In 2006, John A. Spertus, MD, and his colleagues at the Mid America Heart Institute of Saint Luke’s Hospital in St. Louis, engineered a web-based tool—PREDICT (Patient Refined Expectations for Deciding Invasive Cardiac Treatments)—to scientifically enhance the informed consent process and provide better procedural outcome transparency to patients.
With help of a grant provided by the National Institutes of Health and the American Heart Association, a pilot program using the web-based tool has expanded from Saint Luke’s to other cardiac care hospitals in the U.S. including the Mayo Clinic in Rochester, Minn., the Yale-New Haven Hospital in New Haven, Conn., the Henry Ford Clinic in Detroit and six other facilities.
“To date, hundreds of patients at Saint Luke’s undergoing planned procedures have reviewed and signed the easy-to-visualize, graphically formatted consent form prior to their procedures,” said Saint Luke’s.
Additionally, the PREDICT tool is the first consent form involved in the process of care continuum and was developed to provide patients a better picture of their own projected outcomes during surgery.
“In the rapidly changing world of cardiovascular medicine, physicians face an increasingly complex array of information about possible survival rates, risk factors and future outcomes for certain heart patients,” said Spertus. “Although new data to individually estimate the risks and benefits of treatment are available, the usual informed consent process remains vague and anecdotal.”
According to Saint Luke’s, the PREDICT tool, using data from American College of Cardiology’s National Cardiovascular Data Registry, generates a tailored consent form to show the risk of potential complications—mortality, bleeding and restenosis—during cardiac surgery.
In 2008, a trial performed by Spertus and colleagues compared 335 patients undergoing nonemergent cardiac catheterization who received either standard consent forms (142 patients) or PREDICT consent forms (193 patients) (Circ Cardiovasc Qual Outcomes:2008;1:21-28).
The researchers compared patient experience with informed consent prior to and post-PREDICT. The results showed that 72 percent of patients in the PREDICT group read their consent forms compared to only 44 percent in the standard consent group.
Additionally, 85 percent of patients in the PREDICT patient consent group said that they were informed of the risk of complication and adverse events during surgery compared to 62 percent in the standard consent form group.
“Individualized consent forms with patient-specific risks were associated with improved participation in the consent process, reduced anxiety and better risk recall,” the authors wrote.
While use of the PREDICT tool is still in the pilot phase, Spertus said that “the chasm between available evidence to transparently share patients’ unique profile of risk and the way current medicine is practiced is huge.”