BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
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.


METHODS:
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.

FINDINGS/RESULTS:
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.

IMPACT:
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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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Kaafarani HM, Itani KM. Classification versus valuation and grading of surgical complications. Journal of the American College of Surgeons. 2009 Aug 1; 209(2):290-1; author reply 291-2. [view]
2. Volpp KG, Rosen AK, Rosenbaum PR, Romano PS, Itani KM, Bellini L, Even-Shoshan O, Cen L, Wang Y, Halenar MJ, Silber JH. Did duty hour reform lead to better outcomes among the highest risk patients? Journal of general internal medicine. 2009 Oct 1; 24(10):1149-55. [view]
3. Rosen AK, Loveland SA, Romano PS, Itani KM, Silber JH, Even-Shoshan OO, Halenar MJ, Teng Y, Zhu J, Volpp KG. Effects of resident duty hour reform on surgical and procedural patient safety indicators among hospitalized Veterans Health Administration and Medicare patients. Medical care. 2009 Jul 1; 47(7):723-31. [view]
4. Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J, Wilson M, Karsonovich C, Parmelee P. Enhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trial. Annals of surgery. 2010 Jul 1; 252(1):27-36. [view]
5. Itani KM, Kim L. Mechanical bowel preparation or not for elective colorectal surgery. Surgical Infections. 2008 Dec 1; 9(6):563-5. [view]
6. Itani KM, Akhras KS, Stellhorn R, Quintana A, Budd D, Merchant S. Outcomes associated with initial versus later vancomycin use in patients with complicated skin and skin-structure infections. Pharmacoeconomics. 2009 Jan 1; 27(5):421-30. [view]
7. Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J, Wilson M, Karsonovich C, Parmelee P. Predictors of comprehension during surgical informed consent. Journal of the American College of Surgeons. 2010 Jun 1; 210(6):919-26. [view]

Journal Other

1. Itani KM. Let us not forget the Association of VA Surgeons (AVAS). Surgery. 2009 Sep 1; 146(3):525; author reply 525-6. [view]

Conference Presentations

1. Itani K, Sorenson S, Stokes M, Shelbaya A, Spiesser J, McKinnon P. A Regional Comparison of Resource Utilization in Patients (Pts.) with Methicillin-Resistant Staphylococcus aureus (MRSA) Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Linezolid (LZD) vs Vancomycin (VAN). Paper presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; 2009 Sep 12; San Francisco, CA. [view]
2. Gopal RK, Yamashita TE, Campbell J, Prochazka AV. Ambulatory Care Providers' Work Environment Associated with Poor Quality of Care and Provider Burnout. Paper presented at: Society of General Internal Medicine Annual Meeting; 2009 May 14; Miami, FL. [view]
3. Fink AS, Prochazka AV, Henderson WG, Bartenfeld DH, Nyirenda C, Itani K, Webb AL, Parmelee PA, Bottrell MM, Rosendale DR. Benefits of “Repeat Back” Within a Computer-Based Informed Consent Program. Paper presented at: VA HSR&D National Meeting; 2009 Feb 13; Baltimore, MD. [view]
4. Kaafarani HM, Rosen AK, Nebeker J, Shimada S, Mull HJ, Rivard P, Shin M, Long B, Savitz A, Itani K. Developing Trigger Tools for Surveillance of Adverse Events in Same-Day Surgery: A Literature-Based, End-User Inspired & Expert-Evaluated Methodology: Health Services Research and Development. Paper presented at: VA HSR&D National Meeting; 2009 Feb 11; Baltimore, MD. [view]
5. Itani K, Weigelt J, Stevens DL, Dryden MS, Battacharyya H, Kunkel M, Baruch A. Efficacie et tolerance du linezolide dans le traitement de infections de la peau et des tissues mous documentes a SARM. Les Journees Nationales d’infectiologie. Paper presented at: French Society for Infectious Diseases Annual Conference; 2009 Jun 10; Lyon, France. [view]
6. Gopal RK, Yamashita TE, Campbell J, Prochazka AV. Lack of Decision Latitude and High Psychological Demands are Associated with Internal Resident Burnout. Paper presented at: Society of General Internal Medicine Annual Meeting; 2009 May 14; Miami, FL. [view]

DRA: Health Systems Science
DRE: none
Keywords: Surgery
MeSH Terms: Informed Consent