Once you have assessed
your needs and partnered with clinicians to develop appropriate
written support material for informed consent, you are ready
to address the consent process itself. This is the interaction
between the patient and the clinician (and, indirectly,
with the whole team involved in the development of the informed
consent form) to inform the patient about the options and
to discuss the patient’s decision. All too often,
this process is a mere formality with the consent sheet
thrust in front of the patient for signature with minimum
explanation. Even in institutions with more regard for the
process, there is ample room for improvement.
The steps recommended in the nearby Figure
are really quite simple. They call upon the clinician to:
(1) acknowledge that informed consent requires more than
a signature on a piece of paper; (2) commit to (and create
time for) basic patient-physician communication; and (3)
ensure that each patient has understood the content of the
informed consent form. These same three points can
be emphasized to clinicians early in your education process
about informed consent. The last thing that clinicians need
is another set of multi-page guidelines to follow as they
manage their patients. That’s why the detailed suggestions
on the following pages may or may not be useful in your
discussions with staff. They are mostly reminders.
The key point to emphasize in your discussions with
clinicians is that they need to start checking to make sure
that their patients have understood the information.
Of all the interventions studied to improve understanding
after informed consent, this seems to have the most impact.
To help both patients and physicians get ready for this
important interchange, you can consider providing staff
with the checklist of questions for patients (See
Tool 4A Checklist for Patients). Note
that this same checklist, or the informed consent form itself,
can serve as a convenient checklist for clinicians during
the patient visit to ensure that they cover the key points.
Check the Patient’s
Understanding:
The Single Best Thing A Doctor or Nurse Can Do To Improve
Informed Consent
A variety of methods
have been used to increase patient involvement in the consent
process and improve patient comprehension. These methods
include: having other staff (e.g. nurses) provide additional
explanation of information presented by the doctor; giving
patients information or fact sheets that can be taken home;
using consent forms as an outline for discussion with patients
(e.g. to ensure that all key information about risks and
benefits is presented), and using a method in which patients
are asked to repeat back the information that has been presented
to them. Other approaches that may help improve patient
understanding in the consent process (the evidence is mixed)
take advantage of modern technology and include: audiovisual
materials shown in a clinic setting or given to participant
to take home; web-based computer interventions; and phone-based
interventions.
However, the simplest and most reliable method for improving
comprehension involves the “teach back” method
described above. In 2003, the National Quality Forum recommended
30 Safe Practices for Better Healthcare, a set of national
voluntary consensus standards that included a practice for
improving the quality of informed consent. [NQF 2003]
Safe Practice 10 calls for the utilization of the
“teach back” method during the consenting process.
Patients or their designated representatives are asked to
repeat back, or “teach back” in their own words
all the information they were given during the informed
consent. Studies have found that teach back, also called
the show me technique, greatly improves recall and retention
of information by patients. [NQF 2005]
Asking open-ended questions is another simple method for
checking patient understanding. An open-ended question is
one that cannot be answered with a simple yes or no. Instead
of asking a patient “Do you understand?” ask
them “What questions do you have for me?” This
will invite a more detailed response from the patient. It
gives the provider the opportunity to identify gaps in understanding,
or confusion about what was explained (Kleinman 1986). Comprehension also
improves when patients take a more active role in the discussion
of their care. [NQF 2003, NQF 2005]
[Figure] Informed Consent Process
Developed with a grant from the Robert Wood Johnson Foundation
