaluation, they need not give consent for the assessment to occur Competency Evaluation, cont.

41. The patient is deemed incompetent: – Unless the need to pursue treatment is urgent, the cause of the patient’s impairment should be investigated prior to initiating a substituted decision to proceed with treatment contrary to the patient’s wishes – If factors such as fever, hypoxia, sedation or uremia are allowed to resolve, the patient may regain the capacity to make their own decisions – Patients with psychiatric disorders may regain their capacity to make their own decisions with appropriate treatment or with a patient edification of the pertinent clinical data Competency Evaluation, cont.

42. The patient is deemed incompetent: – When fear or anxiety interferes with the patient’s capacity to make treatment decisions; involving their family, friends or other trusted confidents may allow the patient’s capacity to make treatment decisions to be restored Competency Evaluation, cont.

43. If the patient is deemed incompetent: – Seek out a substituted decision maker – In an emergency, a physician may provide treatment that they believe a reasonable person would choose – For patients with an advance directive, follow its directive if it applies – For patients with a medical power of attorney, they should be contacted to provide a decision of treatment that they believe the competent patient would have chosen Competency Evaluation, cont.

44. If the patient is deemed incompetent: – In the absence of an advance directive or power of attorney, family members should be contacted if time is available – State statutes often identify the priority of family members to contact as: Spouse Adult children Parents Siblings Other relatives Competency Evaluation, cont.

45. If the patient is deemed incompetent: – In the event of family members of the same priority having a disagreement in choosing a treatment Assemble the involved family members and as many involved clinical staff members as possible for clarification and discussion Intractable disagreements may require resolution in a court of law Competency Evaluation, cont.