Improving the Informed Consent Process

Obtaining informed consent from a patient for a procedure or treatment is a critical step in the patient-provider communication process; however, it is misnamed. A more accurate descriptive term would be ‘formal consent discussion’ as this better embodies the core function of informed consent: having a discussion with your patient. Lawyers and administrators have warned us that without informed consent that we, as providers, are placing ourselves and our institution at risk. Over time, this has driven us to focus time and attention on getting a consent form signed and witness and given less attention to open ended discussions about the proposed treatment or procedure with our patient. As providers performing procedures or prescribing high risk therapies, the onus falls on us to ensure the consent process was performed fully and fairly. The following steps can help guide you through a patient-centered informed consent process, er, rather, ‘formal consent discussion’. 

Set the stage

There is one place the informed consent process should ideally not happen, and that is the pre-procedure area and definitely not in the procedure room. Many times, especially with last minute or urgent procedures or therapies, this is unrealistic, but nevertheless should it should always be considered if there is a less intimidating area available where you can have a consent conversation with your patient. 

Speak the language

Consent should always be performed in the language your patient prefers to receive his or her medical information in, which may not be the language you’ve been using since you met. Discussing a procedure, its risks/benefits, and alternatives is likely to mean using a lot of medical terminology or descriptive words that could easily be misinterpreted. Ask your patient what language they would prefer to receive such important information in and find a phone or live interpreter. Be sure to document that a professional interpretation service was used, what language was used, and the name or employee ID of the professional performing the translation. 

Speak the facts, not the emotion

The most important idea to keep in mind is that your job is to communicate the facts of the situation to your patient. Be sure they know and understand the diagnosis, the name of the procedure, who is performing the procedure (and who else may be present), why it is recommended (ie: the benefits), what the potential risks are, and what may happen should the procedure be declined. Avoid sounding coercive, intimidating, or biased. Though you may have your own strong feelings about what decision your patient should make, you must respect that it is not your decision to make.  

Document

A thorough formal consent discussion cannot be concluded without thorough documentation. In addition to the signed consent form, a good provider will document the discussion and include those present, what language was spoken, who provided translation, a general description of the patient’s reaction (ie: patient asked many appropriate questions; patient reluctant to discuss; etc.), and any additional requests or wishes the patient made. Adding more detail than “informed consent obtained” is a great way to help you remember a case as well as provide excellent defense against any litigation surrounding the consent process. 

 I’ll be speaking on this topic more thoroughly in October at the NYSSPA Fall 2019 Conference in Albany, NY! 

Joseph Ciavarro