Automated Informed Consent

Automated Informed Consent
Patients and Institutions Benefit Alike

The process of obtaining informed consent from patients prior to providing certain medical services has evolved gradually over the years. In U.S. hospitals and health systems today, this process typically includes documents that patients must sign to acknowledge their physicians have discussed the reason for the procedure, risks, benefits, alternatives, prognosis if declined, and treatment details for procedures they choose to undergo.

The informed consent process should be the subject of periodic review, however, health systems often face more pressing challenges. Institutions today face increasing financial demands, and those demands coupled with the size and diversity of some enterprises can make efforts to manage risk while still promoting quality patient care uniquely difficult. Such is the case at the Los Angeles County Department of Health Services (LACDHS), the second largest health system in the nation. It includes four teaching hospitals, two ambulatory care centers, six comprehensive health centers, and numerous clinics—all spread across a 4,061 square mile geographic area that is larger than the states of Rhode Island and Delaware combined.

Like most hospitals, LACDHS for many years relied on a generic paper form to obtain informed consent. The problem, however, is that these forms must be fairly specific to both the procedure and patient involved. Consequently, physicians often had to customize the form to fit their specialty-specific needs. Over time, this paper-based process resulted in multiple versions of the same form, left lurking in countless cabinets and desk drawers across the enterprise. The end result was a non-standardized approach to the consent process that ranged from very detailed documents to unstructured “fill-in-the-blank” forms.

Handwriting Creates Exposure
The National Quality Forum (NQF) recently released its report, Safe Practices for Better Healthcare–2010 Update. It advocates the adoption of 34 “safe practices” to help healthcare organizations improve patient safety; informed consent is fifth of the 34 processes supported. For many hospitals, attention to the informed consent process has become integral to a proactive approach to risk management and enhanced patient communications.

Yet while “informed consent” truly is the discussion between provider and patient about the relevant aspects and considerations of a recommended medical service, the documentation that immortalizes the discussion is vital. Semantics are important to both patient safety and, ultimately, the quality of patient care. The lack of standardization inherent in individually handwritten notes can result in inconsistencies that open hospitals to patients who may not fully comprehend their care plans—and even potential legal risk in the event of a claim.

Given pens and identical consent forms, no two physicians will fill them out the same way. Each will document, in his or her unique style, the information he or she deems important. More significantly for a teaching facility, the information covered and documented by a resident may vary dramatically from that of an attending physician. Standardization offers a common script for all physicians regardless of their tenure.

A process that relies heavily on handwritten, non-standardized information leaves open the possibility that critical details—procedure risks, for instance—might be illegible or left off of the form entirely. In the legal setting, missing or illegible information is treated as though it has not been provided. Failure to obtain informed consent is one of the top ten reasons why medical malpractice claims are filed against hospitals (Glabman, 2004). Thus, acquiring and documenting informed consent is crucial to ensuring that patients understand and are fully engaged in their care decisions.

Consistency Plays Key Role
Special challenges face organizations with many clinical departments and care settings. One such hurdle is the ability to provide a standard consent form that also is specific to individual procedure and patient.

From a quality and patient safety perspective, consistency in the consent process is imperative. It has been found that conventional, non-standardized consent forms have significant deficiencies and errors (Issa, et al., 2006). Forward-thinking institutions must determine how to engineer a consent procedure that not only diminishes system variability and safety risks, but also enhances cost control and quality care goals.

The first step in the process should be the creation of a centralized, controlled repository for procedure-specific forms. This allows the consent for a procedure prepared by one provider in one facility to mirror a consent for the identical procedure prepared by another provider or at a sister facility, thus eliminating the risk posed by multiple versions of the same consent. But how then to incorporate appropriate variations in patient-specific and procedure-specific details?
The answer at LACDHS came from an assistant nursing director and a neurosurgeon who championed the idea of an automated template model. The pair developed a plan that can be emulated by all facilities within a larger enterprise that seek to change an embedded process. They established a broad base of clinical support for their strategy to standardize the consent, then orchestrated meetings with IT managers, risk managers, and C-suite officials. The decision: pursue the concept further.

Cost vs. Benefit
All health systems in today’s challenging economic climate must carefully consider the cost equation pertaining to any healthcare IT investment. When evaluating the potential automation of the informed consent process, facilities must analyze the cost of developing and maintaining their own electronic clinical content library as the backbone of an in-house consent solution. Smaller facilities that do fewer procedures may find a home-grown approach to be practical and economical. Larger enterprises may conclude that internal development of thousands of procedure-specific consents can be more expensive than purchasing a product that already includes a library extensive enough to support all of their clinical specialties.

Facilities should review their claim histories and their expenses associated with potential legal action. That risk analysis will provide direction as to the level of investment in standardizing the informed consent process. LACDHS, for instance, concluded that the cost to purchase electronic consent technology was less than that associated with defending one lawsuit. However, it also realized that legal issues would not be minimized—and care quality maximized—unless the electronic consent process guaranteed that detailed, procedure-specific information would appear consistently on every consent document.

A primary goal of revamping the informed consent process should be to make certain the new process standardizes particular elements—including crucial risk/benefit information—on every consent form issued throughout the enterprise. After vetting several technology solutions, LACDHS chose an application that offered the ability to specify sections of the document that medical staff cannot change. Staff can always add information to a consent form, but designated risk/benefit details cannot be removed.

Maximizing Patient Care, Minimizing Risk
It is an intense process to move from a purely paper process to an automated one. Through weekly training visits at each facility, LACDHS providers were encouraged to evaluate ways the electronic system could benefit workflow, patient care, and patient safety—thus aligning risk prevention with other organizational goals.
Other large systems that have worked to standardize and automate the informed consent process also have invested in integration. The Department of Veterans Affairs (VA), for example, interfaces its electronic consent application with its electronic health record (EHR). As a result, the VA reports fewer instances of lost or misplaced consent forms with its integrated electronic system (Landro, 2008). Documents in the VA system are created, viewed, signed electronically via digitized signature capture pads, and saved within the electronic record.

Currently, however, consent forms in the LACDHS system remain paper-based. They are printed and signed by patients in ink. But rather than relying on non-standard—and sometimes illegible—handwriting, the printed templates now allow a more systematic approach. For the first time, all providers within the enterprise complete consents the same way.

When discussing a recommended procedure with a patient, providers employing an automated informed consent tool can retrieve a detailed, procedure-specific consent form from the application’s clinical content library. Certain fields within the form—including procedure name, description, indications, benefits, and risks—automatically may be populated from the application’s database. A few text sections may be populated in response to yes/no questions, while other sections may be populated from a variety of sources (including user log-on information, multi-select lists, or short text entries). Needless to say, with an electronic process, every section should be entirely legible.

These applications also provide the ability to “lock” chosen sections so that providers cannot alter them. In LACDHS’s case, this feature ensures that risk details are uniformly included. Additional risks can be identified, but the standard risk language cannot be changed. Providers remain free to customize any “unlocked” sections, such as procedure descriptions, to suit their needs. This flexibility was key to ensuring physician adoption of the automated process.

Another aspect of the informed consent process that requires attention is language. The entire template employed by LACDHS is available in English and Spanish, but the health system has taken the extra step of translating portions of the consent into eight additional languages that reflect its patient population. While the risk portion still requires a translator, the consent language associated with the signature block is written in the patient’s native tongue to aid understanding about care decisions.

Although initially worried that the electronic consents would not provide sufficient risk factor details for their patients, LACDHS providers now report that they seldom need to add additional information. The speed of the process—not having to spend time documenting what is communicated—allows more time for patient discussion, and from a patient safety standpoint, there are fewer steps during which mistakes could occur.

Educational tools within automated informed consent applications also can aid the standardization of patient instruction. Nurses engaged in pre-op counseling may use these applications to print procedure-specific diagrams, pictures, and information to help patients better understand the care they are receiving. Providers should find that it is very convenient to have items all in one place: consents, education documents, anatomical images, and pre- and post-procedure instructions.

In Summary
The consistency afforded by standardizing the informed consent process is one way that hospitals can minimize their risk exposure, while also aiding efforts to improve workflow and patient care. Additional cost benefit can be gained through automating the process and ultimately making it entirely paperless.

It is never easy to change well-entrenched paper processes, so a successful adoption of new strategies must center on provider education. It is essential not just to communicate with staff and clinicians about the coming changes, but to allow them to proactively participate in ensuring that the new approach meets their clinical and patient care needs.

Create “super-users” at each facility in addition to identifying key stakeholders. Make sure each site has a liaison between clinical and risk management/quality/patient safety departments—a clinical super-user is ideal. Up-front identification of clinical needs (for example, which consents are used most, which changes would improve the process) is a key factor in the success of the project.

Realizing that the new approach or new technology can be adapted to their needs helps build staff confidence in it. With the full support of clinicians, a standardized approach to the informed consent process becomes a powerful patient care tool.

Kimberly McKenzie is director of quality improvement and patient safety at Los Angeles County Department of Health Services.

Pat Karnstedt is nursing health facilities consultant at Los Angeles County Department of Health Services.

Fink, A. S., Prochazka, A. V., Henderson, W. G., et al. (2010). Predictors of comprehension during surgical informed consent. Journal of the American College of Surgeons, 210, 919–926.

Glabman, M. (2004). Top ten hospital malpractice claims [and how to minimize them]. Trustee, 57(2), 12-16.

Issa, M. A., Setzer, E., Charaf, C., Webb, A. L. B., Derico, R., Kimberl, I. J., Fink, A. S. (2006). Informed versus uninformed consent for prostate surgery: the value of electronic consents. The Journal of Urology, 176, 694-699.

Landro, L. (2008). Consent Forms That Patients Can Understand. The Wall Street Journal. February 6, 2008, 251(30), D1, D3.

The Los Angeles County Department of Health Services uses the iMedConsent application from Dialog Medical.