Can You Hear Me Now? Best Practices for Fully Informed Consent
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1 Can You Hear Me Now? Best Practices for Fully Informed Consent Standard Register Webinar Series July 10, 2015 Tim Kelly, MS, MBA Director of Marketing INFORMED CONSENT History 1914: the modern notion of informed consent as a protection against battery 1 Patient agreed to an exam but not to tumor removal a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages. 1957: disclosure of risks and alternatives : disclosure of risks that a reasonable person would want to know 3 1 Schloendorff v Society of New York Hospital. 105 N.E. 92 (N.Y. 1914) 2 Salgo v Leland Stanford Jr. Univ. Bd. Trustees. 154 Cal. App. 2d 560, 317 P.2d 170 (1957) 3 Canterbury v Spence. 464 F.2d 772 (DC Cir. 1972) 2 Page 1of 23
2 INFORMED CONSENT Today Procedures allegedly performed without consent Photography allegedly without consent 3 INFORMED CONSENT Agenda Areas for Improvement Compliance and Standardization Patient Safety Lost or Misplaced Consents Liability Improving Comprehension During Informed Consent Automated Informed Consent Concluding Thoughts 4 Page 2of 23
3 Compliance and Standardization STANDARDIZATION Typical Handwritten Form Abbreviations Legibility Variance Patient to Patient Provider to Provider Organization to Organization Issa MA, et al. The Journal of Urology. 2006;176: Page 3of 23
4 STANDARDIZATION AND COMPLIANCE Non-Compliant Forms 157-hospital study: Necessary elements are present only 26 percent of the time 1 Key elements required by: CMS DNV TJC 1 Bottrell MM, et al. Archives of Surgery. 2000;135: Patient Safety Page 4of 23
5 REDUCING THE RISK OF ERRORS NEJM: Case Records of the Massachusetts General Hospital 9 Ring DC, Herndon JH, Meyer GS. N Engl J Med 2010;363: /NEJMcpc Accessed 7/8/15. REDUCING THE RISK OF ERRORS The Case of the Trigger Finger Release A 65 year old woman was evaluated for pain and stiffness in the ring finger of the left hand. Dexamethasone was injected locally. Eight weeks later there was no improvement and informed consent was obtained for a release of trigger finger procedure. 10 Page 5of 23
6 REDUCING THE RISK OF ERRORS The Case of the Trigger Finger Release One hour before the procedure Dr. Ring, the surgeon, translated the preoperative preparation for the patient because no Spanish speaking interpreter was available. Dr. Ring confirmed the persistent trigger finger of the left ring finger with the patient. Dr. Ring then left to perform an extremely challenging carpaltunnel release procedure on a different patient. That patient was very agitated both before and after the procedure. Dr. Ring told himself that the next operation would be the best carpal tunnel release that I have ever performed. 11 REDUCING THE RISK OF ERRORS The Case of the Trigger Finger Release Delays by other surgeons caused a change in the operating room and in the operating room staff, including the nurse who had performed the preoperative assessment on the patient scheduled for the trigger finger release procedure. When Dr. Ring arrived at the OR, the patient was already prepped. Dr. Ring spoke briefly with the patient in Spanish that conversation was believed by the OR staff to be a time out. No formal time out took place. 12 Page 6of 23
7 REDUCING THE RISK OF ERRORS The Case of the Trigger Finger Release Dr. Ring performed an uneventful carpal tunnel release on the patient. 15 minutes later, when dictating the report of the procedure, Dr. Ring realized the error. Dr. Ring immediately apologized to the patient and offered to perform the correct procedure. The staff was reassembled and the trigger finger release procedure was performed without complication. 13 Is Case an anomaly? Page 7of 23
8 REDUCING THE RISK OF ERRORS Wrong Patient/ Wrong Procedure/ Wrong Site Surgery State of Pennsylvania 30 month period A wrong site surgery event will reach a patient once per year in a 300 bed hospital Failure to verify consent forms was a major contributor to errors resulting in the initiation of wrong site surgery 15 Clarke JR, Johnston J, Finley ED. Ann Surg 2007;246: REDUCING THE RISK OF ERRORS Wrong Patient/ Wrong Procedure/ Wrong Site Surgery $21 million award for a case of wrongpatient surgery The Detroit News. news/local/waynecounty/2015/05/07/awardedwoman died operation/ / Published 5/7/15. Accessed 7/8/ Page 8of 23
9 REDUCING THE RISK OF ERRORS WHO Surgical Safety Checklist 17 REDUCING THE RISK OF ERRORS Verification of the Consent Page 9of 23
10 REDUCING THE RISK OF ERRORS American College of Surgeons Template with WHO Checklist Lost or Misplaced Consents Page 10 of 23
11 LOST OR MISPLACED CONSENTS Hopkins Study Consent forms were missing for 66 percent of patients Cases were delayed for 10 percent of patients * Garonzik Wang JM, et al. JAMA Surg. July 10, LOST OR MISPLACED CONSENTS Eliminating Lost or Misplaced Consent Forms Represents $580,000 per year in avoided costs for the average US hospital Baum N. Healthcare Financial Management. 2006;60(2): Page 11 of 23
12 Liability LIABILITY RISK Liability Impact of Inadequate Informed Consent Lack of informed consent is one of the top 10 reasons for hospital malpractice claims 1 Inadequate informed consent was pursued as a secondary cause in more than 90 percent of ophthalmologic malpractice cases 2 1 Glabman M. Trustee 2004;57(2): Kiss CG, Richter Mueksch S, Stifter E, et at. Arch Ophthalmology 2004;122: Page 12 of 23
13 LIABILITY RISK This Corrective Action Plan and Claims Summary are in the public domain and were retrieved from the internet. 25 LIABILITY RISK 26 Page 13 of 23
14 LIABILITY RISK $1.9 million Case 27 Improving Patient Comprehension Page 14 of 23
15 PATIENT COMPREHENSION National Quality Forum (NQF) In 2003, NQF first published Safe Practices for Better Healthcare Endorsed a set of national voluntary consensus standards designed to improve patient safety 29 PATIENT COMPREHENSION National Quality Forum (NQF) NQF Safe Practice 5 Ask each patient or legal surrogate to teach back, or repeat back in his or her own words, key information about the proposed treatments or procedures for which he or she is being asked to provide informed consent. 30 Page 15 of 23
16 PATIENT COMPREHENSION 31 PATIENT COMPREHENSION 32 If the Patient Understood Immediately button is checked, the following is automatically inserted into the progress note: The patient satisfactorily communicated his or her diagnosis. If the Patient Understood with Additional Training button is checked, the following is automatically inserted into the progress note: After further discussion, the patient was able to satisfactorily communicate his or her diagnosis. Page 16 of 23
17 PATIENT COMPREHENSION Methods Setting: 7 VA Medical Centers (Atlanta, Boston, Denver, Houston, Pittsburgh, Portland, Tampa) Surgical Types: Total Hip Arthroplasty Carotid Endarterectomy Laparoscopic Cholecystectomy Radical Prostatectomy 33 PATIENT COMPREHENSION Results Significantly better patient understanding of risks, benefits and alternative treatments The teach back or repeat back process took only 2.6 additional minutes on average Fink AS, Prochazka AV, Henderson WG, et al. Ann Surg 2010;252: Page 17 of 23
18 Electronic, Standardized or Automated Informed Consent ELECTRONIC CONSENT Increased Patient Satisfaction 96 percent of patients preferred the electronic consent system to the traditional approach Issa MM, Setzer E, Charaf C, et al. The Journal of Urology. 2006;176: Page 18 of 23
19 ELECTRONIC CONSENT Provider Satisfaction JHS physicians expressed overwhelming support of the application as well. Michael Butler, MD, CMO Jackson Health System For the Record, October 15, Concluding Thought Consent is Not Always for a Treatment or Procedure Page 19 of 23
20 OTHER TYPES OF CONSENTS New Virginia Law Consent to observation (outpatient) status Went in effect on July 1 39 OTHER TYPES OF CONSENTS New Virginia Law Consent to observation (outpatient) status Went in effect on July 1 40 Page 20 of 23
21 OTHER TYPES OF CONSENTS New Virginia Law Consent to observation (outpatient) status Went in effect on July 1 41 Final Thought A Simple Thing That We Can Do Immediately Page 21 of 23
22 A SIMPLE THING TO IMPLEMENT NOW Case 46 year old male with a femoral neck fracture Image is 2 weeks post surgery 43 A SIMPLE THING TO IMPLEMENT NOW Recommendation Add two blank lines to your consent form(s) 44 Page 22 of 23
23 A SIMPLE THING TO IMPLEMENT NOW Case 46 year old male with a femoral neck fracture Image is 2 weeks post surgery 45 Questions Timothy.Kelly@StandardRegister.com and services/smartworks imedconsent Page 23 of 23
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