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Florida Health Network Turns to Automated Informed Consent
By Michael K. Butler, MD, MHA, CPE, FACPE

Spurred by increasing regulation and industry guidance advocating more thorough patient disclosure, Jackson Health System (JHS) recently decided to implement an automated informed consent application that is integrated with its EHR.

JHS is an integrated academic health care delivery network affiliated with the University of Miami Miller School of Medicine and the Florida International University Herbert Wertheim College of Medicine. The system includes six hospitals, 12 specialty care centers, two long term care centers, and several health clinics and pharmacies.

Although JHS has used an EHR system since 2007, the patient informed consent process remained paper based and mostly nonstandardized until 2012. The paper consent forms included generic risk and benefit descriptions, and it was up to each individual physician—typically those working within each of the specialty clinics—to handwrite procedure-specific details on them.

With the automated informed consent application, once the consent is completed, it is immediately saved and available in the EHR. The solution delivers standardized, comprehensive informed consent documents written in easily understood language that allows physicians and patients to have more efficient and meaningful discussions concerning procedures and treatments instead of expending time filling in a form.

In a relatively short period of time, JHS has significantly decreased incidents of lost or incomplete forms, increased patient satisfaction because of improved comprehension, and gained countless incremental financial improvements from better patient compliance and more complete documentation at the time of each procedure.

Problems With Paper
Perhaps the single biggest concern with the former paper-based process was its lack of standardization. Physicians typically included a procedure’s potential risks, benefits, and alternatives either as they remembered them during an encounter or as they felt were relevant based on each patient’s unique situation. This inconsistency sometimes led to incomplete forms, which may or may not have passed increasing regulatory scrutiny concerning full and consistent disclosure.

Over the last few years, several state medical boards have provided recommendations to health systems about enhancing informed consent documentation for certain procedures. Committee meetings at JHS commenced to decide how best to update the relevant forms to meet those recommendations. In instances when a state board did not provide direction, JHS looked to specialty medical societies for guidance.

However, these kinds of piecemeal document updates were time consuming. In addition, there were no guarantees that physicians actually would use the most recent version of a particular consent form. Forms stashed away in clinic drawers might not be the most recent, which posed potential legal and patient care risks. (By contrast, the electronic consent application now allows JHS to standardize and manage consent content.)

Another dilemma involved coordination among the locations where the consent forms were signed and the locations of the procedures. Forms typically were signed in a clinic office during a preoperative visit. At the time of the procedure, days or even weeks later, the paper form occasionally was determined to be incomplete or unavailable to the operating room staff, causing costly delays and disruptions to the providers’, patients’, and hospitals’ schedules.

JHS physicians wanted greater assurance that informed consent documents would not only consistently protect against liability lawsuits but also enhance the patient-provider experience by spelling out risks, benefits, and alternatives without confusing legal or medical jargon.

JHS was not unique in its informed consent challenges; in fact, at a previous academic health system, I developed an electronic informed consent application to solve the same challenges. The application was not as comprehensive as what ultimately was implemented at JHS, but the principle was the same: Informed consent documents cannot be completed and saved in the medical record (electronic or paper) until all the required information is entered.

Medical and administrative leadership at JHS realized that an automated informed consent application would eliminate the delays caused by the paper forms and mitigate physicians’ legal risk. (There is evidence backing this up, too. A 2012 study of 481 malpractice claims involving informed consent found that 78% of the cases concerned an allegation of an undisclosed risk.)

The electronic solution JHS eventually selected not only satisfies increased regulatory requirements and legal concerns but also is significantly more efficient and user friendly than the previous process. Since the application is Web based, the implementation process required only the addition of a link on the EHR interface to launch the program.

Accessed through a single click in the EHR, the system (iMedConsent application) includes an expansive, searchable library of informed consent forms that automatically populates patient demographic information into required fields. Signatures then are collected on the procedure-specific consent documents using digitized signature capture pads. Once completed, images of the signed consent documents are instantly uploaded to the enterprise document management system integrated with the EHR.

JHS physicians expressed overwhelming support of the application as well. The organization first rolled out the new informed consent process in the specialty clinics, where the electronic forms would get the most use, then to the emergency department and the ICU.

At first, there was hesitation from some physicians who preferred to handwrite their consent forms. A few providers wanted to review each of the program’s preloaded consent documents. However, after an introductory training session and the creation of some sample forms, their concerns were allayed.

Document Management Benefits
Even in the fairly short time since implementation, JHS has accrued numerous noticeable efficiency and documentation benefits. In part, this is achieved by assuring consent forms consistently are written at a sixth-grade reading level, and versions of the consents are available in patients’ three most common languages: English, Spanish, and Haitian Creole.

Not only do informed consent documents contain all the necessary information for patients to easily understand the risks and benefits of their upcoming procedures, unlike the paper forms, they are nearly always available and complete on the date of surgery. JHS estimates that it has reduced the occurrence of misplaced or incomplete forms by 70%. When this achievement is combined with the associated reduction in procedure delays or cancellations, the financial and stakeholder satisfaction benefits are substantial.

Informed consent is a process designed to ensure that each patient has all of the necessary information required to make a decision about his or her care. As a physician, I am particularly gratified that the automated application allows JHS providers to have more meaningful conversations with their patients to ease their concerns about their interventions. Anything providers can do to reduce patients’ stress, improve their recoveries, and enhance their outcomes should always be top priority.

— Michael K. Butler, MD, MHA, CPE, FACPE, is executive vice president and chief medical officer at Jackson Health System in Miami.