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

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Evidence for intervention strategies l.jpg

Evidence for Intervention Strategies

Robert M. Kaplan

UCLA

Schools of Public Health and Medicine

Prepared for Right Care Initiative

August 14, 2009


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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


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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


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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.


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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.


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


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Clinical Event Reduction in Clinical Trials

(Superko, H. R. et al. Circulation 2008;117:560-568))


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From Prospective Studies Collaboration:61 studies, 1 million Adults

Lancet 2002, 360, 1904


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BP Lowering TrialResults

Collins & Peto. Textbook of Hypertension 1994 Blackwell Scientific Publications p1159.


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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.


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Benefits of Lowering BP


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Mortality and AHA Get with the Guidelines Awards

Heidenreich, AHJ (In Press)


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But, BP Control Rates Remain Disappointing


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

Source: NCHS and NHLBI.


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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


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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”


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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


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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


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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


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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


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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


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


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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


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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


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Promising Interventions

  • Medication management

  • Patient empowerment

  • Practice redesign


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Five Trials in Type 2 Diabetes Intervention Fail to Show Patient Outcome Benefits

  • ACCORD


  • ADVANCE


  • VADT


  • UKPDS


  • PROACTIVE


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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


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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


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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).


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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


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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


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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


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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


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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


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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.


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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.


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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.


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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


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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


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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


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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


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