Like most healthcare organizations, CGH Medical Center, based in Sterling, Ill., strives to remain compliant with the wide range of regulations governing healthcare today. Not long ago, however, the 99-bed community medical center realized it had fallen behind in the critical area of informed consent.

CGH Medical Center received a wake-up call in 2006 when risk management staff noted that the facility was not in compliance with Centers for Medicare & Medicaid Services (CMS) interpretive guidelines related to informed consent. CMS states that a well-designed informed consent process should include “a discussion of the risks, benefits, and alternative therapies associated with a contemplated procedure, as well as the patient’s prognosis if he or she declined the proposed treatment.” While leadership at CGH believed that most physicians covered these elements during office visits and included them in the medical record, they were not being properly documented on the consent form that patients signed prior to procedures.

At the time, CGH relied on generic, paper-based informed consent documents. Physicians and staff filled in blanks with the patient’s name and the procedure. On occasion, the doctor would handwrite specifics about risks, benefits and alternative treatments. Besides being non-compliant with CMS guidance, this approach exposed the facility to unnecessary risk if patients could not decipher handwriting or abbreviations, and thus did not fully understand their options at the time of treatment.

Implementing an enterprisewide process change was a formidable but necessary proposition. Leadership realized that asking busy physicians to take the initiative and include greater detail when completing informed consent documents was unreasonable. Even if physicians could be convinced to adopt a new approach, risk management staff was concerned about legibility and consistency from physician to physician and patient to patient.

Finding a Solution

The logical solution was to automate and standardize the informed consent process in order to facilitate compliance with CMS guidelines, without interfering with physician productivity. To maximize the effectiveness of this important process — and to bring itself back into alignment with current regulatory guidance — CGH began the search for a software application that standardizes informed consent throughout the organization. Additionally, the application needed to provide tools that ensure patients receive comprehensive information about their condition and care, with the goal of empowering them to make better healthcare decisions.

Because the automated application offers a complete library of easily understood educational materials and anatomical diagrams, the physician can easily pull up relevant information to explain upcoming therapies.

The medical center began its search by reviewing information from the American Society for Healthcare Risk Management (ASHRM) and networking with colleagues on relevant list serves. It discovered three software products that contained comprehensive information about a wide range of procedures.

While two were limited to facilitating patient education, the third was employed in all Department of Veterans Affairs Medical Centers. This level of experience impressed the leadership at CGH. The application, known as iMedConsent from Duluth, Ga.-based Dialog Medical, also offered consent documents that included extensive content covering elements outlined by CMS and the Joint Commission. In addition, it provided the capacity to eventually integrate with other technology systems the medical center planned to implement, such as an EHR.

CGH participated in a Web-based demonstration of the software and subsequently asked the vendor to deliver a presentation onsite in November 2006. Physicians, nurse managers and clinical nurses attended the session, and provided their support for adopting the software.

Implementation

The project received budgetary approval in January 2007 and implementation began shortly thereafter. A CGH urologist who had used the software in his private practice for the previous 10 years served as physician champion, making presentations to medical staff and answering questions.

Training for nurses and physicians was scheduled for May, but was delayed until July, due to other internal technology projects. Rollout began later that month with the ambulatory center, as well as the urology and the digestive diseases departments. Vendor representatives were onsite to assist with the transition and provide additional training. Later that summer, “train the trainer” sessions were provided to a preceptor group of nurses, who served as an internal resource.

By October, the automated informed consent application was being used by virtually all inpatient and outpatient surgical services. The application comes equipped with a database of more than 2,200 specific procedures, developed by board-certified physicians in each specialty area.

Physicians and nursing staff are able to search for the appropriate informed consent document — which prompts them to fill in variable information such as patient name, physician name, diagnosis, and laterality — and then populates the document with relevant information detailing the procedure, risks, benefits, alternatives and possible consequences of declining the treatment. The document is printed, signed by the patient, witnessed and signed by the physician. Currently, the completed paper form is clipped to the patient record, but will eventually be appended to the EHR as a paperless attachment complete with digitized signatures.

Challenges

Because the automated application offers a complete library of easily understood educational materials and anatomical diagrams, the physician can easily pull up relevant information to explain upcoming therapies. If the patient is about to undergo a laparoscopic cholecystectomy, for example, the physician can print out an explanation about gallstone disease and the proposed procedure, and provide a diagram of the gallbladder and its function. Physician and patient can go over the material in the office, and the patient can take the handout home for later reference, or to share with family members, friends and caregivers.

CGH encountered several minor issues during implementation. For instance, physicians and clinical staff used terminology that differed from language represented in the informed consent documents. In some cases, the software was easily modified, but in others, staff adjusted their naming conventions. Likewise, the database did not include a number of specialty procedures performed at the medical center — such as the possibility of knee arthroscopy converting to an arthrotomy, for instance. CGH worked with the vendor to develop customized procedure-specific consent forms to meet their needs.

Physicians now have a better understanding that informed consent is a continuing process, not a one-time, form-signing event. At the same time, they appreciate the fact that the documents are detailed and can prompt a comprehensive discussion with the patient.

Initially, it also required nursing staff more time to search the database for specific informed consent documents. They solved this issue by creating “favorites” lists — abbreviated lists of the procedures most commonly performed in their departments.

Results and Benefits

CGH began to enjoy significant benefits from the application almost immediately. It facilitates comprehensive, ongoing dialog — conversations that ensure consent is truly “informed.” Although the actual paper form typically is generated at the hospital on the day of procedure, it prompts the nursing staff to review all information covered between the physician and patient during previous encounters. If the patient indicates he or she was not aware of a possible adverse outcome or does not comprehend the extensive nature of a procedure, for instance, the nurse can alert the physician, who can have further discussions with the patient prior to treatment.

The medical center has achieved compliance with CMS interpretive guidelines relative to the informed consent process. In addition, leadership anticipates that CGH will improve the scores it receives during its upcoming Joint Commission survey.

Adoption of automated informed consent underscores the importance of the process to physicians, who are now more conscientious about making sure they have discussed all benefits, risks and alternatives to patients. Physicians now have a better understanding that informed consent is a continuing process, not a one-time, form-signing event. At the same time, they appreciate the fact that the documents are detailed and can prompt a comprehensive discussion with the patient.

The documents help eliminate wrong patient/wrong procedure/wrong site errors. They also serve as a valuable tool during time-out processes — which prompt clinical staff to confirm that the appropriate procedure at the appropriate site is being performed on the appropriate patient — in the operating room and at the bedside. This, in turn, enhances patient safety while reducing exposure to risk and subsequent malpractice liability.

Moving Forward

Since adoption, nursing staff report enhanced communication among clinical staff and physicians. The informed consent documents are consistent throughout the organization. In addition, nursing staff no longer struggle with illegible handwriting — trying to decipher whether the physician wrote “laparoscopy” or “laparotomy” on the informed consent document, for instance. Nor are they forced to translate unfamiliar or non-standard abbreviations that vary from physician to physician.

Perhaps most importantly, physicians note that the application helps facilitate communication with patients, who have become increasingly savvy about their health. Most patients have access to the Internet, which offers vast amounts of both appropriate and misleading information. Comprehensive informed consent documents allow physicians to focus patient attention on accurate information and provide answers to their questions.

Additionally, patients often expect physicians to know all, be all and to cure all. In-depth discussions during the informed consent process allow the physician to ensure the patient maintains appropriate expectations concerning all possibilities that might arise. Implementing automated informed consent at CGH has accomplished our goals of improved compliance and reduced risk. Additionally, physicians now have enhanced communication tools at their fingertips that allow them to improve care and their relationships with patients.