Practice. Theory. Revolutionizing Informed Consent with Certified Patient Decision Aids. Not even close
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1 Revolutionizing Informed Consent with Certified Patient Decision Aids ASLME HLP (Boston, MA) Saturday, June 4, 2016 Thaddeus Mason Pope, JD, PhD Mitchell Hamline School of Law Chasm between theory & practice Theory Appellate opinions re autonomy & self-determination Practice No Not even close 1
2 Too much Too fast Too complex Also in medicine Even if accurate & complete (but often is not) Roadmap 5 Failure of informed consent What are PDAs PDAs are effective Moving PDAs from lab to clinic Certification 2
3 Failure of informed consent law 1972 Jerry Canterbury Justice Mosk lengthy 2016 polsyllabic discourse 3
4 lengthy polsyllabic discourse Still Baby pic me Nothing change entire life Process problem Terrible outcomes 4
5 Only 12 in 100 understand cardiac catheterization Only 5 in 100 understand cancer diagnosis Only 3 in 100 understand PCI 90% fail rate 5
6 Fix Patient decision aids Evidence based educational tools Accurate Complete Understandable 6
7 PDAs work Robust evidence shows PDAs are highly effective > 130 RCTs BUT Hardly any clinical usage 7
8 Promise remains elusive Move PDAs from lab to clinic we must incentivize PDA use Assure PDA quality Certification Risks, benefits, options Complete & accurate Presented meaningfully Free from bias / COI 8
9 Certification assures PDA presents accurate, unbiased, up to date, understandable information + assistance in values/preferences clarification 2010 ACA 3056 Contract with an entity to synthesize evidence and establish consensus based standards
10 No criteria No process No entity for certification 2006 JCE from March
11 Certification 2016 is underway Criteria Process HCA CMO 11
12 In use Labor & Delivery Especially C-section vaginal delivery Submission period April 12, 2016 May 27, 2016 Next priority areas: Joint replacement and spine care (2017) Cardiac care and end of life care (2018) Going beyond certification Incentives 12
13 3 1 Safe harbor for using certified PDA Presumption that duty fulfilled Rebuttable only with clear & convincing evidence 2 State as purchaser 13
14 30% citizens Medicaid - 1.8m Employees - 350k State as first mover 3 New standard of care Looking ahead A single courageous state may... serve as a laboratory; and try novel social... experiments... 14
15 Model White paper on national standards Business model for PDA certification 15
16 Thaddeus Mason Pope, JD, PhD Director, Health Law Institute Mitchell Hamline School of Law 875 Summit Avenue Saint Paul, Minnesota T C E Thaddeus.Pope@mitchellhamline.edu W B medicalfutility.blogspot.com 91 Selected References Thaddeus Pope, Emerging Legal Issues for Providers in the US, in SHARED DECISION MAKING IN HEALTHCARE: ACHIEVING EVIDENCE- BASED PATIENT CHOICE (Oxford University Press 2016) (with Benjamin Moulton). Thaddeus Pope, Legal Briefing: Informed Consent in the Clinical Context, 25(2) JOURNAL OF CLINICAL ETHICS (2014) (with Melinda Hexum). Thaddeus Pope, Legal Briefing: Shared Decision Making and Patient Decision Aids, 24(1) JOURNAL OF CLINICAL ETHICS (2013) (with Mindy Hexum). Thaddeus Pope, Clinicians May Not Administer Life- Sustaining Treatment without Consent: Civil, Criminal, and Disciplinary Sanctions, 9 JOURNAL OF HEALTH & BIOMEDICAL LAW (2013). Thaddeus Pope, Patient Rights, in OXFORD TEXTBOOK OF CRITICAL CARE (Webb, Angus, Finfer, Gattioni & Singer eds., Oxford University Press forthcoming 2015) (with Douglas B. White). Thaddeus Pope, Legal Briefing: The New Patient Self Determination Act, 24(2) JOURNAL OF CLINICAL ETHICS (2013). Thaddeus Pope, Legal Briefing: POLST (Physician Orders for Life-Sustaining Treatment), 23(4) J. CLINICAL ETHICS (2012) (with Mindy Hexum). Thaddeus Pope, Legal Briefing: Informed Consent, 21(1) J. CLINICAL ETHICS (2010). Thaddeus Pope, The Maladaptation of Miranda to Advance Directives: A Critique of the Implementation of the Patient Self Determination Act, 9 HEALTH MATRIX (1999). 16
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