Outcomes research is the fifth discipline of the fifth generation of managed care: utility of a single troponin-T.
OBJECTIVE: The fifth generation of managed care is disease management. Diseases have measurable risk in providing laboratory and medical services. The link between managing services and managing risk can be aided by leveraging the laboratory. We wish to remodel laboratory services to fit the needs of the use, thereby using the laboratory for competitive advantage by redesigning a desired output using a formal structured process. Outcomes research is the systems framework for the remodeling process through the link of laboratory output to clinical and financial outcomes. A process redesign model connects the use of laboratory tests to improved medical services by leveraging resources to achieve measurable improvement over current results. This view of outcomes research seeks both competitive advantage and measurable improvements in quality. METHODOLOGY: This approach is illustrated by the patient presenting with chest pain (CP). A majority of the patients rule out for acute myocardial infarction (AMI), including patients with indigestion, shortness of breath, and other clinical findings. This is the basis for an emergency department (ED) CP observation unit to reduce coronary care unit admission rates. When the Goldman algorithm for discharging low-risk patients with CP from the ED using only clinical features and electrocardiographic findings proved difficult to implement, we turned to measuring the diagnostic efficiency of a new cardiac marker to replace the evolutionary changes in creatine kinase (CK) isoenzyme MB. The physicians making the decision were blinded to the results of the study. We fitted the expected characteristics of the test to the expected results for our program. The test was done on the presenting specimen of 293 evaluable patients with a median of 6.5 hours from the time of onset of CP to the time the specimen was drawn. The result was compared with the evolutionary pattern of CK-MB. RESULTS: The sensitivity of the test at presentation to the ED was 85% compared with < 50% for the presenting CK-MB, the false negative results taken earlier than 3 hours or 10 days after the onset of symptoms. Troponin-T effectively identifies non Q-wave AMI much earlier than the CK-MB. This study led to a prospective randomized clinical trial to demonstrate an improved medical and financial benefit from an early rule in or rule out of severe coronary artery ischemia. CONCLUSION: The study supports our hypothesis that the laboratory can systematically redesign its technology strategy and participate in the construction of a clinical pathway for the discharge from ED or admitting decisions with a test 98% sensitive for identifying patients with serious coronary ischemia by 3.5 hours after the onset of symptoms.