Marriage of Professional and Technical Tasks: A Strategy to Improve Informed Consent Susan Steinemann, MD, Daniel Furoy, BA, Frederick Yost, MD, Nancy.

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