1. Shared Decision Making: A Case Study and Policy Analysis Jeff Belkora, PhD Assistant Professor, Institute for Health Policy Studies Director of Decision Services, Breast Care Center University of California, San Francisco Center for Medicare and Medicaid Services Baltimore, MD November 4, 2009 jeff.belkora@ucsfmedctr.org (650) 533 6965 http://www.jeffbelkora.com/health-reform/ Please use this URL in references to this presentation www.guidesmith.org/evidence List of references to literature www.guidesmith.org/acknowledgments/ Sources of inspiration and support Disclosure of current funding sources: University of California, San Francisco California Breast Cancer Research Program Foundation for Informed Medical Decision Making Palo Alto Medical Foundation

2. 2 Outline 1.Overview of shared decision making 2.Case Study – Decision Services at the UCSF Breast Care Center 3.Policy discussion

3. My professional mission Translating what is good and true about shared decision making into practice Edwards, A. and G. Elwyn, Shared decision-making in health care : achieving evidence-based patient choice. 2nd ed. 2009, Oxford: Oxford University Press. xviii, 414 p.

4. 4 Sometimes, medical decisions are evident Known benefits and harms Benefits >> harms Universal agreement “Synagis is an effective treatment for your premature boy with RSV” “Surfactant for lungs” Evidence-based or effective care

5. 5 Often, decisions are hard (close calls, preference-sensitive care…) Inadequate evidence Significant potential for harms Different patients feel very differently about… Value Timing Likelihood …of benefits and harms “Do we really need a spinal tap to rule out meningitis in my daughter?”

6. 6 Preference-sensitive conditions (partial list) Arthritis of the hip and knee Chronic back pain Chest pain (stable angina) Enlarged prostate (benign prostatic hyperplasia) Early stage prostate cancer Early stage breast cancer End of life care Peripheral vascular disease Gall stones Threat of stroke from carotid artery disease

7. 7 Breast cancer decisions Grade Nodes Size Radiation Hormone therapy Surgery Stage Chemotherapy DiagnosisTreatment

8. 8 What is this patient talking about? “Decision and consultation service was fantastic. Made me feel so well-prepared. This is how medicine should work. “Having the booklet info available online was terrific. This was exactly the material (statistics) I was looking for all over the web, but having a hard time finding in a consolidated format that made sense. “The consultation with doctor was superb. “Everything was very proactive."

9. 9 Shared decision making = informed & involved patients Professional and patient negotiate how they want to work together Review treatment options and outcomes Incorporate patient preferences and values Address patient questions and concerns Charles et al: Shared Decision-Making in the Medical Encounter: What Does It Mean? Soc. Sci. Med., 1997. 44(5): p. 681-92.

10. 10 Shared decision making practices In the context of patient-professional consultations, both sides: –Read / Review –Think –Write –Talk –Record Decision and communication aids facilitate this critical reflection

11. 11 Three steps to inform & involve patients 1. Review decision aids 2. List questions 3. Make notes & recordings

12. 12 Decision aids In 55 trials addressing 23 different screening or treatment decisions: –Greater knowledge and more accurate risk perceptions –Greater satisfaction, participation, and confidence in decisions –Fewer undecided patients, and fewer choosing major surgery “Patient decision aids increase people's involvement and are more likely to lead to informed, values-based decisions.” O'Connor et al: Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev, 2003

13. 13 Question listing 33 randomized controlled trials involving 8,244 patients Statistically significant increases in question asking and satisfaction “Interventions to help patients address their information needs within consultations produce limited benefits to patients” Kinnersley et al: Interventions before consultations for helping patients address their information needs. Cochrane Database Syst Rev, 2007(3).

14. 14 Audio-recording, notetaking, summarizing 15 randomized studies involving 2,318 participants 9 measured recall of information 5 found statistically significant increases in information recall* “The provision of recordings or summaries of key consultations may benefit most adults with cancer.” Pitkethly et al: Recordings or summaries of consultations for people with cancer. Cochrane Database Syst Rev, 2008. *The trials were too heterogeneous to allow meta-analyses.

15. 15 Benefits of being informed and involved Positive psychological outcomes in 26 of 35 trials* –Anxiety, depression, quality of life, and well-being Positive physical outcomes in 11 of 25 trials* –Pain and functional status Griffin et al: Effect on health-related outcomes of interventions to alter the interaction between patients and practitioners. Ann Fam Med, 2004. 2(6): p. 595-608. *The trials were too heterogeneous to allow meta-analyses. “A range of approaches can achieve changes in this [patient-professional] interaction and some show promise in improving patients’ health.”

16. 16 Informed and involved patients – key to quality? Ethical and educational benefits + Knowledge + Value concordance + Satisfaction Psychological and physical benefits System benefits + Countervailing force to supplier-induced overtreatment + More appropriate resource use (Lewin: $4.1 billion savings in 2010) + Safety check + Quality

17. 17 Theory of diffusion – Rogers, Geoff Moore Rogers, E.M., Diffusion of innovations. 5th ed. 2003, New York: Free Press. Moore, G.A., Crossing the chasm. 1991, [New York, N.Y.]: HarperBusiness.

18. 18 Tipping point for shared decision making Innovators and early adopters have proved concept State and federal legislation: demonstration projects The last mile in comparative effectiveness research? O'Connor, A.M., et al., Toward the 'tipping point': decision aids and informed patient choice. Health Aff, 2007. 26(3): p. 716-25.

19. 19 Innovators and Early Adopters Academic –Ottawa, Sydney, Cardiff, Dartmouth, UCSF… –International Patient Decision Aids Standards collaboration Non-Profit –Foundation for Informed Medical Decision Making (FIMDM) –Center for Information Therapy Industry –Healthwise, Health Dialog, … –Kaiser, GroupHealth, Partners, … Government (more on this later) –State legislatures –Federal bills

20. 20 Healthwise, Inc. (Source: IRS 990 PF) Non-profit founded in 1975 $19 million revenue in FY 2007-2008 “Dissemination of printed and electronic educational, objective, evidence-based consumer healthcare materials, which empower consumers to make informed health decisions ($13 million)” –106 million health handbooks and 15 million brochures distributed –896 million consumers reviewed electronic health information Development of and regular updates to educational, objective, evidence-based consumer health information this includes writing, editing, designing, printing and engineering of electronic health information, printed health handbooks, and other media ($6 million)

21. 21 Foundation for Informed Medical Decision Making Non-profit founded by Jack Wennberg and Al Mulley in 1989 Licensing agreement with Health Dialog in 1997 –5% royalty on revenues: $18 million in FY2008 (IRS 990-PF) Develop patient decision aids to facilitate shared decision-making –No $ from device or drug manufacturers Fund research on informing and involving patients in decisions Support clinical demonstrations of shared decision-making Advance policy to support informed medical decision making

22. 22 Eleven FIMDM Primary Care demonstration sites Dartmouth-Hitchcock Medical Center, NH Massachusetts General Hospital, Boston, MA MaineHealth, Portland, Maine Mercy Clinics Inc, Des Moines, Iowa Oregon Rural Practice-based Research Network, Portland, Oregon Palo Alto Medical Foundation, Palo Alto, California Pittsburgh VA Health Care System, Pittsburgh, Pennsylvania Stillwater Medical Group, Stillwater, Minnesota University of California San Diego, San Diego, California University of North Carolina at Chapel Hill, North Carolina White River Junction VA Medical Center, Vermont

23. 23 Four FIMDM specialty care demonstration sites Allegheny General Hospital Breast Care Center, Pittsburgh, PA Dartmouth Hitchcock Comprehensive Breast Program, NH Dartmouth Hitchcock Urology and Radiation Oncology, NH University of California San Francisco Breast Care Center, CA

24. 24 Health Dialog, Inc Founded in 1997 –“Health Dialog was built in collaboration with the not-for-profit Foundation for Informed Medical Decision Making (FIMDM) to address unwarranted variation in healthcare.” –“Health Dialog is a leading provider of care management, healthcare analytics, and decision support” One of Inc.’s 500 fastest-growing private companies 2003-2005 –2005 revenue of $136 million (2007: $235 million) –20 million lives served in 2007 Acquired in 2008 by Bupa for $775 million

25. 25 Inventory of Decision Aids

26. 26 International Patient Decision Aids Standards Background document and checklist at http://ipdas.ohri.cahttp://ipdas.ohri.ca Fragment: Elwyn et al: Developing a quality criteria framework for patient decision aids. BMJ, 2006. 333(7565): p. 417.

27. 27 Outline 1.Overview of shared decision making 2.Case Study – Decision Services at the UCSF Breast Care Center 3.Policy discussion

28. 28 Current research and clinical roles at UCSF Assistant Professor, Surgery and Health Policy, UCSF Director of Decision Services, UCSF Breast Care Center

29. 29 My work translating decision research into practice Mendocino Cancer Resource Center UCSF, PAMF Cancer Support Community (formerly Wellness Community)

30. 30 UCSF Breast Care Center Laura Esserman, Director

31. 31 Belkora (back left) and Volz (front right) oversee 10 premedical interns

32. 32 Decision Support in Practice 1. Monitor health 2. Detect problems 3. Make appointments 4. Visit professionals 5. Debrief visits 6. Decide and take action Care Planning Navigation Survivorship Navigation

33. 33 Decision Support in Practice 1. Monitor health 2. Detect problems 3. Make appointments 4. Visit professionals 5. Debrief visits 6. Decide and take action List questions Review decision aids Notes Recordings Summaries Care Planning Navigation Survivorship Navigation

34. 34 Premed explains Decision Services (video clip) http://centerforinnovation.mayo.edu/transform/jeff-belkora.html

35. 35 Decision Aid video clip illustrating risk communication

36. 36 Question-listing checklist and audio clip

37. 37 Fragment of a question list (see handout) SITUATION I was diagnosed with breast cancer in August and had surgery a month later, followed by radiation I want to understand the following terms on the pathology report: –Moderately differentiated infiltrating carcinoma –Surgical margins free of tumor – does that mean that there is none for 1/2 cm around edges? I am currently on Arimidex.

38. 38 Audio-recording and note-taking excerpt

39. 39 Fragment of consultation notes (see handout) SITUATION Infiltrating ductal carcinoma breaks through duct membrane and invades breast tissue. Your closest margin is 0.5 cm, others are 2.0 cm. CHOICES No chemotherapy Stay on Arimidex, maintain weight, exercise –Come to UCSF once every 4-6 months for monitoring, have mammograms done here Chemotherapy –4 cycles of Adriamycin + Cytoxan (AC): 1 dose every 3 weeks, each dose takes about 90 min. If you do decide to go on AC, we need to do an echocardiogram or a MUGA scan on your heart to determine how well it squeezes. –OR 4 cycles of Taxotere + Cytoxan (TC)

40. 40 Patient reaction to decision aid (video clip)

41. 41 Patient reaction to audio-recording and note-taking

42. 42 Impact of decision aids at UCSF Survey of 1185 patients sent 1700 decision aids 2005-2008 –36% response rate –96% said “I would recommend” the decision aids –Median satisfaction of 10 Survey of 540 patients sent 936 decision aids in 2008 Unpublished data

43. 43 Impact of question-listing, audio-recording, note-taking 285 question-listing, audiorecording, notetaking services –242 had received decision aids Unpublished data

44. 44 Physician Shared Decision Making BehaviorsYesTotal% Provider discussed more than one treatment10210696% “Participated in this choice as much as I wanted to”707495% Provider recommended a treatment9110190% Provider discussed the benefits of treatment choices A LOT8610185% Provider had answered ALL their questions11614182% Provider asked which choice the patient thought was best629764% Patient made a treatment decision8413164% Provider discussed risks and side effects A LOT559955% From 285 sessions, 180 patient surveys (63%) Unpublished data

45. 45 Outline 1.Overview of shared decision making 2.Case Study – Decision Services at the UCSF Breast Care Center 3.Policy discussion

46. 46 Common elements in legislative initiatives* Platform for pilot or demonstration projects Clear economic incentives Preference-sensitive conditions Certification/quality standards Professional training Evaluation *From analysis by the Foundation for Informed Medical Decision Making: Update for Milbank Memorial Fund Reforming States Group

47. 47 States activity on shared decision making (Foundation for Informed Medical Decision Making) Kuehn: States explore shared decision making. JAMA, 2009. 301(24): p. 2539-41.

48. 48 House bill: shared decision making demonstrations “…The Center for Medicare and Medicaid Innovation… shall establish a shared decision making demonstration program…”

49. 49 Senate Finance bill: broader language “The Innovation Center would test innovative payment and service delivery models to reduce program expenditures under Medicare, Medicaid, and CHIP while preserving or enhancing the quality of care furnished to individuals under such titles.”

50. 50 Discussion: Reconciling the House and Senate bills Shared decision making: singled out for demonstration projects? –Yes, no, maybe? If yes, what are your insights on the process of reconciliation? –Who else should I speak with? –Others in shared decision making community willing and able to help