Does Patient-Centered Care Mean that Informed Consent is Necessary for Clinical Performance Measures?

There is great enthusiasm for new models for health systems that may promote patient-centered decision making, such as patient-centered medical homes.1 The purpose of patient-centered decision making is to allow each patient to make an informed decision, taking into account their preferences while knowing potential harms and benefits; it is an important facet of patient-centered care.2 However, at the same time as patient-centered care is being pursued, clinical performance measures are proliferating (for example, requiring diabetics to have hemoglobin A1Cs ≤ 7).3 Whereas patient-centered care seeks to tailor decisions based on the harms and benefits for individual patients, and how individual patients value those harms and benefits, performance measures seek to standardize care, therefore pushing in the opposite direction. Clinical performance measures serve the vital function of extending the reach of evidence-based interventions that provide clinical benefit. Given the vast reservoir of preventable morbidity and mortality in the United States, clinical performance measures are also crucial for healthcare systems, even though they may occasionally conflict with patient-centered care. How can patient-centered care coexist with clinical performance measures? One approach would be to identify patients with preferences that conflict with a particular clinical performance measure. Such patients would have the option of declining to meet the performance measure, which would remove them from the “denominator” when achieving that performance measure is calculated. It may be noted that if clinical performance measures were constructed to exclude patients who refuse to participate or who are otherwise ‘nonstandard’ (e.g., unusual preferences), this could make them unsuitable candidates for any formal consent process. However, clinical performance measures are generally not constructed or implemented with explicit consideration of nonstandard patients. Consider a typical patient for whom the non-health benefit from declining a performance measure may exceed the health benefit from assenting to that performance measure: a diabetic with a short life expectancy due to multiple chronic diseases, who is well-informed about potential diabetes complications and the importance of complying with the diabetes performance measures (e.g. obtaining a hemoglobin A1C below 7), yet values these health benefits less than the non-health benefits of avoiding the logistical hassles of additional medications and needle sticks. This patient should have the option of refusing to consent to the diabetes performance measure, and to have this refusal documented through an informed consent procedure. Then that patient would be removed from the denominator when that measure is calculated. Patient-centered decisions to ignore performance standards would then not “count against” the physician or the health system by lowering their grades on the particular performance measure. Additionally, requiring a formal “opt-out” process would guard against practitioners “gaming” the system by simply removing all nonadherent patients from their assessments. Of course, competent patients always have the option of declining care. But given that some clinical environments pursue clinical performance measure targets with sufficient zeal so as to nearly constitute a coercive environment, practitioners facing such pressures are less likely to engage in a shared decision involving communication of harms and benefits.