HMT The more serious the disease, the more complex the treatment, and the more complex the treatment, the more opportunities for mistakes or misunderstandings. This maxim is particularly pertinent to specialties like oncology where services range from preventive, to diagnostic, to therapeutic, to palliative. Treatment modalities may include surgery, chemotherapy or radiation. Therapy could be delivered from multiple locations including ambulatory centers, hospitals and satellite clinics.

In this complex environment, patient safety depends upon comprehensive and accurate documentation, timely flow of information between providers, and communication with patients. The informed consent process can serve as a vital tool throughout the continuum of care by establishing an ongoing foundation for: provider/patient dialog; a means to validate the patient’s understanding of the diagnosis, treatment options and prognosis; and, a detailed and confirmatory record of what was agreed upon.

As one of 39 National Cancer Institute-designated Comprehensive Cancer Centers and one of the largest in the world, leadership at The University of Texas M. D. Anderson Cancer Center recognized the importance of a thorough informed consent process to patient safety. In 2007, M. D. Anderson implemented an advanced automated solution, which had been embedded directly into its electronic medical record (EMR) system to maximize effectiveness.

The Problem

To paraphrase a familiar advertising slogan, patient safety is "Job One" for us at M. D. Anderson and we are acutely aware of how easily it can be compromised. Patients being diagnosed and treated here are extremely vulnerable — physically, mentally and emotionally. They are often facing a frightening diagnosis and a confusing array of choices. Complex therapies based on the patient’s specific condition are frequently prescribed. New drugs and new protocols become available on an ongoing basis, and promising clinical studies may offer the best chance for managing the disease.

The AICA consent forms, however, contain information and details about potential scenarios, thus matching the flexibility required by the surgical team. Physicians can explain these intraoperative decision points — as well as the possible need for expanded or supplemental procedures — clearly and concisely during the informed consent process.

At the same time, these options carry risks and may have a grave impact on the patient’s life. Over the past few years, we have made a concerted effort to enhance patient safety. Literature reviews have made it very clear that medical errors remain common in spite of efforts to reduce their incidence.

A recent study in The Annals of Surgery (published by Lippincott, Williams & Wilkins, a unit of Wolters Kluwer Health) of all Pennsylvania hospitals and surgery centers, for instance, reviewed wrong-site surgery reports over a period of 30 months. During that time, there were 427 reports of procedures that involved near misses (253 of the total) or surgical interventions started (174 of the total). Errors within these 427 procedures included 34 involving the wrong patient, 39 involving the wrong procedure, 298 involving the wrong side, and/or 60 involving the wrong part. In addition, 83 patients had incorrect procedures done to completion.

The report went on to reveal that two common means for preventing wrong-site surgeries were intervention by patients and their families (in 57 instances) and verification of informed consent documents (in 43 cases). We see these two sources as inter-related because: the better informed patients and their families are, the better prepared they will be to serve as "safety partners" in care delivery; and, the more effective we make our informed consent process, the more errors we can avoid.

We also recognized that improving our informed consent process would have additional and immediate benefits. Previously, informed consent documents would be obtained by a provider and sent to health information management or medical records for scanning. Once scanned, it would be available through the EMR.

Unfortunately, there was often a lag between obtaining the informed consent and when it was scanned and appended to the medical record. This meant that important information might not be readily available throughout the care continuum and might even delay procedures, which was a frustrating and potentially dangerous occurrence for patients. It was also an expensive problem for the cancer center, which incurs costs and loses revenue when OR facilities are not used as scheduled.

This became such a problem, in fact, that physicians and nurses would give a hard copy of the executed informed consent form to patients, telling them to keep it with them at all times. Clearly, this "fall-back" solution is not one that best demonstrates the competency of one of the nation’s leading cancer care centers.

The Solution

In order to address the shortcomings inherent to our paper-based informed consent process, we began to explore automated informed consent applications (AICAs) and found they offered a range of benefits. We discovered that advanced AICAs provide a library of standardized, procedure-specific consent forms that not only document the consent discussions, but also provides the option of having relevant and reproducible educational materials available at the provider’s fingertips.

The latest solutions, in fact, can be customized to a patient’s specific circumstances and are written in jargon-free, plain English. Providers are able to walk through important information and print out relevant materials for the patient to take home for later review and to share with family members. This is vitally important for a cancer center because patients are often under significant stress when having discussions with their provider and retain only a fraction of the information they received.

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iMedConsent system

In addition, because the executed informed consent document is stored digitally and appended to the electronic patient record, it is readily available to any provider at any given time. Caregivers can be confident that they have complete and current information about the services and procedures for which the patient has provided consent, thereby reducing errors and enhancing patient safety. Automation likewise removes any possibility that the consent document could be altered in any way after the patient has signed it. Once obtained, the executed informed consent document can be accessed for review, but not for modification.

The decision of which automated solution to adopt was made in tandem with the development of other technology systems at M. D. Anderson. It was a priority to partner with a vendor who would collaborate with our clinical and technical teams to ensure that the application was flexible and would integrate smoothly. During this period of development, we were introduced to the iMedConsent system from Duluth, Ga.-based Dialog Medical, which offered a wide spectrum of features and functionality, as well as staff who were eager to work closely with us throughout implementation.

Implementation

M. D. Anderson is unique in that it boasts an internally developed EMR called ClinicStation. Initially, we had evaluated a large number of EMR systems but found none that provided the flexibility of integrating financial, clinical and research functionality that we sought. Fortunately, we had the technology, infrastructure and skilled staff in place to build precisely the type of EMR required by our distinctive institution. We determined early in our project to offer providers an automated tool to assist with the informed consent process and that it would be valuable to embed an AICA within ClinicStation rather than to have it operate as a stand-alone software application. This novel approach to deploying an AICA required the expertise and collaboration of both the AICA vendor and the IT staff of M. D. Anderson.

M. D. Anderson is unique in that it boasts an internally developed EMR called ClinicStation. Initially, we had evaluated a large number of EMR systems but found none that provided the flexibility of integrating financial, clinical and research functionality that we sought.

After integration of the AICA within ClinicStation, we adopted a phased approach to implementing the AICA in order to maximize success and drive adoption by demonstrating incremental benefits to various user groups. Stage 1 used the AICA to automate the completion of common forms that patients receive when they enter the cancer center. This "baby step" gave us the opportunity to validate the embedded interface within ClinicStation while underscoring the gained operational efficiencies. In stage 2, we utilized the AICA to automate the completion of a simple, common consent form — consent for tissue banking — via an interface with the institution’s pathology system. This phase illustrated that the technology was easy to use and could help ensure compliance with FDA requirements.

As we approached stage 3, the AICA vendor worked closely with representatives from our patient education department to finalize the overarching clinical content supplied by the AICA. We compared the consent forms already included in the AICA with the procedures historically performed at M. D. Anderson, and the AICA vendor developed any that were missing. Likewise, we confirmed that all forms supported a sixth- to eighth-grade reading level.

The last stage — ongoing throughout 2008 — is the rollout of the AICA for surgical and chemotherapy consents. The first unit to go live was the Gynecology Center on February 5, 2008. Use of the AICA will be expanded to all clinical departments within the cancer center, including radiation therapy, before the end of the year.

Results

We began to identify the benefits of an AICA almost immediately after implementation. Executed informed consent documents, stored within the electronic patient record, became available to all care providers on demand. This allowed staff members to more accurately confirm if the scheduled procedure was precisely the one for which consent had been obtained, reducing the potential for errors and thus enhancing patient safety.

Immediate access to a detailed, procedure-specific consent form also ensured that surgical cases were not delayed while staff attempted to locate the missing form or re-consented a patient or the patient’s surrogate for a procedure. We found this to be especially important from a patient safety standpoint. Cancer patients undergoing surgery receive a bolus injection of antibiotics, timed to reach maximum concentration and peak efficacy at the time of incision. Absent informed consent documents previously triggered delays and caused this "optimum surgical window" to be missed, to the possible detriment of the immuno-compromised patient’s wellbeing. This is no longer a concern because the consent is always at hand, facilitating the timely initiation of procedures.

Both providers and patients have told us they appreciate the clarity with which they can communicate "possible procedures" via the AICA. In many oncology cases, physicians may not know precisely what they will find when they begin surgery and therefore cannot state with certainty the full extent of the given procedure. The physician may perform a laparotomy, for instance, during which he may discover lymph nodes need to be removed. The AICA consent forms, however, contain information and details about potential scenarios, thus matching the flexibility required by the surgical team. Physicians can explain these intraoperative decision points — as well as the possible need for expanded or supplemental procedures — clearly and concisely during the informed consent process. This allows our physicians to perform a complete procedure when indicated, without interrupting the OR session for additional consent or rescheduling the patient for a second procedure at a later time. Both of these alternatives are less than ideal since they increase the cost of care and potentially expose the patient to greater risk.

Moving Forward

Because of the success thus far, we plan to expand our reliance on the AICA over the course of the next two years. For instance, we will integrate the AICA with our OR scheduling system to automatically verify that the procedures for which informed consent has been obtained correspond to the scheduled procedures. This integration will provide yet another layer of protection against wrong-patient/wrong-procedure/wrong-site surgery and ensure that proper informed consent has been obtained for all planned procedures. The potential to leverage the AICA for use in research consents, beyond consent for tissue banking, will also be explored.

In the long term, the AICA will also be utilized to prepare Advance Directives. We envision that this will allow patients to produce living wills, identify healthcare proxies and convey medical powers of attorney. The availability of these documents in electronic form within the patient’s medical record will allow the institution to better follow patient wishes about future medical care if the patient becomes unable to express personal desires due to illness or incapacity.

Here at M. D. Anderson Cancer Center, there can be no doubt that our AICA is having a tremendous impact on patient safety. Providers now have vital information at their fingertips, which helps reduce delays and errors. Likewise, patients have a clear understanding of their condition and treatment, which allows them to serve as an informed partner in their care.

Lourdes N. Thompson, RN, is IT project manager/clinical projects, and Ted Banaglorioso, RN, and Greg Putch are business systems analysts in EMR Development and Support at the University of Texas M. D. Anderson Cancer Center, Houston. Contact them at lnthompson@mdanderson.org; TBanaglo@mdanderson.org ; and, geputch@mdanderson.org.

• August 2008 FEATURE ARTICLES •

POC/Decision Support: Case History

Automated Informed Consent