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Documentation of Decision-Making Capacity, Informed Consent, and Health Care Proxies: A Study of Surrogate Consent
Psychosomatics 2011:52:521–529
© 2011 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.
Original Research Reports Documentation of Decision-Making Capacity, Informed Consent, and Health Care Proxies: A Study of Surrogate Consent Anna Glezer, M.D., Theodore A. Stern, M.D., Elizabeth A. Mort, M.D., Susan Atamian, R.N., Joshua L. Abrams, J.D., Rebecca Weintraub Brendel, M.D., J.D.
Background: Patients in the general hospital are routinely asked to make decisions about their medical care. However, some of them are unable to express a choice, understand the information provided, weigh the options, or make a decision for themselves; when this occurs, the task of making an appropriate medical decision is left to another—a substitute decision-maker (SDM). Objective: We sought to understand the practice patterns surrounding surrogate consent. We hypothesized that SDMs would be used frequently for patients with an altered mental status (AMS) but that there would be insufficient documentation of health care proxies (HCP) and of clinician assessment of a patient’s decision-making capacity. Methods: A retrospective chart review was conducted on inpatients who underwent a lumbar puncture. The review assessed whether patients had a HCP
in the record, if the patient’s mental status was evaluated prior to obtaining informed consent, if the patient’s capacity was addressed in this assessment, and whether a SDM was asked to provide the informed consent. Results: Consistent with our hypotheses, we found that the majority of patients did not have documentation of a HCP in the record. We found that the mental status of all patients was assessed prior to the procedure, but that documentation regarding assessment of decisionmaking capacity was lacking. Conclusions: Our pilot investigation suggests that there is need for improvement in our evaluation and documentation of altered mental status and a patient’s ability to make informed decisions. To this end, several quality-improvement suggestions are discussed. (Psychosomatics 2011; 52:521–529)
O
someone other than the patient. This substitute decisionmaker (SDM) is asked to make the decision that best approximates what the patient would have wanted if he or she had the ability to make the decision (i.e., substituted judgment). In
n any given day, most patients in the general hospital are asked to make decisions about their medical care. For each of them, informed consent constitutes the foundation for the collaborative process with their physicians for each of these medical decisions.1 This decision-making process relies upon the patient receiving the appropriate information, weighing the risks and benefits of the intervention (and the lack thereof), and deciding about whether to embark upon the intervention or treatment. However, some patients are unable to express a choice, to understand the information provided, to weigh the options, or to make a decision for themselves. When one of these situations occurs, the task of making an appropriate medical decision must be made by Psychosomatics 52:6, November-December 2011
Received May 10, 2011; revised June 22, 2011; accepted June 24, 2011. From University of California San Francisco, Department of Psychiatry, Psychiatry and the Law Program, San Francisco, CA. Send correspondence and reprint requests to Anna Glezer, M.D., University of California San Francisco, Department of Psychiatry, Psychiatry and the Law Program, 401 Parnassus Avenue, LP-0984, San Francisco, CA 94143; e-mail: [email protected] © 2011 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.
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Documentation of Decision-Making Capacity, Informed Consent, and Health Care Proxies situations where the patient’s interests are not, or cannot be, known, the SDM must decide in the patient’s best interest. Substitute Decision-Maker (SDM) Multiple terms have been used to describe a SDM. The phrase, SDM has both legal and laymen’s definitions;2 the individual named as the SDM is often (but not always) a family member of the patient to whom the medical team has turned to make decisions for an incapacitated individual. The phrase, Health Care Proxy (HCP), refers to a specific legal document that names a person, called the agent, who will hold the power to make medical decisions for the person who completed the HCP, identified as the principal, should the principal become incapacitated.3 When the principal is determined to lack capacity for certain decisions, the agent is able to make a decision based on what he or she believes the principal would do. Such decisions include both medical and psychiatric treatment. (See Table 1 for definitions of terms related to substitute decision-making.) Objectives for the Study We sought to understand the practice patterns that surround surrogate consent at a large urban general hosTABLE 1.
Terms Related to Substitute Decision-Making
Health Care Proxy (HCP)
Guardianship
Living Will
Power of Attorney (POA)
Advance Directive
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A legal document that a patient completes to designate another person as their medical decision-maker, should they become incapacitated. The HCP can be revoked at any time.12 A legal arrangement under which one person, the guardian, has the legal right and duty to care for another. Guardianship may be limited to medical or financial decisions or be more global in nature.13,14 A document that delineates a person’s wishes (either generally or specifically about the withholding or withdrawal of lifesustaining treatment) when that person is no longer able to make decisions about his or her treatment. Living wills are not recognized in all states as binding legal documents, but they are a good source of information about a patient’s wishes.15 An instrument in writing whereby one person, the principle, appoints another as his agent and provides that agent with the authority to act on behalf of the principle.16 A general term for treatment preferences and SDM designation. HCPs, living wills, and POAs are examples of advance directives.
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pital. We wished to learn whether patients were being asked about their HCPs and when and how SDMs were being asked to make critical decisions on behalf of patients. We focus specifically on HCPs, as this is the only legally recognized advance directive used in Massachusetts, where this study was conducted. Reasons to evaluate this practice included a desire to improve care and to comply with state and federal regulations. In November of 1990, Congress passed the Patient Self-Determination Act, as an amendment to Omnibus Budget Reconciliation Act of 1990.4 The Patient Self-Determination Act stated that patients have the right to facilitate their own health care decisions, to accept or refuse treatment, and to create an advance care directive. Facilities have an obligation to inquire about advance directives and to document their existence in the medical record, as well as to educate staff about advance directives.5 To enable us to survey patients who may not have had the capacity to make medical decisions and therefore may have needed a SDM, we required a subject pool with a significant number of patients who were likely to have an altered mental status and who were likely to need to give informed consent for a procedure. To ensure sufficient numbers, we selected patients who had undergone a lumbar puncture (LP), as this diagnostic procedure requires informed consent and is commonly performed in patients with an altered mental status. Our hypotheses were based on our clinical experience: (1) we anticipated a low rate of inclusion of the HCP document in the chart, even if a SDM was relied upon; (2) we hypothesized that a SDM would be used frequently in patients with an altered mental status; (3) we hypothesized that while clinicians often make decisions implicitly or explicitly about a patient’s decisional capacity in determining whether or not a SDM is required, their documentation of this decision-making process would be inadequate or missing from the record; (4) we anticipated that the document of informed consent would be universally present. METHODS Our retrospective chart review study was conducted at the Massachusetts General Hospital after obtaining approval from its Institutional Review Board (IRB). The records of 590 patients were surveyed for eligibility. The pool of patients was derived from a list of all patients who had cerebrospinal fluid (CSF) samples sent to the laboratory between January 1, 2010 and June 30, 2010. We excluded Psychosomatics 52:6, November-December 2011
Glezer et al.
FIGURE 1.
Sample Selection. ER ⴝ Emergency room; LP ⴝ Lumbar puncture; AMS ⴝ Altered mental status
590 patients Exclude: outpatients, ER patients Exclude: patients who did not have LP performed Exclude: patients without AMS on admission
38 patients
outpatients and those who had the LP in the Emergency Department (ED), as well as those who had an LP for a purpose other than for assessment of altered mental status (e.g., as obtained during shunt placements/revisions). Patients were excluded if they lacked evidence of an altered mental status on admission, as noted in the admission note, or if they had the LP procedure performed emergently. The remaining charts were examined with an instrument developed by the investigators. (See Figure 1 for graphic representation of this selection process.) The 27-item questionnaire (see Appendix A) included basic demographic data, eligibility requirements, questions about HCP documentation, the evaluation of altered mental status, and the assessment of capacity. Altered mental status was defined as “evidence of alterations in alertness, orientation, behavior (including hallucinations/psychosis), or cognition (including memory impairment).” To ensure reliability, two clinicians independently reviewed the same seven charts and established inter-rater reliability before the rest of the records were reviewed.
RESULTS A total of 38 patients with altered mental status were included in the study. These patients were, on average, 62 years old (⫾14) and had a length of stay in the hospital of 15 days. Primary diagnoses on discharge varied, but the most common one was “Altered Mental Status.” Our first hypothesis—that there would be few HCPs in the chart—proved correct. Of the 38 patients, 15 Psychosomatics 52:6, November-December 2011
(39%) patients had the existence of a HCP documented in the record (either in the nursing triage packet or elsewhere in the chart). However, only 9 (24% of the total and 60% of those whose records indicated the existence of a HCP) had the actual HCP in the chart. In all nine cases, the HCP had been signed before the LP was performed, see Figure 2. All patients had their consent for the LP documented (in a procedure note or on a consent form), although only 33 (87%) patients had a signed consent form in the chart. Twentyfive (66%) patients had a surrogate’s signature on the consent form, while 8 (21%) signed the form themselves. Our second and third hypotheses were verified. Of those 25 patients who had a surrogate sign the form, 6 (24%) had a HCP in the chart. All 25 also had documentation of a mental status examination conducted within 24 hours before the LP, and 23 of 25 had documentation of an altered mental status (based on level of alertness, orientation, behavior, or cognition). However, of those 25 who had a surrogate’s signature, only three of 25 revealed any reference to decisional capacity; 21 of 25 had sufficient documentation to infer a lack of capacity to consent for the procedure (see Table 2). Of those who signed their own consent form (eight patients; 21%), seven of eight had documentation of an altered mental status; none referred to decisional capacity; three of eight had documentation sufficient to infer that they had the capacity to consent to an LP (based on mental status exam documented within 24 hours of the procedure that included data on alertness, orientation, behavior and cognition, compared with a general determination of “al-
FIGURE 2.
Health Care Proxy (HCP) Documentation.
38 patients
15 patients HCP documented to exist
6 patients HCP not in chart
23 patients HCP not documented
9 patients HCP in chart
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Documentation of Decision-Making Capacity, Informed Consent, and Health Care Proxies
TABLE 2.
Surrogate-Signed Sample of 25 Patients
Altered mental status documented Decisional capacity documented Documentation sufficient to suggest lack of capacity to sign consent
n
%
23 3 21
92 12 84
tered mental status” on admission) while one of eight had enough documentation to infer that they lacked the capacity to provide consent. Five patients had no consent form for the LP in the chart, in contrast with our final hypothesis that all patients would have an informed consent document in their charts. All had documentation of an altered mental status within 24 hours of the procedure. None of the five records revealed any reference to decisional capacity of the patients. Four of the five had enough documentation to infer a lack of capacity to consent to the LP. As there was no consent form in these charts, we were unable to determine if the patient or a surrogate signed the consent for the procedure. DISCUSSION The findings of our pilot investigation suggest there is need for improvement in our evaluation and documentation of altered mental status and a patient’s ability to make informed decisions. This begins with a more thorough understanding of the issue of informed consent and capacity. Issue of Informed Consent All patients, until an evaluation determines otherwise, are presumed competent to make their own decisions; as such, each individual must give informed consent for any non-emergent procedure. Informed consent is not merely the act of signing a document for consent to a procedure;1 instead, it represents the process of being provided with, and discussing/weighing the options, regarding an intervention’s risks and benefits. If a patient lacks the capacity to give consent, a SDM is asked to provide informed consent. Informed consent law, developed from torts of medical battery (defined as unwanted touching without consent) is based on the principle that all individuals have the right to make decisions that affect their well-being.6 To provide informed consent, a person must be able to appreciate the risks and benefits of making the decision.7 Exceptions to this rule include emergencies; in these circumstances there is often insufficient time to clarify an 524
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individual’s true state of mind and arrival for care implies consent.8 Issue of Capacity The issue of capacity is at the heart of discussions about surrogate decision-making. However, before one can decide upon who can serve as a SDM, several practical questions need to be answered about decisional capacity. Who can assess capacity? How does one determine whether a patient has the capacity to make a decision? Can a patient have the capacity to make one decision but not another? Any physician is able to evaluate and assess a patient’s decision-making capacity. A patient must meet four criteria in order to demonstrate capacity. In their landmark paper, Appelbaum and Grisso described the four elements of a capacity evaluation.9,10 First, a person must be able to communicate a clear, consistent choice. Second, the patient must understand the relevant information (including the risks and benefits of a particular decision). Third, the patient must appreciate the situation and its consequences (particularly as they apply to that person). Finally, the patient must be able to rationally manipulate the information. Given these requirements, it is easy to see how capacity may fluctuate (e.g., while unconscious, a person lacks capacity, but after awakening may have the clarity of mind to make decisions). After an evaluation has been completed, if a patient is deemed to lack capacity, a surrogate is sought by clinical staff. A person may have the capacity to make one decision, but not another (e.g., to accept but not to refuse a lifesaving procedure or to be transferred to a rehabilitation facility). These conclusions relate to the risks and benefits of a specific decision. Consenting to a procedure or a decision that is of low risk requires a lower threshold for capacity compared with one that is high risk. For example, a person may not be able to provide consent (due to cognitive impairment) for a complicated medical procedure, but be able to name a HCP agent, because he trusts someone else (e.g., his daughter) to make medical decisions on his behalf. As a general rule, the threshold for capacity to complete a HCP is lower than it is to make medical decisions. Notably, most of our patients had documentation of a mental status exam in their charts within 24 hours of the LP; for many, there was sufficient documentation to infer the patient’s capacity to make a decision, although decisional capacity was not actually documented in the majorPsychosomatics 52:6, November-December 2011
Glezer et al. ity of cases. For example, one patient was noted as having an alteration in alertness and a lack of response to verbal stimuli. Decisional capacity was not documented for this patient, but given the description of the mental status, it can be deduced that this patient did not have capacity to consent to an LP. This suggests that many clinicians regularly evaluate a patient’s mental status and have a general clinical sense about when a patient can and cannot make decisions for him/herself. However, this is insufficient. It is helpful to begin with a working definition of altered mental status. In this study, we used “alterations in a patient’s alertness, orientation, behavior, or cognition.” Alertness refers to whether the patient was arousable to voice and be aware of what was taking place around him/her, or, in contrast, somnolent, stuporous, or comatose. Orientation refers to a patient’s knowledge of his/her name, place, and the current date. Behavior includes a patient’s cooperativeness, his/her possible agitation, and his/her experience of hallucinations. Cognition refers to a patient’s attention, memory, and knowledge processing. Following assessment of a patient’s mental status, regardless of whether it is altered, it is important to evaluate decision-making capacity. In the case of a LP, a patient would needs to be able to express his or her choice to have the LP and be able to understand the potential risks of the procedure (e.g., infection, bleeding), as well as the benefits (e.g., diagnostic clarification). The patient would need to be able to apply those risks and benefits to himself/herself and to reason rationally about the decision. This capacity evaluation is an integral part of the informed consent process, which involves more than a patient merely signing a consent form. Notably, in our study, 13% of the patients’ charts also had missing consent forms (5/38). One reason to assess a patient’s capacity is to be able to ascertain if the patient is actually agreeing to the procedure (i.e., providing informed consent) or is merely an incompetent accepter, as the standard for moving forward with a procedure is informed consent. For example, one of the study subjects who signed her LP consent form had an altered mental status documented. It was possible to infer that she lacked the capacity to make her own medical decision. In this case, the appropriate next step should have been to turn to the patient’s SDM. Quality Improvement Strategies These results lead to the question of how to improve the implementation and use of SDMs. More specifically, we wondered how we can improve hospital compliance Psychosomatics 52:6, November-December 2011
with patient completion of a HCP, the rate of HCP documentation, and with capacity evaluations before invoking a HCP. To begin, it is helpful to think about reasons why consent forms may be missing or HCPs are not completed. These may include clinicians feeling pressed for time or that they would serve their patients better by focusing on other clinical duties, lack of familiarity with advance directives or the elements of informed consent, or simply not having easy access to the appropriate documentation. Several multipronged approaches seem reasonable to improve compliance, given that multiple possibilities exist as reasons for noncompliance. The first is to educate clinical staff. Providing instruction on the process of mental status evaluation, informed consent, and capacity assessment should be a core part of continued training and education efforts. It may be helpful to tie such sessions to incentives. Second, clinicians should be prompted to address a patient’s decision-making capacity when obtaining informed consent (e.g., the actual consent form or procedure note document could be modified to include a sentence that capacity has been assessed and the patient has the capacity to agree and to sign). Last, to ensure that more patients are being offered the opportunity to complete a HCP, a form could be added to discharge procedures (which is usually a time when patients and their families are calmer and can think about these complex decisions, compared with the time of admission) or annual physicals. In order for clinicians and other staff to have access to these important documents, institutions might also consider having easily accessible registries for HCP data. However, while these suggestions may help in certain institutions, they may not be universally useful. Therefore, it is up to each hospital and clinical care facility to evaluate their performance on this matter of patient completion of HCPs and clinician evaluations of patient capacity prior to invocation of HCPs and then supply an appropriate intervention (see Figure 3 for a graphic representation of the process). A HCP is a document that may be revoked at any time. In contrast, a guardian is a person—a family member or otherwise—appointed by a court to act on behalf of the patient once it is determined that the patient lacks the capacity to make decisions for himself or herself. The standard is that the guardian provides substitute judgment for the patient, that is, acts in such a way as the patient would want. Guardianship cannot be revoked by the patient. The powers of guardians as well as assorted regulations differ from state to state. For example, in Massachusetts, a guardian may not sign a person into a psychiatric hospital for treatment. However, in Massachusetts and other states, the HCP agent is the legal SDM. Other states www.psychosomaticsjournal.org
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Documentation of Decision-Making Capacity, Informed Consent, and Health Care Proxies
FIGURE 3.
Graphic Representation of the Process to Assess and Document Capacity and Invoke a Substitute Decision-Maker.
Patient requiring intervention/procedure
Normal
Mental Status Exam
Exception: A minor Exception: An emergency
Altered 1) Expresses a choice 2) Understands the relevant information 3) Appreciates the situation and consequences 4) Can manipulate the information rationally
Proceed with informed consent process
Has capacity to make the decision
Capacity Evaluation
Lacks capacity to make the decision
Documentation
use a Power of Attorney (POA) or an advance directive (also known as a living will), while 11 states have a SDM hierarchy (i.e., a pecking-order to contact when a clinician needs to identify a decision-maker). Limitations This study has several limitations. As this pilot was conducted at a single center and had only a small number of subjects, future forays into this topic should include larger numbers of patient records at various institutions. Second, the procedure chosen was an LP, a diagnostic procedure as opposed to a treatment intervention. A treatment intervention would have a different set of risks and benefits with a potentially higher level of risk and, therefore, a need for a higher bar for capacity to agree to the intervention. It may be useful to repeat this investigation with a treatment intervention as the procedure chosen. Last, all the capacity assessments for providing informed consent were conducted by the primary team or the neurological service performing the LP. The psychiatric consultation service, while involved in some of the cases to speak to issues of agitation management or comorbid depression, did not assess decision-making capacity. One potential future direction is to investigate potential differences in capacity assessments between the consultant when involved and the primary team, as these concordance rates have been shown to be about 67% overall.11 526
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Substitute DecisionMaker
CONCLUSIONS Asking a patient about an advance directive is not only a federal regulation, it is important for clinical care. This pilot investigation was conducted to learn how one hospital complies with this regulation and what means are used to evaluate a patient’s ability to make decisions. Our results suggest that there is room for improvement in several domains, from the initial asking of all patients about completing a HCP to the assessment of a patient’s capacity to invoke the HCP. Moving forward, institutions must assess their own needs and address specific deficits in education and documentation to ensure that each patient is offered the opportunity to complete a HCP and that each patient’s decision-making capacity is evaluated and documented before he or she consents to any procedure or before invoking a SDM.
Disclosure: Authors Anna Glezer, Elizabeth A. Mort, Joshua L. Abrams, Susan Atamian, and Rebecca Weintraub Brendel have no disclosures. Author Theodore A. Stern has the following disclosures: Salary: Academy of Psychosomatic Medicine (Editor; Psychosomatics); Royalties: Mosby/Elsevier and McGraw-Hill (editor, textbooks of general hospital psychiatry). Psychosomatics 52:6, November-December 2011
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References 1. Lidz CW, Meisel A, Zerubavel E, et al: Informed Consent: A Study of Decision-making in Psychiatry. New York: Guilford Press, 1984 2. Schouten R, Brendel RW: Legal aspects of consultation, in Massachusetts General Hospital Handbook of Hospital Psychiatry, 6th ed. Stern TA, Fricchione GL, Cassem NH, et al, Ed. Philadelphia: Saunders Publishing, 2010; pp. 639 – 650 3. Brendel RW, Schouten R, Levenson JL: Legal issues, in American Psychiatric Publishing Textbook of Psychosomatic Medicine, 2nd ed. Levenson, JL. Ed. Washington DC: American Psychiatric Publishing, 2011; pp.19 –32 4. Patient Self Determination Act, 42 U.S.C. 1395cc(a) (1990) 5. Patient Self Determination Act, Final Regulations, 60 C.F.R. 123 at 33294 (1995) 6. Brendel RW, Wei MH, Schouten R, et al: An approach to selected legal issues: confidentiality, mandatory reports, abuse and neglect, informed consent, capacity decisions, boundary issues, and malpractice claims. Med Clin N Am 2010; 94:1229 –1240 7. Schouten R, Edershein JG: Informed consent, competency, treatment refusal, and civil commitment, in Massachusetts General
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8. 9. 10. 11.
12. 13. 14. 15. 16.
Hospital Comprehensive Clinical Psychiatry. Stern, TA, Rosenbaum JF, Fava M, et al, Eds. Philadelphia: Mosby, 2008; pp.1143–1154 Brendel RW, Schouten R: Legal concerns in psychosomatic medicine. Psychiatr Clin N Am 2007; 30:663– 676 Applebaum P, Grisso T: Assessing patients’ capacities to consent to treatment. N Engl J Med 1988; 319:1635–1638 Applebaum P: Assessment of patients’ competence to consent to treatment. N Engl J Med 2007; 357:1834 –1840 Kornfield DS, Muskin PR, Tahil FA: Psychiatric evaluation of mental capacity in the general hospital: a significant teaching opportunity. Psychosomatics 2009; 50:468 – 473 Massachusetts General Laws Chapter 201D Black’s Law Dictionary, 6th ed. St. Paul: West Paul Publishing Co., 1990; pp. 706 Massachusetts Uniform Probate Code. Chapter 521, 2008 Black’s Law Dictionary, 6th ed. St. Paul: West Paul Publishing Co., 1990; p. 1599 Black’s Law Dictionary, 6th ed. St. Paul: West Paul Publishing Co., 1990; pp. 1171–1172
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Documentation of Decision-Making Capacity, Informed Consent, and Health Care Proxies APPENDIX: A A tool for documentation of health care proxies, substitute decision-makers, and mental status in patients undergoing a lumbar puncture Demographics Patient medical record number: __________ ______________ Age: Date of Admission: Date of Discharge: Diagnoses on discharge (from discharge note) Primary: Secondary: Eligibility Is there evidence on admission of impaired/altered mental status? [] Yes [] No If Yes, what is it? __________________________ If No, end of survey. Chart Review Information Existence of Health Care Proxy documented somewhere in medical record? [] Yes [] No If yes, then where? [] Actual document present in chart. Date signed: __________________________ [] Nursing intake/admission packet reports presence of HCP [] Elsewhere __________________________ If no, then [] Nursing intake/admission specifies “No” [] Nursing intake/admission packet specifies “Unable to respond” Is there any evidence that the patient has a temporary or permanent guardian? [] Yes [] No If yes, what is the evidence? __________________________ If yes, what is the expiration date of the guardianship? __________________________ Do advance directives exist? (Limitations in life sustaining treatment, as noted in HPI) [] Yes [] No Procedure (Lumbar Puncture) Related Information Date of procedure: Is there any evidence that this was an emergency procedure? [] Yes [] No Service performing procedure: Service of record at time of LP: Consent Documentation Was consent obtained? [] Yes []No If yes, what is the evidence? [] Procedure note [] Consent form If consent form is present, did the patient sign the form? [] Yes [] No If no, did a surrogate? (HCP, Guardian, Family member, Friend, Other) If obtained via phone, from whom? Capacity Assessment Is there documentation of mental status within 24 hours of procedure? [] Yes [] No Was there evidence of Altered Mental Status as evidenced by alterations in: Alertness? [] Yes [] No and Orientation? (Person, place, time) [] Yes []No Behavior (including hallucinations/psychosis)? [] Yes [] No 528
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Glezer et al. Cognition (including memory impairment)? [] Yes [] No Was there any reference to decisional capacity? [] Yes []No Is there adequate documentation to infer capacity to consent to LP? [] Yes [] No Is there documentation of the 4-point formal assessment? [] Yes [] No Was there a psychiatric consultation? [] Yes [] No
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© 2011 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.
Original Research Reports Documentation of Decision-Making Capacity, Informed Consent, and Health Care Proxies: A Study of Surrogate Consent Anna Glezer, M.D., Theodore A. Stern, M.D., Elizabeth A. Mort, M.D., Susan Atamian, R.N., Joshua L. Abrams, J.D., Rebecca Weintraub Brendel, M.D., J.D.
Background: Patients in the general hospital are routinely asked to make decisions about their medical care. However, some of them are unable to express a choice, understand the information provided, weigh the options, or make a decision for themselves; when this occurs, the task of making an appropriate medical decision is left to another—a substitute decision-maker (SDM). Objective: We sought to understand the practice patterns surrounding surrogate consent. We hypothesized that SDMs would be used frequently for patients with an altered mental status (AMS) but that there would be insufficient documentation of health care proxies (HCP) and of clinician assessment of a patient’s decision-making capacity. Methods: A retrospective chart review was conducted on inpatients who underwent a lumbar puncture. The review assessed whether patients had a HCP
in the record, if the patient’s mental status was evaluated prior to obtaining informed consent, if the patient’s capacity was addressed in this assessment, and whether a SDM was asked to provide the informed consent. Results: Consistent with our hypotheses, we found that the majority of patients did not have documentation of a HCP in the record. We found that the mental status of all patients was assessed prior to the procedure, but that documentation regarding assessment of decisionmaking capacity was lacking. Conclusions: Our pilot investigation suggests that there is need for improvement in our evaluation and documentation of altered mental status and a patient’s ability to make informed decisions. To this end, several quality-improvement suggestions are discussed. (Psychosomatics 2011; 52:521–529)
O
someone other than the patient. This substitute decisionmaker (SDM) is asked to make the decision that best approximates what the patient would have wanted if he or she had the ability to make the decision (i.e., substituted judgment). In
n any given day, most patients in the general hospital are asked to make decisions about their medical care. For each of them, informed consent constitutes the foundation for the collaborative process with their physicians for each of these medical decisions.1 This decision-making process relies upon the patient receiving the appropriate information, weighing the risks and benefits of the intervention (and the lack thereof), and deciding about whether to embark upon the intervention or treatment. However, some patients are unable to express a choice, to understand the information provided, to weigh the options, or to make a decision for themselves. When one of these situations occurs, the task of making an appropriate medical decision must be made by Psychosomatics 52:6, November-December 2011
Received May 10, 2011; revised June 22, 2011; accepted June 24, 2011. From University of California San Francisco, Department of Psychiatry, Psychiatry and the Law Program, San Francisco, CA. Send correspondence and reprint requests to Anna Glezer, M.D., University of California San Francisco, Department of Psychiatry, Psychiatry and the Law Program, 401 Parnassus Avenue, LP-0984, San Francisco, CA 94143; e-mail: [email protected] © 2011 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.
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Documentation of Decision-Making Capacity, Informed Consent, and Health Care Proxies situations where the patient’s interests are not, or cannot be, known, the SDM must decide in the patient’s best interest. Substitute Decision-Maker (SDM) Multiple terms have been used to describe a SDM. The phrase, SDM has both legal and laymen’s definitions;2 the individual named as the SDM is often (but not always) a family member of the patient to whom the medical team has turned to make decisions for an incapacitated individual. The phrase, Health Care Proxy (HCP), refers to a specific legal document that names a person, called the agent, who will hold the power to make medical decisions for the person who completed the HCP, identified as the principal, should the principal become incapacitated.3 When the principal is determined to lack capacity for certain decisions, the agent is able to make a decision based on what he or she believes the principal would do. Such decisions include both medical and psychiatric treatment. (See Table 1 for definitions of terms related to substitute decision-making.) Objectives for the Study We sought to understand the practice patterns that surround surrogate consent at a large urban general hosTABLE 1.
Terms Related to Substitute Decision-Making
Health Care Proxy (HCP)
Guardianship
Living Will
Power of Attorney (POA)
Advance Directive
522
A legal document that a patient completes to designate another person as their medical decision-maker, should they become incapacitated. The HCP can be revoked at any time.12 A legal arrangement under which one person, the guardian, has the legal right and duty to care for another. Guardianship may be limited to medical or financial decisions or be more global in nature.13,14 A document that delineates a person’s wishes (either generally or specifically about the withholding or withdrawal of lifesustaining treatment) when that person is no longer able to make decisions about his or her treatment. Living wills are not recognized in all states as binding legal documents, but they are a good source of information about a patient’s wishes.15 An instrument in writing whereby one person, the principle, appoints another as his agent and provides that agent with the authority to act on behalf of the principle.16 A general term for treatment preferences and SDM designation. HCPs, living wills, and POAs are examples of advance directives.
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pital. We wished to learn whether patients were being asked about their HCPs and when and how SDMs were being asked to make critical decisions on behalf of patients. We focus specifically on HCPs, as this is the only legally recognized advance directive used in Massachusetts, where this study was conducted. Reasons to evaluate this practice included a desire to improve care and to comply with state and federal regulations. In November of 1990, Congress passed the Patient Self-Determination Act, as an amendment to Omnibus Budget Reconciliation Act of 1990.4 The Patient Self-Determination Act stated that patients have the right to facilitate their own health care decisions, to accept or refuse treatment, and to create an advance care directive. Facilities have an obligation to inquire about advance directives and to document their existence in the medical record, as well as to educate staff about advance directives.5 To enable us to survey patients who may not have had the capacity to make medical decisions and therefore may have needed a SDM, we required a subject pool with a significant number of patients who were likely to have an altered mental status and who were likely to need to give informed consent for a procedure. To ensure sufficient numbers, we selected patients who had undergone a lumbar puncture (LP), as this diagnostic procedure requires informed consent and is commonly performed in patients with an altered mental status. Our hypotheses were based on our clinical experience: (1) we anticipated a low rate of inclusion of the HCP document in the chart, even if a SDM was relied upon; (2) we hypothesized that a SDM would be used frequently in patients with an altered mental status; (3) we hypothesized that while clinicians often make decisions implicitly or explicitly about a patient’s decisional capacity in determining whether or not a SDM is required, their documentation of this decision-making process would be inadequate or missing from the record; (4) we anticipated that the document of informed consent would be universally present. METHODS Our retrospective chart review study was conducted at the Massachusetts General Hospital after obtaining approval from its Institutional Review Board (IRB). The records of 590 patients were surveyed for eligibility. The pool of patients was derived from a list of all patients who had cerebrospinal fluid (CSF) samples sent to the laboratory between January 1, 2010 and June 30, 2010. We excluded Psychosomatics 52:6, November-December 2011
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FIGURE 1.
Sample Selection. ER ⴝ Emergency room; LP ⴝ Lumbar puncture; AMS ⴝ Altered mental status
590 patients Exclude: outpatients, ER patients Exclude: patients who did not have LP performed Exclude: patients without AMS on admission
38 patients
outpatients and those who had the LP in the Emergency Department (ED), as well as those who had an LP for a purpose other than for assessment of altered mental status (e.g., as obtained during shunt placements/revisions). Patients were excluded if they lacked evidence of an altered mental status on admission, as noted in the admission note, or if they had the LP procedure performed emergently. The remaining charts were examined with an instrument developed by the investigators. (See Figure 1 for graphic representation of this selection process.) The 27-item questionnaire (see Appendix A) included basic demographic data, eligibility requirements, questions about HCP documentation, the evaluation of altered mental status, and the assessment of capacity. Altered mental status was defined as “evidence of alterations in alertness, orientation, behavior (including hallucinations/psychosis), or cognition (including memory impairment).” To ensure reliability, two clinicians independently reviewed the same seven charts and established inter-rater reliability before the rest of the records were reviewed.
RESULTS A total of 38 patients with altered mental status were included in the study. These patients were, on average, 62 years old (⫾14) and had a length of stay in the hospital of 15 days. Primary diagnoses on discharge varied, but the most common one was “Altered Mental Status.” Our first hypothesis—that there would be few HCPs in the chart—proved correct. Of the 38 patients, 15 Psychosomatics 52:6, November-December 2011
(39%) patients had the existence of a HCP documented in the record (either in the nursing triage packet or elsewhere in the chart). However, only 9 (24% of the total and 60% of those whose records indicated the existence of a HCP) had the actual HCP in the chart. In all nine cases, the HCP had been signed before the LP was performed, see Figure 2. All patients had their consent for the LP documented (in a procedure note or on a consent form), although only 33 (87%) patients had a signed consent form in the chart. Twentyfive (66%) patients had a surrogate’s signature on the consent form, while 8 (21%) signed the form themselves. Our second and third hypotheses were verified. Of those 25 patients who had a surrogate sign the form, 6 (24%) had a HCP in the chart. All 25 also had documentation of a mental status examination conducted within 24 hours before the LP, and 23 of 25 had documentation of an altered mental status (based on level of alertness, orientation, behavior, or cognition). However, of those 25 who had a surrogate’s signature, only three of 25 revealed any reference to decisional capacity; 21 of 25 had sufficient documentation to infer a lack of capacity to consent for the procedure (see Table 2). Of those who signed their own consent form (eight patients; 21%), seven of eight had documentation of an altered mental status; none referred to decisional capacity; three of eight had documentation sufficient to infer that they had the capacity to consent to an LP (based on mental status exam documented within 24 hours of the procedure that included data on alertness, orientation, behavior and cognition, compared with a general determination of “al-
FIGURE 2.
Health Care Proxy (HCP) Documentation.
38 patients
15 patients HCP documented to exist
6 patients HCP not in chart
23 patients HCP not documented
9 patients HCP in chart
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TABLE 2.
Surrogate-Signed Sample of 25 Patients
Altered mental status documented Decisional capacity documented Documentation sufficient to suggest lack of capacity to sign consent
n
%
23 3 21
92 12 84
tered mental status” on admission) while one of eight had enough documentation to infer that they lacked the capacity to provide consent. Five patients had no consent form for the LP in the chart, in contrast with our final hypothesis that all patients would have an informed consent document in their charts. All had documentation of an altered mental status within 24 hours of the procedure. None of the five records revealed any reference to decisional capacity of the patients. Four of the five had enough documentation to infer a lack of capacity to consent to the LP. As there was no consent form in these charts, we were unable to determine if the patient or a surrogate signed the consent for the procedure. DISCUSSION The findings of our pilot investigation suggest there is need for improvement in our evaluation and documentation of altered mental status and a patient’s ability to make informed decisions. This begins with a more thorough understanding of the issue of informed consent and capacity. Issue of Informed Consent All patients, until an evaluation determines otherwise, are presumed competent to make their own decisions; as such, each individual must give informed consent for any non-emergent procedure. Informed consent is not merely the act of signing a document for consent to a procedure;1 instead, it represents the process of being provided with, and discussing/weighing the options, regarding an intervention’s risks and benefits. If a patient lacks the capacity to give consent, a SDM is asked to provide informed consent. Informed consent law, developed from torts of medical battery (defined as unwanted touching without consent) is based on the principle that all individuals have the right to make decisions that affect their well-being.6 To provide informed consent, a person must be able to appreciate the risks and benefits of making the decision.7 Exceptions to this rule include emergencies; in these circumstances there is often insufficient time to clarify an 524
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individual’s true state of mind and arrival for care implies consent.8 Issue of Capacity The issue of capacity is at the heart of discussions about surrogate decision-making. However, before one can decide upon who can serve as a SDM, several practical questions need to be answered about decisional capacity. Who can assess capacity? How does one determine whether a patient has the capacity to make a decision? Can a patient have the capacity to make one decision but not another? Any physician is able to evaluate and assess a patient’s decision-making capacity. A patient must meet four criteria in order to demonstrate capacity. In their landmark paper, Appelbaum and Grisso described the four elements of a capacity evaluation.9,10 First, a person must be able to communicate a clear, consistent choice. Second, the patient must understand the relevant information (including the risks and benefits of a particular decision). Third, the patient must appreciate the situation and its consequences (particularly as they apply to that person). Finally, the patient must be able to rationally manipulate the information. Given these requirements, it is easy to see how capacity may fluctuate (e.g., while unconscious, a person lacks capacity, but after awakening may have the clarity of mind to make decisions). After an evaluation has been completed, if a patient is deemed to lack capacity, a surrogate is sought by clinical staff. A person may have the capacity to make one decision, but not another (e.g., to accept but not to refuse a lifesaving procedure or to be transferred to a rehabilitation facility). These conclusions relate to the risks and benefits of a specific decision. Consenting to a procedure or a decision that is of low risk requires a lower threshold for capacity compared with one that is high risk. For example, a person may not be able to provide consent (due to cognitive impairment) for a complicated medical procedure, but be able to name a HCP agent, because he trusts someone else (e.g., his daughter) to make medical decisions on his behalf. As a general rule, the threshold for capacity to complete a HCP is lower than it is to make medical decisions. Notably, most of our patients had documentation of a mental status exam in their charts within 24 hours of the LP; for many, there was sufficient documentation to infer the patient’s capacity to make a decision, although decisional capacity was not actually documented in the majorPsychosomatics 52:6, November-December 2011
Glezer et al. ity of cases. For example, one patient was noted as having an alteration in alertness and a lack of response to verbal stimuli. Decisional capacity was not documented for this patient, but given the description of the mental status, it can be deduced that this patient did not have capacity to consent to an LP. This suggests that many clinicians regularly evaluate a patient’s mental status and have a general clinical sense about when a patient can and cannot make decisions for him/herself. However, this is insufficient. It is helpful to begin with a working definition of altered mental status. In this study, we used “alterations in a patient’s alertness, orientation, behavior, or cognition.” Alertness refers to whether the patient was arousable to voice and be aware of what was taking place around him/her, or, in contrast, somnolent, stuporous, or comatose. Orientation refers to a patient’s knowledge of his/her name, place, and the current date. Behavior includes a patient’s cooperativeness, his/her possible agitation, and his/her experience of hallucinations. Cognition refers to a patient’s attention, memory, and knowledge processing. Following assessment of a patient’s mental status, regardless of whether it is altered, it is important to evaluate decision-making capacity. In the case of a LP, a patient would needs to be able to express his or her choice to have the LP and be able to understand the potential risks of the procedure (e.g., infection, bleeding), as well as the benefits (e.g., diagnostic clarification). The patient would need to be able to apply those risks and benefits to himself/herself and to reason rationally about the decision. This capacity evaluation is an integral part of the informed consent process, which involves more than a patient merely signing a consent form. Notably, in our study, 13% of the patients’ charts also had missing consent forms (5/38). One reason to assess a patient’s capacity is to be able to ascertain if the patient is actually agreeing to the procedure (i.e., providing informed consent) or is merely an incompetent accepter, as the standard for moving forward with a procedure is informed consent. For example, one of the study subjects who signed her LP consent form had an altered mental status documented. It was possible to infer that she lacked the capacity to make her own medical decision. In this case, the appropriate next step should have been to turn to the patient’s SDM. Quality Improvement Strategies These results lead to the question of how to improve the implementation and use of SDMs. More specifically, we wondered how we can improve hospital compliance Psychosomatics 52:6, November-December 2011
with patient completion of a HCP, the rate of HCP documentation, and with capacity evaluations before invoking a HCP. To begin, it is helpful to think about reasons why consent forms may be missing or HCPs are not completed. These may include clinicians feeling pressed for time or that they would serve their patients better by focusing on other clinical duties, lack of familiarity with advance directives or the elements of informed consent, or simply not having easy access to the appropriate documentation. Several multipronged approaches seem reasonable to improve compliance, given that multiple possibilities exist as reasons for noncompliance. The first is to educate clinical staff. Providing instruction on the process of mental status evaluation, informed consent, and capacity assessment should be a core part of continued training and education efforts. It may be helpful to tie such sessions to incentives. Second, clinicians should be prompted to address a patient’s decision-making capacity when obtaining informed consent (e.g., the actual consent form or procedure note document could be modified to include a sentence that capacity has been assessed and the patient has the capacity to agree and to sign). Last, to ensure that more patients are being offered the opportunity to complete a HCP, a form could be added to discharge procedures (which is usually a time when patients and their families are calmer and can think about these complex decisions, compared with the time of admission) or annual physicals. In order for clinicians and other staff to have access to these important documents, institutions might also consider having easily accessible registries for HCP data. However, while these suggestions may help in certain institutions, they may not be universally useful. Therefore, it is up to each hospital and clinical care facility to evaluate their performance on this matter of patient completion of HCPs and clinician evaluations of patient capacity prior to invocation of HCPs and then supply an appropriate intervention (see Figure 3 for a graphic representation of the process). A HCP is a document that may be revoked at any time. In contrast, a guardian is a person—a family member or otherwise—appointed by a court to act on behalf of the patient once it is determined that the patient lacks the capacity to make decisions for himself or herself. The standard is that the guardian provides substitute judgment for the patient, that is, acts in such a way as the patient would want. Guardianship cannot be revoked by the patient. The powers of guardians as well as assorted regulations differ from state to state. For example, in Massachusetts, a guardian may not sign a person into a psychiatric hospital for treatment. However, in Massachusetts and other states, the HCP agent is the legal SDM. Other states www.psychosomaticsjournal.org
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FIGURE 3.
Graphic Representation of the Process to Assess and Document Capacity and Invoke a Substitute Decision-Maker.
Patient requiring intervention/procedure
Normal
Mental Status Exam
Exception: A minor Exception: An emergency
Altered 1) Expresses a choice 2) Understands the relevant information 3) Appreciates the situation and consequences 4) Can manipulate the information rationally
Proceed with informed consent process
Has capacity to make the decision
Capacity Evaluation
Lacks capacity to make the decision
Documentation
use a Power of Attorney (POA) or an advance directive (also known as a living will), while 11 states have a SDM hierarchy (i.e., a pecking-order to contact when a clinician needs to identify a decision-maker). Limitations This study has several limitations. As this pilot was conducted at a single center and had only a small number of subjects, future forays into this topic should include larger numbers of patient records at various institutions. Second, the procedure chosen was an LP, a diagnostic procedure as opposed to a treatment intervention. A treatment intervention would have a different set of risks and benefits with a potentially higher level of risk and, therefore, a need for a higher bar for capacity to agree to the intervention. It may be useful to repeat this investigation with a treatment intervention as the procedure chosen. Last, all the capacity assessments for providing informed consent were conducted by the primary team or the neurological service performing the LP. The psychiatric consultation service, while involved in some of the cases to speak to issues of agitation management or comorbid depression, did not assess decision-making capacity. One potential future direction is to investigate potential differences in capacity assessments between the consultant when involved and the primary team, as these concordance rates have been shown to be about 67% overall.11 526
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Substitute DecisionMaker
CONCLUSIONS Asking a patient about an advance directive is not only a federal regulation, it is important for clinical care. This pilot investigation was conducted to learn how one hospital complies with this regulation and what means are used to evaluate a patient’s ability to make decisions. Our results suggest that there is room for improvement in several domains, from the initial asking of all patients about completing a HCP to the assessment of a patient’s capacity to invoke the HCP. Moving forward, institutions must assess their own needs and address specific deficits in education and documentation to ensure that each patient is offered the opportunity to complete a HCP and that each patient’s decision-making capacity is evaluated and documented before he or she consents to any procedure or before invoking a SDM.
Disclosure: Authors Anna Glezer, Elizabeth A. Mort, Joshua L. Abrams, Susan Atamian, and Rebecca Weintraub Brendel have no disclosures. Author Theodore A. Stern has the following disclosures: Salary: Academy of Psychosomatic Medicine (Editor; Psychosomatics); Royalties: Mosby/Elsevier and McGraw-Hill (editor, textbooks of general hospital psychiatry). Psychosomatics 52:6, November-December 2011
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References 1. Lidz CW, Meisel A, Zerubavel E, et al: Informed Consent: A Study of Decision-making in Psychiatry. New York: Guilford Press, 1984 2. Schouten R, Brendel RW: Legal aspects of consultation, in Massachusetts General Hospital Handbook of Hospital Psychiatry, 6th ed. Stern TA, Fricchione GL, Cassem NH, et al, Ed. Philadelphia: Saunders Publishing, 2010; pp. 639 – 650 3. Brendel RW, Schouten R, Levenson JL: Legal issues, in American Psychiatric Publishing Textbook of Psychosomatic Medicine, 2nd ed. Levenson, JL. Ed. Washington DC: American Psychiatric Publishing, 2011; pp.19 –32 4. Patient Self Determination Act, 42 U.S.C. 1395cc(a) (1990) 5. Patient Self Determination Act, Final Regulations, 60 C.F.R. 123 at 33294 (1995) 6. Brendel RW, Wei MH, Schouten R, et al: An approach to selected legal issues: confidentiality, mandatory reports, abuse and neglect, informed consent, capacity decisions, boundary issues, and malpractice claims. Med Clin N Am 2010; 94:1229 –1240 7. Schouten R, Edershein JG: Informed consent, competency, treatment refusal, and civil commitment, in Massachusetts General
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Hospital Comprehensive Clinical Psychiatry. Stern, TA, Rosenbaum JF, Fava M, et al, Eds. Philadelphia: Mosby, 2008; pp.1143–1154 Brendel RW, Schouten R: Legal concerns in psychosomatic medicine. Psychiatr Clin N Am 2007; 30:663– 676 Applebaum P, Grisso T: Assessing patients’ capacities to consent to treatment. N Engl J Med 1988; 319:1635–1638 Applebaum P: Assessment of patients’ competence to consent to treatment. N Engl J Med 2007; 357:1834 –1840 Kornfield DS, Muskin PR, Tahil FA: Psychiatric evaluation of mental capacity in the general hospital: a significant teaching opportunity. Psychosomatics 2009; 50:468 – 473 Massachusetts General Laws Chapter 201D Black’s Law Dictionary, 6th ed. St. Paul: West Paul Publishing Co., 1990; pp. 706 Massachusetts Uniform Probate Code. Chapter 521, 2008 Black’s Law Dictionary, 6th ed. St. Paul: West Paul Publishing Co., 1990; p. 1599 Black’s Law Dictionary, 6th ed. St. Paul: West Paul Publishing Co., 1990; pp. 1171–1172
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Documentation of Decision-Making Capacity, Informed Consent, and Health Care Proxies APPENDIX: A A tool for documentation of health care proxies, substitute decision-makers, and mental status in patients undergoing a lumbar puncture Demographics Patient medical record number: __________ ______________ Age: Date of Admission: Date of Discharge: Diagnoses on discharge (from discharge note) Primary: Secondary: Eligibility Is there evidence on admission of impaired/altered mental status? [] Yes [] No If Yes, what is it? __________________________ If No, end of survey. Chart Review Information Existence of Health Care Proxy documented somewhere in medical record? [] Yes [] No If yes, then where? [] Actual document present in chart. Date signed: __________________________ [] Nursing intake/admission packet reports presence of HCP [] Elsewhere __________________________ If no, then [] Nursing intake/admission specifies “No” [] Nursing intake/admission packet specifies “Unable to respond” Is there any evidence that the patient has a temporary or permanent guardian? [] Yes [] No If yes, what is the evidence? __________________________ If yes, what is the expiration date of the guardianship? __________________________ Do advance directives exist? (Limitations in life sustaining treatment, as noted in HPI) [] Yes [] No Procedure (Lumbar Puncture) Related Information Date of procedure: Is there any evidence that this was an emergency procedure? [] Yes [] No Service performing procedure: Service of record at time of LP: Consent Documentation Was consent obtained? [] Yes []No If yes, what is the evidence? [] Procedure note [] Consent form If consent form is present, did the patient sign the form? [] Yes [] No If no, did a surrogate? (HCP, Guardian, Family member, Friend, Other) If obtained via phone, from whom? Capacity Assessment Is there documentation of mental status within 24 hours of procedure? [] Yes [] No Was there evidence of Altered Mental Status as evidenced by alterations in: Alertness? [] Yes [] No and Orientation? (Person, place, time) [] Yes []No Behavior (including hallucinations/psychosis)? [] Yes [] No 528
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Glezer et al. Cognition (including memory impairment)? [] Yes [] No Was there any reference to decisional capacity? [] Yes []No Is there adequate documentation to infer capacity to consent to LP? [] Yes [] No Is there documentation of the 4-point formal assessment? [] Yes [] No Was there a psychiatric consultation? [] Yes [] No
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