Marriage of Professional and Technical Tasks: A Strategy to Improve Informed Consent Susan Steinemann, MD, Daniel Furoy, BA, Frederick Yost, MD, Nancy Furumoto, MD, Geoffrey Lam, BS, Kenric Murayama, MD University of Hawaii John A. Burns School of Medicine Department of Surgery Honolulu, Hawaii

Informed Consent  “Every human being of adult years and sound mind has a right to determine what shall be done with his own body and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damage.”  1914 – Judge Cardozo  1957 – term first used  Key element of the doctor-patient relationship  Law of Battery – precursor of the current legal doctrine of informed consent Sprung, et al. Crit Care Med 1989

Informed Consent  Mechanism by which individual autonomy is exercised in the context of medical therapy  Process of obtaining informed consent  Improves patient satisfaction  Improves health outcomes  Increases compliance with treatment recommendations Davis, et al. JAMA 2003

Informed Consent  In order to give informed consent, patients must  Have sufficient information to make an informed decision  Including risks, benefits, & alternatives  Be competent to give consent  Be aware of the right to refuse therapy  Voluntarily agree to the procedure Angelos, et al. Curr Surg 2002

Informed Consent  Angelos, et al (Curr Surg 2002)  PGY-1 residents  Have inadequate knowledge to adequately communicate information about surgical risks, benefits, and alternatives  Could NOT correctly answer most questions posed by patients about the procedure

Informed Consent  ASE 2002, April 2004 (Steinemann, et al.)  Resident didactic program focusing solely on informed consent in the ICU  Significantly increased the knowledge and confidence of residents and medical students regarding informed consent  Did NOT improve the informed consent rate for invasive ICU procedures

Cognitive Task Analysis  CTA course on central line insertion improves knowledge and technical skill Traditional Group Course Group P -value Total Score (14-items) <0.001 # attempts to ID vein # attempts to insertion Time (min) to complete Velmahos, et al. Am J Surg 2004

Hypothesis The rate that surgical residents obtained informed consent for invasive bedside ICU procedures would be increased by adding education about informed consent to a cognitive task analysis curriculum developed to teach these bedside procedures.

Methods  Cognitive Task Analysis development  Identify key technical and professional steps (2 trauma/CC surgeons)  Central venous catheterization  Arterial catheterization  Tube thoracostomy  Steps refined by panel of CC surgeons  8-12 “key steps” for each procedure  Informed Consent – 1 st key step for each procedure

Methods  Curriculum  PGY-1 asked to list key steps for procedures  2 hr workshop – technical, cognitive, professional components of each procedure  Post-training  List key steps from memory  Assessment by faculty on procedure  Prohibition of independent performance until after demonstration of competency professionally, cognitively, and technically

Methods  Sept ‘04 – Feb ’05  PGY-1 surgical residents  CTA re: informed consent  Properly identified as key step or not  Pre-CTA versus post-CTA  Performance  Consent obtained or not  Post-CTA versus historical controls  Fisher’s Exact Test  Significance at P < 0.05

Results  9 PGY-1 surgical residents  Informed consent listed as key step Listed consent Did not list Total Pre-CTA Course Post-CTA course Total P <

Results  Clinical performance  Was informed consent obtained? Consent No Consent Total Study Group39342 Control Group Total P <

Summary of Data  Informed consent a ‘key step’  Pre-CTA – 19%  Post-CTA – 77%  42 procedures proctored  Technical competency – 86%  Indications/risks correct – 100%  Informed consent obtained – 93%  Historical control – 29%

Conclusions  CTA valuable method for instruction of invasive procedures  Improves cognitive understanding of procedures  Comparable clinical performance  Significantly improves understanding of the Informed Consent process and the rate of compliance by surgical residents in obtaining Informed Consent

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