The Informed Consent Process and the Electronic Medical Record
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1 The Informed Consent Process and the Electronic Medical Record Mercer Medical Center Macon, Georgia July 14, 2005 Aaron S. Fink, MD Professor of Surgery Emory University Manager, Surgical and Perioperative Care Atlanta VAMC
2 Informed Consent Process Critical health care process Clinically: Provide patient with vital information about benefits, risks and alternatives Ethically: Preserves patient autonomy the belief that a competent person has the right to determine what will be done to them
3 AMA Code of Medical Ethics Obligates a physician to: Present the medical facts accurately Help the patient make choices from among the therapeutic alternatives consistent with good medical practice
4 Informed Consent Legal Principle Every human being of adult years and sound mind has the right to determine what shall be done with his body, and a surgeon who performed an operation without his patient s consent commits an assault for which he is liable for damages Judge Benjamin Cardoza; Schloendorff v NY Hosp, 211 N.Y. 125 at 129, (1914)
5 Informed Consent and State Law Legislation in all 50 states requires that a patient be advised of all possible complications and alternative treatment options before he or she is allowed to sign a consent form Extent of discussion varies from state to state
6 Standards for Informed Consent Prudent patient standard:* Provider must disclose all that an average, reasonable pt would consider material to his decision whether to undergo the proposed treatment Includes: Risks that could affect the decision of a reasonable person Incidence of injury and degree of possible harm Alternative choices of treatment Chance of death or disability Prudent physician standard: What an expert (usually a physician) would or would not have done in a particular situation *Canterbury v Spence 464 F2d 772 [DC Cir 1972]
7 Standards Applicable to Informed Consent JCAHO CMS Individual Hospital Policy State Law Texas and Louisiana require disclosure of specific risks
8 JCAHO: Necessary Elements of Diagnosis Informed Consent Purpose of Rx or procedure Risks and benefits of Rx or procedure Alternatives to the Rx or procedure The risks and benefits of not receiving treatment
9 Informed Consent and Georgia Law Butler v South Fulton Medical Center:* Even if provided proper and legal disclosure, a patient must comprehend what the physician is saying and understand the information on the consent form so (s)he can voluntarily offer permission for the proposed intervention *452 ES 2d 768 GA [1994]
10 Comprehension and Informed Consent Patients comprehension of surgical procedures is suboptimal, even if measured immediately following informed consent A survey of 11 studies (n =704) revealed that patients comprehension averaged 48% Significant patient factors: Age Education IQ Impaired cognitive function Locus of control Anxiety Other significant factors: Instrument used Content area of questions Time since consent
11 Challenges Physicians may do a good job with the communication aspects of informed consent The process varies significantly from clinician to clinician Documentation is typically weak
12 Traditional Written Consent Form Note: Limited descriptions Illegible handwriting Use of unacceptable abbreviations
13 Challenges with the Traditional Current Consent Form Time-consuming Details may be limited Content varies from provider to provider Risk of missing sections, signatures or dates Involves paper Often lost or misplaced
14 Limitations of Conventional Informed Consent Documents Review of 540 written consent forms from 157 hospitals The four basic elements of informed consent (risks, benefits, alternatives and other key aspects of the procedure) were present in only 26% of the documents Bottrell MM et al.: Arch Surgery 2000;135:26-33.
15 VA Experience A review of 91 written consent forms for radical prostatectomy: 29% -- inadequate information regarding Rx benefits 42% -- no mention of alternative Rx 85% -- all five standard risks not listed Issa MM, et al. AVAS Scientific Symposium, Houston, April 2002
16 VA Experience A review of 91 written consent forms for radical prostatectomy: The use of blood transfusion was disclosed on 90% of the consent forms HOWEVER, proper consent for blood products was not obtained in 82% of the cases Issa MM, et al. AVAS Scientific Symposium, Houston, April 2002
17 Potential Opportunities!!! Patient Safety Malpractice Issues Documentation Issues
18 Patient Safety Providing informed consent information to patients in written form may increase the patients comprehension of the procedure Better informed patients may be more compliant, less anxious and more satisfied
19 Potential Patient Safety Impact of Informed Consent Improving missed, incomplete or poorly understood informed consent is a significant patient safety opportunity Better informed patients are less likely to experience medical errors by acting as another layer of protection Shojania K et al. (eds.): Making Health Care Safer: A Critical Analysis of Patient Safety Practices. AHRQ; Evidence Report/Technology Assessment No. 43; AHRQ publication 01-E058.
20 Malpractice Expenses and Informed Consent Impact on malpractice claims From , the VA paid $555,752,354 in malpractice claims (mean = $46,314,363/yr) Legal expenses associated with these claims was ~ $11.3 million/year Lack of informed consent cited as primary cause in 2.7% of claims (> $ 1.55 M/yr) Weeks WB et.al.: Law Med Ethics 2001; 29:
21 Predictors for Malpractice Lawsuits One of the strongest [predictors] is the doctor's ability to communicate effectively with the patient. Informed consent problems are more likely to arise for a doctor who doesn't communicate well. But perhaps even more importantly, a doctor who doesn't communicate well is not likely to build a healthy relationship with a patient such that if a bad outcome did happen in medical care, the patient would be inclined to forgive rather than sue. Michelle Mello, PhD, JD, Assistant Professor of Health Policy and Law, Harvard School of Public Health. NPR Radio Interview: January 15, 2005.
22 Other Opportunities to Improve Traditional Informed Consent Lost or misplaced consent documents that delay OR procedures Costs associated with scanning consent documents
23 Study of Missing Consent Documents (Two VA Medical Centers) Percent of Procedures 100% 100% 92% 100% 80% 60% Traditional (paper) consent process Automated consent process 40% 20% 0% 6% Progress Note in the Patient Chart Consent Form in the Patient Chart O Hara R. Electronic Support for Patient Decisions: Automating and Integrating ting the Informed Consent Process. Presented at the 21 st Annual TEPR Conference, Salt Lake City, May 17, 2005.
24 Cost of Lost or Misplaced Consent Documents Cost of OR time = $20 per minute Time to find or re-obtain lost consent document ~ 10 minutes Cost per case = $200!
25 Annual Cost of Lost or Misplaced Consent Documents 212,000,000 Procedures performed in the U.S. each year 1 8% Percentage of consents that are lost or misplaced 2 16,960,000 Approx. number of lost or misplaced documents 10 minutes OR time spent replacing a lost/misplaced consent 2,826,667 Hours of wasted OR time each year $1,200 Average cost of OR time per hour 3,4 $3,392,000,000 Cost of lost or misplaced consent documents in U.S. 5,764 Number of U.S. hospitals 5 $588,480 Average Cost per U.S. hospital due to lost or misplaced consent documents 1 Inpatient Surgery, Data for the U.S. for 2002, National Center for Health Statistics (NCHS) NHAMCS: 2001 Outpatient Department Summary Emergency Department Summary. 2 Pilot Study of imedconsent - Report to the Health Systems Committee and the Informatics and Data Management Committee, Veterans Health Administration. 3 Salvati, E.A. and Wright, T.M. J Bone Joint Surg Am 2003; 85: Brodsky, J.B. Anesthesiology 1998; 88: AHA Hospital Statistics
26 Other Opportunities to Improve Traditional Informed Consent Lost or misplaced consent documents that delay OR procedures Costs associated with scanning consent documents Annual costs of scanning consent forms and advanced directives at 3 VA facilities ~ $80,000 per facility
27 Veterans Healthcare Administration 158 Hospitals 5.1 million patients treated annually 742,000 patients received inpatient services 49.8 million outpatient clinic visits
28 Veterans Healthcare Administration 15,000 physicians VA facilities are affiliated with: 107 medical schools 55 dental schools 1,200 other schools 81,000 health professionals receive training in VA facilities each year
29 Project to Improve the Informed Consent Process The VA is the nation s leader in the application of computer technology to patient medical record Potential Issues: Need to document the informed consent discussion as a progress note within the patient s EMR Lack of standardization from physician to physician and facility to facility Particularly acute for facilities with many residents
30 imedconsent TM Developed by Dialog Medical (Duluth, GA) Interfaces with VISTA and CPRS Allows providers to generate customized documents and handouts supporting informed consent and patient education Deemed to offer significant promise of improving informed consent by VHA Purchased by 15 VA Medical Centers
31 Urology Study Evaluate the automated informed consent application in the Outpatient Urology Clinic Applicable procedures Vasectomy Bladder Biopsy Cystoscopy Ureteral Stent Removal Prostate Biopsy
32 Procedure-Specific Consent Document Developed a procedure-specific consent for vasectomy Addressed the issues of standardization and lack of detail
33 Procedure Room 1 of 3
34 Automated Consent System Mobile computer cart Software Printer Digital signature pad
35 Automated Informed Consent Overview Consent typically obtained by a PA or physician using the computer Patient, physician and witness digitally sign the consent document Document is printed for inclusion in the patient chart Document is digitally stored
36 Patient Satisfaction Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Somewhat Dissatisfied Range: 3-5 SD 0.78 n=13 Range: 1-5 SD 0.88 n=23 Very Dissatisfied 1 0 Satisfaction Compared to Traditional Consent Overall Satisfaction
37 Clinician Satisfaction and Ease of Learning Very Satisfied/Very Easy 5 Somewhat Satisfied/Easy Neither Satisfied/Easy nor Dissatisfied/Difficult 4 3 Range: 4-5 SD 0.44 Range: 4-5 SD 0.33 Somewhat Dissatisfied/Difficult 2 n=9 n=9 Very Dissatisfied/Very Difficult 1 0 Overall Satisfaction Ease of Learning
38 Conclusions Enhanced consistency and efficiency across practice patterns Produced complete and clear documentation Afforded high patient and clinician satisfaction
39 imedconsent Phase II Trial Following favorable Phase I trial, Phase II trial run by VA Center for Ethics in Healthcare 11/03 1/04 in 5 VA Medical Centers Program modified to correct policy, safety, and clinical quality issues raised during Phase I trial Results: Most patients generally liked imedconsent Progressive improvement in practitioner (n = 41) and chief of surgery (8 of 14) responses Ease of use = very good in final week Substantial improvement in compliance with VA policy Issues: Only 3 of 5 sites were able to fully participate Due to the low number of [practitioner] responses, results may not be representative
40 imedconsent Current Status HSC and IDMC recommended natl. purchase Supported by VA Natl. Leadership Bd. 2/19/04 July, 05: installed and implemented in 125/158 medical centers Completion anticipated by mid August, 2005 Templates developed for all specialties except Neurosurgery and Hematology-Oncology
41 imedconsent Issues? Patient level effects: Comprehension Satisfaction Anxiety Compliance with directed care? Provider satisfaction? Impact on work flow? Cost/Benefit ratio
42 imedconsent Demonstration
43 Consent Library
44 Consent Builder VA Version
45 Diagnosis is Selected
46 Provider(s) is(are) Selected
47 Final Consent Document
48 Signatures are Collected
49 Document with Embedded Signatures
50 Patient Education Documents
51 Patient Education
52 Pre- and Post-Procedure Instructions
53 Anatomical Image Gallery
54 Annotatable Image
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Dealing with Medical Errors What should I say? R Singh MB BChir MA (Cantab) MBA MD (SUNY) Department of Family Medicine Associate Professor and Associate Director, UB Patient Safety Research Center Presented