title: Improving the process of informed consent for percutaneous coronary intervention: patient outcomes from the Patient Risk Information Services Manager (ePRISM) study.
abstract: BACKGROUND
  While the process of informed consent is designed to transfer knowledge of the risks and benefits of treatment and to engage patients in shared medical decision-making, this is poorly done in routine clinical care. We assessed the impact of a novel informed consent form for percutaneous coronary intervention (PCI) that is more simply written, includes images of the procedure, and embeds individualized estimates of outcomes on multiple domains of successful informed consent and shared decision-making.
  
  
  METHODS
  We interviewed 590 PCI patients receiving traditional consent documents and 527 patients receiving novel ePRISM consents at 9 US centers and compared patients' perceptions, knowledge transfer, and engagement in medical decision-making. Heterogeneity across sites was assessed and adjusted for using hierarchical models.
  
  
  RESULTS
  Site-adjusted analyses revealed more frequent review (72% for ePRISM vs 45% for original consents) and better understanding of the ePRISM consents (ORs=1.8-3.0, depending upon the outcome) with marked heterogeneity across sites (median relative difference [MRD] in the ORs of ePRISM's effect =2-3.2). Patients receiving ePRISM consents better understood the purposes and risks of the procedure (ORs=1.9-3.9, MRDs=1.1-6.2), engaged more in shared decision-making (proportional OR=2.1 [95% CI=1.02-4.4], MRD=2.2) and discussed stent options with their physicians (58% vs. 31%; site-adjusted odds ratio=2.7 [95% CI=1.2, 6.3], MRD=2.6) more often.
  
  
  CONCLUSIONS
  A personalized consent document improved the process of informed consent and shared decision-making. Marked heterogeneity across hospitals highlights that consent documents are but one aspect of engaging patients in understanding and participating in treatment.
authors: Saint Luke's Mid America Heart Institute/University of Missouri - Kansas City, Kansas City, MO. Electronic address: spertusj@umkc.edu.
authors: John A
authors: JA
authors: Spertus
authors: Washington University, Saint Louis, MO.
authors: Richard
authors: R
authors: Bach
authors: Integris Hospital, Oklahoma, OK.
authors: Charles
authors: C
authors: Bethea
authors: Saint Luke's Mid America Heart Institute/University of Missouri - Kansas City, Kansas City, MO.
authors: Adnan
authors: A
authors: Chhatriwalla
authors: Yale University, New Haven, CT.
authors: Jeptha P
authors: JP
authors: Curtis
authors: Saint Luke's Mid America Heart Institute/University of Missouri - Kansas City, Kansas City, MO.
authors: Elizabeth
authors: E
authors: Gialde
authors: Henry Ford Hospital, Detroit, MI.
authors: Mayra
authors: M
authors: Guerrero
authors: Saint Luke's Mid America Heart Institute/University of Missouri - Kansas City, Kansas City, MO.
authors: Kensey
authors: K
authors: Gosch
authors: Saint Luke's Mid America Heart Institute/University of Missouri - Kansas City, Kansas City, MO.
authors: Philip G
authors: PG
authors: Jones
authors: Baystate Medical Center, Springfield, MA.
authors: Aaron
authors: A
authors: Kugelmass
authors: The Heart Hospital at Baylor, Plano, TX.
authors: Bradley M
authors: BM
authors: Leonard
authors: Kaiser Hospital, San Francisco, CA.
authors: Edward J
authors: EJ
authors: McNulty
authors: St. John's Hospital, Springfield, IL.
authors: Marc
authors: M
authors: Shelton
authors: Mayo Clinic, Rochester, MN.
authors: Henry H
authors: HH
authors: Ting
authors: Saint Luke's Mid America Heart Institute/University of Missouri - Kansas City, Kansas City, MO.
authors: Carole
authors: C
authors: Decker
mesh_terms: D000368:Aged; D003327:Coronary Disease / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D003657:Decision Making; D005260:Female; D006801:Humans; D058980:Information Literacy; D007255:Information Services; D007258:Informed Consent / Q000592:standards*; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D062526:Patient Navigation / Q000379:methods / Q000592:standards; D010358:Patient Participation / Q000379:methods / Q000523:psychology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods; D058996:Quality Improvement; D018570:Risk Assessment / Q000379:methods; D012963:Sociometric Techniques
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