Weathering the Perfect Storm

July 1, 2008

An examination of procedures intended to ensure consent is truly informed.

A perfect storm is brewing around the concept of “informed consent” and its impact may have wide-ranging business implications for healthcare facilities that do not heed the warning signs.

 It has been noted that all too often, informed consent is seen simply as a burdensome administrative practice that involves obtaining a signature on a form for the legal protection of physicians and institutions. Although the document itself might contain detailed information about the procedure and related issues (e.g., possible risks or side effects), providers may not take the time to ensure the patient fully understands all aspects of the care they are about to receive. The consent document, frequently written in medical or legal jargon, is normally signed shortly before the patient undergoes the procedure for which they have been scheduled, oftentimes when he or she may be under stress and have little time to decipher or consider all issues presented in the document.

An examination of procedures intended to ensure consent is truly informed.

A perfect storm is brewing around the concept of “informed consent” and its impact may have wide-ranging business implications for healthcare facilities that do not heed the warning signs.

 It has been noted that all too often, informed consent is seen simply as a burdensome administrative practice that involves obtaining a signature on a form for the legal protection of physicians and institutions. Although the document itself might contain detailed information about the procedure and related issues (e.g., possible risks or side effects), providers may not take the time to ensure the patient fully understands all aspects of the care they are about to receive. The consent document, frequently written in medical or legal jargon, is normally signed shortly before the patient undergoes the procedure for which they have been scheduled, oftentimes when he or she may be under stress and have little time to decipher or consider all issues presented in the document.

When is a Patient “Informed?”

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 Healthcare policy makers and thought leaders have recently begun to question the effectiveness of this traditional approach. They argue that obtaining a signature under these conditions does not ensure that a patient is fully “informed.” This, in turn, begs a larger question: If patients are not fully informed, how can they possibly provide genuine consent?

 As a result, attention is being directed at the effectiveness of current informed consent processes from a number of quarters, including:

 Accreditation organizations. In February 2007, The Joint Commission released a public policy white paper entitled, “‘What Did the Doctor Say?’ Improving Health Literacy to Protect Patient Safety.” This report warns that failure to provide patients with information about their care, in ways that they can understand, will continue to undermine other efforts to improve safety.

 Risk managers. Attorneys and risk managers recognize that genuine informed consent reduces risk in two important areas. First, informed consent documentation significantly decreases the chance of errors such as wrong-site surgeries. It has been estimated that a properly completed consent form could eliminate up to 45 percent of wrong-site surgical procedures. Such a form, made available during the “time-out” process prior to procedures, enables members of the surgical team to verify the correct patient, the correct procedure and the correct site. Also, patients who fully understand their conditions, alternative treatments and risks are less likely to consider litigation in the event of an unfavorable outcome. These patients have a rapport with their physicians and, through ongoing dialog, feel like an equally responsible partner in all decisions. Because they more clearly understand all consequences and proactively choose a course of action, they more consistently accept results and view themselves as full partners in the decision-making process, even when faced with undesirable—but not unexpected—outcomes.

 Payers. The Centers for Medicare and Medicaid Services (CMS) codified standards for information that should be contained in well-designed and properly executed consent forms. These standards set forth the elements that should be present, including the name of the procedure; material risks; name of the practitioner performing the procedure; name of the practitioner who obtained consent; and date, time and signatures of the patient and witnesses.

 In its State Operations Manual, Appendix A—Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, Section A-0392, revised April 2007, CMS instructs surveyors to “…interview two or three post-surgical patients, as appropriate based on their ability to provide a cogent response, or the patients’ representatives to see how satisfied they are with the informed consent discussion prior to their surgery.”

 What is the potential risk to noncompliant providers? Losing their eligibility to bill CMS for treatments provided to Medicare and Medicaid patients.

 Caregivers themselves. Perhaps most importantly is the conclusion to which caregivers themselves have arrived: Medical staff increasingly recognize that patients are partners in the healthcare delivery system, and that patients who understand their conditions and care plans are more compliant, less anxious, and more satisfied.

Revising Healthcare’s Approach

 A growing body of research and anecdotal evidence confirms the important role that informed consent plays in the delivery of safe and effective care. Likewise, properly executed informed consent has significant business implications for healthcare organizations of all sizes and specialties. It potentially has a direct impact on the risk of litigation, levels of reimbursement and patient satisfaction.

 To optimize the value informed consent can play at all levels of an organization, and throughout the healthcare continuum, providers must undergo a genuine paradigm shift. They can no longer limit their concept of informed consent to a single conversation, often conducted in a pre-op holding area, with the intent of obtaining the patient’s signature on a sheet of paper that could easily be lost or misplaced. Instead, they must recognize that informed consent is a dialog that takes place over the course of time and one that focuses on ensuring that patients gain a comprehensive understanding of their condition, treatment alternatives, risks and benefits, and possible outcomes.

 In its February 2007 white paper, The Joint Commission offered a number of recommendations to effect the necessary changes: 1) The redesign of informed consent forms and the informed consent process; 2) The use of established patient communication methods such as “teach back;” and, 3) The sensitization, education and training of clinicians, healthcare organization leaders and staff regarding health literacy issues and patient-centered communications.

 To accomplish their internal “informed consent paradigm shift,” some organizations are exploring approaches like the use of technology to ensure their informed consent processes become more standardized. These automated or computer-assisted applications facilitate ongoing communication between provider and patient. Providers use the systems to assist them in informing patients about conditions and procedures, providing pre- and post-procedure instructions, and documenting consent for procedures. Documentation is often accomplished via electronic capture of signatures. These informed consent forms can be saved electronically and forwarded to other providers. Perhaps a physician obtained consent in his office several days prior to a procedure. This document can be sent to OR personnel and printed out for reference in the surgical suite. In addition, some applications allow the informed consent document to be automatically integrated with electronic medical records systems (EMR).

 Informed consent documentation significantly decreases the chance of errors such as wrong-site surgeries. Also, patients who fully understand their conditions, alternative treatments and risks are less likely to consider litigation in the event of an unfavorable outcome.

Conclusion

 In addition to documenting the consent process, automated solutions that put a library of relevant and reproducible materials at the provider’s fingertips make it easy to educate patients. Some applications allow content, written in jargon-free, easy-to-understand language, to be customized to a patient’s specific circumstances. Providers can walk through important information with the patient, and print out relevant materials for the patient to take home for later review and to share with family members.

 It makes sense to consider technological solutions to problems inherent in traditional, paper-based informed consent processes. In the past 20 years, healthcare facilities have successfully applied technology to other critical processes, such as computerized physician order entry and EMRs. It is critical for forward-thinking organizations to turn their attention to the ubiquitous process of informed consent and consider technology that can help overcome regulatory, reimbursement and patient safety concerns.

Case Study: Houston Facility Converts To Automated Informed Consent Process

 Community Medical Center (Community), part of St. Luke’s Episcopal Health System in Houston, converted from paper-based informed consent to an automated application in 2006. The impetus for this move was an impending Joint Commission accreditation survey (which ultimately took place in December of that year) and the realization that its informed consent documents were at risk for noncompliance with The Joint Commission, CMS and State of Texas requirements.

 Although it dedicated staff and financial resources to remaining current with these requirements, regulatory guidance changed faster than Community could respond. Before the 2006 survey, the changing regulatory landscape resulted in the facility’s warehouse having 25,000 noncompliant forms on hand. Leadership estimated it would cost $15,000 to destroy the outdated forms, on top of the costs to revise and reprint new documents. Even so, the institution could not guarantee that all old forms would be destroyed. Some departments kept hidden caches, which they might have continued to use until supplies were depleted.

 After reviewing alternatives, Community decided to implement an automated informed consent application in mid-2006. The selected application contains a comprehensive library of forms that cover more than 2000 procedures. Because they are electronic, each consent document can be easily customized or updated to reflect regulatory or facility guidance. The application is integrated with the hospital’s patient information system, which populates the consent forms with appropriate demographic information. Using menus and check boxes, providers can quickly construct detailed informed consent documents for each patient. The material is presented in lay terms and providers walk through the form to ensure patients understand all facets of their care. The signed form then accompanies the patient to the OR, or it can be scanned back into Community Medical Center’s document management system, so OR staff can access it electronically.

 Results have been positive. Providers, especially nurses, have been very enthusiastic about the new system because they understand the compliance issues prompting the conversion to electronic documentation, and because they recognize the system enables them to provide better care. The leadership at St. Luke’s Episcopal Health System is supportive of this project because it will realize a positive return on investment in less than two years through reductions in printing costs, expenses to destroy outdated documents, and OR time previously spent hunting for missing or incomplete informed consent documents. Most importantly, The Joint Commission gave Community Medical Center glowing scores relative to informed consent, noting that everything was in place when patient records were reviewed.

Margaret Reiter, RN, PhD, is assistant vice president and chief nursing officer for St. Luke’s Community Medical Center in Houston. Timothy Kelly, MS, MBA, is vice president for Atlanta-based Dialog Medical Inc.They can be reached at
[email protected] and [email protected].

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