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Re-Designing Informed Consent: Creating Harmony Between the Law & Health Literacy

Delivered at the Institute of Medicine's Workshop on Informed Consent & Health Literacy, Washington, D.C., July 28, 2014
by

Chris Trudeau

on 31 July 2014

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Transcript of Re-Designing Informed Consent: Creating Harmony Between the Law & Health Literacy

Re-designing
consent forms
Creating harmony between the law and health literacy
Prof. Christopher R. Trudeau
Thomas M. Cooley Law Schoo
l
How do we create a form
that complies with the law
and
promotes a conversation?
Forms for procedures are easier to attack than forms for clinical trials
Why?
Because there are fewer rules & regs
Mostly state-based common law
Some state regs, but they typically mirror the common law
Two standards for informed consent?
(1) the reasonable-physician standard
(professional-custom standard)
(2) the reasonable-patient standard
How does health literacy fit with these standards?
It currently doesn't .
But it can . . .
For patient standard, lawyers must make health lit arguments.
For custom standard, IOM, AMA, etc must advocate to change the custom.
But can we do something
now
to aid patient understanding?
The law & health literacy are not mutually exclusive.
YES
What must be disclosed in a consent form?
a description of the procedure
the risks
the alternatives
patient's consent to treatment
other legal disclosures
(depends on the state & provider's needs)
Most current forms are hard to understand
Understand where the form fits into the process
Step #1
Patient & provider discuss the need for procedure;
Patient receives education info (or completes tutorial);
Preps for procedure;
Goes to appointment;
Receives consent form;
Patient & provider further discuss, using teach back.
Ideally...
Step #2: Create Clear Content
Step #3: Consider Design Strategy
Limited to 2 pages for all content;
space for office admin needs
signature lines
Incorporate health lit concepts (teach back? numeracy? plain language);
must include legal content (risks, alternatives, description);
need consent language.
And now for something completely different . . .
A clear colonoscopy consent form
(incorporating teach back)
Version #1: includes descrip. of alternatives
Understand where the form fits into the process
Patient & provider discuss the need for procedure;
Patient receives education info (or completes tutorial);
Preps for procedure;
Goes to appointment;
Receives consent form;
Patient & provider further discuss, using teach back.
Ideally...
Version #2: More white space,
diff. design, alts. minimized
Cover legal bases
use plain language
incorporate teachback
add more legal protection?
Don't let lawyers tell you it can't be done.
Full transcript