Evidence for Intervention Strategies

1. Evidence for Intervention Strategies Robert M. Kaplan UCLA Schools of Public Health and Medicine Prepared for Right Care Initiative August 14, 2009

2. NIH View of Translational Research According to the National Institutes of Health, “in order to improve human health, scientific studies must be translated into practical applications.” Phase I Phase II Community research and application Bench research Clinical research

3. Where is this going • Cardiovascular disease is common • Risk factors have been known for 50 years • Evidence clearly shows that modifying some risk factors reduces events • Population level modification of risk factors has been disappointing • Several strategies show promise for risk factor modification in group pracrtices

4. More than one in three adults have prevalent CVD Prevalence of CVD in adults age 20 and older by age and sex (NHANES: 2005-2006). Source: NCHS and NHLBI. These data include coronary heart disease, heart failure, stroke and hypertension.

5. There are more than 850,000 CVD deaths per year 1/3rd before age 75, 50% higher than cancer deaths CVD deaths vs. cancer deaths by age. (United States: 2005). Source: NCHS and NHLBI.

6. 6 Year CHD Mortality by Total Serum Cholesterol 356,222 Men Screened for MRFIT, Aged 35-57 Yrs

8. Clinical Event Reduction in Clinical Trials (Superko, H. R. et al. Circulation 2008;117:560-568))

9. From Prospective Studies Collaboration:61 studies, 1 million Adults Lancet 2002, 360, 1904

10. BP Lowering TrialResults Collins & Peto. Textbook of Hypertension 1994 Blackwell Scientific Publications p1159.

11. Evidence Based Opinions Most people with HTN will need 2 or 3 medications to control BP. Diuretic/ACEI, Diuretic/ARB, CCB/ACEI, CCB/ARB likely good first choices for combination Rx. Diuretic/CCB combination of uncertain effectiveness. Reserpine underused, but probably a good third line agent.

12. Benefits of Lowering BP

13. Mortality and AHA Get with the Guidelines Awards Heidenreich, AHJ (In Press)

14. But, BP Control Rates Remain Disappointing

15. Extent of Awareness, Treatment and Control of High Blood Pressure by Age (NHANES: 2005-2006). Source: NCHS and NHLBI.

16. Berwick's Rules for Dissemination Berwick, JAMA. 2003;289:1969-1975. Seven ‘rules' for translating research into practice; require an implementer to 1) find sound innovations 2) find and support innovators 3) invest in early adopters 4) make early adopter activity observable 5) trust and enable reinvention 6) create slack for change 7) lead by example

17. Lessons Development and dissemination of Guidelines is insufficient to change provider behaviors Multiple techniques more effective than single technique interventions Additional non-physician interactions with patients (nurses, case-managers) often beneficial Non-traditional venues for prevention can lead to improved results vs. “usual care”

18. Electronic Health Records/Clinical Decision Support Systems Systematic review of 68 controlled trials of CDSS (Hunt, JAMA 1998): most trials demonstrated a benefit for preventive services Meta-analysis (Balas, Arch Int Med 2000), 33 studies;1500 clinicians and >50K patients: Prompting increases preventive care performance by 13.1% (95%CI 10.5-15.6%) 2005 systematic review to identify CDSS key features (Kawamoto, BMJ): CDSS improved clinical practice in 68% of 70 RCTs-- but not evidence presented on clinical improvement

19. Not all interventions work:CDSS for CVD in primary care Tierney WM et al, JGIM 2003 EMR used to identify patients with CHF/CHD and generate care suggestions (from national CPGs). Pharmacists and MDs randomized to see or not see suggestions as they cared for CHF, CHD patients (2X2 factorial) recommendations printed on encounter form; and info in window at workstation used enter orders/ dispense medicine “Help” key to view CPGs and reference “Escape” key to avoid all suggestions for that patient that day

20. CDSS for CVD in primary care Evaluated among 706 patients Any care suggestions made for 88-90% of patients Compliance with suggestions: 22-23% (same in all 4 groups) No effect on patient quality of life, medication compliance, or health care utilization Same group had previously shown improvement with CDSS reminder system! Tierney WM et al, JGIM 2003

21. Other Negative CDSS trials Eccles et al, BMJ 2002 , angina No effects on referrals, prescribing, or patient outcomes Montgomery et al, BMJ 2000, HTN, CDSS vs. chart reminders vs. usual care Calculated CVD risk score, BP goals, did not suggest HTN therapy Need multifaceted interventions to get clinicians to use systems, CDSS that actually provides help that is valued by clinicians

22. CDSS and Cholesterol Van Wyk et al studied decision support with respect to screening and treatment of dyslipidemia based on Dutch guidelines Setting: 38 Dutch general practices (77 physicians) and 87,886 of their patients Each practice was randomly assigned to receive alerts, on-demand support, or no intervention

23. van Wyck et al Circ 2008;117:371-378

24. Electronic health record use in United States and Quality Analyzed 2003-04 national ambulatory medical care survey (NAMCS) In 2004, 20% of visits to non-federal, office-based physicians used electronic health records EHR visits NOT associated with any difference in performance for 14 of 17 quality indicators Suggestion of worse use of statins Better performance- avoiding benzo use for depression, and fewer routine urinalyses Not clear if CDSS was common feature of EHRs, however Linder JA et al, Arch Intern Med 2007;167:1400-05

25. Lessons(Adapted from Bertoni, 2009) Development and dissemination of Guidelines is insufficient to change provider behaviors Multiple techniques more effective than single technique interventions Additional non-physician interactions with patients (nurses, case-managers) often beneficial Non-traditional venues for prevention can lead to improved results vs. “usual care” EHR/ CDSS shows promise, however yet to be established that this is panacea

26. Promising Interventions • Medication management • Patient empowerment • Practice redesign

27. Five Trials in Type 2 Diabetes Intervention Fail to Show Patient Outcome Benefits • ACCORD
 • ADVANCE
 • VADT
 • UKPDS
 • PROACTIVE

28. Medication Therapy Management (MTM)-The Ashville Study • Co‐pays are waived on prescription medications and medical supplies, including home blood glucose monitors, on the condition that patients meet monthly with pharmacist • Monthly meetings are between patients and clinically trained pharmacists working under the direction of a physician • Patients are required to attend education programs in community‐based centers • Pharmacists confer with physicians about recommendations to adjust medication regimens and coordinate treatment by sharing patient updates

29. Problems with Ashville Studies • No control group • Participants self-selected. They represent about 620 volunteers from 12,000 eligible • Observed changes in CVD risk factors were quite modest • Some of the risk factor changes (ie HDL) change in the wrong direction. • Different numbers of people participated in the various follow-ups. There are, for example, 187 participants at baseline but just 11 at long-term follow-up

30. Reasons to Support MTM • Cochrane review ( 2000) The Cochrane group found pharmacist-based interventions encouraging • Increasing evidence form controlled studies that the Ashville principles can be used to control CHD risk factors. The effect on health outcomes awaits evaluation (Carter et al 2008).

31. RCT of Cardiovascular Risk Intervention by Pharmacists 675 with CVD, or DM+1 other RF identified by pharmacists in Sask/Alberta based on Rx Point of care LDL, patient gets value and brochure, fax to PCP summarizing CVD risk factors, test result (vs. usual care) Follow-up visits or calls with pharm every 4 wks. Composite endpoint: Full lipid profile by PCP, or drug started/ titrated by 16 wks RCT ended early: Primary endpoint 57% vs 31% usual care; OR 3.0 (95% CI 2.2-4.1) Tsuyuki RT et al, Arch Int Med 2002

32. RCT of Cardiovascular Risk Intervention by Pharmacists 675 with CVD, or DM+1 other RF identified by pharmacists in Sask/Alberta based on Rx Point of care LDL, patient gets value and brochure, fax to PCP summarizing CVD risk factors, test result (vs. usual care) Follow-up visits or calls with pharm every 4 wks. Composite endpoint: Full lipid profile by PCP, or drug started/ titrated by 16 wks RCT ended early: Primary endpoint 57% vs 31% usual care; OR 3.0 (95% CI 2.2-4.1) Tsuyuki RT et al, Arch Int Med 2002

33. Community-Based Care Trial Primary prevention 1 year RCT, Baltimore MD (JHU GIM) High risk, but CVD-free, sibs aged 30-59, of African American probands with CHD event at age<60 Community based care vs. “Enhanced” primary care. Targets: HTN, LDL>3.37mmol/l, smoking. Goal: Reduce Framingham Risk Becker, DM et al. Circulation 2005;111:1298-1304

34. Community-Based Care Trial CBC: Nurse practitioner+ comm. health worker Offices easily accessible; no appointments, evening hours available prn on-site exercise, conference room, children’s play room. Pharmacy cards for BP, Lipids, Smoking cessation meds YMCA available 2 nights/week for CBC patients. Enhanced primary care: Guideline dissemination, results of screening, patient education materials Pharmacy Cards (mailed to practice for EPC patients) YMCA available to their EPC patients 2 nights/week Becker, DM et al. Circulation 2005;111:1298-1304

35. Percentage achieving goals at 1 - year follow - up by intervention group (LDL - C Becker, D. M. et al. Circulation 2005;111:1298 - 1304 Copyright © 2005 American Heart Association Percent achieving goals at 1 year follow up by intervention group

36. Stanford Chronic Disease Self Management Program (CDSMP) • Well characterized in numerous publications for patients with various chronic conditions including asthma, arthritis, lung disease and chronic disease. It has been adapted for multiple disease states and has been studied in the United States as well as in United Kingdom, Australia, Canada and Mexico.

37. Components • 6 session, community-based program • Goal: To enable participants to build self-efficacy for assuming a major role maintaining their health and managing their chronic health conditions. • Components • action planning and feedback, • behavior modeling, • problem-solving and decision making relating to chronic disease management.

38. Evidence of Effectiveness for CDSMP • 2008 (CDC) conducted a review of published studies suggested reduction in healthcare expenditures (Gordon and Galloway 2008). • Four studies reported lower ER visits, • three studies demonstrated reduced hospitalizations • four studies reported reduced number of days in the hospital, • two studies reporting statistically significant reductions in outpatient visits.

39. What is ALL? • ALL stands for • Aspirin 81 mg, • Lisinopril 20 mg, & • Lipid lowering with simvastatin 40 mg/day • ALL is a Polypill • Suggested that the clinical and cost effectiveness of increasing ALL use in • CAD and • diabetic (55+) populations

40. Evaluation of ALL (Polypill)TIPPS Trial 50 Centers in India (ACC 2009) • Double-blind study, enrolled 2053 patients aged 45 to 80 years without cardiovascular disease but with one risk factor type 2 diabetes, high blood pressure, smoker within past five years, increased waist-to-hip ratio, or abnormal lipids • Pill well tolerated, but • Lower than expected reductions in • LDL • SBP • Compliance lower than expected • No health outcome data available at this time

41. Conclusions • The epidemiology of CVD has been known for 50 years • Clinical trials have shown the benefits of intervention for lipids and blood pressure • Three promising approaches have been reviewed in detail • Medication Therapy Management • Chronic Disease Self Management Program • Polypill (ALL) • All require further evaluation • But, it is time to take action

42. Impact of Prevention on reducing Burden of CVD NHANES: 78% of US population aged 20-80 eligible for >1preventive intervention If perfect delivery/compliance, 63% of MI and 31% of CVA reduced Avg life expectancy 1.3 yrs longer R Kahn et al Circulation 2008