The frequently quoted adage “the more things change, the more they stay the same” was first penned by a French journalist in 1849. Now over 150 years later, this view seems applicable to today’s healthcare environment. By way of example, even in this time of tremendous change, the Centers for Medicare & Medicaid Services (CMS) is now addressing an issue that the Department of Veterans Affairs (VA) addressed over a decade ago.
This latest example of national policy mirroring VA practice is the Quality of Informed Consent Documents Measure, which CMS is proposing to add to its Hospital Inpatient Quality Reporting (IQR) program. In the measure’s methodology report, CMS states that “most informed consent documents do not meet a minimum patient-centered standard to support informed decision-making.” Yet as early as 2002, the VA identified concerns within its own informed consent policies and processes that parallel many of those now targeted by CMS.
At that time, in addition to recognizing the significant role the consent process plays in shared decision-making, the VA also understood its business implications—especially delays in operating room (OR) start times caused by misplaced paper consent forms. In response to those concerns, the VA launched its Electronic Support for Patient Decisions (ESPD) initiative in 2004.
Fortunately, today’s health systems can readily implement changes to address the lessons the VA learned as it examined its consent processes during the ESPD implementation. Such changes can not only meet the proposed IQR measure, but can also strengthen the commitment to shared decision-making.
Following the VA’s Example
CMS notes that although comprehensive informed consent documents enhance patient comprehension and satisfaction, they are seldom given to patients early enough or with sufficient detail and explanation to encourage their involvement in formulating their care plans. The VA came to a similar conclusion, in part due to studies such as Hospital Informed Consent for Procedure Forms: Facilitating Quality Patient-Physician Interaction, which showed that most consent forms failed to contain the basic elements required for adequate informed consent. As such, these forms appeared designed to authorize treatment and protect providers from liability rather than providing critical information needed to help patients make better health decisions.
Aaron S. Fink, M.D.
Mindful of such research, during its ESPD program the VA considered a software approach to support the informed consent process. The goal of this approach was to automate and standardize the informed consent process to ensure consistent provision of detailed, easy-to-understand, procedure-specific consent documents for the thousands of services and procedures performed in VA medical centers.
At the time of the ESPD program (2004), the VA’s VistA Computerized Patient Record System (CPRS) was arguably one of the best EHR infrastructures available. This system allowed the VA to deploy an automated solution for generating and documenting consents within its EHR. Obviously, since that time the nationwide proliferation of EHRs has facilitated widespread use of automated consent tools in hospitals and practices outside the VA.
Deployment of such automated consent solutions offers several critical benefits in achieving compliance with the Quality of Informed Consent Documents Measure. First, the measure requires providers to enter detailed language describing the procedure, the reason for performing the procedure, the risks, benefits and alternatives. Software that draws on a database of previously-vetted consents offers a practical solution for reproducibly generating comprehensive and legible forms (the measure proposes an additional point if the content is typed) specific to the proposed treatment.
The second way automation can aid compliance with the measure involves timing. In the proposed measure, 25 percent of the score is earned by obtaining and documenting the patient’s consent at least one day before the procedure occurs. As CMS has realized, the time consent is obtained has proved to be a crucial factor when seeking to enhance shared decision-making via informed consent. In fact, as my colleagues and I have reported, the time spent in the consent discussion is one of the most powerful predictors of patient comprehension. We found that the optimal amount of time for the conversation was 15 to 30 minutes—an amount of time that usually isn’t practical in a rushed pre-op environment.
Although the CMS measure only requires consent forms to be signed the day prior to a procedure, the VA altered its consent policies to allow the pre-operative discussion and form execution to be completed as early as 60 days prior to the procedure (subject to certain limitations). Such workflow adaptations allow providers to print documents for patients to take home so they can review and then ask questions well in advance of the day before their procedures. Thus, the VA redesigned its consent process emphasizing shared decision-making while facilitating capture and retention of the signed document.
Benefits beyond compliance
If adopted as part of the Hospital IQR Program, compliance with the Quality of Informed Consent Documents Measure should improve an organization’s star rating as well as its opportunity to recover its 2-percent Medicare holdback. As the VA found, however, improving shared decision-making through a detailed consent process also can yield other advantages, including:
Improved OR utilization: A 2013 study by Johns Hopkins University’s Department of Surgery found that in 66 percent of OR cases, signed paper consent forms were not immediately available at the time of surgery. These misplaced forms led to a delay in 14 percent of OR cases. Given the expense of running active operating suites (estimated to cost hospitals up to $60 per minute), the cumulative financial cost attributable to OR delays can be staggering.
Use of an automated consent process allows consent documents to be signed electronically during the shared decision-making discussion days or weeks before the procedure. Indeed, as noted above, the VA altered its policies to allow either physicians or physician extenders to pre-prepare forms electronically well in advance of a patient encounter without finalizing them. Then, providers could access the document from the EHR, go through it with the patient, answer any questions and obtain signatures well before the day of surgery.
Lower malpractice-related expenses: In the 11 years before the VA began its ESPD initiative, about 1.5 percent of its tort claims were primarily associated with inadequate informed consent. Although a small portion of overall VA tort claims, these cases still resulted in financial judgements of approximately $50,000 a year as well as millions of dollars in legal expenses.
Inadequate informed consent is a significant legal risk. One 2004 legal review found that even when consent is not central to the plaintiffs’ allegations, it is often leveraged as additional evidence against physicians, or “as an alternative point of attack when the case is otherwise weak.”
Clearly, detailed patient- and procedure-specific consent forms can greatly reduce liability risk. Some electronic consent tools can even generate a progress note in the EHR to document when the consent discussion occurred as well as details discussed during the encounter. At a minimum, automation at least provides date- and time-stamps (a JCAHO requirement) on easily accessible completed forms.
Fully Informed and Shared Decisions
There is one additional aspect of CMS’s informed consent quality measure that goes beyond the VA’s 2004 ESPD initiative. The measure requires providers to quantify the probability of at least one procedure-specific risk to the patient. The American College of Surgeons’ National Surgical Quality Improvement Program Surgical Risk Calculator—which provides quantitative risks for more than 1,500 surgical procedures—might offer significant assistance in this regard if amalgamated with an automated informed consent process.
While new and unusual, the quantified risk probability is another element that CMS likely hopes will transform the informed consent process from a formality into a true shared decision-making discussion. Together, physicians and patients can work toward a meaningful understanding of a procedure’s benefits and risks in a comfortable environment, ensuring that care aligns with each patient’s expectations, preferences and goals.
Aaron Fink, M.D., is professor emeritus of surgery at Emory University. He was chief of surgical service at the Atlanta VA Medical Center during the pilot program and implementation of the VA’s Electronic Support for Patient Decisions initiative.