Legal briefing: Shared decision making and patient decision aids

Journal of Clinical Ethics

Volumn 24, Issue 1, 2013, Pages 70-80

  Pope, Thaddeus Mason ^a,b   Hexum, Melinda ^a,b  

^a Health Law Institute   (United States)

^b HAMLINE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DECISION MAKING; DECISION SUPPORT SYSTEM; DOCTOR PATIENT RELATION; ETHICS; HUMAN; INFORMED CONSENT; MEDICOLEGAL ASPECT; PATIENT; PATIENT PARTICIPATION; PHYSICIAN; PSYCHOLOGICAL ASPECT; UNITED STATES;

DECISION MAKING; DECISION SUPPORT TECHNIQUES; HUMANS; INFORMED CONSENT; LEGISLATION, MEDICAL; PATIENT PARTICIPATION; PATIENTS; PHYSICIAN-PATIENT RELATIONS; PHYSICIANS; UNITED STATES;

MLCS; MLOWN;

EID: 84877354211     PISSN: 10467890     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (119)

1. T. M. Pope, "Legal Briefing: Informed Consent", The Journal of Clinical Ethics 21, no. 1(Spring 2010):72-82.
2. Patient Protection and Affordable Care Act (ACA), Pub. L. No. 111-148, tit. III, sec. 3506
3. codified at 42 U. S. C. § 299b-36.
4. P. A. Ubel, Critical Decisions: How You and Your Doctor Can Make the Right Medical Choices Together (New York: Harper Collins 2012);
5. "New Era of Patient Engagement", Health Affairs 32, no. 2(2013):202-426;
6. E. O. Lee and E. J. Emanuel, "Shared Decision Making to Improve Care and Reduce Costs", New England Journal of Medicine 368, no. 1(2013):6-8.
7. C. Hsu et al., "Incorporating Patient Decision Aids into Standard Clinical Practice in an Integrated Delivery System", Medical Decision Making 33, no. 1(2013):85-97;
8. J. C. Brehaut, "Informed Consent Documents Do Not Encourage Good-Quality Decision Making", Journal of Clinical Epidemiology 65, no. 7(2012):708-24;
9. M. Hostetter and S. Klein, "Helping Patients Make Better Treatment Choices with Decision Aids", Quality Matters (October-November 2012).
10. Notably, Dialog Medical's iMedConsent solution is being used in "more than 200 hospitals, and in thousands of physician practices." http://www.dialogmedical.com/products/, accessed 15 February 2013. And 10 healthcare organizations, including Massachusetts General Hospital, are implementing and testing decision aids as "demonstration sites" for the Informed Medical Decisions Foundation. Decision aids are also being used in clinical trials.
11. B. W. Palmer et al., "Effectiveness of Multimedia Aids to Enhance Comprehension of Research Consent Information: A Systematic Review", IRB: Ethics and Human Research 34, no. 6(2012):1-15.
12. Myrtus is evaluating how digital patient decision aids might simplify enrollment and enhance patients' understanding during the informed consent process for human subject research, http://www.mytrus.com/, accessed 15 February 2013.
13. D. McCarthy et al., "What Did the Doctor Say? Health Literacy and the Recall of Medical Instructions", Medical Care 50, no. 4(2012):277-82;
14. F. J. Fowler Jr. et al., "Improving and Involving Patients to Improve the Quality of Medical Decisions", Health Affairs 30, no. 4(2011):699-706;
15. M. Brezis et al., "Quality of Informed Consent for Invasive Procedures", International Journal for Quality Health Care 20, no. 5(2008):352-7;
16. D. B. White et al., "Toward Shared Decision Making at the End of Life in Intensive Care Units Opportunities for Improvement", Archives of Internal Medicine 167, no. 5(2007):461-7;
17. J. S. King and B. W. Moulton, "Rethinking Informed Consent: The Case for Shared Medical Decision-Making", American Journal of Law & Medicine 32, no. 4(2006):429-501;
18. M. M. Bottrell et al, "Hospital Informed Consent for Procedure Forms: Facilitating Quality Patient-Physician Interaction", Archives of Surgery 135, no. 1(2000):26-33;
19. C. H. Braddock et al., "Informed Decision Making in Outpatient Practice: Time to Get Back to Basics", Journal of the American Medical Association 282, no. 24(1999):2313-20.
20. U. S. C. § 299b-36 (b) (2);
21. Patient-Centered Outcomes Research Institute, "PCORI PFA Cycle I Awardees", (21 December 2012), http://www.pcori.org/assets/PFA-Awards- Cycle-l-2012.pdf, accessed 15 February 2013
22. IOM, Crossing the Quality Chasm: A New Health System for the 21st Century (Washington, D. C.: National Academy Press, 2001).
23. U. S. C. § 299b-36 (b) (l).
24. B. L. McAneny, "Report of the Council on Medical Services", CMS Report 7-A-10: Shared Decision Making (2010), http://www.ama-assn.org/ resources/docs/cms/al0-cms-rpt-7.pdf, accessed 15 February 2013.
25. G. Elwyn et al., "Investing in Deliberation: A Definition and Classification of Decision Support Interventions for People Facing Difficult Health Decisions", Medical Decision Making 30, no. 6(2010):701-11.
26. "Patient Decision Aids", Ottawa Research Hospital Institute, http://decisionaid.ohri.ca/AZlist.html, accessed 15 February 2013.
27. http://www.acpdecisions.org/, accessed 15 February 2013.
28. http://www.decisionlaboratory.com/, accessed 15 February 2013.
29. http://www.healthwise.org/, accessed 15 February 2013.
30. http://www.informedmedicaldecisions.org/, accessed 15 February 2013.
31. http://shareddecisions.mayoclinic.org/, accessed 15 February 2013.
32. http://www.dialogmedical.com/ (developer of "iMedConsent"), accessed 15 February 2013.
33. http://www.emmisolutions.com/home, accessed 15 February 2013.
34. http://www.health dialog.com/Main/defa ult, accessed 15 February 2013.
35. http://kramesstaywell.com/Home, accessed 15 February 2013.
36. http://www.patient-education.com/ (developer of "X-Plain"), accessed 15 February 2013.
37. https://www.welvie.com/index.aspx, accessed 15 February 2013.
38. http://www.effectivehealthcare.ahrq.gov/ehc/decisionaids/prostate-cancer/ , accessed 15 February 2013;
39. http://www.rightcare.nhs.uk, accessed 17 February 2013.
40. D. Stacey et al., "Decision Aids for People Facing Health Treatment or Screening Decisions", Cochrane Database of Systematic Reviews 10, no. CD001431(2011): doi: 10.1002/14651858. CD001431. pub3.
41. D. Arterburn et al., "Introducing Decision Aids at Group Health Was Linked to Sharply Lower Hip and Knee Surgery Rates and Costs", Health Affairs 31, no. 9(2012):2094-104;
42. A. D. M. Kennedy et al., "Effects of Decision Aids for Mennoraghia on Treatment Choices, Health Outcomes and Costs", Journal of the American Medical Association 288, no. 21(2002):2701-8.
43. D. Veroff et al., "Enhanced Support for Shared Decision Making Reduced Costs of Care for Patients with Preference-Sensitive Conditions", Health Affairs 32, no. 2(2013):285-93.
44. A. E. Volandes et al., "Randomized Controlled Trial of a Video Decision Support Tool for Cardiopulmonary Resuscitation Decision Making in Advanced Cancer", Journal of Clinical Oncology 31, no. 3(2013):380-6;
45. A. E. Volandes et al., "A Randomized Controlled Trial of a Goals-of-Care Video for Elderly Patients Admitted to Skilled Nursing Facilities", Journal of Palliative Medicine 15, no. 7(2012):805-11;
46. J. McCannon et al., "Augmenting Communication and Decision Making in the Intensive Care Unit with a Cardiopulmonary Resuscitation Video Decision Support Tool: A Temporal Intervention Study", Journal of Palliative Medicine 15, no. 12(2012):1382-7;
47. A. El-Jawahri et al., "Use of Video to Facilitate End-of-Life Discussions with Patients with Cancer: A Randomized Controlled Trial", Journal of Clinical Oncology 28, no. 2(2010):305-10.
48. Lewin Group, Bending the Curve: Technical Documentation (New York, N. Y.: Commonwealth Fund, 2008), http://www/lewin. com/publications/Publication/325, accessed 15 February 2013.
49. G. A. Lin et al., "An Effort to Spread Decision Aids in Five California Primary Care Practices Yielded Low Distribution, Highlighting Hurdles", Health Affairs 32, no. 2(2013):311-20;
50. M. W. Friedberg, "A Demonstration of Shared Decision Making in Primary Care Highlights Barriers to Adoption and Potential Remedies", Health Affairs 32, no. 2(2013):268-75;
51. V. A. Shaffer, "Why Do Patients Derogate Physicians Who Use a Computer-Based Diagnostic Support System?" Medical Decision Making 33, no. 1(2013):108-18;
52. D. L. Frosch et al., "Authoritarian Physicians and Patients' Fear of Being Labeled 'Difficult' among Key Obstacles to Shared Decision Making", Health Affairs 31, no. 5 (2012) 1030-8.
53. Even before the ACA, the Empowering Medicare Choices Act would have required the U. S. DHHS to promulgate regulations establishing standards and requirements for shared decision making under Medicare, based on the results of a pilot program. H. R. 2580, 111th Cong., 1st Sess. (2009) (Blumenauer, D-Ore.);
54. S. 1133, 111th Cong., 1st Sess. (2009) (Wyden, D-Ore.). The companion bills ultimately died in committee.
55. The stated purpose of this section of the Affordable Care Act is to "facilitate collaborative processes between patients, caregivers or authorized representatives, and clinicians that engages [sic] the patient, caregiver or authorized representative in decision making, provides patients, caregivers or authorized representatives with information about treatment options, and facilitates the incorporation of patient preferences and values into the medical plan. " 42 U. S. C. § 299b-36 (a).
56. U. S. C. § 299b-36 (c).
57. U. S. C. § 299b-36 (d).
58. U. S. C. § 299b-36 (e).
59. U. S. C. § 299b-36 (e).
60. In addition to those measures described below, Section 3013 of ACA authorizes DHHS to award grants to develop, improve, update, or expand "quality measures." 42 U. S. C. § 299b-31. Section 3013 directs DHHS to prioritize those measures that allow the assessment of "use of shared decision making tools"
61. U. S. C. § 299b-31 (c) (2).
62. ACA § 3021, codified at 42 U. S. C. § 1315a (a).
63. ACA § 3021, codified at 42 U. S. C. § 1315a (a).
64. ACA § 3021, codified at 42 U. S. C. § 1315a (c).
65. ACA § 3021, codified at 42 U. S. C. § 1315a (b) (2) (B) (ix).
66. CMMS, CMMI, "Health Care Innovation Awards", http://innovation. cms. gov/initiatives/Health-Care-Innovation-Awards/, accessed 15 February 2013.
67. CMMS, CMMI, "Healthcare Innovation Award Project Profiles", http://innovation. cms.gov/Files/x/HCIA-Project-Profiles.pdf, last updated 30 July 2012. A search of the document for "decision" turned up a handful of projects with a focus on implementation of shared decision-making models, including: (1) MedExpert International, Inc.'s Quality Medical Management System, (2) the Trustees of Dartmouth College's "Patient and Family Activators" project, and (3) Welvie, LLC's "Shared decision-making for preference-sensitive surgery" project.
68. U. S. C. § 299b-7;
69. http://www.ef/ective health care.ahrq.gov/in dex. cfm/wh o-is-in volved-in - the-effective-health-care-program1/, accessed 15 February 2013;
70. http://gold.ahrq.gov/projectsearch/grant-search.jsp, accessed 15 February 2013. Search in abstract title field for "decision aid" or "decision tool" for AHRQ-funded projects related to patient decision aids.
71. http://effectivehealthcare.ahrq.gov/index.cfm/tools-and-resources/ patient-decisionaids/, accessed 15 February 2013.
72. R. Fleurence et al., "How the Patient-Centered Outcomes Research Institute Is Engaging Patients and Others in Shaping its Research Agenda", Health Affairs 32, no. 2(2013):393-400.
73. ACA § 6301, codified at 42 U. S. C. § 1320e.
74. Patient-Centered Outcomes Research Institute, "National Priorities for Research and Research Agenda" (21 May 2012) http://www.pcori.org/ assets/PCORI-National-Priorities-and-Research-Agen da-2012-05-21-FINAL.pdf, accessed 15 February 2013.
75. Patient-Centered Outcomes Research Institute, "PCORI PFA Cycle I Awardees" (21 December 2012) http://www.pcori.org/assets/PFA-Awards-Cycle- 1-2012.pdf. At least two studies sought to assess whether decision aids improved the quality of decision-making or clinical outcomes (for pediatric type I diabetes, Shared Medical Decision Making in Pediatric Diabetes, p. 17; for chest pain patients in the emergency department, Shared Decision Making in the Emergency Department: The Chest Pain Trial, p. 4). One study sought to develop a decision tool to inform the medical decision making of parents of children with disorders of sex development (Decision Support for Parents Receiving Genetic Information about Child's Rare Disease, p. 21).
76. ACA § 3022, codified at 42 U. S. C. § 1395jjj.
77. ACA § 3022, codified at 42 U. S. C. § 1395jjj (ab).
78. ACA § 3022, codified at 42 U. S. C. § 1395jjj (b) and (d).
79. ACA § 3022, codified at 42 U. S. C. § 1395jjj (b) (2) (G).
80. DHHS, "Final Rule: Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations", 76 Fed. Reg. 67, 802, 67, 828 (2 Nov. 2011).
81. A. Shafir and J. Rosenthal, Shared Decision Making: Advancing Patient-Centered Care through State and Federal Implementation (Informed Medical Decisions Foundation, 2012);
82. D. L. Frosch et al., "Shared Decision Making in the United States: Policy and Implementation Activity on Multiple Fronts", German Journal for Evidence and Quality in Health Care 105, no. 4 (2011) 305-12.
83. J. King and B. Moulton, "Group Health's Participation in a Shared Decision-Making Demonstration Yielded Lessons, Such As Role of Culture Change", Health Affairs 32, no. 2(2013):294-302.
84. Wash. S. B. 5930(2007), enacted as 2007 Laws Ch. 259
85. codified at Wash. Rev. Code §§ 7.70.060 & 41.05.033.
86. Wash. H. B. 1311 (2011)
87. enacted as 2011 Laws Ch. 313, codified at Wash. Rev. Code § 70.250.050.
88. Wash. H. B. 2318(2012), enacted as 2012 Laws Ch. 101
89. codified at Wash. Rev. Code § 7.70.060.
90. Wash. Admin. Code §§ 182-60-005 to -030.
91. Mass. Acts. Ch. 224 § 19
92. codified at Mass. Gen. Laws Ann. 12C § 20.
93. Vt. S. B. 129 (2009) (Lunge); enacted as 2009 Act 49.
94. Vermont Department of Health, "VER-MONT2009: Shared Decision Making: Report to the Legislature on Act 49, Section 4" (15 January 2010), http://www.leg.state.vt.us/reports/2010ExternalReports/252637.pdf, accessed 15 February 2013.
95. Me. LD 1358 (2009) (Mills), enacted as 2009 Maine Laws Ch. 104. The original bill would have required health insurance carriers and the MaineCare program to implement shared decision making.
96. Shared Decision Making Study Group for the Dirigo Health Agency's Maine Quality Forum, The Practice and Impact of Shared Decision Making (February 2011) http://muskie.usm.maine.edu/Publications/PHHP/Shared-Decision-Making-Final- Report.pdf, accessed 15 February 2013.
97. "INFORMED CONSENT: Guidelines from the Maine Board of Licensure in Medicine", http://www.docboard.org/me/administrative/POLICIES/ INFORMED%20CONSENT.doc, accessed 15 February 2013.
98. Minn. Admin. Rules 4764.0040.
99. Conn. H. B. 5193 (2009) (Sayers);
100. Okla. S. B. 1002 (2012) (Adelson).
101. Minn. S. F. 696, 86th Legis. Sess. (2009);
102. Minn. H. F. 1140, 86th Legis. Sess. (2009);
103. Minn. S. F. 542, 87th Legis. Sess. (2011) (Berglin).
104. N. Sawicki, "Patient Protection and Decision-Aid Quality: Regulatory and Tort Law Approaches", Arizona Law Review 54, no. 3(2012):621-72.
105. R. Avraham, "Clinical Practice Guidelines: The Warped Incentives in the U. S. Healthcare System", American Journal of Law & Medicine 37, no. 1(2011):7-40;
106. @ M. J. Mehlman, "Medical Practice Guidelines as Malpractice Safe Harbors: Illusion or Deceit?" Journal of Law, Medicine and Ethics 40, no. 2(2012):286-300. Advance directives are also often developed by nonclinicians, yet meant for implementation by clinicians.
107. J. S. King and B. Moultonassert, "a rigorous accreditation process [for patient decision aids], such as the Cochrane System Review, is necessary to protect the interests of physicians and patients." They note, "While many creators of decision aids have spent significant time and resources developing their instruments and techniques, these efforts have largely been ad hoc and may differ substantially from one another. Additionally, these aids may be biased toward or against treatments"
108. J. E. Wennberg et al., "Extending the P4P Agenda, Part 1: How Medicare Can Improve Patient Decision Making and Reduce Unnecessary Care", Health Affairs 26, no. 1(2007):1564-74.
109. G. Elwyn et al., "Assessing the Quality of Decision Support Technologies Using the International Patient Decision Aid Standards Instrument (IPDASi)", PLoS ONE 4, no. 3: e4705, doi:10.1371/joumal.pone.0004705.
110. Ottawa Hospital Research Institute, Decision Aid Library Inventory (DALI), http://decisionaid. ohri.ca/cochinvent.php, accessed 15 February 2013.
111. For an exploration of the decision aids in the Ottawa Hospital Research Institute's Library, see http://decisionaid.ohri.ca/AZinvent.php, accessed 15 February 2013.
112. N. N. Sawicki, "Informed Consent Beyond the Physician-Patient Encounter: Tort Law Implications of Extra-Clinical Decision Support Tools", Annals of Health Law 21, no. 1(2012):1-10.
113. Wash. Rev. Code Ann. § 7.70.060.
114. Wash. Rev. Code Ann. § 7.70.060.
115. M. J. Barry, Jr., et al., "Reactions of Potential Jurors to a Hypothetical Malpractice Suit Alleging Failure to Perform a Prostate-Specific Antigen Test", Journal of Law, Medicine and Ethics 36, no. 2(2008):396-402.
116. Only four states-New Hampshire, Rhode Island, Oklahoma, and Oregon-have case law or statutes that reject the objective "reasonable patient" standard. E. M. Tenenbaum, "Revitalizing Informed Consent and Protecting Patient Autonomy: An Appeal to Abandon Objective Causation", Oklahoma Law Review 64, no. 4(2012):697-758.
117. U. S. C. § 299b-36 (intending to promote the use of patient decision aids for "preference sensitive care").
118. U. S. C. § 299b-36 (b) (2) (defining "preference sensitive care" as "medical care for which the clinical evidence does not clearly support one treatment option such that the appropriate course of treatment depends on the values of the patient or the preferences of the patient, caregivers or authorized representatives regarding the benefits, harms and scientific evidence for each treatment option. ").
119. Scott v. Bradford, 606 P.2d 554 (Okla. 1979).