ANNE HUBEN-KEARNEY, RN, BSN, MPA, CPHQ, CPHRM, CPPS, DFASHRM
Assistant Vice President, Risk Management Group
AWAC Services Company, a member company of Allied World
Informed consent is an interactive process between a patient and a psychiatrist, not a form or a one-time conversation. The same holds true for informed refusal, which is the process of discussion when a patient refuses treatment, including voluntary hospitalization. This article will review the what, why, who, when and how of informed consent and informed refusal to emphasize the importance of engaging patients with their treatment while reducing the potential for liability.
What is Informed Consent?
Informed consent is a process of communication between a psychiatrist and a patient. Although laws differ from jurisdiction to jurisdiction, the basic requirements for a valid consent process are essentially the same. That means a discussion of:
- The clinical indications for the treatment, such as medication or voluntary hospitalization
- A description of what is involved with the treatment or medication
- Intended benefits and probable risks for the specific recommended treatment or medication and the alternatives, including the risks and/or benefits of the alternatives, which could include doing nothing
Why Obtain Informed Consent?
Physicians have both a legal and an ethical obligation to ensure that patients are informed about their healthcare so they can participate in decision making related to their care. Obtaining a patient’s informed consent to mental health treatment is guided by professional codes of ethics, statutes, regulations and case law.
Despite this, failure to obtain informed consent is among the most common allegations in medical malpractice claims against psychiatrists. Failure to obtain informed consent occurs when a psychiatrist does not provide adequate information for the patient to make an informed decision about treatment. When making a claim of failure to obtain an informed consent, the patient must show that if adequate information had been provided, they would have made a different decision. Signing an informed consent form is validation that the process has occurred and that an agreement has been reached.
A battery occurs when a patient is treated or touched without prior consent. In claims for battery, the treatment need not to have been negligent or have caused an untoward result. Nonetheless, often the plaintiff will assert a claim of negligence along with a claim of failure to obtain informed consent or battery. The only negligence that needs to be shown is that the psychiatrist failed to obtain the consent of the patient.
Who Can Provide Informed Consent or Informed Refusal?
Assessing a patient’s medical decision-making capacity is generally part of every medical encounter. Often, it is very clear that a patient can make rational decisions and there is no reason to believe otherwise. There are times when mental health patients may not be capable of making decisions, require a surrogate decision maker or are deemed incompetent.
Should a surrogate be involved with decision making, ensure that they have the legal authority to make healthcare decisions by asking for a copy of the court documents or evidence of a psychiatric advance directive, and retain the document in the medical record. Each state has differing requirements for appointment of a substitute decision-maker. As such, psychiatrists should refer to specific state laws and regulations regarding decision-making.
State laws also vary regarding decision making for minors, such as both parents being required to agree on the decision versus allowing one parent to make the decision for treatment and medications for their children. For divorced parents, ask for a copy of the custody agreement as part of your initial intake to learn whether one parent or both parents have decision-making authority.
Some states allow minors to make their own medical decisions with the age to consent varied by state. For those without this legal right, and if the minor is of such an age and maturity that they would understand the proposed treatment and the risks/benefits of the proposed treatment, the psychiatrist should also discuss these issues with the minor as well as the parent/guardian. Involving the minor patient in the treatment decision process is critical to forming an alliance with the patient and allows them to express their wishes despite their legal inability to give consent.
When Do I Need to Obtain Informed Consent?
Informed consent should be viewed as an ongoing process and should be obtained by the psychiatrist prior to initiating psychiatric treatment. Informed consent is a non-delegable responsibility.
When prescribing/recommending medications that are FDA approved but have black box warnings – or that are considered off-label – be sure to specifically discuss these warnings and associated risks and benefits with the patient. Furthermore, the psychiatrist should document that the patient is aware of the warnings associated with the use of the proposed medication when reviewing the presence or absence of any side effects from any medications at each session.
For psychiatrists who participate in clinical trials, a specific consent document is important for each individual study. The informed consent process should be continued throughout the duration of a clinical trial. As with any treatment or procedure, the psychiatrists involved in the trial should explain the details of the study before the participant becomes involved. The informed consent document should include details explaining the study, including purpose, duration, required procedures (if any) and the provider to contact if questions/concerns. Further, risks and potential benefits of the experimental treatment should be explained both verbally and within the informed consent document.
What Are Best Practices to Obtain Informed Consent?
A valid consent process must be put in terms that the patient or parent/guardian/surrogate decision-maker can understand, which means using simple, plain language (such as “don’t use” rather than “abstain”). Use lay terms instead of medical jargon, acronyms or abbreviations.
A valid consent process is one in which the patient or parent/guardian/surrogate decision-maker can ask questions and receive responsive, understandable answers. One way of assuring that the individual understands the treatment and/or use of medication is the “teach-back” method. Teach back confirms the patient’s understanding of treatment and medication instructions by asking them to repeat the information or instructions using their own words. Keep in mind the purpose of asking a patient to tell you about the medication regimen is not a test of the patient’s knowledge but rather a test of how well you explained the instructions in a manner the patient understands.
Use a qualified medical interpreter for any patient who is deaf or hard of hearing or has limited English proficiency (LEP). The use of friends and family to translate for patients is strongly discouraged. Friends and family members may not be impartial, may not know medical terminology, may not use the patient’s own words and may not be comfortable asking sensitive or potentially embarrassing questions (consider a teenager asking her grandfather about his substance abuse history). Inappropriate/inaccurate translation increases the risk for medication errors, avoidable readmissions and other adverse events. Failure to provide interpretation services can make patients feel their needs have been ignored and is associated with medical malpractice allegations including inadequate explanation of diagnosis, inadequate explanation of treatment and inadequate or negligent informed consent.
What Is Informed Refusal?
A patient who has the capacity to make decisions (or his/her designee) has the right to refuse treatment. As with informed consent, the psychiatrist has the duty to explain in lay terms and in the language the patient/designee can understand, the information needed for the patient to make a truly informed decision about refusing that treatment or medication. A provider cannot force or coerce a patient to undergo treatment against his or her will.
As with informed consent, the process of communication regarding informed refusal includes education on the recommended treatment, high risk medication or other interventions. It requires candid discussion of the recommended care and treatment, the reasons for the proposed treatment or medication, the potential consequences of refusal (including significant risks beyond “your condition may worsen”), but more specifically, risks related to progression of the disorder (such as worsening insomnia, increased paranoia, pronounced signs of tardive dyskinesia).
Why Obtain Informed Refusal?
Informed refusal cases arise from situations where patients or their families claim that the patient was not made aware of the risks associated with refusing the proposed treatment or medication. Even if it seems that the risks of refusal are blatantly evident, the psychiatrist needs to review the consequences of the patient’s refusal.
When Should Informed Refusal Be Obtained?
If a patient does not adhere to the treatment plan or medication regimen, there needs to be discussion on why the patient is noncompliant. If the patient understands the treatment plan (for example, not taking an appetite suppressant while taking a prescribed stimulant), the psychiatrist should discuss the risks of not following the prescribed medication precautions and the recommendations. The psychiatrist should consider obtaining informed refusal related to noncompliance with the treatment plan or medication regimen.
A refusal may not be accepted if in an emergency or if the unavoidable and forcible administration of a medication is required due to the patient being a threat to themselves or others. Once the emergency passes, consent must be obtained from the patient for future administration of medications/treatment. In psychiatric inpatient settings, even an involuntarily committed patient generally has a right to refuse recommended medications. Depending on the state, however, a court order may be required to administer medications/treatment without a patient’s consent. As each state has specific laws and regulations, it is important to check with your state regarding this issue.
What Are the Best Practices to Obtain Informed Refusal?
The same techniques and tools used for informed consent need to be used for informed refusal. But informed refusal requires asking the patient WHY they are refusing the care, treatment or medication. Is it because they cannot afford the medications? Are there transportation challenges to get to appointments? Could it be a high deductible for diagnostic testing? If you know the reason(s) behind the refusal, you may be able to help the patient or refer them to resources available for support.
Teach back is a good tool to clearly hear from the patient what they understood from the conversation: “I understand that you are refusing the treatment – I want to be sure you are aware of the consequences with not having the testing, medication, etc. – please tell me what you understand from our conversation and your plans to refuse.”
An informed refusal and the recommendations should be revisited, if possible, at subsequent office or treatment visits. But always respect the patient’s right to refuse care and treatment.
Asking the patient to sign a specific informed refusal form is advised. The patient may not wish to sign a form, however the discussion, the potential risks of noncompliance, the patient’s reasons for refusal and any follow-up should be documented in the medical record.
Documenting the informed consent or the informed refusal process should be done in a manner that reflects the education process undertaken with the patient, and not done in a conclusory way. The documentation needs to be in the medical record and should reflect the discussion, plan, patient understanding by teach back and any educational materials provided to the patient. If a form is used, ensure that each and all areas are filled out completely, leaving no blanks.
The informed consent process is crucial in the practice of psychiatry to not only demonstrate concern for your patients but also to protect you from liability if a claim for intentional or negligent informed consent or battery is brought against you. This process should not be taken lightly and is an important step in the overall treatment of the patient. Consult with your attorney or risk management professional when you have questions.