Tips on redesigning the informed consent process
Tips on redesigning the informed consent process
Joint Commission red flags issue for improvement
The public policy white paper on low health literacy released by The Joint Commission based in Oakbrook Terrace, IL, contains 35 specific recommendations on addressing this issue.
One recommendation is "The redesign of informed consent forms and the informed consent process."
In our article on The Joint Commission's call to action published in the April 2007 Patient Education Management we interviewed experts about ways to improve patient education materials so they could be read and understood more easily.
At that time many discussed ways to improve the informed consent process. Following are several suggestions they made:
Revise consent forms with patient/family advisor input for this is essential, says Cezanne Garcia, MPH, CHES, associate director for Patient & Family Centered Care and Education Services at the University of Washington Medical Center in Seattle.
"Our patient teaching sheets that accompany our consent forms reinforce the verbal conversation/teaching that takes place. These sheets are based on preferred/ideal material development standards," says Garcia.
Good content and graphic standards include material that is written at a sixth to eighth grade reading level printed in a 12-point font. The text should be upper and lower case for information that is written in all capitalization is hard to read. Bulleted lists and headings make material easier to read and illustrations provide visual images of what is described in the text.
"It would be ideal if the informed consent was written by the patient in words he or she understands," says Fran London, MS, RN, a health education specialist at The Emily Center at Phoenix (AZ) Children's Hospital.
When patients are being asked to sign an agreement to an invasive procedure or treatment they should be asked to teach back what they are taught. When they are able to do this they are ready to make an informed decision. They understand what it is they are agreeing to, says London.
One of the biggest problems with informed consent forms is that staff in legal services is not willing to change the language so the forms are easy to read and understand, says Sandra Cornett, PhD, RN, director of the OSU/AHEC Health Literacy Program at The Ohio State University in Columbus.
"Of course the form is only one part of the informed consent process," she adds.
Clinicians must provide individualized explanations and clarification and make sure patients really understand what is taught and written by using the teach back method.
"Without that intense provider/patient communication effort consent is really not 'informed'," says Cornett.
She suggests institutions establish a multidisciplinary committee to set standards and guidelines or policies and procedures to ensure that the informed consent process is done in a way that helps patients clearly understand and that the forms are written in plain language.
The committee would monitor how the informed consent process is being implemented by conducting documentation audits, and surveying patients and staff.
The patient education coordinator should sit on this committee to provide expertise for writing in plain language.
This committee would also put in place staff education for all involved in the informed consent process.
Sources
For more information about creating an informed consent process that emphasizes clear communication, contact:
- Sandra Cornett, PhD, RN, Director, OSU/AHEC Health Literacy Program, Office of Health Sciences, The Ohio State University, 218 Meiling Hall, 370 West 9th Ave., Columbus, OH 43210-1238. Phone: (614) 292-0716. E-mail: [email protected].
- Cezanne Garcia, MPH, CHES, Associate Director, Patient & Family Centered Care and Education Services, University of Washington Medical Center,1959 N.E. Pacific St., Box 356052, Seattle, WA 98195-6052. Phone: (206) 598-8424. 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].
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