For legal protection, use informed consent process
For legal protection, use informed consent process
Cover info once and again and assess understanding
A signed consent form is not proof in a court of law that the patient understood the information given regarding the purpose, benefits, risks, and alternatives to a procedure or treatment.
"If a person did not fully understand what the procedure or treatment entailed, they did not receive informed consent. It is up to the medical professional to determine if the person has the capacity to understand, deliberate, and make informed choices. If they don't understand then the medical professional failed to perform his/her functions for obtaining informed consent. The legal ramifications are numerous," says Gabby Reissland, RN, JC, director of risk management and legal services at the Ohio State University Medical Center in Columbus.
How do you make sure a person received informed consent?
The best practices would be to have protocols on what content to include in the teaching and on the form. Teaching guidelines would provide the information to convey, and good teaching practices would require learning assessments to determine what additional information is needed, says Debra Hall, MA, patient education coordinator at All Saints Healthcare in Racine, WI.
Fran London, MS, RN, a health education specialist at the Phoenix (AZ) Children's Hospital, adds, "To ensure the learner understands, there has to be a conversation. Guide the learner into verbalizing the key elements of the consent: what the procedure is for, what the risks are, what the alternatives are, and whatever other things they legally need to know before consenting."
The best way to evaluate understanding is to ask the learner to teach back the information that was just taught. It can be helpful to ask the learner how he or she would explain the consent contents to a family member, says London.
During the teaching session the educator should listen to cues from the learner that indicate poor understanding. For example, the patient may focus on a possible complication not understanding there is another treatment available, explains London.
"To make sure patients have given their consent with full knowledge medical professionals must know their patient or ask probing questions to determine whether or not the person understands the process being undertaken," says Reissland.
If legal action occurs a medical facility would need to prove that a reasonable person in society would be able to deliberate and choose whether or not to undergo a specific procedure based on information given regarding the purpose, benefits, risks, and alternatives.
The best way to establish this proof is to have a systematic, thorough process for informed consent that is followed by everyone that performs the task of obtaining informed consent, says Reissland.
In that way, every person that performs the task can explain in succinct terms the procedure and then relate it to what was told to the specific plaintiff at the time the plaintiff received informed consent, she explains. An alternative is to tape every informed consent, she adds.
Readable form a must
While the form is just the paper to show that the consent process occurred it is important that patients understand the information on it. Therefore forms should be written at a fifth-grade to eighth-grade reading level. Usually they are written too high, says Jackie A. Smith, PhD, an associate clinical professor at the University of Utah College of Nursing in Salt Lake City.
To show that institutions need to evaluate their consent forms to ensure they are clearly written at an appropriate grade level, Smith conducted an informal study in 2001. She asked members of a patient education and staff education listserv to send medical/surgical consent forms they currently used. As a result she received 64 forms from 14 hospitals representing a wide variety of treatments and procedures.
She tested all but five of the forms with the SMOG Readability Formula. Those she filtered out were too short to determine their readability with the simple test, which uses the length of sentences and the number of three-syllable words to determine the grade level of the written material.
When Smith finished her evaluation she determined that, on average, a person would have to have finished his or her sophomore or junior year in college to be able to read and comprehend the form.
"None of the forms met the recommended criteria for optimal readability," she says.
In addition she noticed that many used very small font sizes that were difficult to read and had medical terms that were not easily understood.
Hall says that in addition to writing reading materials at a fifth- to eighth-grade level there needs to be a lot of white space rather than a lot of text. This is helpful for people who struggle with reading.
Smith says some consent forms for teenagers created at the University of Utah included illustrations as well as simple language. The forms were pre-tested before they were finalized.
In addition to readability, consent forms should contain five key elements according to the Chicago-based American Society for Healthcare Risk Management, says Smith. Those are: the diagnosis or suspected diagnosis; the name/nature and purpose of the treatment or procedure; the risk/benefits and alternatives; an estimate of probability of success; and the consequences if the advice is not taken.
"A lot of consent forms I looked at might have had parts of the key elements but they really weren't complete," says Smith.
The results of the study were reported at the annual conference of the Health Care Education Association based in Amarillo, TX. Many health care professionals who had submitted the forms for review were present at the meeting and said they would try to rewrite the forms, says Smith.
"Certainly the information part of the form, and really the legal part, too, can be written at an appropriate reading level," says Smith.
However educators must remember that consent is part of a process — it is not just a form, she says.
[Editor's note: Debra Hall says there are many resources that help with the creation of readable consent forms and the process of education. She recommends a 30-minute video on low health literacy titled "Help Your Patients Understand" produced by the Chicago-based American Medical Association.
Also the Seattle-based University of Washington School of Medicine web site has information on informed consent. See http://eduserv.hscer.washington.edu/bioethics/topics/consent.html.]
Sources
For more information about the process of informed consent, contact:
- Debra Hall, MA, patient education coordinator, All Saints Healthcare, 2805 Spring St., Racine, WI 53405. Phone: (262) 687-4246. E-mail: [email protected].
- Fran London, MS, RN, health education specialist, The Emily Center, Phoenix Children's Hospital, 1919 East Thomas Road, Phoenix, AZ 85016-7710. Phone: (602) 546-1408. E-mail: [email protected]
- Gabby Reissland, RN, JD, director of risk management and legal services, Ohio State University Medical Center, 168 Doan Hall, 410 W. 10th Ave., Columbus, OH 43210. Phone: (614) 293-8446. E-mail: [email protected].
- Jackie A. Smith, PhD, associate clinical professor, University of Utah College of Nursing, 10 South 2000 East, Salt Lake City, UT 84112. Phone: (801) 581-4804. E-mail: [email protected].
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.