Informed Consent


Technology Makes Best Use of Diminished Time

Informed consent is the communication process between a patient and physician that ultimately results in the patient’s agreement to undergo a treatment or procedure.[1] In spite of the significant legal and ethical implications associated with this critical decision-making process, the means for reaching these far-reaching discussions is often beset by challenges.  Although physicians, in general, do an excellent job with explaining planned procedures to patients, the documentation associated with those conversations is often severely lacking.  Patients typically receive either a “generic consent-to-treat” document or a “fill-in-the-blank” document.  Neither approach captures what patients have discussed with their physicians.  Thus, patients entering hospitals for planned procedures are likely to find that as few as 26 percent of consent forms cover the four basic elements of informed consent.[2]

Given the struggles with documenting informed consent, it is not surprising to find that a recent survey of 402 physicians, 87 percent reported that “most” or “some” of their patients were under- or misinformed.[3] In that same survey, 78 percent of physicians reported that recent changes in reimbursement have decreased the time available to spend with their patients.  Strategic use of new technology may offer an innovative solution to these predicaments.  A 2011 commentary in the Journal of the American Medical Association observed that software tools such as the iMedConsent™ application used by the Department of Veterans Affairs (VA) hospitals may liberate physicians to address individual patient concerns more effectively.[4]

While many providers and organizations lack awareness that automated tools exist, forward-thinking practices will typically employ electronic consent software to prepare detailed patient information packets that serve to educate patients about planned procedures.  These packets, which may contain educational materials and pre- and post-procedure instructions, are always provided during an office visit before the scheduled procedure.  Typically those packets include a copy of the procedure-specific consent form, and this task of compiling and distributing this material can usually be delegated to technicians and other staff members.  When the patient signs that comprehensive, easy-to-understand consent form at a later visit, the patient is always offered a copy of the consent form which then serves as transcript to help the patient remember the informed consent conversation and their choices.[5]

Larger practices and hospitals that have invested heavily in automation have even more flexibility with respect to documenting informed consent using automated tools.  Providers typically obtain consent electronically in exactly in the manner as they do with conventional paper consent forms.  The difference is that the workstations, tablet computers, and mobile point-of-care devices in the organization now have access to informed consent software that puts the procedure-specific information and forms at the provider’s fingertips.  Signatures can be obtained by using a retail-style digitized signature capture pad or by using the stylus on a tablet computer.  The innate flexibility of an automated informed consent tool allows hospitals and large practices to encourage providers to acquire consents in the manner that is best suited to the style and preferences of the individual provider.[6]

Automation Leverages “Best Practices” to Reduce Liability Exposure

Efficient use of time is not the only reason to embrace an automated informed consent software tool.  Many providers are motivated by a desire to minimize risk.  Inadequate informed consent has been found to be a secondary cause in more than 90 percent of ophthalmologic malpractice cases,[7] while other research has found that only 39 percent of closed claims against anesthesiologists were judged to have adequate informed consent.[8]

It has been observed that a thorough informed consent process, supported by a software tool that generates detailed, procedure-specific and patient-specific consent forms, serves as a form of preemptive disclosure.[9] Exceptional patient communication ultimately becomes a risk mitigation strategy when patients and their families fully understand the full range of potential complications that may result from a planned treatment or procedure, and that information is provided to them in easy-to-understand language.

Computer-based tools that assist with documenting the informed consent process can also support other practices that may reduce liability exposure.  Obtaining consent in the physician’s office —, as opposed to the preoperative holding area —, and documenting that consent discussion as a supplemental note in the medical record both have been shown to reduce liability exposure in a large study of malpractice claims alleging inadequate informed consent.[10] Even though 64 percent of the claims in that study were dismissed or found to be in favor of the defendant, the average total cost per single claim was still in excess of $207,000 – more than double the annual cost of an electronic informed consent tool for the average hospital.

Use of an automated informed consent application easily allows for documentation of the informed consent discussion in the physician’s office.  These web-based tools can prepare consent documents using a hospital’s template and the form preferred by the physician’s practice – both documents contain the same detailed description of the procedure, risks, benefits and alternatives that are unique to the treatment planned for a particular patient.  Facilitating the completion of this process – well before the patient arrives at the hospital or surgery center – ensures that documentation of informed consent does not become the equivalent of a “medical Miranda warning.”[11] Office-based informed consent systems typically cost less than one dollar per day and discounts on these tools are often available through professional liability insurers such as Medical Protective, or professional organizations such as the American College of Surgeons or the American Urological Association.

When an automated informed consent tool is integrated with the electronic health record (EHR) or practice management system, other benefits are realized.  Providers need not take the time to prepare a note describing completion of an informed consent discussion in the EHR.  The informed consent software, in concert with the EHR, serves to automatically generate that detailed note in the medical record – a note that, along with the signed consent form, serves to better reduce liability risk.

Electronic Support Ensures Efficient Patient Flows

A major issue with paper-based informed consent forms is that they can be easily lost or misplaced.  The inability to locate these critical documents has been estimated to contribute $3.3 billion to the cost of health care in the U.S. due to resulting operating room delays.[12] Those delays are particularly challenging for physicians, who increasingly are pressed for time.  Automated informed consent tools ensure that digitized images of signed consent forms instantly are available to the operating room staff for the pre-procedure verification and for the time-out.

Other factors that are burdensome to physicians and extremely costly to healthcare institutions additionally impact patient flows.  For instance, patients may arrive at hospitals ill-prepared for planned procedures, resulting in expensive cancellations.  Meanwhile, patients who fail to follow post-operative instructions risk costly and often unreimbursed readmissions.  The most sophisticated informed consent software tools address these inefficiencies by providing detailed pre-procedure instructions and comprehensive discharge instructions.  Use of an automated informed consent tool to provide pre-procedure instructions has been found to result in patients who take greater ownership in preparing for their procedures.[13] Similarly, the delivery of discharge instructions via an automated informed consent application was found to result in a 63 percent reduction in one medical center’s 14-day readmission rate.[14]

Patient Understanding and Satisfaction are Enhanced

A recent prospective, randomized multi-center study employing an automated informed consent software tool to evaluate patient comprehension of planned procedures uncovered two major findings.[15] First, and not surprisingly, patient understanding increased when physicians spent more time with their patients.  The second finding was that the use of “teach-back” or “repeat-back” also significantly improved patient comprehension.

During this study, providers were prompted to ask patients a series of six questions to confirm patient understanding.  This technique – a National Quality Forum-Endorsed Safe Practice[16] – was facilitated by the automated informed consent application.  The software tool allowed providers to quickly verify and document patient understanding of the major aspects of contemplated procedures.

As the study demonstrates, patients can significantly benefit from automated informed consent solutions.  The software employed in all VA hospitals, for instance, allows the patient and the physician to review information together on a computer screen, or it allows the patient to take a detailed document home to review at his or her own pace with family members.[17] In addition, any provider throughout the VA health system can easily check the consent form within the patient’s electronic health record and answer questions as needed.  As to patient satisfaction with an automated informed consent process: a study of VA urology patients found that 96 percent preferred the electronic process to a traditional paper-based informed consent process.[18] It is reasonable to conclude, therefore, that employing electronic tools to assist with informed consent is a valuable asset to efforts to improve efficiency, reduce risk, enhance safety and ensure patient satisfaction.

 


[2] Bottrell MM, Alpert H, Fishbach RL, Emanuel LL. Hospital informed consent for procedure forms: facilitating quality patient-physician interaction. Archives of Surgery. 2000;135:26-33.

[3] Executive summary of findings from a national survey of physicians. Conducted by Lake Research Partners. February 2009. http://www.informedmedicaldecisions.org/pdfs/WhitePaperExecutiveSummary.pdf Accessed June 9, 2011.

[4] Schenker Y, Meisel A. Informed consent in clinical care practical considerations in the effort to achieve ethical goals. JAMA;305(11):1130-1131.

[5] Wortz G. Reducing liability risk through informed consent. Journal of Medical Practice Management. 2010;27:203-208.

[6] McBride C. When it comes to HIT, patience pays off – patient consent forms enhance standardization, access for multispecialty clinic. MGMA Connexion. 2010;10(8):23-24.

[7] Kiss CG, Richter-Mueksch S, Stifter E, Diendorfer-Radner G, Velikay-Parel M, Radner W. Informed consent and decision making by cataract patients. Archives of Ophthalmology. 2004;122:94-98.

[8] Caplan RA, Posner KL. Informed consent in anesthesia liability: evidence from the closed claims project. ASA Newsletter. 1995;59(6):9-12.

[10] Bhattacharyya T, Yeon H, Harris MB. The Medical-Legal Aspects of Informed Consent in Orthopaedic Surgery. The Journal of Bone & Joint Surgery. 2005; 87:2395-2400

[11] Meisel A, Kuczewski M. Legal and ethical myths about informed consent. Archives of Internal Medicine. 1996;156(22):2521-2526.

[12] Baum N. The case for automated informed consent. Healthcare Financial Management. 2006;60(2):106-112.

[15] Fink AF, Prochazka AV, Henderson WG, et al. Predictors of comprehension during surgical informed consent. Journal of the American College of Surgeons. 2010;210:919–926.

[16] National Quality Forum. Safe practices for better healthcare: A consensus report – 2010 Update. Washington, DC: National Quality Forum; 2010.

[17] Franklin D. Uninformed consent: tech solutions for faulty permissions in health care. Scientific American. 2011. http://www.scientificamerican.com/article.cfm?id=uninformed-consent-mar-11 Accessed June 9, 2011.

[18] Issa MM, Setzer E, Charaf C, et al. Informed versus uninformed consent for prostate surgery: the value of electronic consents. The Journal of Urology. 2006;176:694-699.

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