American Heart Association Late-Breaking Clinical Trial Report

American Heart Association Late-Breaking Clinical Trial Report

Custom consent forms help patients better understand heart procedures

ORLANDO, FLA., Nov. 14, 2011 ¯ Patients who received personalized, easy-to-understand consent forms before angioplasty or stent implantation better understood the procedure, the potential risks of treatment and were more engaged in shared decision-making with their doctors, according to late-breaking research presented at the American Heart Association’s Scientific Sessions 2011.

      In the study, patients at nine treatment centers got either a personalized Patient Risk Information Services Manager (PRISM) consent form or standard consent forms before undergoing procedures to open blocked heart arteries.

      The PRISM form, which is generated through a Web-based tool, allows doctors to input patients’ specific health information and to execute complex prediction models that generate each patient’s individualized risks and benefits of treatment. These results were imbedded into a consent form that included educational pictures of the procedure. It was written at an 8^th or 9^th grade reading level, in contrast to typical hospital forms that are often written in legal language and above the college reading level. Standard informed consent forms are usually generic and don’t contain customized information about risks based on patients’ individual clinical characteristics.

      “The current consent process is terribly flawed in that it does not educate patients effectively about their procedures,” said John A. Spertus, M.D., M.P.H., the study’s lead researcher and chair and professor at the University of Missouri, in Kansas City. “Nor does it support shared medical decision-making.”

      Compared to the 590 patients using standard consent forms, the 527 patients using the PRISM forms were more likely to:

• Read the form (72 percent vs. 45 percent) and understand it (52 percent vs. 31 percent).
• Feel that treatment descriptions (49 percent vs. 25 percent) and complications (50 percent vs. 27 percent) were clear.
• Feel less nervous about the procedure (77 percent vs. 62 percent).
• Know there was a risk of death (66 percent vs. 36 percent) and bleeding (61 percent vs. 31 percent) from the procedure.
• Discuss stent options with their doctor (58 percent vs. 31 percent).

      Those using the PRISM form were also less likely (52 percent vs. 72 percent) to feel that the doctor alone determined which type of stent ¯ drug eluting or bare metal ¯ was used in their procedure.

      “In an era of increasing calls for personalized medicine, this is an important opportunity to advance that principle by sharing with each patient their expected risks and benefits from treatment,” said Spertus, clinical director of Outcomes Research at Saint Luke’s Mid America Heart Institute.

Importantly, the results varied by site, suggesting that some hospitals took better advantage of the forms than others, Spertus said.

      More research is needed as to whether patients who actively shared in making decisions are more likely to adhere to recommended therapies or have better long-term outcomes, he said.

Co-authors are Richard Bach, M.D.; Charles Bethea, M.D.; Adnan Chhatriwalla, M.D.; Jeptha Curtis, M.D.; Elizabeth Gialde, R.N.; Mayra Guerrero, M.D.; Kensey Gosch, M.S.; Philip Jones, M.S.; Aaron Kugelmass. M.D.; Bradley Leonard, M.D.; Edward McNulty, M.D.; Marc Shelton, M.D.; Henry Ting, M.D., M.B.A.; and Carole Decker, R.N., Ph.D.