Based on all the information just summarized, two points stand out: (1) Patients have a fundamental right and need to receive information, both orally and written, about their care in a manner they can fully comprehend and that will lead to truly shared decision-making, and (2) current practices of informed consent are often inadequate and are especially hampered by growing rates of health illiteracy in the U.S.
So, what can be done?
A number of studies indicate
that improving consent forms and the overall consent process
can lead to better patient comprehension and recall. Although
the research on improved consent forms has been mixed, some
studies have found that when consent forms are improved,
patients are more likely to read and understand them before
signing. [Pereira 1995, Davis 1998]. Using a consistent
informed consent template as a starting point for the creation
of forms for various procedures also appears to improve
consistency and quality in the forms. [Takimoto 2007] The
Queensland Government (Australia) offers a useful example
of how consistency in format and content can improve overall
quality and anticipate the need for language services (Figure 1). Providing clear
and simple information about procedures may
also lower patient anxiety levels [Kerrigan 1993, Coyne
2003] and increase understanding and recall in a way that
produces a more deliberative decision-making process. [Meade
1999, NWGLH 1998, Campbell 2004, Paaschle-Orlow 2003]
However, a clearly written
consent form does not guarantee that patients will
read and understand them. A properly constructed and clearly
formatted consent form is a necessary but not sufficient
condition for ensuring that patients read, understand, and
remember the information presented. Thus, a variety of other
methods are needed to increase patient involvement in the
consent process and improve patient comprehension of the
information presented. For example, several recent studies
show that repeating information to patients in various formats
and modes and at different times can strengthen comprehension
and recall. [Alaishuski 2008, Migden 2008, Moseley 2006,
Cohn 2007]
Figure 1. Example of Informed Consent
Form from Queensland Australia.
Note that the main categories remain consistent from
procedure to procedure.
Based on a review of the literature on informed consent and, more broadly, on patient-physician communication (much of which is summarized in Appendices A and B), we have generated recommendations and tools that can help anyone wanting to improve their informed consent. Specifically, these recommendations emphasize (1) gaining consensus within the organization to make the required changes, (2) improving the consistency and quality of the written consent form and the related written educational materials and (3) improving the structure and content of the informed consent process, especially in terms of soliciting feedback from the patient to ensure comprehension. Key “best practices” that we endorse in the next section include:
Recognize differences in education or literacy levels
and provide more help to patients with less education
or low literacy.
Have extended discussions with patients and when possible
have other staff (e.g. nurses) provide additional explanation
of information presented by the doctor.
To ensure thoroughness in content and consistency in
language, employ a consistent outline or template when
starting to create informed consent forms for different
procedures.
Use lower reading levels, better formatting, graphics,
shorter lengths, and remove unnecessary material.
Use consent forms as an outline for discussion with
patients (e.g. to ensure that all key information about
risks and benefits is presented).
Give patients information or fact sheets that can be
taken home.
Consider use of multimedia formats (e.g. webcasts, podcasts,
DVDs) along with written information to bolster understanding
Use a “teach back” method in which patients are asked
to repeat back the information that has been presented
to them.
Make sure patients are given an opportunity to decline
procedures and are aware of their right to do so.
Implementing these practices
will require coordinated efforts from administrative and
clinical leadership, clinical staff, risk managers and legal
counsel. We encourage all those involved in delivering quality
healthcare to consider adding the suggestions and tools
provided in the next section, “How to Improve
Your Informed Consent,” to their ongoing quality
improvement efforts.
How to Use the Rest of this Guide
The four activities described next contain dozens of practical recommendations on how to improve informed consent.
1] Gain Organizational Consensus:
Use these ideas to set the stage for or start the
discussion about change within your organization.
2] Assess Status & Prioritize Needs: Gather information and evidence from within your own organization to figure out what works, and what doesn't work, in your current procedures and policies.
3] Improve Your Written Consent Forms and Other Educational Materials: Get down to work and improve the language, style, clarity, and content of your written educational materials and consent forms.
4] Improve Your Consent Process: Don't forget that informed consent involves more than a piece of paper—use these ideas to add substance to the full dynamic interaction with patients.
These four main activities could be seen as “steps”
to be done in sequence or, alternatively, a user could
pick specific activities and ideas that are most needed
in his or her setting and concentrate there. Certainly
a comprehensive approach would be ideal but spot improvements—a
focus in cardiology, an effort to improve Spanish
translations, a Grand Rounds talk on informed consent,
or even just an attempt to simplify and test a single
consent form—are better than nothing. In other
words, use as many of the following ideas as possible
and keep in mind that the clinical and legal staff
within your own organization will likely bring other
valuable suggestions for improving your consent procedures
while remaining within the necessary legal and organizational
bounds. This Guide is simply a starting point or
roadmap. As described already, somebody within your
organization needs to provide the real spark—by
becoming the advocate—to translate these ideas
into real progress and improvement.
So, who exactly should take responsibility for all
this work? The answer to that question will vary in
every institution. In many cases, it will be an individual
involved in quality assurance activities or within
one busy clinical department, who initiates the discussion
for an educational program on informed consent ([1]
Gain Organizational Consensus) or a review of
existing forms ([2]
Assess Status & Prioritize), or generation of
newer and better forms ([3]
Improve Your Written Consent Forms and Other Educational Materials). In other cases, it may
be an ad hoc committee of clinicians working with
the organization's attorney to create a more comprehensive
and coordinated plan for review and improvement. There
is no one best way to improve. There are many possible
ways. Several of these are laid out for your consideration
in the remainder of this Guide.
Developed with a grant from the Robert Wood Johnson Foundation
