Practice of Medicine

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The Process of Creating and Sharing a Treatment Plan with Patients

Executive Summary 

A signed consent form is important but does not take the place of the shared decision-making process between a provider and patient. Shared decision-making is a process in which a provider uses their professional knowledge, judgment and experience to come to an understanding and plan with the patient in light of the patient’s knowledge and preferences. For low-risk procedures, verbal consent is usually acceptable. For more major procedures, a signed consent form is important for legal, regulatory and accreditation requirements. 

Recommended Actions 

  • Discuss the nature, risks and alternatives of treatment with each patient, as well as the risks of not proceeding. 
  • Document all patient interactions during which shared decision-making takes place. 
  • When necessary, ask the patient to sign a written consent form that confirms you reviewed the important aspects of treatment and the patient understands them. 

We tend to think of “informed consent as having the patient sign a form prior to performing surgery in the OR. This may be misleading, however, from several perspectives. 

  1. Obtaining informed consent is a process, not a form.  In fact, the form itself may not be required, but the process always is. 
  2. Informed consent is part of a shared decision-making process in which the provider comes to an understanding and plan with the patient, based on both the professional knowledge, judgment and experience of the provider and the knowledge and preferences of the patient. 
  3. The shared decision-making process would ideally be performed anytime a treatment, either surgical or medical, is recommended, not just before major surgery. 
  4. The signed consent form or permit is important for legal, regulatory and accreditation requirements, but does not take the place of the shared decision-making process. The form is further evidence that the process has taken place.  
  5. The process should be performed by the treating provider and include a discussion of the indications for the recommended treatment, the nature of the treatment, the risks of that treatment, alternatives to that treatment and risks of not proceeding. 

Let’s look at an office scenario. 

A patient presents to a medical office with a history of a recently swollen knee. Upon examination, you note that they have an effusion with some tenderness and redness, and you recommend joint aspiration. Should you: 

  1. Tell the patient you are going to aspirate some fluid and proceed; or 
  2. Tell the patient what you think might be going on, why you are recommending aspiration, what you would do without aspirating, the risks of joint aspiration, and obtain verbal consent before proceeding, with documentation; or 
  3. Write all of the above on a surgical permit, which the patient signs, then proceed. 

The majority of practices do a verbal informed consent for arthrocentesis, but either option 2 or 3 would be acceptable. Recall that surgical permits may not be required by law in some states, but may be required by institutions as the best evidence they have that the process of informed consent did take place. 

In an office setting, we recommend that physicians obtain a permit as part of the overall process in higher-risk procedures, especially with cosmetic procedures or those involving neurologic structures. For minor procedures with low risk, verbal consent is usually acceptable. It never hurts to obtain a surgical permit, but there should always be documentation that the process took place. Make sure to know the laws specific to your state. 

Although we may think of informed consent in the context of procedures, equal consideration should be given to invoking the process when prescribing medications such as long-term steroid use, warfarin, certain chemotherapeutic agents, chronic narcotics and aminoglycosides.  

The informed consent process is part of everyday practice and part of a shared decision-making effort with patients. Sometimes that process rises to the level of documentation with a signed permit, and physicians should always assess and document a patient’s understanding before proceeding. We feel that a properly conducted process reduces the threat of subsequent allegations of negligent informed consent, and we can defend against those allegations with appropriate documentation that the process occurred. 

Lessons Learned  

  • Develop specific protocols for providers to follow when obtaining informed consent for different types of treatment. 
  • Provide a hospitable environment for patients to ask questions that further their understanding of the recommended treatment. 
  • Stay up to date with federal and state laws regulating informed consent. 

Potential Damages 

Disputes regarding informed consent occur relatively frequently and pose the risk of expensive and timely litigation. Physicians may be liable for negligence if they fail to obtain necessary consent. 

Quiz 

Answers are provided below 

True or false?  

Question 1: Informed consent is a shared decision-making process between providers and their patients. 

Question 2: Anyone can take care of informed consent. 

Question 3: Informed consent is only necessary for risky treatment. 

Answers 

Question 1: True. In informed consent, the provider and patient come to a shared understanding and treatment plan based on the professional knowledge, judgment and experience of the provider and the knowledge and preferences of the patient. 

Question 2: False. The treating provider should go through the process of informed consent, discussing recommended treatment, its nature, risks of having and, conversely, avoiding treatment, and alternatives. 

Question 3: False. Informed consent is necessary for many types of treatment, including when prescribing medications. Shared decision-making ideally should take place anytime a treatment is recommended, not just before major surgery.  

01/23

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Disclaimer

The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.