The black box and improving informed consent

This was another educational and emotional day for me at the Telluride QI/PS summer camp. The first part of the day was focused on informed consent and shared decision making. I was moved to tears watching the story of Michael Skolnik and am so thankful to his parents for sharing their story with us.

It really got me thinking about the appropriate use of the informed consent document and how poorly we often counsel and consent our patients for complex and dangerous procedures.

In Michael’s case we will never know what transpired between him and the surgeon on the day he was consented for that second procedure. But Michael is not the first nor will he be the last patient who cannot tell us whether he received and understood all the necessary information to make an appropriate decision about such an invasive procedure.

Should we as physicians be relying on that piece of paper, our note in a chart, and what the patient remembers to ensure appropriate consent has been obtained?

I do not think so.

First we heard over and over again today that it did not matter if the consent was signed that alone is not sufficient to protect the patient and the physician. Second physician documentation is often poorly done, does not encompass the entire conversation and relies on automated texts to populate documents, making them unreliable. And finally our patients may not understand what has been said to them because of a multitude of reasons including; language barriers, literacy, emotional & physical distractions etc.

So for this reason I have been mulling over what we could do to ensure patients are being counseled using the tenants of shared decision making and a potential solution I have heard is the idea of the “black box”. In aviation the “black box” or flight recorder is simply a device to record the happenings of the aircraft and in the event of an adverse outcome it can be reviewed to determine what contributed to the bad outcome. What if instead of requiring physicians only to sign a paper document with their patient, we required them to be recorded with their patient completing the informed consent process using the tools of shared decision making.

What I picture is during my preoperative office visit or when I meet the patient in the emergency department or on the labor floor instead of saying “I will be right back with a piece of paper that we need to review and sign,” saying “ For your safety and future knowledge I’d like to record the very important conversation we are about to have.” This recording could then be stored for future reference by either the patient or physician, and in those unfortunate cases of unintended poor outcomes it could be reviewed.

I recognize there would be issues with ensuring HIPPA compliance along with patient and physician comfort with being recorded. But to those who would say these are barriers, I would respond that with the ability and comfort we experience today with digital media and health technologies I actually think these are minor hurdles.