The Engaged Patient: Understanding and Participating in Shared Health Decisions

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1 The Engaged Patient: Understanding and Participating in Shared Health Decisions By Tom Bartol, NP Richmond Area Health Center HealthReach Community Health Centers

2 Welcome Mike Gendreau, Director, Outreach, Education and Communications, Community Health Options Health insurance company Licensed in Maine Qualified Health Plan (Marketplace certification) Consumer Operated & Oriented Plan (CO-OP) Non-profit (501(c)29)

3 A biologist, a chemist, and a statistician are out hunting Statistician: We got em!

4 Objectives As a result of attending this session, the learner will: 1. Define shared decision making and how it might benefit a patient 2. Discuss risk, risk reduction and how they apply to potential outcomes 3. Identify resources and strategies to engage in decision making about various health strategies, treatments and interventions

5 Disclosure Statement The presenter has no affiliations with the health care industry or financial conflict of interests

6 Patient Engagement Ask, What matters to you? as well as What is the matter?.. Ascertaining the patients needs, values and goals at that point in time. Simplify Something that is Complicated (like what Apple and other industries have done) Share information Make patients the CONSUMER or CUSTOMER (rather than the recipient)

7 How do we do Shared Decision Making outside of Health Care? Buying a car Auto repairs Choosing a college Financial investments These are based on relationships, information, making rational decisions usually which we are paying for ourselves Are health care choices made like any of these?

8 First some perspective

9 What are we hearing? 1 in 19 people will get colon cancer! Lifetime risk of developing, not dying of colon cancer 1 in 8 women will get breast cancer! Lifetime risk of getting breast cancer, not dying from it Prostate cancer, the leading cause of cancer in men! Most diagnosed, but not the biggest cancer killer 51,000 people will die of colon cancer this year! That s 2% of all deaths, less than 1/10 of all cancer deaths, less than die each year from influenza and pneumonia and about the same number that die of nephritis and nephrotic syndrome each year

10 Lifetime Risk of Death 100% Author s Observation

11 Shared decision making is: a tool to translate the evidence into clinical practice in a patient centered way rejecting the one-size-fits-all approach Seaburg et. al. Circulation 2014;129:

12 Shared Decision Gives the Patient a Perspective: What is the goal of treatment/procedure? What is the baseline risk? What is risk reduction with intervention? What are the risks of the intervention? What other options are there to achieving the goal? What is the cost? Gives a perspective, from which to make a choice about health care

13 1. What is the goal? Goals are often the driving force to prevent cancer, prevent heart attack, prevent stroke, etc. Most health care treatments deliver probabilities of being successful: Cure or prevent condition in a some people Improve the condition somewhat for more Do nothing for many or even most of those treated and maybe even cause some harm Will it change what you do as a result? How will it effect your goals for life and its quality?

14 2. Assess Baseline Risk (no two people are the same) Family History (genetics) Lifestyle Exercise Dietary Intake Habits (smoking, ETOH, etc) Other risk factors/or medical history Socioeconomic Status/Satisfaction/Purpose in life (or Are you happy? )

15 BASELINE RISK Woloshin S et al. JNCI J Natl Cancer Inst 2008;100:

16 Breast Cancer Risk Assessment Tool Breast Cancer Risk Assessment Tool, accessed 1/11/16

17 Breast Cancer Risk Assessment Tool Breast Cancer Risk Assessment Tool, accessed 1/11/16

18 3. Risk Reduction Reduction from Baseline Risk 50% off coupon Save $0.50 on a $1.00 item Saves $ on a $ item Relative Risk Reduction is 50% Absolute Risk Reduction is the amount saved ($0.50 vs $500.00). Higher baseline risk, higher the absolute reduction Baseline risk gives a perspective for Relative Risk Reduction

19 AFCAPS/TexCAPS: Results after 5 Years 3304 Lovastatin 3301 Placebo Number with Primary Endpoint 116/3304 (3.5%) 183/3301 (5.5%) Relative Risk Ratio Relative Risk Reduction Absolute Risk Reduction (ARR) = /5.5 =.37 or 37% = 2% JAMA 1998;279:

20 Framing: The Way the Data is Presented 37% reduction in 1 st major coronary events 3304 patients treated with lovastatin for 5 years: prevent 67 1 st major coronary events Has no preventive effect on 3118 patients Taking lovastatin for ~5 years can reduce risk of 1 st major coronary event from 5.5 in 100 to 3.5 in 100 Risk of NOT having 1 st major coronary event 94.5 out of 100 without taking simvastatin 96.5 out of 100 with taking simvastatin JAMA 1998;279:

21 Number Needed to Treat (NNT) A tool to help give a perspective on a treatment risk vs benefit Number of people who must be treated for given time period to prevent 1 event Number Needed to Harm (NNH): Number needed to treat to get one harm event

22 Statin Drug Given for 5 Years for Heart Disease Prevention (Without known heart disease) Thennt.com accessed 2/22/15

23 4. What Are the Risks of Intervention/Procedure? Side effects/complications/radiation exposure False positive results Results are positive but no disease exists Leads to further testing/treatment Very high when there is low pre-test probability False negative results Disease exists but tests are negative

24 Risks from Colonoscopy 5 serious complications per 1000 colonoscopies (increases with increased age) Levin TR et al. Ann Intern Med 2006 Dec 19; 145:880-6.

25 Potential Harms of Mammography False Positive Results Occurs in about 10% of women over 10 years Can lead to fear, additional procedures, & biopsies False Negative Results 6-46% of women with invasive cancer will have negative mammograms Radiation induced breast cancer Overdiagnosis: Treating cancers that would never have caused symptoms or death accessed 4/22/13 Rosenberg RD, Yankaskas BC, Abraham LA, et al.: Performance benchmarks for screening mammography. Radiology 241 (1): 55-66, 2006 Elmore JG, Barton MB, Moceri VM, et al.: Ten-year risk of false positive screening mammograms and clinical breast examinations. N Engl J Med 338 (16): , 1998 Hubbard RA, Kerlikowske K, Flowers CI, et al.: Cumulative probability of false-positive recall or biopsy recommendation after 10 years of screening mammography: a cohort study. Ann Intern Med 155 (8): , 2011

26 National Lung Screening Trial: Screening High Risk Patients with Low Dose CT Scan: 6 Year Follow Up Data Low Dose CT CXR Number Screened 26, Number Positive Screen 7191 (27.3%) 2387 (9.2%) Number Positives with additional procedures (CT, PET, Bx, Bronchoscopy) 6369 (90.4%) 2176 (92.7%) Dx of Lung Cancer (%) 292 (1.1%) 190 (0.7%) 6 yr f/u Lung CA Mortality 1.66% 1.33% RRR Lung CA deaths 20% ARR Lung CA deaths 0.33% 95% of the people that screen positive do not have lung cancer (False Positives) N Engl J Med 2013; 368:

27 Low-Dose CT Screening for Lung Cancer accessed 2/28/15

28 5. What Other Options Lifestyle changes Surveillance/Observation Do nothing/ignore

29 Reducing Cancer Deaths About 30% of cancer deaths are due to the five leading behavioral and dietary risks: high body mass index low fruit and vegetable intake lack of physical activity tobacco use alcohol use Exercise can reduce risk of: Breast cancer 20-80% Colon Cancer 30-40%

30 EPIC Study 23,000 people doing 4 simple behaviors: Not smoking Exercising 3.5 hours/week Eating healthy diet (fruits, vegies, beans, whole grains, nuts, seeds, and limited meat) Maintaining healthy weight (BMI<30) Prevented: -93% of Diabetes -50% of Strokes -81% of Heart attacks -36% of Cancers Simply maintaining BMI<30 resulted in 67% cumulative reduction in these chronic diseases! If we had pills that did this all the expert guidelines would recommend them! Ford et. Al. Arch Intern Med. 2009;169:

31 6. Cost To the patient Out of pocket expenses Time missed from work/family Costs of resultant treatment To the system Covered does not mean it is free We all pay for health care

32 Putting Shared Decision Making Into Practice

33 Aspirin to Prevent a First Heart Attack or Stroke (Primary Prevention)

34 Aspirin to Prevent Cardiovascular Disease with past history of CV Disease or Stroke (Secondary Prevention)

35 SPRINT Trial: Is lower B/P Better? Primary Endpoint: MI, ACS, Stroke, Heart failure, or CV Death (mean f/u 3.26 years) Intensive Treatment Number of Participants Standard Treatment Mean Systolic B/P 121 mmhg 134 mmhg Average # of Medications 3 2 Events over 3 years 5.2% (243/4678) 6.8% (310/4683) Serious Events r/t Meds 4.7% (220/4678) 2.5% (118/4683) Death from Any Cause 3.3% (155/4678) 4.5% (210/4683) Serious events R/T medications twice as high in IT group as ST group (4.7 vs 2.5%) The SPRINT Research Group. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med 2015: DOI: /NEJMoa

36 Dual Antiplatelet Therapy After Drug Eluting Stent (after 12 months) 9961 pts with DES placement and DAPT for 12 months and stable or unstable CAD 30 months treatment ASA + Clopidogrel N=5020 ASA Alone N=4921 Stent thrombosis 0.4% (19/5020) 1.4% (65/4921) Major cardiovascular or cerebrovascular event 4.3% (211/5020) 5.9% (285/4921) Moderate or severe bleeding 2.5% 1.6% All cause mortality 2.0% (98/5020) 1.5% (74/4921) Mauri et. Al. DAPT Trial, NEJM 2014;371(23):

37 Results from Journals Mauri et. Al. DAPT Trial, NEJM 2014;371(23):

38 How Much Will Lower Cholesterol Help me? Total Cholesterol readsheet%20new.aspx?w_nav=ln, accessed 2/02/14

39 How Much Will Lower Cholesterol Help me? Total Cholesterol 245 Total Cholesterol preadsheet%20new.aspx?w_nav=ln, accessed 2/02/14

40 Will a Statin Help? Primary Prevention (no history of previous known heart disease) accessed 2/22/15

41 How Much Will Lower Cholesterol Help an Older Person? Total Cholesterol preadsheet%20new.aspx?w_nav=ln, accessed 2/02/14

42 CVD Risk Calculation in 79 y/o Female Total Cholesterol 270 Total Cholesterol preadsheet%20new.aspx?w_nav=ln, accessed 2/02/14

43 Strength and Balance Training Programs for Preventing Falls in the Elderly accessed 2/22/15

44 Should I get the Shingles Vaccine? Vaccine efficacy 3 year study (RRR): Age a 70% reduction Age a 64% reduction Age >70 a 38% reduction Shingles Incidence per year based on Age <50 = 2: = 5-7: = 7: = 10:1000 What is the risk reduction for the = 12: year old once s/he is 70??? Cost: ~ $ cash price Side effects Pain, swelling, itching at injection site(64% vs 14%), headaches Mayo Clin Proc 2007 Nov; 82:1341. Clin Infect Dis 2012; 54:922

45 I m 50, Its Time for a Mammogram accessed 12/5/14

46 Additional ways to reduce risk: Physically Increase physical active women activity, have either a lower risk intensity, of developing duration, breast or frequency, cancer can than inactive reduce women risk of developing reduction colon cancer varies (between by percent 20-80%).

47 Mammograms: National Cancer Institute: Benefits: Based on solid evidence in RTC s for women age Associated with 15-20% relative risk reduction Absolute mortality benefit over 10 years ~1% Harms: Based on solid evidence, screening mammography may lead to the following harms: Overdiagnosis, False Positives, False Negatives, and Radiation Induced Breast Cancer accessed 4/22/13 Moss SM, Cuckle H, Evans A, et al.: Effect of mammographic screening from age 40 years on breast cancer mortality at 10 years' follow-up: a randomised controlled trial. Lancet 368 (9552): , 2006

48 What about Prostate Cancer Sceening? accessed 12/5/14

49 I have Atrial Fibrillation, How much will anticoagulation my risk of stroke? accessed 2/3/16

50 accessed 1/23/14

51 Shared Decision Making in Broader Sense Not just a single decision: e.g. colonoscopy or not, statin or not A look at what is most likely to cause an individual health problems and deciding where the consumer wants to focus efforts Early PREVENTION has been proven effective

52 Take Home Points We call it evidence based but the evidence only tells us PROBABILITIES The studies rarely, if ever, exactly apply to your patient Individualize treatment to each patient based on risk Get engaged to be part of the decision process Ask for information (baseline risk, risk reduction, etc.) Share your preferences It s not black and white. The right choice is the one the patient chooses Find some tools and resources

53 Tools and Resources Baseline Risk Chart Woloshin S, Schwartz LM, & Welch HG. The risk of death by age, sex, and smoking status in the United States: Putting health risk in context. J Natl Cancer Inst 2008;100: Harding Center for Risk Literacy Fact Boxes Cardia Risk: Number Needed to Treat (NNT) National Cancer Institute Physician Data Query (PDQ)

54 A call for true healthcare overhaul may have no natural constituency among the interests fighting over healthcare policy. But it should have an ally in the largest and ultimately the most important interest group: patients and that includes every single one of us.

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