E THE OPEN MIND
CME
Ethical Opportunities with the Perioperative Surgical Home: Disruptive Innovation, Patient-Centered Care, Shared Decision Making, Health Literacy, and Futility of Care Lee A. Goeddel, MD, MPH, John R. Porterfield, Jr., MD, MSPH, Jason D. Hall, BA, BS, JD, and Thomas R. Vetter, MD, MPH
T
here has been a major impetus for American health care to adopt learning health care systems1,2 “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the health care delivery process and leads to continual improvement in care.”3 The American Society of Anesthesiologists Perioperative Surgical Home Learning Collaborativea is fostering such learning health care systems. An ethics framework for such learning health care systems has been proposed to assess the ethical utility of their activities (Table 1).4,5 In this Open Mind article, we will first assert that, to be a disruptive innovation, the Perioperative Surgical Home should increase health care equity by expanding patient access to high-quality perioperative care. We will then focus on 4 other ethical opportunities. To fulfill the ethical tenets of a learning health care system (Table 1)4,5 and to be of greatest added value to the surgical population, this novel health care model must: (a) enhance patient-centered care, (b) embrace shared decision making, (c) increase health literacy, and (d) reduce futile surgery. Each of these represents a potential opportunity that must be validated with rigorous interdisciplinary health services research.
THE PERIOPERATIVE SURGICAL HOME AS A DISRUPTIVE INNOVATION
A sustaining innovation results in novel products and services that can be sold for higher profits to the best customers of the industry. A sustaining innovation does not create new markets but evolves existing ones, allowing firms to compete successfully in the existing market. Its value to society is limited to those who can access it.
From the Department of Anesthesiology, University of Alabama at Birmingham, Birmingham, Alabama. Accepted for publication January 30, 2015. Funding: University of Alabama Department of Anesthesiology internal funds. The authors declare no conflicts of interest. Reprints will not be available from the authors. Address correspondence to Thomas R. Vetter, MD, MPH, Department of Anesthesiology, University of Alabama at Birmingham, JT 862, 619 19th St. S., Birmingham, AL 35249. Address e-mail to [email protected]. Copyright © 2015 International Anesthesia Research Society DOI: 10.1213/ANE.0000000000000700
1158 www.anesthesia-analgesia.org
Innovations in health care have predominantly sustained a system fraught with inaccessibility, inefficiency, and excess costs.6–8 As defined by Christensen et al.,6–8 a disruptive innovation also creates new products and services, but ones that are less expensive, simpler, more convenient, and more accessible. By creating a new market, a disruptive innovation eventually displaces the existing market. It also enables participation of a new set of customers previously ignored or shut out by the existing market. However, it should be noted that Christensen et al.’s theory of disruptive innovation is based largely on case examples and is applied retrospectively. In 2000, Christensen et al.7 asked: “Will disruptive innovation cure health care?” Unfortunately, health care has remained expensive and inaccessible to many Americans.6,8 Disruptive innovation can improve health care, but only if it first disrupts an existing system in which “pharmaceutical companies, hospitals, physicians, device manufacturers, and insurers are able to ensure their financial health [prosperity] over patients’ financial or physical well-being.”9 Equitable health care requires the creation of patient-centered systems, systems responsive to a patient’s individual wishes and circumstances. Improving health care equity requires reallocation of resources and better alignment of capabilities with patients’ needs, particularly for patients who have been historically underserved.10 In its 2001 “Crossing the Quality Chasm,” the Institute of Medicine called for improvements in 6 dimensions of health care performance, including greater equity.11,12 In the interim, inequity in health and health care in the United States continues to be the norm.13 Recent health care reforms, including the Patient Protection and Affordable Care Act of 2010, offer an opportunity to create a more equitable American health care system. Specifically, financial incentives and penalties that make equity an element of value within a value-based health care model, including for surgical and anesthetic care, will reduce health care disparities and move the nation toward greater equity in health care.13 a American Society of Anesthesiologists: Perioperative Surgical Home Learning Collaborative. Available at: http://www.asahq.org/. Accessed December 16, 2014.
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Ethical Opportunities with the Perioperative Surgical Home
Table 1. Learning Health Care System Ethics Framework Applicable to the Perioperative Surgical Home4,5 Ethical obligation Respect the rights and dignity of patients, family members, loved ones, and patient surrogates Respect clinicians’ judgments Provide optimal clinical care to each patient Avoid imposing nonclinical risks and burdens on patients Address and reduce unjust health inequalities Conduct continuous learning activities that improve the quality of clinical care and health care systems Contribute to the common purpose of improving the quality and value of clinical care health care systems
The nascent Perioperative Surgical Home model has been labeled by its innovators and early adopters as a disruptive innovation that creates disruptive alliances and transformative integrated care.14,15 However, to be a truly successful disruptive innovation, any variant of the Perioperative Surgical Home will need to provide perioperative care more simply, more accessibly, at lower cost, and thus within reach of more patients.16 One possible mechanism to achieve these goals with the Perioperative Surgical Home is by improving operational efficiency, thereby increasing operational margins. Greater efficiency would expand resource availability for patients who are currently underserved. Greater health care equity will thus result from the attendant broader and more equal patient access to high-quality perioperative care. This is especially critical among currently underserved and vulnerable racial and ethnic minorities, as well as individuals with lower socioeconomic status, who suffer poorer health outcomes because of chronic diseases and higher allcause mortality.13,17
ENHANCING PATIENT-CENTERED CARE
Berwick18 defined patient-centered care as “the experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.” Patient centeredness is manifested in the understanding that health care value, including for surgical and anesthetic services, is most validly assessed from the patient’s perspective.19–21 Patient-centered care is not simply capitulating to patients’ requests. Patient-centered health care is not a smorgasbord, offering patients what they want, when they want it, regardless of value or cost. Patient-centered care is not throwing information at patients and leaving them to sort it out on their own.22 Patient-centered care is teamwork by clinicians and patients, building healing relationships, and grounded in communication and trust among clinicians, patients, and patients’ families.22 Such teamwork and healing relationships are mandatory to achieve the potential benefits of the Perioperative Surgical Home. They are manifested in the Perioperative Surgical Home by robust patient education, engagement, and empowerment to expect surgical and anesthetic care that fulfills their individual needs, wishes, and context throughout the preoperative, intraoperative, and postoperative periods.23 If the Perioperative Surgical Home can
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enhance culturally sensitive patient-centered care, particularly among racial and ethnic minorities and individuals with lower socioeconomic status, this health care model will legitimately be a disruptive innovation that reduces health care disparities and increases health care equity.
EMBRACING SHARED DECISION MAKING
Shared decision making makes health care more patient centered. Shared decision making is a continuum.24 When a difficult medical decision needs be made, at their discretion, patients are encouraged to include friends, family, and other health care providers in examining how the outcomes of a particular medical or surgical decision align with the patient’s culture, values, and preferences.25 A recent study of the quality of informed consent found that, before major surgery, 13% of patients could not recall the procedure to be performed, its indications, risks, or alternatives.26 More striking, 33% of patients reported that the decision to proceed with surgery did not address their preferences, values, or goals. Populations at significant risk for concerns about fully informed consent were those speaking a different language and with lower educational levels, indicating a need for targeted interventions in these groups. Addressing this deficiency in current practice, the Perioperative Surgical Home can foster communication among patients, their chosen confidants, and their clinicians to improve decision quality. The requisite preoperative assessment in the Perioperative Surgical Home is the appropriate venue to inform the patient and family about their clinicians’ professional opinions and consensus on the advisability of the planned procedure. Additionally, the creation and implementation of best practice informed consent can specifically address the needs of patient groups who are not adequately served by existing ad hoc informed consent processes. Shared perioperative decision making is not intended to supplant the surgeon’s pivotal acumen, judgment, and role. It is also not intended to supplement the expert assessment of the anesthesiologist advising the patient before surgery and then preparing the patient for surgery. However, the Perioperative Surgical Home can facilitate a more consistently open communication among multiple providers to generate a clear clinical summary for the decision makers (patients, family members, and all clinicians). This clinical summary includes the necessity of the procedure, potential benefits, implications of possible complications, and clinicians’ recommendations for preoperative health optimization.
OPTIMIZING HEALTH LITERACY
Health literacy is “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”27,28 Health literacy is a requirement for perioperative patient-centered care and shared decision making. Many Americans with the greatest health care needs have the least ability to comprehend the information required to navigate the United States health care system.29 Increasing health literacy requires an investment by patients, health care professionals, and health systems.30
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E The Open Mind Inadequate health literacy has been associated with greater hospital utilization, poorer health status, and increased mortality.28,31–33 In 1 study, low health literacy was a significant, independent, and modifiable risk factor for hospital reutilization (readmission or return to the emergency department) during the 30 days after discharge.34 Improved health literacy has reduced chronic disease severity, decreased emergency department visits and hospitalizations, and improved patient satisfaction.35,36 In a recent study of 2026 general surgery patients in an urban setting in the United States, who had a mean of 10 years of education, only 19% possessed adequate health literacy.36 Lower health literacy is more common in individuals living below the poverty line, of an ethnic or cultural minority, living in the southern or western regions of the United States, with less than a high school education, or above the age of 65 years.28 Health care providers should take every opportunity to improve the public’s general literacy. This includes examining and modifying their own activities, assumptions, and environments to remove health literacy–related barriers that hinder access to information, navigation of services, and decision making.30 As a consistent nexus of the surgeon, anesthesiologist, medical consultants, and primary care physician, the Perioperative Surgical Home is an ideal opportunity to evaluate a surgical patient’s health literacy by using tools previously validated in the surgical population.37 Application of these tools can optimize health care literacy in the surgical population.38 This is especially important in those patients at greater risk of inadequate health literacy and poor decision quality.35 The Perioperative Surgical Home could also mitigate postdischarge events (e.g., patient medication errors, patient noncompliance with discharge instructions, and 30-day readmissions), decrease decisional regret, and possibly lessen the burden of malpractice litigation.36
AVOIDING FUTILE SURGERY
In 1999, the American Medical Association (AMA) recommended a process-based approach to determining medical futility, allowing institutions to circumvent an externally determined definition of futility and instead to apply a local case-by-case definition. This AMA framework incorporated patient centeredness and shared decision making as important elements39 consistent with the goals of the Perioperative Surgical Home. This AMA concept of medical futility has been subsequently summarized as follows: It is not within the authority of the members of the medical profession to invade the patient’s physical integrity by performing a futile intervention, nor is it within the powers of the patient…to oblige a doctor to do so. This holds, in particular, for medical procedures that amount to a violation of the principle of beneficence, involving the infliction of iatrogenic harm without the prospect of markedly improving the patient’s condition.40
Another approach to medical futility has emphasized better communication and negotiation.41,42 Complexity of patients’ medical comorbidities must be balanced with the patients’ values and preferences.41 The 4 essential actions of principled negotiation are then ideally applied, including in the surgical patient (Fig. 1).41,43
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Figure 1. The 4 essential actions of principled negotiation that can be applied to arrive at a negotiated surgical decision.41,43
Although the concept is quite controversial, qualitative futility is pertinent to the surgical patient. Qualitative futility refers to the scenario in which, even if technically successful, an intervention (e.g., a surgical procedure) may result in an outcome of insufficient or unacceptable functional status.42 Many elderly Americans undergo surgery in the year before their death. The rate varies regionally, suggesting discretion in clinicians’ decisions to intervene surgically at the end of life.44 Qualitative futility may be playing a role. Some 5% of patients seen in the preoperative assessment clinic of a tertiary care hospital died within 1 year of their procedure.45 Did these patients’ surgeries improve their remaining quality of life? Notably, in this same cohort of surgical patients, only 49% of these patients were aware of their planned intensive care unit admission, highlighting the need for better physician-patient communication.26 The Perioperative Surgical Home model is well suited to address this most challenging ethical issue. By reframing the futility of care of the surgical patient as resulting from inadequate physician-patient communication, Grant et al.42 have advocated methods of improving communication and strengthening the patient-physician relationship. To this end, a preoperative assessment clinic within a Perioperative Surgical Home can specifically facilitate determining surgical futility by providing the opportunity (a) to define futility for the patient and family, in terms of certain objective clinical criteria (e.g., the Model for End-Stage Liver Disease or MELD score46 and cancer prediction tools or prognostic nomograms from the Memorial Sloan Kettering Cancer Centerb) and subjective criteria (e.g., health-related quality of life) and (b) to foster communication and negotiation among the patient, family, and all clinicians, including the primary care physician, before the day of high-risk surgery.41,47 Delivering this communication as a scripted monologue will likely create professional animosity and patient confusion. The sensitive subject of surgical futility must be a dialogue that engages the patient, the family, and all caregivers. Patients must weigh the possibility of the futility of their proposed surgery against palliative and supportive care. A robust Perioperative Surgical Home can be an important Memorial Sloan Kettering Cancer Center: Prediction Tools—A Tool for Doctors and Patients. Available at: http://www.mskcc.org/nomograms. Accessed January 4, 2015.
b
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Ethical Opportunities with the Perioperative Surgical Home
mechanism for improving access to palliative and supportive care across the trajectory of disease, helping inform this decision. This will likely require a new, consistently effective mechanism for dialogue among surgeons, anesthesiologists, medical consultants, and primary care physicians. All physicians must learn that informing a patient that there is no effective medical intervention does not constitute a dereliction of professional duty (i.e., patient abandonment).
CONCLUSIONS
The Perioperative Surgical Home can be a disruptive innovation within a learning health care system. The Perioperative Surgical Home has the potential to address complex patient care–related ethics issues that have not been adequately addressed in present models of perioperative care. This ability to achieve significant changes represents an opportunity to expand the scope and contribution of anesthesiologists, working in close concert with our surgical, medical, and primary care colleagues. E DISCLOSURES
Name: Lee A. Goeddel, MD, MPH. Contribution: This author helped write the manuscript. Attestation: Lee A. Goeddel approved the final manuscript. Name: John R. Porterfield, Jr., MD, MSPH. Contribution: This author helped write the manuscript. Attestation: John R. Porterfield, Jr., approved the final manuscript. Name: Jason D. Hall, BA, BS, JD. Contribution: This author helped write the manuscript. Attestation: Jason D. Hall approved the final manuscript. Name: Thomas R. Vetter, MD, MPH. Contribution: This author helped write the manuscript. Attestation: Thomas R. Vetter approved the final manuscript. This manuscript was handled by: Steven L. Shafer, MD. REFERENCES 1. Smith M, Halvorson G, Kaplan G. What’s needed is a health care system that learns: recommendations from an IOM report. JAMA 2012;308:1637–8 2. Smith M, Saunders R, Stuckhardt L, McGinnis JM, Institute of Medicine. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington, DC: National Academies Press, 2013 3. Institute of Medicine Roundtable on Evidence-Based Medicine. Summary. In: Olsen L, Aisner D, McGinnis JM, eds. The Learning Healthcare System: Workshop Summary. Washington, DC: National Academies Press, 2007:1–36 4. Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep 2013;Spec No:S16–27 5. Grady C, Wendler D. Making the transition to a learning health care system. Commentary. Hastings Cent Rep 2013;Spec No:S32–3 6. Hwang J, Christensen CM. Disruptive innovation in health care delivery: a framework for business-model innovation. Health Aff (Millwood) 2008;27:1329–35 7. Christensen CM, Bohmer R, Kenagy J. Will disruptive innovations cure health care? Harv Bus Rev 2000;78:102–12, 199 8. Christensen CM, Grossman JH, Hwang J. The Role of Disruptive Technology and Business Model Innovation in Making Products and Services Affordable and Accessible the Innovator’s Prescription: A Disruptive Solution for Health Care. New York, NY: McGraw-Hill, 2009:1–36 9. Lee PV, Lansky D. Making space for disruption: putting patients at the center of health care. Health Aff (Millwood) 2008;27:1345–8
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10. Fiscella K. Health care reform and equity: promise, pitfalls, and prescriptions. Ann Fam Med 2011;9:78–84 11. Berwick DM. A user’s manual for the IOM’s “Quality Chasm” report. Health Aff (Millwood) 2002;21:80–90 12. Institute of Medicine, Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press, 2001 13. Alberti PM, Bonham AC, Kirch DG. Making equity a value in value-based health care. Acad Med 2013;88:1619–23 14. American Society of Anesthesiologists. Anesthesiology 2014 Opening Session: are you the anesthesiologist of the future? ASA Newsl 2014;78:32 15. Kain ZN, Hwang J, Warner MA. Disruptive innovation and the specialty of anesthesiology: the case for the perioperative surgical home. Anesth Analg 2015;120:1155–7 16. Christensen CM. Disruptive innovation: can health care learn from other industries? A conversation with Clayton M. Christensen. Interview by Mark D. Smith. Health Aff (Millwood) 2007;26:w288–95 17. Smith P. Justice, health, and the price of poverty. In: Battin MP, Rhodes R, Silvers A, eds. Medicine and Social Justice: Essays on the Distribution of Health Care. New York, NY: Oxford University Press, 2012:255–64 18. Berwick DM. What “patient-centered” should mean: confessions of an extremist. Health Aff (Millwood) 2009;28:w555–65 19. Neuman MD. Patient satisfaction and value in anesthesia care. Anesthesiology 2011;114:1019–20 20. Porter ME. What is value in health care? N Engl J Med 2010;363:2477–81 21. Vetter TR, Ivankova NV, Pittet JF. Patient satisfaction with anesthesia: beauty is in the eye of the consumer. Anesthesiology 2013;119:245–7 22. Epstein RM, Fiscella K, Lesser CS, Stange KC. Why the nation needs a policy push on patient-centered health care. Health Aff (Millwood) 2010;29:1489–95 23. Vetter TR, Goeddel LA, Boudreaux AM, Hunt TR, Jones KA, Pittet JF. The Perioperative Surgical Home: how can it make the case so everyone wins? BMC Anesthesiol 2013;13:6 24. Kon AA. The shared decision-making continuum. JAMA 2010;304:903–4 25. Barry MJ, Edgman-Levitan S. Shared decision making—pinnacle of patient-centered care. N Engl J Med 2012;366:780–1 26. Ankuda CK, Block SD, Cooper Z, Correll DJ, Hepner DL, Lasic M, Gawande AA, Bader AM. Measuring critical deficits in shared decision making before elective surgery. Patient Educ Couns 2014;94:328–33 27. Ratzan SC, Parker RM. Introduction. In: Selden CR, Zorn M, Ratzan SC, Parker RM, eds. National Library of Medicine Current Bibliographies in Medicine: Health Literacy. NLM Pub No CBM 2000–1. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services, 2000 28. Committee on Health Literacy, Board of Neuroscience and Behavioral Health, Institute of Medicine. What is health literacy? In: Nielsen-Bohlman L, Panzer AM, Kindig DA, eds. Health Literacy: A Prescription to End Confusion. Washington, DC: National Academies Press, 2004:31–58 29. Parker RM, Ratzan SC, Lurie N. Health literacy: a policy challenge for advancing high-quality health care. Health Aff (Millwood) 2003;22:147–53 30. Rudd RE. Improving Americans’ health literacy. N Engl J Med 2010;363:2283–5 31. Tsilimingras D, Bates DW. Addressing postdischarge adverse events: a neglected area. Jt Comm J Qual Patient Saf 2008;34:85–97 32. Peterson PN, Shetterly SM, Clarke CL, Bekelman DB, Chan PS, Allen LA, Matlock DD, Magid DJ, Masoudi FA. Health literacy and outcomes among patients with heart failure. JAMA 2011;305:1695–701 33. Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med 2011;155:97–107 34. Mitchell SE, Sadikova E, Jack BW, Paasche-Orlow MK. Health literacy and 30-day postdischarge hospital utilization. J Health Commun 2012;17(suppl 3):325–38
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E The Open Mind 35. Sheridan SL, Halpern DJ, Viera AJ, Berkman ND, Donahue KE, Crotty K. Interventions for individuals with low health literacy: a systematic review. J Health Commun 2011;16(suppl 3):30–54 36. Komenaka IK, Nodora JN, Machado L, Hsu CH, Klemens AE, Martinez ME, Bouton ME, Wilhelmson KL, Weiss BD. Health literacy assessment and patient satisfaction in surgical practice. Surgery 2014;155:374–83 37. Komenaka IK, Nodora JN, Machado L, Hsu CH, Klemens AE, Martinez ME, Bouton ME, Wilhelmson KL, Weiss BD. Health literacy assessment and patient satisfaction in surgical practice. Surgery 2014;155:374–83 38. Tsahakis JM, Issar NM, Kadakia RJ, Archer KR, Barzyk T, Mir HR. Health literacy in an orthopaedic trauma patient population: improving patient comprehension with informational intervention. J Orthop Trauma 2014;28:e75–9 3 9. Council on Ethical Judicial Affairs American Medical Association. Medical futility in end-of-life care: report of the council on ethical and judicial affairs. JAMA 1999;281:937–41 40. Moratti S. The development of “medical futility”: towards a procedural approach based on the role of the medical profession. J Med Ethics 2009;35:369–72
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41. Burns JP, Truog RD. Futility: a concept in evolution. Chest 2007;132:1987–93 42. Grant SB, Modi PK, Singer EA. Futility and the care of surgical patients: ethical dilemmas. World J Surg 2014;38:1631–7 43. Fisher R, Ury W, Patton B. The Method Getting to Yes: Negotiating Agreement Without Giving In. 2nd ed. Boston, MA: Houghton Mifflin Harcourt, 1992:15–94 44. Kwok AC, Semel ME, Lipsitz SR, Bader AM, Barnato AE, Gawande AA, Jha AK. The intensity and variation of surgical care at the end of life: a retrospective cohort study. Lancet 2011;378:1408–13 45. Barnet CS, Arriaga AF, Hepner DL, Correll DJ, Gawande AA, Bader AM. Surgery at the end of life: a pilot study comparing decedents and survivors at a tertiary care center. Anesthesiology 2013;119:796–801 46. Kamath PS, Wiesner RH, Malinchoc M, Kremers W, Therneau TM, Kosberg CL, D’Amico G, Dickson ER, Kim WR. A model to predict survival in patients with end-stage liver disease. Hepatology 2001;33:464–70 47. Cooper Z, Corso K, Bernacki R, Bader A, Gawande A, Block S. Conversations about treatment preferences before high-risk surgery: a pilot study in the preoperative testing center. J Palliat Med 2014;17:701–7
anesthesia & analgesia
CME
Ethical Opportunities with the Perioperative Surgical Home: Disruptive Innovation, Patient-Centered Care, Shared Decision Making, Health Literacy, and Futility of Care Lee A. Goeddel, MD, MPH, John R. Porterfield, Jr., MD, MSPH, Jason D. Hall, BA, BS, JD, and Thomas R. Vetter, MD, MPH
T
here has been a major impetus for American health care to adopt learning health care systems1,2 “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the health care delivery process and leads to continual improvement in care.”3 The American Society of Anesthesiologists Perioperative Surgical Home Learning Collaborativea is fostering such learning health care systems. An ethics framework for such learning health care systems has been proposed to assess the ethical utility of their activities (Table 1).4,5 In this Open Mind article, we will first assert that, to be a disruptive innovation, the Perioperative Surgical Home should increase health care equity by expanding patient access to high-quality perioperative care. We will then focus on 4 other ethical opportunities. To fulfill the ethical tenets of a learning health care system (Table 1)4,5 and to be of greatest added value to the surgical population, this novel health care model must: (a) enhance patient-centered care, (b) embrace shared decision making, (c) increase health literacy, and (d) reduce futile surgery. Each of these represents a potential opportunity that must be validated with rigorous interdisciplinary health services research.
THE PERIOPERATIVE SURGICAL HOME AS A DISRUPTIVE INNOVATION
A sustaining innovation results in novel products and services that can be sold for higher profits to the best customers of the industry. A sustaining innovation does not create new markets but evolves existing ones, allowing firms to compete successfully in the existing market. Its value to society is limited to those who can access it.
From the Department of Anesthesiology, University of Alabama at Birmingham, Birmingham, Alabama. Accepted for publication January 30, 2015. Funding: University of Alabama Department of Anesthesiology internal funds. The authors declare no conflicts of interest. Reprints will not be available from the authors. Address correspondence to Thomas R. Vetter, MD, MPH, Department of Anesthesiology, University of Alabama at Birmingham, JT 862, 619 19th St. S., Birmingham, AL 35249. Address e-mail to [email protected]. Copyright © 2015 International Anesthesia Research Society DOI: 10.1213/ANE.0000000000000700
1158 www.anesthesia-analgesia.org
Innovations in health care have predominantly sustained a system fraught with inaccessibility, inefficiency, and excess costs.6–8 As defined by Christensen et al.,6–8 a disruptive innovation also creates new products and services, but ones that are less expensive, simpler, more convenient, and more accessible. By creating a new market, a disruptive innovation eventually displaces the existing market. It also enables participation of a new set of customers previously ignored or shut out by the existing market. However, it should be noted that Christensen et al.’s theory of disruptive innovation is based largely on case examples and is applied retrospectively. In 2000, Christensen et al.7 asked: “Will disruptive innovation cure health care?” Unfortunately, health care has remained expensive and inaccessible to many Americans.6,8 Disruptive innovation can improve health care, but only if it first disrupts an existing system in which “pharmaceutical companies, hospitals, physicians, device manufacturers, and insurers are able to ensure their financial health [prosperity] over patients’ financial or physical well-being.”9 Equitable health care requires the creation of patient-centered systems, systems responsive to a patient’s individual wishes and circumstances. Improving health care equity requires reallocation of resources and better alignment of capabilities with patients’ needs, particularly for patients who have been historically underserved.10 In its 2001 “Crossing the Quality Chasm,” the Institute of Medicine called for improvements in 6 dimensions of health care performance, including greater equity.11,12 In the interim, inequity in health and health care in the United States continues to be the norm.13 Recent health care reforms, including the Patient Protection and Affordable Care Act of 2010, offer an opportunity to create a more equitable American health care system. Specifically, financial incentives and penalties that make equity an element of value within a value-based health care model, including for surgical and anesthetic care, will reduce health care disparities and move the nation toward greater equity in health care.13 a American Society of Anesthesiologists: Perioperative Surgical Home Learning Collaborative. Available at: http://www.asahq.org/. Accessed December 16, 2014.
May 2015 • Volume 120 • Number 5
Ethical Opportunities with the Perioperative Surgical Home
Table 1. Learning Health Care System Ethics Framework Applicable to the Perioperative Surgical Home4,5 Ethical obligation Respect the rights and dignity of patients, family members, loved ones, and patient surrogates Respect clinicians’ judgments Provide optimal clinical care to each patient Avoid imposing nonclinical risks and burdens on patients Address and reduce unjust health inequalities Conduct continuous learning activities that improve the quality of clinical care and health care systems Contribute to the common purpose of improving the quality and value of clinical care health care systems
The nascent Perioperative Surgical Home model has been labeled by its innovators and early adopters as a disruptive innovation that creates disruptive alliances and transformative integrated care.14,15 However, to be a truly successful disruptive innovation, any variant of the Perioperative Surgical Home will need to provide perioperative care more simply, more accessibly, at lower cost, and thus within reach of more patients.16 One possible mechanism to achieve these goals with the Perioperative Surgical Home is by improving operational efficiency, thereby increasing operational margins. Greater efficiency would expand resource availability for patients who are currently underserved. Greater health care equity will thus result from the attendant broader and more equal patient access to high-quality perioperative care. This is especially critical among currently underserved and vulnerable racial and ethnic minorities, as well as individuals with lower socioeconomic status, who suffer poorer health outcomes because of chronic diseases and higher allcause mortality.13,17
ENHANCING PATIENT-CENTERED CARE
Berwick18 defined patient-centered care as “the experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.” Patient centeredness is manifested in the understanding that health care value, including for surgical and anesthetic services, is most validly assessed from the patient’s perspective.19–21 Patient-centered care is not simply capitulating to patients’ requests. Patient-centered health care is not a smorgasbord, offering patients what they want, when they want it, regardless of value or cost. Patient-centered care is not throwing information at patients and leaving them to sort it out on their own.22 Patient-centered care is teamwork by clinicians and patients, building healing relationships, and grounded in communication and trust among clinicians, patients, and patients’ families.22 Such teamwork and healing relationships are mandatory to achieve the potential benefits of the Perioperative Surgical Home. They are manifested in the Perioperative Surgical Home by robust patient education, engagement, and empowerment to expect surgical and anesthetic care that fulfills their individual needs, wishes, and context throughout the preoperative, intraoperative, and postoperative periods.23 If the Perioperative Surgical Home can
May 2015 • Volume 120 • Number 5
enhance culturally sensitive patient-centered care, particularly among racial and ethnic minorities and individuals with lower socioeconomic status, this health care model will legitimately be a disruptive innovation that reduces health care disparities and increases health care equity.
EMBRACING SHARED DECISION MAKING
Shared decision making makes health care more patient centered. Shared decision making is a continuum.24 When a difficult medical decision needs be made, at their discretion, patients are encouraged to include friends, family, and other health care providers in examining how the outcomes of a particular medical or surgical decision align with the patient’s culture, values, and preferences.25 A recent study of the quality of informed consent found that, before major surgery, 13% of patients could not recall the procedure to be performed, its indications, risks, or alternatives.26 More striking, 33% of patients reported that the decision to proceed with surgery did not address their preferences, values, or goals. Populations at significant risk for concerns about fully informed consent were those speaking a different language and with lower educational levels, indicating a need for targeted interventions in these groups. Addressing this deficiency in current practice, the Perioperative Surgical Home can foster communication among patients, their chosen confidants, and their clinicians to improve decision quality. The requisite preoperative assessment in the Perioperative Surgical Home is the appropriate venue to inform the patient and family about their clinicians’ professional opinions and consensus on the advisability of the planned procedure. Additionally, the creation and implementation of best practice informed consent can specifically address the needs of patient groups who are not adequately served by existing ad hoc informed consent processes. Shared perioperative decision making is not intended to supplant the surgeon’s pivotal acumen, judgment, and role. It is also not intended to supplement the expert assessment of the anesthesiologist advising the patient before surgery and then preparing the patient for surgery. However, the Perioperative Surgical Home can facilitate a more consistently open communication among multiple providers to generate a clear clinical summary for the decision makers (patients, family members, and all clinicians). This clinical summary includes the necessity of the procedure, potential benefits, implications of possible complications, and clinicians’ recommendations for preoperative health optimization.
OPTIMIZING HEALTH LITERACY
Health literacy is “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”27,28 Health literacy is a requirement for perioperative patient-centered care and shared decision making. Many Americans with the greatest health care needs have the least ability to comprehend the information required to navigate the United States health care system.29 Increasing health literacy requires an investment by patients, health care professionals, and health systems.30
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E The Open Mind Inadequate health literacy has been associated with greater hospital utilization, poorer health status, and increased mortality.28,31–33 In 1 study, low health literacy was a significant, independent, and modifiable risk factor for hospital reutilization (readmission or return to the emergency department) during the 30 days after discharge.34 Improved health literacy has reduced chronic disease severity, decreased emergency department visits and hospitalizations, and improved patient satisfaction.35,36 In a recent study of 2026 general surgery patients in an urban setting in the United States, who had a mean of 10 years of education, only 19% possessed adequate health literacy.36 Lower health literacy is more common in individuals living below the poverty line, of an ethnic or cultural minority, living in the southern or western regions of the United States, with less than a high school education, or above the age of 65 years.28 Health care providers should take every opportunity to improve the public’s general literacy. This includes examining and modifying their own activities, assumptions, and environments to remove health literacy–related barriers that hinder access to information, navigation of services, and decision making.30 As a consistent nexus of the surgeon, anesthesiologist, medical consultants, and primary care physician, the Perioperative Surgical Home is an ideal opportunity to evaluate a surgical patient’s health literacy by using tools previously validated in the surgical population.37 Application of these tools can optimize health care literacy in the surgical population.38 This is especially important in those patients at greater risk of inadequate health literacy and poor decision quality.35 The Perioperative Surgical Home could also mitigate postdischarge events (e.g., patient medication errors, patient noncompliance with discharge instructions, and 30-day readmissions), decrease decisional regret, and possibly lessen the burden of malpractice litigation.36
AVOIDING FUTILE SURGERY
In 1999, the American Medical Association (AMA) recommended a process-based approach to determining medical futility, allowing institutions to circumvent an externally determined definition of futility and instead to apply a local case-by-case definition. This AMA framework incorporated patient centeredness and shared decision making as important elements39 consistent with the goals of the Perioperative Surgical Home. This AMA concept of medical futility has been subsequently summarized as follows: It is not within the authority of the members of the medical profession to invade the patient’s physical integrity by performing a futile intervention, nor is it within the powers of the patient…to oblige a doctor to do so. This holds, in particular, for medical procedures that amount to a violation of the principle of beneficence, involving the infliction of iatrogenic harm without the prospect of markedly improving the patient’s condition.40
Another approach to medical futility has emphasized better communication and negotiation.41,42 Complexity of patients’ medical comorbidities must be balanced with the patients’ values and preferences.41 The 4 essential actions of principled negotiation are then ideally applied, including in the surgical patient (Fig. 1).41,43
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Figure 1. The 4 essential actions of principled negotiation that can be applied to arrive at a negotiated surgical decision.41,43
Although the concept is quite controversial, qualitative futility is pertinent to the surgical patient. Qualitative futility refers to the scenario in which, even if technically successful, an intervention (e.g., a surgical procedure) may result in an outcome of insufficient or unacceptable functional status.42 Many elderly Americans undergo surgery in the year before their death. The rate varies regionally, suggesting discretion in clinicians’ decisions to intervene surgically at the end of life.44 Qualitative futility may be playing a role. Some 5% of patients seen in the preoperative assessment clinic of a tertiary care hospital died within 1 year of their procedure.45 Did these patients’ surgeries improve their remaining quality of life? Notably, in this same cohort of surgical patients, only 49% of these patients were aware of their planned intensive care unit admission, highlighting the need for better physician-patient communication.26 The Perioperative Surgical Home model is well suited to address this most challenging ethical issue. By reframing the futility of care of the surgical patient as resulting from inadequate physician-patient communication, Grant et al.42 have advocated methods of improving communication and strengthening the patient-physician relationship. To this end, a preoperative assessment clinic within a Perioperative Surgical Home can specifically facilitate determining surgical futility by providing the opportunity (a) to define futility for the patient and family, in terms of certain objective clinical criteria (e.g., the Model for End-Stage Liver Disease or MELD score46 and cancer prediction tools or prognostic nomograms from the Memorial Sloan Kettering Cancer Centerb) and subjective criteria (e.g., health-related quality of life) and (b) to foster communication and negotiation among the patient, family, and all clinicians, including the primary care physician, before the day of high-risk surgery.41,47 Delivering this communication as a scripted monologue will likely create professional animosity and patient confusion. The sensitive subject of surgical futility must be a dialogue that engages the patient, the family, and all caregivers. Patients must weigh the possibility of the futility of their proposed surgery against palliative and supportive care. A robust Perioperative Surgical Home can be an important Memorial Sloan Kettering Cancer Center: Prediction Tools—A Tool for Doctors and Patients. Available at: http://www.mskcc.org/nomograms. Accessed January 4, 2015.
b
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mechanism for improving access to palliative and supportive care across the trajectory of disease, helping inform this decision. This will likely require a new, consistently effective mechanism for dialogue among surgeons, anesthesiologists, medical consultants, and primary care physicians. All physicians must learn that informing a patient that there is no effective medical intervention does not constitute a dereliction of professional duty (i.e., patient abandonment).
CONCLUSIONS
The Perioperative Surgical Home can be a disruptive innovation within a learning health care system. The Perioperative Surgical Home has the potential to address complex patient care–related ethics issues that have not been adequately addressed in present models of perioperative care. This ability to achieve significant changes represents an opportunity to expand the scope and contribution of anesthesiologists, working in close concert with our surgical, medical, and primary care colleagues. E DISCLOSURES
Name: Lee A. Goeddel, MD, MPH. Contribution: This author helped write the manuscript. Attestation: Lee A. Goeddel approved the final manuscript. Name: John R. Porterfield, Jr., MD, MSPH. Contribution: This author helped write the manuscript. Attestation: John R. Porterfield, Jr., approved the final manuscript. Name: Jason D. Hall, BA, BS, JD. Contribution: This author helped write the manuscript. Attestation: Jason D. Hall approved the final manuscript. Name: Thomas R. Vetter, MD, MPH. Contribution: This author helped write the manuscript. Attestation: Thomas R. Vetter approved the final manuscript. This manuscript was handled by: Steven L. Shafer, MD. REFERENCES 1. Smith M, Halvorson G, Kaplan G. What’s needed is a health care system that learns: recommendations from an IOM report. JAMA 2012;308:1637–8 2. Smith M, Saunders R, Stuckhardt L, McGinnis JM, Institute of Medicine. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington, DC: National Academies Press, 2013 3. Institute of Medicine Roundtable on Evidence-Based Medicine. Summary. In: Olsen L, Aisner D, McGinnis JM, eds. The Learning Healthcare System: Workshop Summary. Washington, DC: National Academies Press, 2007:1–36 4. Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep 2013;Spec No:S16–27 5. Grady C, Wendler D. Making the transition to a learning health care system. Commentary. Hastings Cent Rep 2013;Spec No:S32–3 6. Hwang J, Christensen CM. Disruptive innovation in health care delivery: a framework for business-model innovation. Health Aff (Millwood) 2008;27:1329–35 7. Christensen CM, Bohmer R, Kenagy J. Will disruptive innovations cure health care? Harv Bus Rev 2000;78:102–12, 199 8. Christensen CM, Grossman JH, Hwang J. The Role of Disruptive Technology and Business Model Innovation in Making Products and Services Affordable and Accessible the Innovator’s Prescription: A Disruptive Solution for Health Care. New York, NY: McGraw-Hill, 2009:1–36 9. Lee PV, Lansky D. Making space for disruption: putting patients at the center of health care. Health Aff (Millwood) 2008;27:1345–8
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