title: Implementing an innovative consent form: the PREDICT experience.
abstract: BACKGROUND
  In the setting of coronary angiography, generic consent forms permit highly variable communication between patients and physicians. Even with the existence of multiple risk models, clinicians have been unable to readily access them and thus provide patients with vague estimations regarding risks of the procedure.
  
  
  METHODS
  We created a web-based vehicle, PREDICT, for embedding patient-specific estimates of risk from validated multivariable models into individualized consent documents at the point-of-care. Beginning August 2006, outpatients undergoing coronary angiography at the Mid America Heart Institute received individualized consent documents generated by PREDICT. In February 2007 this approach was expanded to all patients undergoing coronary angiography within the four Kansas City hospitals of the Saint Luke's Health System. Qualitative research methods were used to identify the implementation challenges and successes with incorporating PREDICT-enhanced consent documents into routine clinical care from multiple perspectives: administration, information systems, nurses, physicians, and patients.
  
  
  RESULTS
  Most clinicians found usefulness in the tool (providing clarity and educational value for patients) and satisfaction with the altered processes of care, although a few cardiologists cited delayed patient flow and excessive patient questions. The responses from administration and patients were uniformly positive. The key barrier was related to informatics.
  
  
  CONCLUSIONS
  This preliminary experience suggests that successful change in clinical processes and organizational culture can be accomplished through multidisciplinary collaboration. A randomized trial of PREDICT consent, leveraging the accumulated knowledge from this first experience, is needed to further evaluate its impact on medical decision-making, patient compliance, and clinical outcomes.
authors.affiliation: Saint Luke's Mid America Heart Institute, 4401 Wornall Rd, Kansas City, MO 64111, USA. c1decker@saint-lukes.org
authors.forename: Carole
authors.initials: C
authors.lastname: Decker
authors.forename: Suzanne V
authors.initials: SV
authors.lastname: Arnold
authors.forename: Olawale
authors.initials: O
authors.lastname: Olabiyi
authors.forename: Homaa
authors.initials: H
authors.lastname: Ahmad
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Gialde
authors.forename: Jamie
authors.initials: J
authors.lastname: Luark
authors.forename: Lisa
authors.initials: L
authors.lastname: Riggs
authors.forename: Terry
authors.initials: T
authors.lastname: DeJaynes
authors.forename: Gabriel E
authors.initials: GE
authors.lastname: Soto
authors.forename: John A
authors.initials: JA
authors.lastname: Spertus