GRAND RAPIDS — InforMD cofounder and President Ian Fellows had made himself an expert on informed consent well before learning he was going into have his appendix removed.
By definition, informed consent is a legal condition in which a person has given consent to a medical treatment or participating in a clinical trial based upon a full appreciation and understanding of the facts and implications regarding that procedure.
As it applies to Fellows, it’s a binding agreement between patient and care-provider stating that the patient knew the risks and possible complications before a surgical procedure.
“Most people don’t even remember it,” he said. “I had already started the company so I was very aware of informed consent. And so these two residents came in, ‘We’re going to do some surgery, clean you up, you’ll be all right because the guy who is going to do it will be good.'”
The pair explained why he needed the procedure and what the risks were, then handed him the agreement and a pen.
“So I pulled out the big gun: ‘What about death?'” Fellows said.
“What do you mean?” the response was.
“That’s a possibility right?”
“Yeah, but that’s why we don’t mention it. It’s just informed.”
This type of situation prompted Fellows to leave the medical device field to launch InforMD in 2002 at the West Michigan Science and Technology Initiative incubator facility at Grand Valley State University’s Cook-DeVos Center for Health Sciences. His partner, CEO Richard Towbin, M.D., keeps an office in Pennsylvania.
“If I wasn’t in so much pain, I would have started laughing,” Fellows recalled. “Everybody we know and most of our investors have had some bad description and some shortened informed consent. They go in and don’t really understand what’s going on.”
Well before his own experience, Fellows said he and Towbin had learned the imperfections of the informed consent process. At its best, informed consent is a 20-minute conversation between patient and doctor. The patient, likely nervous and frightened, is still engaged and concerned. The doctor commits time and patience to ensure the procedure is completely understood, and how it compares to alternatives. Percentages of complication are presented.
Through this, the patient is empowered to make the decision.
In practice, that isn’t usually the case.
There are extremes on both ends. A patient concerned less with the risks of the treatment than being treated may agree to a procedure with little coaxing. A harried doctor might walk in, buzz through an explanation in 20 seconds and disappear, leaving a nurse to confront any concerns.
Even at diligent institutions, the experience is not consistent among hospitals or doctors.
Fellows used his recent procedure as an example.
“The two residents, one was from India, the other was English, but that’s not even the point. What’s the consistency from a physician to a resident? You don’t know.”
With such potential for misunderstanding and inconsistency, the informed consent process creates a host of legal and administrative challenges for hospitals and their insurers.
Besides doing little to improve the patient’s experience, a flawed informed consent process can remove the agreement’s legal protection against a malpractice suit and even provide the basis for one.
As InforMD’s core product, Advoca, rolls out of beta testing, Fellows hopes to change that.
Advoca is a comprehensive, interactive system designed to address all of the flaws of informed consent.
Beta tested at Duke Medical Center, West Michigan Heart and Spectrum Health’s Fred and Lena Meijer Heart Center, Advoca works like this:
The nurse or doctor creates an account for the patient, who then accesses the program at bedside with a tablet PC or on a computer in a separate room.
“Are you John Smith?” Advoca asks. “This is an animated guide to the medical procedure you are considering. The Advoca system was created to help you understand and be comfortable with procedures your doctor has recommended.”
Using graphic icons and simple, inoffensive animation, Advoca walks the patient through the procedure; its risks and the complications and the percentages in which those occur; and the alternatives to treatment.
The tutorial is written by leading procedural specialists. Duke’s Kevin Harrison wrote the first offering, Left Heart Catherization, with assistance from West Michigan Heart’s David Wohns and Richard McNamara.
Dispersed through the presentation are questions about the information presented.
“A huge part of this is capturing that interaction,” Fellows said. “To be able to go back and prove at a certain date and time that a certain person used it and this is exactly what they answered.”
After the patient finishes the session, the doctor receives a report on his comprehension. Answers and the time taken on each question are tracked. The doctor reviews problem areas of understanding with the patient, and the informed consent document is signed.
Through this, the uncertainties of informed consent are removed. Every patient using Advoca receives the same presentation and provides feedback to demonstrate understanding.
Advoca saves the physician the time spent on informed consent for other uses, like surgery. From a liability standpoint, the Advoca report is admissible in court.
In the beta test, patients have averaged 95 percent comprehension of 23 questions.
“The beta test has given us the confidence to go forward,” Fellows said. “Using the same system we have now, we’re going to start to produce a full library.”
Currently, InforMD is concentrating on two areas: cardiology and plastic surgery.
Fellows said that InforMD has identified more than 90 procedures across 17 specialties to include in the Advoca library. Maintaining the library could provide as much business as the product itself. He plans to issue updates on a quarterly basis, including both major changes and updated complication percentages.
Other key InforMD employees in the Advoca launch have been Danielle Young and David Mouatt. Fellows said that the firm should be expanding and hiring in the near future.
“Just by tapping a small percentage of the market, this will be huge,” said Remos Lenio, an investor in the company and principal of Hartwick Capital. “With the desire for medical startups in this region, I think this is a success story for West Michigan.”