Honesty is the Best Policy When Things Don’t Go Well
By Anne M. Menke, RN, PhD
OMIC Risk Manager
Digest, Spring 2007
Faced with a medical error, patients want their doctor to do three things: explain what happened, say he or she is sorry that the patient experienced the poor outcome, and assure the patient that steps will be taken to prevent the same thing from happening to others.1 While many physicians want to talk to their patients in this way about errors and other adverse events, they may hesitate to do so for a variety of reasons. Some fear that disclosing errors and complications may prompt a lawsuit. Others may lack the communication skills necessary to respond to a patient’s anger and grief with compassion rather than defensiveness. When other health care providers or organizations are involved, some physicians may feel conflicting loyalties or be concerned about the impact of a disclosure discussion on collegial relationships, referral patterns, or credentialing.
Ophthalmologists calling OMIC’s Risk Management Hotline frequently ask for advice about revealing errors, offering apologies, or waiving fees. OMIC’s approach is founded on the principles of honesty, compassion, and fairness to both the ophthalmologist and the patient, and is designed to help minimize the risk and severity of claims and lawsuits. Over the years, articles in Argus (now published by the American Academy of Ophthalmology as EyeNet) and the OMIC Digest have offered advice on this topic. Dr. Jerome Bettman noted that “when complications arise, honesty is the best policy.” He encouraged physicians to “tell the patient what has happened as soon as possible.” Dr. Byron Demorest advised that “waiving your bill may avert a claim following a poor clinical outcome.” Paul Weber, vice president of OMIC’s Risk Management/Legal Department, reminded insureds, “don’t be afraid to say you’re sorry.”2 OMIC’s claims experience indicates that whatever the event or situation, communicating with the patient or patient’s family about the adverse outcome sympathetically and non- defensively within the shortest appropriate time period may help dispel much of the patient’s anger, confusion, and distrust. A patient’s belief that he or she is not being told the whole story, or is not being given the opportunity to ask the physician questions and vent feelings, often provokes a decision to seek the advice of an attorney and pursue a medical malpractice claim against the ophthalmologist. Indeed, studies have shown that patients who sued their physician often did so because their doctor did not help them understand what happened.
Patients who experience unanticipated outcomes are often confused about the difference between a poor or unsatisfactory outcome—a maloccurrence—and malpractice. An unanticipated outcome may or may not be the result of error or negligence, and not all errors are the result of medical malpractice. In fact, further investigation into an unanticipated outcome or allegation of negligence may reveal that what initially appeared to be malpractice was actually the result of the disease process itself or an unforeseeable or unpreventable complication of a risky, or even life- or vision-saving, treatment. To assist policyholders in dealing with patients following unanticipated outcomes, OMIC offers confidential, individual counseling through our Risk Management Hotline at (800) 562-6642, ext. 651. During these conversations, we help the ophthalmologist prepare for disclosure discussions, conduct an event analysis to evaluate the causes of unanticipated outcomes and improve patient outcomes in the future, respond to complaints, and weigh options when faced with a request for a refund. OMIC’s detailed recommendations on “Responding to Unanticipated Outcomes” are available as a document from our web site and are applied to case studies in two presentation formats, a CD and online course. This issue of the Digest illustrates many of these approaches. This article presents how an error, a complication, and unmet expectations were handled by three OMIC policyholders. Policy Issues discusses apologies in relation to OMIC’s policy coverage; the Closed Claim Study examines fee waivers; and the Hotline discusses waivers, refunds, and indemnity payments.
“Taking the High Road” When an Error Occurs
A 44-year-old man presented for bilateral LASIK correction of hyperopia. The next day, he reported significant visual difficulties, which examination revealed were due to high hyperopia and astigmatism. The ophthalmologist explained that the results were not what he expected. He told the patient he wanted to review the records and asked the patient to return the next day. The ophthalmologist contacted OMIC when he discovered that the patient had been treated with another patient’s laser settings. The physician explained that the first patient of the day had cancelled his surgery and that the second patient did not correct staff members when they repeatedly called him by the other patient’s name.
The ophthalmologist planned to tell the patient what had happened and provide treatment to address his visual difficulties at no charge. We agreed with his approach. After unsuccessful trials of contact lens and glasses, the patient underwent refractive lens exchange with implantation of a toric lens, followed by bilateral LASIK to treat residual refractive error, all at no charge to the patient. While his UCVA was 20/20 on the first postoperative day, his vision quality later deteriorated. At that point, the patient not only stopped seeing the surgeon, but sought legal advice.
An independent medical examination confirmed central irregular astigmatism that could not be corrected surgically, and BCVA of 20/80 OD and 20/100 OS. The ophthalmologist was disheartened that an error had harmed his patient but remained proud of “taking the high road” to stand by his patient and develop better patient identification policies. His honest, compassionate response was acknowledged by the plaintiff and his attorney. The case was settled for $85,000 on his behalf; the refractive surgery center paid $15,000.
Failure to Disclose Is Difficult to Defend
As sometimes happens in cataract surgery, a tear occurred in the posterior capsule, allowing a small fragment to drop into the posterior chamber. The ophthalmologist performed a minimal anterior vitrectomy and proceeded to place the IOL in the posterior chamber. Postoperative visual acuity was 20/100, with the IOP elevated at 30. The surgeon prescribed anti-inflam- matory, antibiotic, and pressure- lowering drops. Over the next ten months, the IOP fluctuated from a low of 18 to a high of 38, with VA progressively declining to LP. On the last visit, the patient expressed her unhappiness about the outcome and promised to seek a second opinion.
The patient was true to her word and ultimately filed a lawsuit, during which she learned for the first time of the intraoperative complication. Defense and plaintiff experts agreed that the surgery was indicated and that the complication itself was evidence of a maloccurrence rather than malpractice. Unfortunately for both the ophthalmologist and the patient, they also concurred in their criticism of the surgeon for neither documenting nor disclosing the complication. Furthermore, they noted that the postoperative management was negligent in that no effort was made to find or remove the lost fragment, despite ongoing problems with elevated intraocular pressure and decreasing visual acuity. They felt that an early referral to a retinal specialist could have resulted in a better outcome for the patient. The policyholder agreed, and the patient was compensated $200,000.
As this case demonstrates, physicians are often reluctant to inform patients of complications, but patients clearly want to be told. Indeed, one study showed that 98% of patients want to be informed of even a minor error, and the more severe the outcome, the more patients and families desire information. While 92% of patients thought they should always be told about complications, only 60% of physicians thought so. Similarly, 81% of patients said they wanted to know about future adverse outcomes associated with complications, but only 33% of physicians thought patients should be told about such adverse outcomes.3
OMIC policyholders who are unsure about whether and how to disclose an adverse event to a patient can discuss the matter with our risk management specialists. Had OMIC been consulted in this situation, we would have encouraged the ophthalmologist to approach the patient at her postoperative visit with the following information: “Mrs. Jones, as you noticed, your vision is not what you and I expected, and your eye pressure is high today. Yesterday, there were some problems during the surgery. Part of your lens fell into the back of your eye. If I had removed it, your eye could have been injured. I am putting you on some drops to control the pressure and swelling and prevent an infection. I’ll watch your eye closely. If the pressure doesn’t come down, or your vision doesn’t improve, I’ll want you to see a retina specialist who may need to remove the piece of lens. I’m so sorry this has happened to you. I’m going to do all I can to help you deal with this complication and protect your vision. Do you have any questions?” Such a discussion will not only strengthen the physician-patient relationship and help involve the patient in his or her care, but can also prevent an allegation of fraudulent concealment, which could open the door to punitive damages.
Some Patient Expectations Cannot Be Met
A 65-year-old presented to an ophthalmologist with a complaint of droopy upper eyelids. Examination revealed bilateral ptosis and mechanical upper eyelid entropion. After a detailed informed consent discussion, the patient agreed to a bilateral upper lid blepharoplasty and internal ptosis repair. The surgeon was pleased with the outcome; the patient was not. As she put it, she “missed the face she was born with.” The ophthalmologist responded with patience and compassion as the patient continued to express her discontent. When she wrote a letter threatening a lawsuit and complaint to the Centers for Medicare and Medicaid (CMS) if he did not pay for surgery by another ophthalmologist, the insured called OMIC for assistance. He was disappointed that the patient was unhappy but felt he had provided the best possible care. We agreed with his decision to deny her request and helped him craft a letter in which he stated that while he was sorry she continued to be unhappy about her outcome and the fact that surgery had not met her expectations, he was unwilling to pay for additional consultations or treatment. In response to the patient’s claim letter, OMIC had the case reviewed by an oculoplastics specialist, who felt the surgeon had provided excellent care. The patient’s com- plaint to CMS was similarly dismissed and the patient never filed a lawsuit.
Two of the ophthalmologists discussed in this article had frank but empathetic conversations with their patients about the unanticipated outcomes, while the third chose not to document or disclose the complication. All three received written patient complaints or demands for money, two of which resulted in indemnity payments. Talking to patients in a forthright manner will not necessarily prevent claims and lawsuits, but it will help physicians feel they have responded with dignity and professionalism, in accordance with the ethical standards of the American Academy of Ophthalmology and the American Medical Association. Such an approach can also decrease the amount the physician may need to pay to compensate the patient if compensation is warranted.
1. Vincent C, Young M, Phillips A, “Why do patients sue doctors? A study of patients and relatives taking legal action,” The Lancent, 1994; 343:1609-13.
2. Bettman, Jerome W, Sr, MD, “When Complications Arise, Honesty is the Best Policy,” Argus, May 1992. Demorest, Byron H, MD, “Waiving Your Bill May Avert a Claim Following a Poor Clinical Outcome,” Argus, Nov 1992. Weber, Paul, JD, “Don’t Be Afraid to Say You’re Sorry,” OMIC Digest, Spring 2001.
3. American Society for Healthcare Risk Management (ASHRM), “Disclosure of unanticipated outcomes: The next step in better communication with patients (first of three parts),” May 2003. ASHRM website, www.ashrm.org, accessed September 2004.
My Doctor Never Told Me That Could Happen
By Anne M. Menke, RN, PhD
OMIC Risk Manager
Digest, Summer 2007
Why do patients sue? This question, pondered by most physicians at some point in their careers, prompted a famous study that was published in JAMA in 1992. GB Hickson and his co-authors queried obstetrical patients who filed lawsuits after their infant had experienced permanent injuries or death. The study showed that patients initiated malpractice claims, in descending order of frequency, when they were advised to sue by a knowledgeable acquaintance (often a physician), needed money, believed there was a cover-up, felt their child would have no future, wanted more information, or wanted revenge or to protect others. 1 This article will explore physician-patient communication with particular focus on how to use the informed consent process to keep the lines of communication open before and after surgical procedures.
The insurance industry has long known that the majority of claims involve a relatively small number of physicians. The Hickson study authors wondered why. Do these high risk physicians attract higher risk patients? Do they practice bad medicine? Or do they relate differently with patients? In order to explore the relationship between physicians’ malpractice experience and their patients’ satisfaction, the authors devised a new study and asked a different group of mothers about their satisfaction with pregnancy and delivery care (see table 1). 2
The results confirmed the authors’ hypothesis that lawsuit frequency correlates with the volume of patient complaints about interpersonal aspects of care. Physicians with no claims history were perceived as “concerned, accessible, and willing to communicate,” whereas those with multiple claims were viewed as “hurried, uninterested, and unwilling to listen and answer questions.” In a companion article that examined quality of clinical care, SS Entmann et al found no correlation between prior malpractice history and either objective or subjective measures of quality of care. 3 This supports the Hickson findings that factors other than bad medicine are to blame for lawsuit frequency.
the central role that provider- patient rapport plays in malpractice claims was also supported by a 1994 finding by hB Beckman et al that a breakdown in patient-physician communications could be associated with over 70% of professional liabil- ity litigation.4 Patients would rather not sue their physicians. Vincent et al note that they want their doctor to do three things after a poor out- come: explain what happened, say he or she is sorry that the patient experienced the poor outcome, and assure the patient that steps will be taken to prevent the same thing from happening to other patients.5
Risk management experts have suggested that much of this communication dysfunction could be avoided by engaging the patient and family in a constructive, ongoing informed consent dialogue designed to invite them to participate in their care, clarify misconceptions, and minimize unrealistic patient expectations. Rather than being a purely legal function that must be fulfilled prior to invasive procedures, consent becomes an opportunity to establish a “therapeutic alliance” between the ophthalmologist and the patient wherein each acknowledges the clinical uncertainties that exist to some degree with each medical or surgical intervention.6 As the next section shows, forging such an alliance takes careful consideration and thoughtful communication.
What Do Patients Want?
Weighing the risks and benefits of a proposed surgery is central to the informed consent process and begins with understanding what the patient wants from surgery. CK Pager’s expectations and outcomes in Cataract surgery (EOCS) study analyzed preoperative expectations about outcomes and studied what led to patient satisfaction.7 After an informed consent discussion, patients completed the Visual function index, known as the VF-14, and indicated what they felt their score would be after surgery. Expectations ran “unreasonably high” in the patients in this 2004 study. They anticipated achieving a mean VF-14 score of 96.1 (an 11 point gain), and fully 60% assumed they would achieve a perfect score of 100 postoperatively. One might expect satisfaction to correlate with improvement in VF or the actual outcome. instead, patients weren’t satisfied unless they got what they expected, and those with an ocular comorbidity were most likely to be dissatisfied. When patients had expectations of reading small print, doing fine handiwork, reading a newspaper, or driving at night, they were decidedly unhappy if they had difficulty performing these tasks postoperatively. Indeed, few patients realistically achieved their goal, leading Pager to conclude that 70-year-old patients expect cataract surgery to enable them to see like 20-year-olds. Given the current advertising about the benefits of “multifocal” and “premium” IOLs, it is worth noting that these unrealistic patients all had monofocal implants, and had not been subjected to advertising promising them full recovery of their youthful vision. The only suggestion the study offered was to use the informed consent process to contribute to more accurate patient expectations.
What Do Patients Hear?
What do patients hear and understand about risk during an informed consent discussion? More pointedly, if patients expect perfect vision, how can ophthalmologists prepare them to accept not only realistic outcomes but possible complications? Unfortunately, just as prospective patients overestimate the benefits of cataract surgery, they underestimate the risks.8 In a study by CG Kiss et al, patients were provided with a standardized informed consent document that fully explained the risks, benefits, and alternatives. When questioned after the consent discussion, patients nonetheless believed that cataract surgery was relatively easy. Fully 76% felt there was no risk of a complication; when pressed, 60% maintained that even in their own surgery, there was no risk of a severe complication. Even when they finally admitted that the risk of a severe vision-threatening complication was real, 77% did not take risk into account when making the decision to proceed with surgery. Indeed, 78% said that the discussion had no impact on their decision, while the rest reported that it only confirmed the choice they had already made.
What frustrates ophthalmologists and healthcare risk managers is that these same patients may well claim in court that the discussion never took place or that they never would have consented to the surgery if informed of the risks. The authors of the study acknowledge that some patients do lie, but feel this explanation does not account for flawed recall of the informed consent discussion. They concluded instead that when patients come to ophthalmologists with a visual problem, they have already made a decision to have surgery in order to solve the problem and improve their vision. When confronted with what they perceive as negative objections (i.e., an accounting of associated risks), patients experience stress. Since they need to feel comfortable with their decision and minimize the stress, patients hear (and remember) what enhances a positive attitude and devalue (and forget) objections. In other words, patients “believe in and hope for the best.” To counteract this cognitive dissonance and help patients take in more accurate information about the risks of treatment, patients should be given information about the procedure earlier than the day before surgery.7
Why Don’t Patients Hear?
JE Pauling, an expert from a non-medical field who has studied how to communicate risks to the public, feels the problems lie not so much in how patients process information as in the way it is communicated to them.9 In other professions such as aviation and nuclear energy, there is great concern about the consequences of misunderstanding. To decrease its likelihood, only a few well-trained individuals are authorized to speak to the public. They always begin their message by addressing the potential emotional impact of the message before going on to provide information in the form of visual aids.
In the medical field, almost all clinicians are called upon to communicate risk. They receive little to no training, minimize their own and the patient’s emotions, and offer data with few visual aids. Poor process and training are only part of the problem, Pauling argues. Physicians want to build trust with their patients and know that it depends in part upon showing the patient that one is a good doctor. They assume that their patients know they care (“i went into medicine to help people”) and focus their efforts on demonstrating their competence, calling upon science and probability to calculate comparative risks. they are quite comfortable both with accepting a certain level of risk as inherent in treatment and with the uncertain, ever-changing nature of knowledge. Patients, on the other hand, assume that physicians are competent (“she went to medical school”) and watch anxiously for signs that their physician cares about them. Disregarding the data, they are only interested in hearing if the proposed procedure is or isn’t safe for them and knowing the personal consequences of treatment. Moreover, patients consider any discussion of uncertainty as evidence not of competence but rather of the physician’s lack of knowledge (“he doesn’t know the answer”).
Pauling illustrates his points and begins to give some practical advice with the following example. Imagine you are an obstetrician and are trying to help a 39-year-old woman understand her risk of having a fetus with Down’s syndrome. You know that it is 1.2% or 1 in 83. You provide these figures and reassure the woman that her risk is “quite low.” As table 2 shows, however, a patient’s perception of quite low is different, as anything higher than 1% is actually considered a high risk. Only when the likelihood falls in the 1 in 1000 to 1 in 10,000 range is it considered by patients to be a low risk.
In addition to using the same risk calculus, there are other steps physicians can take. First, use a common denominator to place the particular patient’s risk in a continuum (e.g., for a 35-year-old woman, the risk of having a child with Down’s syndrome is <3/1,000, and for a 40- year-old woman, it is <9/1,000). Second, to improve the likelihood of being understood, the physician can translate this information into a visual aid by using a graph available online at www.riskcomm.com. A 35-year-old woman would see a chart with stick figures for 1000 people. Three of those would be darkened to represent the number of women who will have a Down’s infant. The woman would also note that the vast majority—997/1000 women in her age group—are likely to have a child without Down’s syndrome. Providing both a positive and negative perspective and context enhances the message. Finally, relate the risk to one the patient knows and understands (e.g., people have a 1 in 10,000 risk of being struck by lightning or of dying from an accident in their own home).
Please go to the Risk Management Recommendations section of www.omic.com for an extended version of this article, including detailed suggestions for the consent process and footnote references.
Message from the Chairman—Hostile Patients
Over the past five years, OMIC has witnessed a steep drop in the number of claims and lawsuits reported by its members, from a high of 284 in 2003 to 203 in 2008. At the same time, the number of OMIC insureds increased from 3,200 in 2003 to 3,939 by year-end 2008. While we are delighted to see this downward trend, there has been a dramatic increase in the number of reported “incidents” (potential claims) to OMIC’s claims and risk management departments. Nearly 6% of OMIC insureds reported an incident in 2008, up from a low of 2.7% in 2004. Many of these incident reports relate to behavior problems, i.e., difficult, noncompliant, and hostile patients. What accounts for this increase?
Recent membership data from the American Academy of Ophthalmology indicates that the average ophthalmologist sees 114 patients per week. Collectively, OMIC insured ophthalmologists, now numbering nearly 4,100, see over 450,000 patients per week. Thus, it is not surprising that some of these patients and their family members will confront us with challenging behavioral problems such as those cited in the lead article.
As this summer’s angry “town hall” meetings and ongoing health care reform debate in Congress demonstrate, people are angry and fearful about the system and the health care being provided. Patients are confronted with a dizzying array of unfamiliar procedures, treatment options, and medication regimens. Issues around insurance and paying for care can further confuse and stress patients.
Physicians have a duty to their staff and other patients to provide a civil and safe practice environment, but disruptive patients expose us, our staff, and other patients to potentially abusive, violent behavior. They can affect our bottom line as well. Non-payment for services, time taken away from providing care to other patients, responding to litigation or regulatory complaints, and even, in some cases, the need for damage-control public relations all take their toll.
This year, OMIC began offering a risk management course, Difficult Physician-Patient Relationships. Some of the situations addressed include dealing with hostile and noncompliant patients, communicating with patients who are deaf or limited English speaking, and what to do when patients have vision problems that impair their ability to drive (see this issue’s Hotline article). In addition, OMIC’s web site offers a wealth of protocols on the subject of difficult patients, and risk management staff are available to answer questions and provide guidance to insureds and their staff, who are asked to apply their best clinical judgment even when faced with angry ultimatums from patients.
OMIC risk management staff have learned that one way to prevent frustration and keep patients informed is to provide procedure- specific patient education documents and videos produced by the Academy together with informed consent documents provided by OMIC. Although education is not a fool-proof method of eliminating patient dissatisfaction, it can go a long way toward making the health care you provide more understandable.
Richard L. Abbott, MD OMIC Chairman of the Board
Assuring Safe Passage Through the Healthcare System
By Anne M. Menke, RN, PhD
OMIC Risk Manager
Digest, Fall 2009
During our recent OMIC Forum on “Shared Care” at the AAO annual meeting, Dr. Steven Brown presented the following case involving four competent, experienced physicians. A primary care physician (PCP) referred an elderly gentleman to a comprehensive ophthalmologist (CO) for evaluation of a grey spot in his eye. After diagnosing a melanoma, the CO referred the patient to a retina specialist for confirmation and treatment options. The retina specialist offered the patient a choice between radiation and enucleation, and reported back that the patient chose enucleation. The CO then referred the patient to an oculoplastic surgeon for the procedure, which was completed two weeks after the initial ophthalmological evaluation. So far, the patient had received timely, effective, well-coordinated care. Nonetheless, when the patient died from metastatic disease that was diagnosed by his PCP eight months after his eye was removed, his family requested the medical records and concluded that the care was negligent. They reached their conclusion after finding a report from the retina specialist to the CO, advising him of the need for tests to monitor for metastasis. The family proceeded to sue the PCP, CO, and oculoplastic surgeon, alleging failure to follow-up and coordinate care. Investigation revealed that all three physicians knew the patient was at risk for metastatic disease, and knew which tests to order to monitor for it. Yet no one took the responsibility to clarify who was in charge, and none of them ordered the necessary tests. The oculoplastic surgeon testified that he had explained the need for follow-up to the patient but did not provide his recommendations in writing or document them in his record. No doubt the patient was not able to truly hear these care instructions while facing a new diagnosis of cancer and recovering from an enucleation.
Patient “Hand Off” A Critical Moment In Care
The Joint Commission (TJC) receives regular reports of medical errors that occur at the hospitals, ambulatory surgery centers, and other healthcare organizations that it accredits. By analyzing the problems, TJC hopes to understand not only which errors occur but more importantly what causes them. What TJC determined echoes the findings of the OMIC case. The top factor contributing to medical error was not lack of knowledge or technical skills or inexperience. Rather, it was problematic communication: the information conveyed during care was incomplete, inaccurate, and/ or misinterpreted. Ineffective communication occurred in 70% of “sentinel events,” a term TJC uses for incidents that have the most serious outcomes. Just as with the OMIC case, fully half of the time, the harmful communication breakdown occurred during a “patient hand off.”1
Patient safety experts, aware of the dangers of the hand off, have focused attention on ways to ensure communication and coordination of care during the moments when patients transition from one provider, facility, or unit to another. “Lost in Transition: Challenges and Opportunities for Improving the Quality of Care” points to our fragmented American healthcare system as the cause: decreasing numbers of primary care physicians, increasing numbers of patients with more than one disease who require diagnostic tests and specialists, and a payment system that does not reimburse physicians for the time it takes to communicate with one another and coordinate care.2
A literature review of care transitions found that patients referred to a specialist arrived 49% of the time with no information about the patient. The consultants apparently responded in kind, as the referring physicians complained that even four weeks after the consultation, 25% had not received a report back. PCPs said they were not notified that patients had been hospitalized and rarely received discharge summaries. The few that came were inadequate for directing care. Patients received even less information. Those sent for tests said that 17% of the time the physician had not received the results by the time of the office visit scheduled to discuss them. More than 75% of physicians report not informing patients when test results are normal, and 33% do not even disclose abnormal results. The author concluded that, “Care among multiple providers must be coordinated to avoid wasteful duplication of diagnostic testing, perilous polypharmacy, and confusion about conflicting care plans.”3
To help ophthalmologists coordinate care and follow up on referrals, test results, and appointments, OMIC developed a tracking system, which is discussed in the Hotline article and presented in detail in our document, “Noncompliance: A Frequent Prelude to Malpractice Lawsuits,” available in the risk management recommendations section at www.omic.com. A tracking system is only effective, however, if all physicians involved in the care of a patient are clear on who is in charge of ordering, interpreting, communicating, and acting upon the results of tests and consultations. As the OMIC case demonstrates, sending a letter with the proper recommendations does not lead to safe care if the message is not received and acknowledged. A more active process is required. Several new regulations imposed on healthcare facilities have been adopted to force physicians, nurses, and other caregivers to better coordinate care and hand off patients. The first is medication reconciliation, the second is standardized hand-off discussions; each will be addressed in turn.
Reducing Errors from Medication Changes
OMIC claims experience and the studies discussed so far show that patients and providers alike appear to be inadequately prepared for their role in the next phase of care. This is particularly true with changes to medications, which occur regularly when patients undergo diagnostic/surgical procedures, are diagnosed with new conditions, or are hospitalized. Too many times, neither the patient nor the prescribing physician has accurate and complete information about the patient’s current medication regime. The stage is thus set for errors and adverse drug events that result in patient harm, hospitalization, increased costs, and allegations of medical malpractice.
Take anticoagulants, for example, which are among the top three classes of drugs involved in medication errors. Ophthalmologists who are planning procedures with a high risk of bleeding, such as blepharoplasty, routinely inquire about prescription and over-the-counter drugs that influence the clotting cascade, and make changes to the drug regimen preoperatively. OMIC claims studies have shown, however, that patients misremember which medications they are taking, misrepresent—often when faced with financial problems—when they last had clotting studies done by their primary care physician, or do not think to report recent cardiac procedures, such as the placement of stents. Failure to confirm dosages, test results, and the intended change in medication with PCPs and cardiologists, failure to confirm that a patient has indeed stopped medications as directed, and failure to provide comprehensible, written instructions on how and when to restart medications have all led to malpractice lawsuits. Adverse medication events such as these indicate the need for an explicit process of “medication reconciliation” at key transition moments, such as a new diagnosis, admission for surgery, or discharge from a healthcare facility. This step is now a “National Patient Safety Goal” that facilities must meet in order to maintain accreditation by organizations such as TJC and AAAHC.4 And while time consuming, the process works: studies show that medication reconciliation decreases medication errors by 70% and adverse drug events by 15%.2
Tools to Improve the Quality of Hand Offs
One study of hand offs looked at the accuracy of information exchanged by nurses during shift change. Twelve fictitious patients were created, and nurses passed on information during five consecutive hand overs.
Oral communication resulted in the loss of all data. Note taking during hand off reduced data loss to 31%. It was only when a standardized form was combined with oral exchange of information that data loss was minimal.5 Studies such as this convinced many organizations, including the Institute of Medicine, the Department of Defense Patient Safety Program (DOD), Kaiser Permanente, and AORN (Association of periOperative Registered Nurses) to produce tools to better structure patient hand offs. These teams learned that standardized hand offs shifted the focus from the people involved in the exchange (often hierarchical) to the patient, and led to common expectations about what was going to be communicated, how the communication would be structured, and the required elements. Most importantly, the process requires two-way conversation in which critical information is verified and clear responsibility for ongoing care is established.
The toolkit jointly developed by the DOD and AORN is particularly useful to ophthalmologists as it focuses on team building and was developed specifically for perioperative care.6 It provides information on several standardized hand-off formats (see TALK TO ME IN SBAR and I PASS the BATON). Ophthalmologists would be well advised to become familiar with these hand-off processes, now that the Joint Commission, in National Patient Safety Goal 2E, requires facilities to implement a standardized approach to hand offs. TJC has clarified its expectations: hand offs must be interactive, allowing for participants to ask and answer questions; they must include accurate, current information; interruptions during hand offs should be minimized; they must include a process for verification of the received information, including read back or repeat back if needed; and other necessary patient information should be available for review.7 It will no doubt take time to hone the hand-off process, but the effort will clearly result in safer care and less liability.
1. JCAHO. “Improving Hand-off Communications: Meeting National Patient Safety Goal 2E.” Joint Perspectives on Patient Safety 2006; 6(8): 9-15.
2. Coleman EA and Berenson RA. “Lost in Transition: Challenges and Opportunities for Improving the Quality of Care.” Ann Intern Med 2004; 140: 533-536.
3. Bodenheimer, Thomas. “Coordinating Care—A Perilous Journey Through The Healthcare System.” New England Journal of Medicine 2008; 358: 10.
4. Several resources provide medication reconciliation tools. The Agency for Healthcare Research and Quality has a primer available at http://www.psnet.ahrq.gov/primer.aspx?primerID=1. The Institute for Healthcare Improvement has a tool to help review medical records to catch medication errors and develop an effective reconciliation process; this tool is available at www.ihi.org.
5. Pothier D, Monteiro P, Mooktiar M, Shaw A. “Pilot study to show the loss of important data in nursing handover.” British Journal of Nursing 2005; v.14, n.20.
6. The toolkit, which includes slide presentations, sample tools, and forms developed for perioperative use, is available at www.aorn.org.
7. The Joint Commission’s National Patient Safety Goal on hand-off communication can be found at www.jointcommission.org.
Older Patients Need Additional Informed Consent Consideration
By Anne M. Menke, RN, PhD
OMIC Risk Manager
Digest, Fall 2010
To view the tables referred to, go to http://www.omic.com/new/digest/DigestFall_20110107.pdf
Older patients make up a significant portion of the patient population of most ophthalmologists, and their numbers will grow as life expectancy increases. At the recent American Academy of Ophthalmology meeting in Chicago, an ethics symposium addressed the challenges of obtaining informed consent from older patients. The panelists have agreed to allow OMIC to present some of their comments and suggestions here, particularly those related to aging, decision-making capacity, surrogate decision makers, and cognitive impairment.
Take the Impact of Aging Into Account
OMIC Director, Harry A. Zink, MD, speaking from the perspective of an ophthalmologist, pointed out that certain aspects of the physical condition of older patients impact the care and consent process. These include declining vision, hearing, and memory, as well as cognitive disorders such as dementia. Providing for the needs of these patients comes when many practices are already struggling with time constraints, so ophthalmologists will need to come up with a smarter process of care. Dr. Zink suggests enlisting staff and family members, repeating information and instructions, and providing them in writing, using large print whenever possible. Focus on a few main points and confirm understanding by asking the patient to repeat these main points. Ask a family member to be present during consent discussions, and ensure that decisions made by surrogate decision makers truly reflect the patient’s wishes.
Evaluate the Patient’s Decision-Making Capacity
Representing OMIC, I presented the medicolegal aspects of consent. Physicians know they have a legal obligation to inform patients of their condition, as well as the risks, benefits, and alternatives of the proposed treatment, including no treatment. If patients do not feel that surgeons have fulfilled this duty, they—as plaintiffs—may sue for “lack of informed consent.” To succeed, they must prove that the ophthalmologist did not inform them of the risks, benefits, and alternatives, AND that they would have refused treatment if advised of the risks. Plaintiff attorneys have alleged lack of informed consent on the basis that patients did not have adequate time to make an informed decision or the information on which to base it. Additionally, they have claimed that patients were under the influence of mind-altering medications that impacted their judgment. Attorneys representing older patients may challenge the patient’s ability to make an informed choice. Consider this scenario reported to OMIC by an oculofacial plastic surgeon.
A 70-year-old patient, accompanied by a man she identified as her boyfriend, requested a facelift. Her ophthalmologist determined that she was an appropriate candidate, clarified her goals, and obtained her informed consent. By the time the preoperative nurse called her to review the physician’s orders, the patient could not recall that she was having surgery. The nurse determined that the problem was not simply a matter of forgetfulness. Before the nurse could contact the surgeon, the boyfriend called her to assure her that the patient remembered the surgery and still wanted to proceed. After hearing from the nurse, the ophthalmologist contacted OMIC’s Risk Management Hotline.
While judges determine a person’s competency, physicians use their clinical skills to decide if a patient has “decision-making capacity” or DMC. Adult patients are presumed to have DMC if they understand their condition and the risks associated with the recommended procedure and are able to communicate their wishes. The oculofacial surgeon andI discussed the need to re-examine the patient to determine if she had decision-making capacity and whether there were signs of elder abuse. If the patient’s confusion persisted, the surgery would need to be cancelled.
Surrogate Decision Makers
If a patient lacks DMC, a surrogate decision maker must be found to make the informed consent decision before surgery is allowed to proceed. States recognize that some patients may temporarily or permanently lose their ability to make decisions on their own behalf and have developed mechanisms for determining who may decide in the patient’s stead (see this issue’s Hotline column).
Distinguish the Effects of Aging from Dementia
Patients who lack DMC, especially if they previously demonstrated it, need further evaluation. If you think the cause of the cognitive impairment is Alzheimer’s, you would be right about 60% of the time, according to Chicago gerontologist Dr. Shellie Williams. As the proportion of the u.S. population age 65 and older increases, the prevalence of dementia (the general term for a decline in cognitive functioning) will also increase. In 2009, there were approximately 5.3 million patients with Alzheimer’s, with a new diagnosis rendered every 70 seconds. Researchers estimate that Alzheimer’s disease (AD) and other dementias affect approximately 5% of individuals age 65 and older and as many as 30% to 40% of individuals age 85 and older. In the absence of effective treatment to prevent AD, 8.5 million Americans may have this disorder by 2030.1
Far from a routine part of growing older, dementia is a progressive, terminal disease of the brain that destroys brain cells. (See WHAT’S THE DIFFERENCE?2) Dr. Williams explained that many diseases cause dementia, including Alzheimer’s, Parkinson’s, Lewy Body, and vascular disorders. Dementia increases the morbidity and mortality of other diseases and the risk of adverse events, and limits the patient’s ability to follow medical directions and consent to care. The disease burden is significant: despite care totaling $148 billion, and the unpaid assistance of some 9.9 million caregivers, Alzheimer’s is the sixth leading cause of death, Dr. Williams reported. Dementia is present when memory issues are accompanied by a decline in at least one other area, such as language, motor skills, recognition, or executive function (performance of complex tasks or judgment/reasoning). The combined impairment degrades the patient’s baseline cognition and functioning and leads to a decreased ability to care for oneself and live independently.
Screen for Cognitive Impairment
Clues that a patient needs to be screened for dementia include poor control of a previously controlled medical condition as well as many of the attributes of “difficult patients,” i.e., missed appointments, failure to refill a medication, change in behavior, and disheveled appearance. According to Dr. Williams, dementia is routinely unrecognized and undiagnosed despite its growing prevalence. Physicians were unaware of cognitive impairment in more than 40% of their cognitively impaired patients. Only 24% of patients had a documented diagnosis of dementia, even though their screening exam demonstrated moderate to severe dementia.
Family members failed to recognize a problem with memory in 21% of demented seniors. As many of those who did notice a change attributed it to the normal aging process, only 53% of seniors with memory problems were referred to a physician.3
Family members can help the ophthalmologist determine if there is cognitive impairment. Dr. Williams suggests asking them the following questions about the patient: Does your family member repeat questions? Forget words or names? Have poor recall of familiar people and places? Fall often? Have difficulty taking medications? Talk less? Show poor judgment? Wander? Have trouble using tools and appliances? Misplace items? Seem irritated, angry, or aggressive?
In addition to getting input from family members, physicians can use screening tools. Dr. Williams presented two brief screening methods, either of which can be utilized by ophthalmologists in a matter of minutes. The first is called the “Mini- Cog.” Ask the patient to repeat and remember three words: BALL-FLAG- TREE. Next assign the clock-drawing task (CDT). Ask the patient to draw a clock with the hands set for ten after eleven. Once the clock is drawn, ask the patient to recall the three words. The CDT is considered normal if all numbers are present on the clock in the correct sequence and position and the hands readably display the requested time.4 Abnormal clocks will be missing quarters or have bunched, repeated, or missing numbers. Each word the patient remembers is worth a point, and the CDT is scored as either normal or abnormal. (See MINI-COG SCORING ALGORITHM.)
The second possible screening test is called the “Six-Item Screener.”5 Short-term memory deficit is a hallmark of dementia. The authors chose to target disorientation in three of the questions, specifically temporal disorientation (problems recalling the day of the week, month, and year) since it occurs before disorientation to place and is rarely seen in those not experiencing dementia. Three-item recall helps to identify patients with cognitive impairment. Here is the script: “I would like to ask you some questions that ask you to use your memory. I am going to name three objects. Please wait until I say all three words, then repeat them. Remember what they are because I am going to ask you to name them again in a few minutes. Please repeat these words for me: APPLE-TABLE-PENNY.”5 The physician may repeat the names three times if necessary; the repetition is not scored. The script continues: “What year is this? What month is this? What is the day of the week? What were the three objects that I asked you to remember?” Each correct answer is worth a point. A score of ≤ 4 points is considered positive for cognitive impairment.
Arrange Additional Care for Cognitively Impaired Patients
Patients with a positive screening test for cognitive impairment need additional care. Explain to the patient and family member that the screening test indicates the need for a more detailed evaluation from the patient’s primary care physician or a specialist. Patients with cognitive impairment may exhibit denial or feel that treatment would be futile. Explain that there are many conditions that can cause cognitive impairment and that earlier treatment affords the best chance for optimal functioning. In addition to documenting your assessment and discussion, contact the PCP’s office to schedule an appointment for the patient, and send a referral note with the screening results.
Even with cognitive impairment, patients need to continue to treat their eye conditions. Review and simplify the patient’s medication regimen. Provide medication and care instructions both orally and in writing in simple terms. Involve family members and friends in the patient’s home care whenever possible. Evaluate the patient’s ability to drive.6 Alert staff to the patient’s status so additional time can be provided for appointments and education, if needed. Taking these extra steps to obtain consent and screen for cognitive impairment will help patients and their families meet the considerable challenges of aging and dementia.
1. “Alzheimer’s Disease.” http://www.alz.org/ national/documents/topicsheet_alzdisease.pdf. Accessed 12/3/10.
2. Alzheimer’s Association. “Ten Warning Signs of Alzheimer’s.” http://www.alz.org/national/documents/ brochure_10warnsigns.pdf. Accessed 12/3/10.
3. Chodosh J, Petitti DB, Elliott M, Hays RD, Crooks VC, Reuben DB, Buckwalter JG, Wenger N. “Physician Recognition of Cognitive Impairment: Evaluating the Need for Improvement.” J. Am Geriatr. Soc. 2004; 52(7): 1051-9.
4. Borson S, Scanlan J, Brush B, Vitaliano P, Dokmak A. Int. J. Geriatr. Psychiatry. 2000; 1021-1027.
5. Callahan CM, Unverzagt FW, Jui SL, Perkins AJ, Hendrie HC. Medical Care. 2002; 40: 771-781.
6. See “Visual Requirements for Driving” on the AAO’s web site (www.aao.org). The 2010 edition of the American Medical Association’s Physician’s Guide to Assessing and Counseling Older Drivers includes a 10-minute tool called the “Assessment of Driving-Related Skills,” which screens for problems in cognition, vision, and motor/somatosensory functions that may affect driving (www.ama-assn.org).
