Informed Consent and Capacity Assessment (ON)

Primer

Consent and Capacity are two central tenets in modern medicine and critical to patient autonomy, the respect for personal dignity, and the delivery of ethical care by physicians. This page focuses specifically on legislation and laws in the province of Ontario, Canada. The basic principles can be applied throughout Canada, because of the 2003 Supreme Court ruling (Starson v. Swayze) but please be aware of your own jurisdiction's specifics.[1]

Consent

Obtaining Informed Consent is the process of getting permission from a patient before conducting a healthcare intervention (e.g. - prescribing a medication or a surgical procedure). Only a health practitioner (i.e. - usually the most responsible provider, or MRP) who has the knowledge to answer a person’s questions about the treatment can carry out the process of obtaining informed consent to the treatment. For a patient to provide consent to a treatment, they must be capable (i.e. - able to “understand” and “appreciate” the nature of a treatment - see Capacity section below). There is no specific age requirement to consent (but obviously one must factor that a 4-year-old will not have the same understanding of any treatment compared to a 40-year-old).

When a physician obtains informed consent, it must:

  1. Be related to a treatment or treatment plan
  2. Be informed (the nature of treatment, risks, side effects, expected benefits, alternatives, likely consequences of refusing are discussed)
  3. Be voluntary (not under coercion, or under duress)
  4. Not be obtained through fraud or misrepresentation (by the physician)

Consent is Also Required Before You Disclose Patient Information!

Separate from treatment consent, communication/disclosure consent must also be obtained from patients prior to divulging personal health information to the patient's family or friends.

How to Obtain Consent

The key components of obtaining informed consent from your patient includes discussing the following:

  1. Nature of the treatment
  2. Expected benefits of the treatment
  3. Material risks of the treatment
  4. Material side effects of the treatment
  5. Alternative courses of action (i.e - alternate treatments including non-pharmacological)
  6. Likely consequences of not having the treatment
  7. Likely consequences of having the treatment

What Are 'Material' Risks and Side Effects?

Material risks or side effects of treatment include:
  • Those which are probable or likely to occur
  • Those which are possible if they carry serious consequences
  • Those which a reasonable person in the patient’s specific circumstances would want to know in order to make a decision to give or refuse consent

Sample Documentation for Informed Consent for a Medication Class

Class Documentation
Antipsychotics Consent was obtained to start the antipsychotic. The benefits of treatment were discussed, including reduction of psychotic symptoms, improved insight, judgment, and reduction in maladaptive behaviours. We also discussed the likely possibility of worsening symptoms and the clinical course without treatment. The rare risk of death/CVA, NMS, parkinsonism, involuntary movements due to EPS were also discussed. We discussed possible side effects including falls, sedation, metabolic syndrome, and QTc prolongation/arrhythmia. We also discussed the importance of ongoing monitoring for metabolic syndrome and side effects such as hyperlipidemia, and elevated glucose.
Antidepressants Consent was obtained to start an antidepressant for the patient. We discussed the common side effects, including nausea, headaches, sexual dysfunction, and increased anxiety, and that most of these side effects will self-resolve 1 to 2 weeks into treatment. Rare but serious side effects, including serotonin syndrome, hyponatremia, elevated bleeding risk, anti-depressant-induced mania/hypomania, and increased risk of suicidal ideation were also discussed.

Sample Documentation for Informed Consent for a Specific Medication

Medication Documentation
Clozapine[2] Consent was obtained to start clozapine for the patient. We discussed the risks and benefits of treatment with clozapine, including side effects such as agranulocytosis, myocarditis, weight gain, hypersalivation, as well as metabolic side effects. We also discussed the benefits of treatment, including reduction in symptoms of psychosis. We also discussed the role of ongoing blood work and monitoring involved.

Emergency Consent

An individual can be treated in an emergency without their consent if they are experiencing severe suffering, or are at risk of sustaining serious bodily harm to themselves or others if the treatment is not given promptly. Similarly, emergency treatment can proceed if the delay required to obtain consent, or their refusal would prolong their suffering, or put themselves at risk of sustaining serious bodily harm. This allows physicians to give medications to manage acute agitation in patients.

Voluntary Patients and Physical Restraints

The key point is that there is a difference between physical restraint/confinement, versus treatment. Physical restraint is not a medical treatment, and therefore consent not is required. However, the Mental Health Act also states there can be NO RESTRAINTS for voluntary or informal patients. In an emergency setting, a voluntary or informal patient can be restrained, but one must immediately reassess the patient's legal status (i.e. - do they now meet criteria for a Form 1), because you CANNOT hold a voluntary patient in seclusion/restraints beyond the immediate emergency situation. However, the bottom line is always safety first!

Capacity

Capacity is the ability to understand and appreciate the consequences of a treatment. The approach to capacity (especially for psychiatric reasons) has become more nuanced in the last few decades. Capacity is no longer a one-time assessment that applies globally to everything. Instead, capacity can fluctuate, and also is specific to the type of treatment being offered.

These are the key points to consider regarding capacity:

  1. An individual is capable until proven otherwise
  2. Capacity can fluctuate (i.e. - someone may be capable at one time regarding a treatment and incapable at another)[3]
  3. Capacity is task-specific (i.e. - capacity for finances is different than capacity for admission to a long-term care facility)
  4. Capacity is treatment-specific (i.e. - antipsychotics vs. mood stabilizers, diabetes management vs. chemotherapy for cancer, neurosurgery for brain cancer vs. acetaminophen for a headache)
  5. Capacity is functional
 (i.e. - just because someone is diagnosed with a mental disorder does not mean they are incapable)
  6. Disagreement or refusal with medical recommendations does not equate to incapacity
  7. Acquiescing to treatment does not prove capacity
  8. The best interests of the person are not relevant to the question of determining capacity

Capacity in Children

Although controversial, it is generally assumed that an individual < 6 years of age not capable, age 6-13 can have partial capacity, and over age 13 can be capable but with variability.

Supreme Court of Canada 2003 Ruling

While a patient need not agree with a particular diagnosis, if it is demonstrated that he has a mental “condition”, the patient must be able to acknowledge the possibility that he is affected by that condition…As a result, a patient is not required to describe his mental condition as an “illness”, or to otherwise characterize the condition in negative terms… Nonetheless, if the patient’s condition results in him being unable to recognize that he is affected by its manifestations, he will be unable to apply the relevant information to his circumstances, and unable to appreciate the consequences of his decision.

– Justice John C. Major, Starson v. Swayze, 2003 Supreme Court of Canada 32, [2003] 1 S.C.R. 722

How to Assess Capacity

Use the Aid To Capacity Evaluation (PDF) as a template when assessing capacity.

A Capacity Assessment involves assessing two branches: (1) the patient's ability to understand the information that is relevant to making a decision about the treatment, and (2) the patient's ability to appreciate the reasonably foreseeable consequences of a decision or lack of a decision. Incapacity occurs when, on a balance of probabilities, the patient fails either one or both branches of the capacity test. Furthermore, this must be documented appropriately in the patient's chart.[4]

When doing a capacity assessment for treatment with medication, you should to discuss treatment options in terms of classes of medications (i.e. - antipsychotics, antidepressants, etc.) This gives you broader coverage to change antipsychotics without needing to do repeat capacity assessments. You cannot obtain capacity/consent beyond a class of medications (i.e. - you cannot do a capacity assessment or obtain consent for all forms of psychiatric medications!). If you deem a patient incapable, you have to ask yourself: the patient is incapable to what specific treatment? There is no such thing as “global incapacity.”

The Two Branches of Capacity

Understanding Appreciation
Description Is the person is able to understand the information that is relevant to making a decision about the treatment? Do they have the cognitive ability to attend to, comprehend, retain and process relevant information? Are they able to appreciate the reasonably foreseeable consequences of a decision or lack of decision. An individual fails this test if they are unable to recognize the possibility that they are affected by the manifestations of the condition you describe to them and cannot appreciate the consequences of the decision being made.
Factors • What information has been given to the patient?
• What is the patient's response to this information? 		• Discuss what you think are the reasonably forseeable consequences from treatment, or lack of treatment.
• Are they able to apply the relevant information to their own circumstances and to weigh foreseeable risks and benefits?
Examples of failing this branch • Individuals with a cognitive condition (e.g. - dementia, traumatic brain injury) that impedes their ability to retain and or process the information.
• There is a very high threshold to actually fail this branch of the test (and most patients will pass it) 		• A patient diagnosed with schizophrenia is able to understand the information about the illness, and that it can affect some people, but does not believe that he/she has that illness, in spite of a two-year history of symptoms consistent with schizophrenia, hospitalization and treatment.
• A patient diagnosed with anorexia nervosa is able to understand and intelligently discuss the nature and consequences of the illness and readily acknowledges that people have to eat or that they may die. In spite of this, the patient is not able to eat and maintains that he/she will be fine.
Documentation

A finding of incapacity need to be documented on the medical record. In Ontario, if incapacity is for psychiatric reasons, a notice to the patient (Form 33) must be given, and rights advice must be notified. For non-psychiatric purposes, one does not need to give a Form 33 to the patient nor notify a rights adviser. However, the physician should provide rights information to the patient. After a finding of incapacity, you should continually assess capacity and document this; this is considered good practice!

Sample Documentation for Capacity Assessment

A capacity assessment was done today. [Patient] agreed/disagreed with a provisional diagnosis of [mental disorder]. [Patient] agreed/disagreed that they had a mental disorder. [Patient] was able/unable to understand the side effects of treatment with an antipsychotic such as paliperidone. When asked how these medications relates to the diagnosis of psychosis/schizophrenia, [Patient] could not apply it to their own situation. Furthermore, when asked in detail about what would happen if they were to stop taking medications, they said [patient quote].

[Patient] was unable to appreciate the foreseeable consequences of taking antipsychotics or lack of taking antipsychotic medications. [Patient] COULD NOT apply the relevant information provided to them to their own circumstances or weigh foreseeable risks and benefits. In particular, they could not appreciate that their non-adherence to medication would likely lead to [symptoms of disorder]. Based on this assessment, [Patient] fails the SECOND BRANCH of the capacity test.

Psychiatric vs. Medical Incapacity in Ontario

In Ontario, psychiatric and medical incapacity are separate. See the table below for an example.

Incapacity for Mental Health vs. Medical Treatment

Incapacity for Mental Health Treatment Incapacity for Medical Treatment
Example Diagnosis Schizophrenia Diabetic Ketoacidosis
Cause of Incapacity Delusions and hallucinations leading to inability to appreciate that treatment is needed Delirium and decreased level of consciousness leading to inability to understand and appreciate that treatment is needed
Proposed Treatment Antipsychotics Insulin
Mental Health Act (MHA) Applies? Yes No
Health Care Consent Act (HCCA) Applies? Yes Yes
Form 33 Required Not required (Rights Advisor does not need to be not notified. Rights Advice only needs to be provided by the health practitioner)
Leaving Against Medical Advice Can leave if status is a voluntary patient. Otherwise, cannot leave if on a Form 1, Form 3, or Form 4. Can leave if status is a voluntary patient. If there is a legitimate safety concern about the patient leaving, you would thus need to issue a Form 1 (e.g. - trying to leave during an episode of delirium)

Grey Areas

There may be situations where a patient may have both medical and psychiatric issues (e.g. delirium + schizophrenia, substance intoxication + schizophrenia, diabetic ketoacidosis + schizophrenia), and it is unclear which underlying issue is causing the incapacity. In this case, you will want to carefully document your reasoning (e.g. - why you think it is primarily psychiatric or primarily medical).

Substitute Decision Makers (SDMs)

In Ontario, if a patient is found incapable, you must find a Substitute Decision Maker (SDM) to give consent on the patient's behalf. The hierarchy of SDMs is dictated by the Healthcare Consent Act (HCCA). Here are some points to consider when an SDM is involved:

Resources

For Providers

References

1) Sklar, R. (2007). Starson v. Swayze: The Supreme Court speaks out (not all that clearly) on the question of “capacity”. The Canadian Journal of Psychiatry, 52(6), 390-396.
2) Parsons B, Kennedy M. A review of recorded information given to patients starting to take clozapine and the development of guidelines on disclosure, a key component of informed consent. Journal of Medical Ethics. 2007;33(10):564-567. doi:10.1136/jme.2006.016808.
3) A Practical Guide to Mental Health and the Law in Ontario, pp. 2-4
4) Psychiatrist’s clinical judgment does not obviate need to meet standards of evidence in CCB hearings: Anten v. Bhalerao