Informed consent for surgical procedures is critical to patient care in the VA. Many studies document limitations in current methods of obtaining informed consent including poor patient comprehension, inadequate time for discussion, poor documentation of consent, and increasing patient anxiety regarding surgery. The VA has addressed this by computerization of the informed consent process utilizing the iMedConsent program. This is fully integrated into CPRS, includes patient education materials, standardizes risk information and guides the clinician through the consent process. Asking patients to "Repeat Back" key points from the informed consent discussion has been proposed as a way to improve comprehension.
The objectives of this study were to determine if Repeat Back would improve patient comprehension, reduce anxiety about surgery, improve patient satisfaction with the consent process and healthcare and be acceptable to providers.
We conducted a multi-site randomized trial at 7 VAMC comparing standard iMedConsent and iMedConsent with Repeat Back. We enrolled 575 subjects scheduled for one of 4 elective surgeries: carotid endarterectomy, total hip arthroplasty, radical prostatectomy and laparoscopic cholecystectomy. Subjects were individually randomized to standard or enhanced iMedConsent. Providers were asked to provide feedback on both standard and enhanced iMedConsent. Patient comprehension was tested immediately after consent using procedure-specific questionnaires. Patient satisfaction with the consent process, decision-making, health care and providers' acceptance of iMedConsent were measured using self-report survey instruments. Patient anxiety was assessed immediately before and after consent using the STAI. Time stamps in the iMedConsent program estimated time spent completing the informed consent process. The study data was linked to the National Surgical Quality Improvement Program, which provides baseline data on 30 day surgical outcomes.
575 patients were enrolled, 276 in Repeat Back group and 299 in No Repeat Back group. There was a statistically significant difference in mean comprehension scores between the Repeat Back group, 71.4% correct and the no Repeat Back group, 68.2% correct. The effect was greatest in the carotid endarterectomy group, 73.4% for Repeat Back versus 67.7% for No Repeat Back. The other surgical types had higher comprehension in the Repeat Back group, but the differences were not statistically significant.
There was no significant difference between the groups in terms of quality of decision making, use of other sources of information, satisfaction with the decision, or receiving the right amount of information. Overall satisfaction with care was very good in both groups with no significant differences in emotional support, patient education, preferences or overall satisfaction. There was no statistically significant difference in the change in anxiety scores between the two groups.
242 providers participated in the study with 79% completing questionnaires. Providers spent more time, 13.5 minutes, obtaining informed consent in the Repeat Back group, compared with 10.9 minutes in the no Repeat Back group. The time spent in the Repeat Back group was higher in all 4 surgical procedures and at all 7 sites. Providers were neutral to slightly favorable regarding Repeat Back.
By looking at ways to improve the surgical informed consent process within the VA, we can better provide quality health care services that our veterans require and deserve.
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