Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? Automating Informed Consent – Are You Overlooking a Safety Opportunity? Neil H. Baum, MD Associate Clinical Professor of Urology Tulane Medical School Louisiana State University Medical School Timothy Kelly, MS, MBA Vice President, Dialog Medical Session Objectives � Improve the safety of your patients � Ensure compliance with regulatory organizations � Reduce your Med/Mal risk � Generate significant cost savings � Endear yourself to your physicians 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 1 of 27
Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? Origins and Evolution of Informed Consent Doctrine Origin of Informed Consent � Protection against battery. � Justice Brown, Appellate Court of Illinois, 1905: Under a free government at least, the free citizen's first and greatest right, which underlies all others—the right to the inviolability of his person, in other words, his right to himself—is the subject of universal acquiescence, and this right necessarily forbids a physician or surgeon, however skillful or eminent, who has been asked to examine, diagnose, advise, and prescribe (which are at least the necessary first steps in treatment and care), to violate without permission the bodily integrity of his patient by a major or capital operation, placing him under an anesthetics for that purpose, and operating on him without his consent or knowledge. . . Pratt v. Davis, 118 Ill. App. 161, 1905 WL 1717 (Ill. App. 1 Dist.) 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 2 of 27
Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? Origin of Informed Consent � Spelled out in statutes and case law in ALL 50 states. Examples of State Statutes � Texas and Louisiana both have Medical Disclosure Panels that specify specific risks that must be disclosed for certain procedures. LA TX � Pennsylvania law requires that physicians disclose their professional credentials, training or experience if so asked by a patient. PA 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 3 of 27
Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? Necessary Elements of Informed Consent � Diagnosis � Purpose of treatment or procedure � Risks and benefits of treatment or procedure � Alternatives including risks and benefits � The risks and benefits of not receiving treatment American Medical Association, Office of the General Counsel, Division of Health Law, www.ama-assn.org, accessed 11-1-05. Current Status of Informed Consent 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 4 of 27
Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? How Are We Doing? � Best-Case Reality � Physicians typically do a good job with the one- way verbal communication aspect. � Documentation is usually inadequate. � Worst-Case Reality � “…informed consent is often seen as simply a burdensome administrative practice that involves obtaining a signature on a form for the legal protection of physicians and institutions.” 1 1 Improving Patient Safety Through Informed Consent for Patients w Improving Patient Safety Through Informed Consent for Patients with Limited ith Limited Health Literacy. 2005. Washington DC: National Quality Forum. Health Literacy. 2005. Washington DC: National Quality Forum. Traditional Consent Forms 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 5 of 27
Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? Traditional Written Consent Form � Note: � Limited descriptions � Illegible handwriting � Use of unacceptable abbreviations Limitations of Traditional Informed Consent Documents � A review of 540 written consent forms, from 157 hospitals, found the necessary elements of informed consent (purpose, risks, benefits, & alternatives) in only 26% of the documents. Bottrell MM, et al. Archives of Surgery 2000;135:26-33. 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 6 of 27
Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? Limitations of Traditional Consent – VA Experience � A review of 91 written consent forms for radical prostatectomy: • The potential need for blood transfusion was disclosed on 90% of the consent forms. • HOWEVER, proper consent for blood products was ONLY obtained in 18% of the cases. Issa MM, et al. AVAS Scientific Symposium, Houston, April 2002. Patient Safety and Informed Consent 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 7 of 27
Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? Patient Safety � IOM Report – To Err Is Human � More than 1 million injuries and nearly 100,000 deaths occur annually in the United States due to mistakes in medical care. � Agency for Healthcare Research and Quality Evidence Report � Identified 79 evidence-based patient safety practices (e.g. use of perioperative Beta-blockers, use of CPOE, use of antimicrobial impregnated CVC catheters, active management of ICU patients by intensivists, etc.) Agency for Healthcare Research and Quality; 2001. Evidence Report/Technology Assessment No. 43 ; AHRQ publication 01-E058. Patient Safety � The AHRQ Evidence Report identified 11 practices that were rated most highly in terms of strength of evidence – one of the 11 – Enhanced Informed Consent � Incomplete or not fully comprehended informed consent is a significant patient safety issue. � Better informed patients “are less likely to experience medical errors by acting as another layer of protection.” 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 8 of 27
Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? Patient Safety � National Quality Forum Safe Practices � 30 healthcare practices that should be universally utilized in applicable clinical care settings to reduce the risk of harm to patients. � Safe Practice No. 10 – Enhanced Informed Consent. Patient Safety � Leapfrog Group � Made up of more than 170 companies and organizations that buy health care – represent >36 million covered lives and over $67 billion in healthcare spending. � Enhanced Informed Consent is a key component of The Leapfrog Group Hospital Quality and Safety Survey . 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 9 of 27
Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? Patient Safety – The Leapfrog Group � Less than one-third of all hospitals responding to the Leapfrog Group’s 2004 survey (287 out of 862 institutions or 33%) reported that they had fully implemented programs to help meet the goals of Safe Practice 10. Implementing a National Voluntary Consensus Standard for Informed Consent – A User’s Guide for Healthcare Professionals. 2005. Washington DC: National Quality Forum. The Leapfrog Group Hospital Quality and Safety Survey Enhanced informed consent is a component of the Safe Practices Score Did not yet meet Leapfrog’s www.leapfroggroup.org Accessed 11-1-05. criteria for a good early stage effort. 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 10 of 27
Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? The Leapfrog Group Hospital Quality and Safety Survey An opportunity to improve upon the informed consent process. 2 of 8 points (25%) www.leapfroggroup.org Accessed 11-1-05. Other Costs Associated with Inadequate or Traditional Informed Consent 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 11 of 27
Automating Informed Consent – Automating Informed Consent – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity? Informed Consent Costs � Medical malpractice/legal liability costs � Transcription costs � Costs associated with a paper-based process � Document scanning costs � Impact of lost or misplaced documents Medical Malpractice/Legal Liability Costs 2006 Annual HIMSS Conference February 12-16, 2006 San Diego 12 of 27
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