Practice of Medicine
The Process of Creating and Sharing a Treatment Plan with Patients
October 20, 2016
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.
- Obtaining informed consent is a process, not a form. In fact, the form itself may not be required, but the process always is.
- Informed consent is a part of the shared decision-making process in which the provider comes to a shared 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.
- The shared decision-making process would ideally be performed anytime a treatment, either surgical or medical, is recommended, not just before major surgery.
- 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.
- 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 the medical office with a history of a recently swollen knee. Upon examination, you note that he has an effusion with some tenderness and redness, and you recommend joint aspiration. Should you:
- Tell him you are going to aspirate some fluid and proceed; or
- Tell him 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 his verbal consent before proceeding, with documentation; or
- 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 the office setting it is recommended that a permit be obtained as part of the overall process in higher-risk procedures, especially with cosmetic procedures or those involving neurologic structures. For more 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 can be viewed as a shared decision-making effort with our patients. Sometimes that process rises to the level of documentation with a signed permit, and should always be conducted with an assessment and documentation of the patient’s understanding prior to 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.
Created by MagMutual from materials provided by COPIC as part of MagMutual and COPIC’s alliance to improve patient safety and quality of care for all of our PolicyOwners.
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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.