Automation helps ensure consent is truly 'informed'

The University of Miami Miller School of Medicine and affiliated Bascom Palmer Eye Institute were among those organizations evaluating the efficiency and effectiveness of their informed consent processes. The organizations found that they came up short relative to today's challenges regarding documentation and compliance. They discovered that patients sometimes did not fully comprehend procedures they were undergoing, and that informed consent documents were often misplaced or unavailable to providers at critical points along the care continuum.

To improve its approach, Bascom Palmer is adopting an automated informed consent application that offers a comprehensive library of procedure-specific informed consent documents, stored electronically for immediate accessibility.

After assessing the previous informed consent process, a number of vulnerabilities were identified:

Traditional approaches were not effective at ensuring all patients received comprehensive or comprehensible information. Generic fill-in-the-blank forms did not provide the detail truly needed to inform patients about specific and often complex procedures. In addition, many of Bascom Palmer's patients are elderly, speak Spanish as their primary language, or suffer from low health literacy. A one-size-fits-all form did not address those various needs, nor did it provide the opportunity for patients to take home materials for review in a less stressful environment. Instituting a process that standardizes informed consent discussions from patient to patient and procedure to procedure was likewise vital in the teaching environment, where physicians exhibit varying levels of experience in patient education and communication.

Automation standardizes informed consent discussions

To counter these problems, an automated informed consent application (iMedConsent application from Dialog Medical, Atlanta, GA) is being implemented that features a comprehensive library of procedure-specific informed consent documents. Ophthalmologists and their staff can select a precise document that provides standardized information about the patient's condition, proposed treatment, risks, benefits, and alternative therapies. Besides the more common therapies, the library includes templates for less typical procedures like the exchange or repositioning of an IOL following cataract surgery. Documents can also be tailored to reflect patient-specific issues-co-morbidities that may increase an individuals' risk, for instance.

Signed informed consent documents are stored electronically, so they can be accessed throughout the continuum of care by multiple providers to enhance patient education and serve as a foundation for ongoing discussions. As a result, the executed informed consent document is instantly available whenever and wherever it is needed. This is especially useful during pre-operative "time out" procedures. Ophthalmologists can confirm information documenting the correct patient/correct procedure/correct eye, as validated by the patient, to minimize risk of error. The institute is also in the process of implementing an electronic medical record (EMR) system and informed consent documents will eventually be appended directly to the patient's chart to improve accessibility further.