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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 HawaiiJohn A. Burns School of Medicine
Department of SurgeryHonolulu, 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 consentSprung, 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)
7.5+2.2 12.6+1.1 <0.001
# attempts to ID vein
6.4+4.2 3.3+2.2 0.05
# attempts to insertion
1.6+1.1 1.1+0.3 0.19
Time (min) to
complete20.6+9.1 15.4+9.5 0.14
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 – 1st 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 consen
t
Did not list
Total
Pre-CTACourse
4 17 21
Post-CTA course
20 6 26
Total 24 23 47P < 0.0001
Results Clinical performance
Was informed consent obtained?
Consent
No Consen
t Total
Study Group 39 3 42
Control Group
14 48 62
Total 53 51 104
P < 0.0001
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
Thank You