Spine surgeons currently face some of the highest malpractice risks of any physician specialty, but one Minnesota-based company is trying to change that.
The inFormed Consent app was created by Dan Kloster, MD, a chronic pain management specialist, with the goal of improving patient understanding of future surgical procedures.
It provides patients with video information of a suggested procedure, and lets them determine whether they feel comfortable moving forward. If so, patients watch a consent video, and the app provides a record of the patient watching the video.
The front-facing camera on the iPad patients use to watch the consent video records the patient and creates a digital record that is stored in their medical record file.
If a consent dispute arises, physicians are equipped with proof that a patient was fully aware of procedure risks.
The company currently provides consent videos for spine, orthopedic, pain management, interventional radiology, plastic surgery, regenerative, bariatric and anesthesia procedures, and is aiming to expand to other specialties.
Brad Hancock, CEO of inFormed Consent and former executive at Johnson and Johnson, Medtronic and St. Jude Medical, connected with Becker’s to explain more about the application and the benefits it can provide for spine surgeons in particular.
Editor’s note: Responses have been lightly edited for clarity and length.
Question: Can you expand a bit on what your app does, and how it will benefit spine
surgeons and their patients?
Brad Hancock: Spine surgery represents one of the most litigious specialties in the United States healthcare system. The rate of annual claims was higher for this specialty than 24
medical specialties, according to one study. Almost 20% of spines surgeons face
medical claims annually. Informed consent is the cause of a medical claim in 29% of
cases filed according to a study. The other challenge many physicians face is that they know, despite doing their best, most patients remember very little of the information presented and more than half of patients don’t read a paper consent. Unfortunately, this lack of clarity leads to anxiety and poor satisfaction scores. By providing a video containing all the information that should be presented in a consent discussion and adding animations and graphics, patients will have a greater understanding of the elements of a proposed procedure. The front-facing camera records the patient as they watch the consent video, creating a digital record the patient was fully informed, and that they watched the entire video. In the event there is a disagreement about the consent process, the surgeon has a record the patient was appropriately consented.
Q: Have you had any luck partnering with malpractice carriers thus far?
BH: Yes, but we expect to add additional carriers in the future. Given that spine surgeons
have a higher probability of a malpractice case than other specialties, the ability to
remove the risk of a case related to the consent process should allow for reduced
malpractice premiums. We are currently working with the largest malpractice risk
brokerage in the country to partner with malpractice carriers to reward those physicians
who implement risk-mitigation programs.
Q: What issues does your platform address related to the consent process?
BH: The inFormed Consent app presents information required as part of the consent discussion. The content is written by an attorney and is vetted by spine specialists to ensure all risks, alternatives and complications are included in the consent video. Providing a video of the consent information, including animation and graphics, helps the patient better understand all the aspects of the surgery, and the front-facing camera, used to record the patients watching the video, creates a document that can be used in the event a claim is filed. Additionally, studies indicate the majority of patients do not read a paper consent. In some cases, patients are presented with a paper consent and asked to “just sign here” without providing the patient with the information they have a right to hear. The use of video to present critical information to patients also increases comprehension and satisfaction scores.
Q: What was your inspiration for the development?
BH: Our co-founder, Dr. Dan Kloster, knew his patients trusted his medical judgement, but he
also felt they did not fully comprehend all the elements involved in a surgery he proposed. Patients were anxious and would often not ask any questions despite the complicated nature of the proposed surgery. He also understood that caretakers and family members who could not attend his discussions with his patient had an interest in the procedure as well. He developed the app to help solve two distinct problems. One issue is physician risk for a lawsuit for a known complication. Patients with a poor outcome are more likely to sue and often state they were never told about the risks. This may be true in some cases but often the patient was informed, but did not recall the conversation. The app protects the physician in this situation because the patented app records the patient watching the procedure specific surgery consent. Once the video is completed, the patient signs the consent to be stored in perpetuity.
The other problem that he wanted to address was patient education. He felt strongly
that an educated patient would feel more comfortable and less anxious. They would ask
more appropriate questions and feel as though their physician had their best interest at
heart. The app also allowed the patient to have a copy for themselves and for their
family to review at any time. He also felt that patients were turning down proposed
procedures because of anxiety and confusion about the procedure itself as well as the
post operative course. By educating the patient, more were accepting of proceeding
with the treatment which led to better functional outcomes for the patient.
Q: What trends are you seeing in spine surgeon malpractice cases over the last three to five years?
BH: In recent years, trends in spine malpractice insurance indicate a decreasing rate of medicolegal cases, but a rise in the amount awarded per claim, with high indemnity payments and defense expenditures leading to increased malpractice premiums for providers. As settlements rise, plaintiffs’ attorneys tend to expect even larger payouts creating a self-perpetuating cycle. Juries that award large sums to plaintiffs may feel concern for an injured person, up to 40% of that indemnity can go to the plaintiff’s attorney, not the plaintiff.
Further, most Americans are unaware that people invest in medical malpractice lawsuits, but hedge funds and other investors often float plaintiffs’ attorneys’ litigation in exchange for a share of the settlement or jury award. In an effort to reduce the risk of a claim related to informed consent spine surgeons are doing the following:
1. Spine surgeons emphasize detailed discussions with patients about their conditions, treatment options (both operative and non-operative), and potential risks and benefits of surgery.
2. Moving beyond traditional informed consent, surgeons are incorporating shared decision-making to involve patients in their treatment decisions, considering their preferences and values.
3. Ensuring patients understand the specifics of the planned surgery, including the surgeon performing the procedure, is crucial. Providing ample time for patients to ask questions and address concerns before surgery is essential. Having patients have time to sign the consent form before the day of surgery reduces the risk of a malpractice claim.
