Informed consent for any medical procedure is a critical patient care process. When properly performed, the informed consent process provides a patient with the information needed to make rational decisions and promotes patient autonomy. Many studies have documented limitations in current informed consent methodologies. These limitations include poor comprehension, inadequate time for discussion, poor documentation of consent, and increased patient anxiety. A survey of some of these studies — involving a total of 704 patients — revealed that the average of patients’ comprehension was only 48%1. Clearly, when less than half of the information communicated during the consent process is understood, there is considerable room for improvement.
Creating a Rigorous Consent Process
Computer-based informed consent programs standardize the informed consent process and improve documentation of this vital healthcare process. Several years ago, the Veterans Health Administration adopted an automated informed consent , which is now fully integrated into their computerized patient record system 2. This program standardizes risk information and offers a structured, computer-based interview which is used to create the informed consent document. The provider seeking consent follows the computer-generated informed consent document with the patient (either on-screen or with a print-out) when reviewing indications, risks, benefits, and alternatives. If desired, the program can be used to review illustrations of the surgical procedure as well as to generate procedure-specific pre- and post-operative patient instruction forms. This new approach offers more structure and is more interactive than standard paper-based informed consent processes.
Unfortunately, even with the electronic approach, patient comprehension may remain suboptimal, especially in patients with limited healthcare literacy, that is those lacking in their “capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions”3. “Repeat-Back” has been suggested as a method by which patient comprehension might be improved when obtaining informed consent. In this technique, patients are asked to recount what they have been told in the informed consent discussion. The clinician then uses these verbalizations to judge the patient’s comprehension of the proposed procedure and to identify areas where the patient requires further education.
Value in Structured, Interactive Discussion
In 2005, my colleagues and I undertook a randomized, multi-center, controlled trial4 to address this issue by examining patients’ comprehension and satisfaction as well as provider acceptability of a Repeat-Back intervention during surgical informed consent obtained using the automated informed consent solution. We found that even without Repeat- Back, use of this computer-based consent tool improved patients’ comprehension of procedure-specific risks, benefits and alternatives from the historical average of 48% to 60%.
Our key finding was that addition of Repeat-Back to the standardized computer-based consent program further improved patient comprehension. In addition, a majority of providers felt that Repeat-Back enhanced their patient’s comprehension of the informed consent. We felt that these findings demonstrated the efficacy of Repeat-Back when added to a structured, computer-based informed consent platform. Unfortunately, our study lacked sufficient power to specifically demonstrate Repeat-Back’s benefit in the small number of patients with limited health literacy.
In a follow-up study1, we further analyzed our data to define those factors predictive of improved patient comprehension. Our key findings were that patients’ race, education, and age, use of the Repeat-Back feature, and total time of the informed consent process were independent predictors of patient comprehension after the surgical informed consent discussion.
It’s a Matter of Time
One of our most striking observations — which we believe to be of major clinical import — was the significant correlation between improved patient comprehension and longer consent process times. Our analysis suggested that comprehension improved as more time was devoted to the informed consent discussion; comprehension appeared to be maximized when the informed consent discussion was undertaken for 15 to 30 minutes.
What’s Your Strategy?
A rigorous informed consent process is difficult and takes time from busy clinical schedules, especially in the current healthcare environment. Such time commitments are rarely recognized or rewarded by health care administrators. One potential option might involve having other patient care team members spend more time talking one-on-one to patients, especially those in vulnerable populations (e.g. with limited healthcare literacy). Alternatively, prior to the definitive informed consent discussion, patients could be provided easy-to-understand consent documents specific to the procedure being contemplated. Early provision of a document that describes all aspects of a planned treatment or procedure allows patients to absorb information and formulate questions prior to the formal consent discussion. We believe that these and other strategies should continue to be explored in seeking to maximize patient comprehension as well as patient autonomy.
1Fink AS, Prochazka AV, Henderson WG, et.al: Predictors of Comprehension during Surgical Informed Consent. J Am Coll Surg 2010; 210:919-926.
2Spotswood S: VA patient consent goes electronic. US Medicine 2005; 41(2):1,37,44.
3Selden C, National Library of Medicine (U.S.). Reference Section. Health literacy. Bethesda, Md. (8600 Rockville Pike, Bethesda 20894): U.S. Dept. of Health and Human Services, Public Health Service, National Institutes of Health, National Library of Medicine, Reference Section; 2000. Available at: http://www.nlm.nih.gov/archive//20061214/pubs/cbm/hliteracy.html
4Fink AS, Prochazka AV, Henderson WG et.al: Enhancement of Surgical Informed Consent by Addition of Repeat Back. A Multicenter, Randomized Controlled Clinical Trial. Ann Surg 2010; 252:27-36.