Automating Informed Consent to Reduce Risk

Sometimes it takes a disaster to become a believer. That’s precisely what happened to James Gottesman, M.D., after he was sued in 1990 for negligence for not diagnosing a patient with cancer. It was this emotionally draining experience that turned Dr. Gottesman, a urologist in the two-physician The Vasectomy Center-Eastside in Issaquah, Wash. into a self-described “zealot” for informed consent.

Originally, Gottesman’s patient presented with an elevated Prostate-Specific Antigen (PSA) level, which led to two consecutive negative prostate biopsies in 1987 and 1988. In 1990, a third prostate biopsy came back positive, and the patient sued for negligence for failure to diagnose cancer earlier.

In Gottesman’s favor, he had his patient sign detailed informed consent forms before each biopsy, which all specifically stated, “Cancer may be present but may not be detected. Additional biopsies may be needed to detect the presence of cancer.” The judge in the case, however, ordered that informed consent couldn’t be a part of the defense’s argument, with penalty of mistrial—the only question to be put to the jury was that of Gottesman’s negligence. The jury did, however, request to see the patient chart that included the informed consent forms, which had been admitted in evidence. After a three-week trial and a 48-hour jury deliberation, Gottesman was acquitted of all charges. After the trial, the jury foreman questioned Gottesman’s strategy of not bringing up the consent forms in trial, and said, “That was the whole case to us.”

Informed Consent Deflects Negligence
“I became a zealot, because then I realized that good informed consent deflects negligence,” Gottesman says. He now uses a web-based system, the iMedConsent Solution from the Atlanta, Ga.-based Dialog Medical (Gottesman also develops urology-specific content for Dialog Medical.), that prepares detailed, procedure specific consent forms and other critical documents for treatments and procedures for every procedure he does. “This is the way to document the discussion between the physician and the patient,” he adds.

American Medical Association (AMA) guidelines state: “Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention.” However, a review of written consent forms by the Archives of Surgery, found that in 157 hospitals, only 26 percent of the consent documents contained the necessary elements of informed consent: purpose, risks, benefits, and alternatives.

Gottesman says he makes his consents as detailed as possible and sometimes customizes the consent form to the patient to add in certain risk factors, for instance if the patient is an athlete or has emphysema. The patient signs the consent form, and it’s scanned into the EHR, and the patient also takes a copy home.

“We know what the risks are. Why not create a library of risks, benefits, and alternative therapies for every procedure we do,” Gottesman says. “And if they sign that, then it would be hard to prove you were negligent if something occurs, which they knew could happen.”

Gottesman points out that surgical procedures and other medical treatments are standardized, but consent forms for these procedures all vary. “Why haven’t we standardized consenting so that everyone uses the same consent form? And by doing so, you’ve created this shared immunity because if everyone uses it, it protects everyone else because it becomes a standard.” He emphasizes a peer-reviewed approach to create standard forms. “If we had standardized forms, so that every practice in the United States has the same form for a certain procedure, how easy would it be to translate it into every language,” he says.

VA Case Study
A study in 2010 was conducted with a total of 575 patients in seven Veterans Health Administration Medical Centers in which informed consent was obtained using the VA's computer based platform (iMedConsent). Patients scheduled for elective surgeries were randomized to two groups: 1) one that was presented with an automated informed consent software application that produces detailed, procedure specific consent forms; 2) one that was presented with the same system with a series of six repeat-back (teach-back) prompts based on National Quality Forum-recommended language and a mechanism for documenting the patient’s response. Comprehension was tested after the informed consent using procedure-specific questionnaires.

In the repeat-back group, providers spent 2.6 minutes longer obtaining informed consent, and the additional time required was documented as being acceptable to providers. The repeat-back group (71.4 percent) had an average comprehension score that was higher than in the no repeat-back group (68.2 percent).

Gottesman recognizes the challenges of standardizing informed consent. For one, he says, most physicians find it hard to relinquish control of developing their own consent forms. And for busy C-level and IT executives, informed consent is hardly high on a priorities list that is filled with meaningful use, 5010, and ICD-10. If privacy breaches of patient health information are a serious issue, healthcare IT leaders need to think about the potential legal costs of informed consent negligence.