Informed
Consent - Background
Definition
- Informed
consent is the communication process between a patient and his
or her physician that results in the patient’s agreement
to undergo a particular medical procedure or treatment.
History
- The concept
of informed consent is rooted in medical ethics and codified as
legal principle. It is based on the assertion that a competent
person has the right to determine what is done to him or her.1
Rationale
- The American
Medical Association recommends that its members disclose and discuss
the following with their patients:2
- The patient's
diagnosis, if known;
- The nature
and purpose of a proposed treatment or procedure;
- The risks
and benefits of a proposed treatment or procedure;
- Alternatives
(regardless of their cost or the extent to which the treatment
options are covered by health insurance);
- The risks
and benefits of the alternative treatment or procedure; and
- The risks
and benefits of not receiving or undergoing a treatment or procedure.
- The requirement for informed
consent is spelled out in statutes and case law in all 50 states.
Inadequacy
of the Conventional Informed Consent Process
Shortcomings
of Written Consent Forms
- The typical
informed consent process, particularly one that relies solely
on traditional written consent forms, is often incomplete or offers
the potential for not fully explaining a particular treatment
or procedure to a given patient.
- A review
of 540 written consent forms, from 157 hospitals, found the
four basic elements of informed consent (risks, benefits, alternatives
and other key aspects of the procedure) to be present in only
26% of the documents.3
- A review
of 91 written urological procedure consent forms, from a VA
Medical Center, found that only 15% contained all appropriate
risks of the procedure.4
Other Challenges
with a Paper-Based Informed Consent Process
- Traditional
paper consent forms are subject to other errors and omissions:
- Missing
signatures (patient, provider or witness) and missing dates
place the validity of the consent document at risk.
- Lost or
misplaced forms may result in delayed or postponed procedures
often at a cost of expensive operating room time.
Patient
Safety
Patient
Safety Background
- More than
1 million injuries and nearly 100,000 deaths occur annually in
the United States due to mistakes in medical care (Source: IOM
Report – To Err Is Human).5
- Based on
the need to make health care safer, the Agency for Healthcare
Research and Quality (AHRQ) undertook a study to identify patient
safety issues and develop recommendations for “best practices”.6
AHRQ
Evidence Report
- The AHRQ
report identified the challenge of addressing shortcomings such
as missed, incomplete or not fully comprehended informed consent,
as a significant patient safety opportunity.7
- The authors
of the AHRQ report hypothesized that better informed patients
“are less likely to experience medical errors by acting
as another layer of protection.”
- The AHRQ
study ranked a more interactive informed consent process among
the top 11 (of the 79 practices reviewed in detail) in terms of
strength of the evidence supporting more widespread implementation.
Priority
for IT Executives and CIOs
- Patient safety
is rapidly becoming a top priority for Information Technology
Executives and Chief Information Officers.
- 47% of
IT executives report that increasing patient safety is their
main focus (Source: 15 th Annual HIMSS Leadership Survey).8
- Nearly
40% of CIOs and other executives said the main factor for growth
in their information technology budgets is medical error reduction
and patient safety (Source: Health Data Management 2004 CIO
Survey).9
Litigation
Malpractice
Insurance and Litigation
- A GAO report
found that malpractice insurance premiums were relatively flat
for most of the 1990’s but began to increase dramatically
beginning in 1999 and 2000 with some increases as high as 165%.10
- Malpractice
insurance rates continue to rise. The largest malpractice insurer
in the state of Massachusetts raised premiums 11% on July 1, 2004.11
- In an effort
to combat the spiraling cost of malpractice insurance, the U.S.
House of Representatives passed the Help Efficient, Accessible,
Low Cost, Timely Healthcare (HEALTH) Act (H.R. 4280) on May 12,
2004. That proposed legislation would cap non-economic damages
in medical malpractice cases at $250,000.
Consequences
of Improper Informed Consent
- Failure to
obtain adequate informed consent, depending on state law, may
place hospitals and care givers at risk for litigation ranging
from medical negligence to battery.
Proceedings
Involving Informed Consent
- Informed
consent is often a factor in medical malpractice litigation. Some
attorneys note that physicians are liable, and that plaintiffs
may be able to recover damages, in cases involving improper informed
consent, even if the procedure is successful.12
- Inadequate
informed consent is often cited as a secondary cause in malpractice
complaints – studies have shown this strategy was pursued
in more than 90% of ophthalmologic malpractices cases.13
Avoiding
Litigation
- The AMA advises
its membership of the following regarding informed consent:
“To
protect yourself in litigation, in addition to carrying adequate
liability insurance, it is important that the communications
process itself be documented. Good documentation can serve as
evidence in a court of the law that the process indeed took
place. A timely and thorough documentation in the patient's
chart by the physician providing the treatment and/or performing
the procedure can be a strong piece of evidence that the physician
engaged the patient in an appropriate discussion.”14
Comprehensive
Informed Consent – Impact and Ethics
Impact
of Comprehensive Informed Consent
- One study
has found that providing informed consent information to patients
in written form increases the patients’ comprehension of
the procedure.15
- It has also
been hypothesized that:
- Better
informed patients are more compliant with medical advice and
recover faster.
- Informed
consent discussions strengthen physician-patient relationships
and increase patients’ confidence in their doctor.
- Well informed
patients are less likely to experience medical errors –
this may result from the patient acting as another layer of
protection (e.g. a patient is able to inform his or her physician
about correct medications or the exact surgical procedure that
he or she is scheduled to undergo).16
Ethics
- The ethical
foundation of informed consent is based on the creation of an
environment that supports respect for patients and protects their
right to autonomous, informed participation in health care decisions.17
Veterans
Health Administration
Electronic
Support for Patient Decisions Initiative
- Veterans
Health Administration
- 15,000
physicians
- 5.1 million
patients
- 162 medical
centers
- In 2004 the
VHA announced its Electronic Support for Patient Decisions Initiative:
- Developed
under the direction of the National Center for Ethics in Health
Care.
- “We owe it to our
veterans to do all we can to ensure that they understand the
care they receive and to make sure that the informed consent
process is as patient-friendly as possible,”
said Secretary of Veterans Affairs Anthony J. Principi. “This
new program is a great complement to the success of VA’s
electronic patient records systems.”
- “We are always
looking for ways to enhance the care we provide,”
said Dr. Ellen Fox, center director. “By supporting
patient decisions on a systems level, we are preventing problems
before they arise. We like to call this ‘preventive ethics’.”
The
iMedConsent™
Solution
Description
- iMedConsent™
is a comprehensive, computer-based, patient education and informed
consent solution developed by Dialog Medical.
Benefits
- iMedConsent™
solution enhances communication between the patient and the physician
by offering:
- A comprehensive
library of education materials that describe different medical
conditions and treatments.
- Detailed
informed consent materials that facilitate a broad discussion
of the given procedure or treatment including:
- Description
of the procedure
- Risks
- Benefits
- Alternatives
- Likely
outcomes if no treatment is elected
- An expansive
collection of anatomical diagrams and images that facilitate
the physician’s ability to describe the nuances associated
with a given condition or procedure.
- A wide
range of post procedural care instructions.
- A comprehensive
library of drug information documents.
- iMedConsent™
solution facilitates the documentation of the consent process
by:
- Providing
printed copies of the procedure-specific consent form.
- Offering
the ability to store the signed consent form electronically.
- Automatically
noting in the patient’s electronic medical record the
details associated with the consent process and the distribution
of any education materials.
3.
Bottrell MM, Alpert H, Fischbach RL, et al. Hospital informed consent
for procedure forms: facilitating quality patient-physician interaction.
Archives of Surgery. 2000;135:26-33.
10.
Medical Malpractice Insurance: Multiple Factors Have Contributed
to Increased Premium Rates. United States General Accounting Office.
Washington, D.C. June 2003. Report GA-03-702.
15.
Winfield AC, Ford CV, James AE, et al. Response of patients to informed
consent for excretory urography. Urol Radiol. 1986;8:35-9.
16.
Pizzi LT, Goldfarb NI, Nash DB. Procedures For Obtaining Informed
Consent in Shojania K, Duncan B, McDonald K, Wachter RM, eds. Making
Health Care Safer: A Critical Analysis of Patient Safety Practices.
Rockville, MD: Agency for Healthcare Research and Quality. Evidence
Report/Technology Assessment No. 43; AHRQ publication 01-E058.
2001:546-554.
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