robert a. gluckman, md, facp regent, american college of physicians chief medical officer-...
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Robert A. Gluckman, MD, FACPRegent, American College of PhysiciansChief Medical Officer- Providence Health
PlansNavy Chapter-American College of
PhysiciansOctober 8,2011
Update in Outpatient Internal Medicine
GoalsUsing evidence to promote accountable care
Practice variation in cardiac careUsing evidence to promote shared decision
makingPSA screening and treatment of early prostate
cancerUsing “consumer” technology to improve chronic
disease managementSystems of care
HypertensionHospital discharge
“Potpourri”New agents for stroke prophylaxis in atrial fibrillationCT screening for lung cancerTreatment choices in COPD
Appropriate Use of PCIMulticenter prospective study of patients within
the National Cardiovascular Data Registry from 7/1/09- 9/30/10
500,154 PCI’s 71.1% acute indications
STEMI, NSSTEMI, unstable angina with high risk features
28.9% non-acute indication17 member expert panel developed
appropriateness criteriaClassified as appropriate, uncertain, inappropriate
Acute interventions 98.6% appropriateInappropriate procedures largely stable patients, >
12 hours from symptom onset
JAMA 2011; 306:53-61
Appropriate Use of PCINon-acute PCI
50.4% appropriate38% uncertain
13.4%% had CCS Class III-IV angina5.1% documented high risk ischemia on non-
invasive testing2.7% > 2 meds (83.5% on 0-1 med)
11.6% inappropriate53.8% no symptoms68.7% documented low risk ischemia on non-
invasive testing42.3% no meds, 53.5% 1 med
Optimal Medical Therapy in Patients Undergoing PCIData collected from National
Cardiovascular Data Registry on 467,211 patients Known CAD, 70% lesion with + stress test or
80% lesion with symptoms Excluded patients with ACS, LM disease or EF
<30%OMT defined as anti-platelet agent, beta
blocker, and statin unless contraindicationsAnalyzed % patients receiving OMT pre and
post publication of the COURAGE Trial.
JAMA 2011;305:1882-1889
Medication Prescription Rates Before PCI
Before COURAGE9/1/2005-3/25/2007
After COURAGE7/1/2007-6/30/2009
OMT 43.5% 44.7%
Anti-platelet agent
88.8% 88.3%
Beta blocker 62.0% 63.1%
Statin 62.4% 63.0%
Medication Prescription Rates After PCI
Before COURAGE9/1/2005-3/25/2007
After COURAGE7/1/2007-6/30/2009
OMT 63.5% 66.0%
Anti-platelet agent
99.0% 99.2%
Beta blocker 74.0% 75.9%
Statin 82.7% 84.7%
ACE/ARB 57.7% 60.7%
Appropriateness of Diagnostic AngiographyRetrospective analysis of 565,504 patients
without previous MI or revascularization from 2005-2008 undergoing elective coronary angiography
JACC 2011;58:801-809
Low CAD RateHospital
High CAD RateHospital
Beta Blocker Use
38% 50%
Low Framingham Risk
33% 21%
High Framingham Risk
14% 21%
Atypical CP 45% 27%
Stable Angina 33% 42%
Positive Stress Test
66% 71%
Mean PCI Volume
562/yr 802/yr
Patients’ and Cardiologists’ Perceptions of the Benefits of PCI in stable CADSurvey of 153 patients undergoing elective
cardiac catheterization with possible PCI and 27 cardiologists at Baystate Medical Center
77% patients had + stress test 65% patients had hx of angina
41% had angina < once per week41% had activity limited by angina
77% who received PCI reported anginaCardiologists’ reported angina in 98% of
these patientsAnnals of Int Med 2010;153:307-313
Reasons for performing and beliefs about PCI.Error bars represent 95% CIs. LV = left ventricular; MI = myocardial infarction; OMT = optimal medical therapy; PCI = percutaneous
coronary intervention.
Rothberg M B et al. Ann Intern Med 2010;153:307-313
©2010 by American College of Physicians
Cardiac Procedures per 1000 Members by Top 6 Regions in 1 Large Employer Group
Opportunity cost: state Opportunity cost: state governmentgovernmentState expenditures (all states), 2006State expenditures (all states), 2006
0%
5%
10%
15%
20%
25%
Medicaid K-12 HigherEd Transport Corrections
Nat’l Assoc of State Budget Officers, Nat’l Assoc of State Budget Officers, 20072007
Practice Variation in the Use of Cardiac Procedures- SummaryThe ACC is leading the way for specialty society
efforts to reduce inappropriate proceduresGeneral internists should be active
collaborators rather than passive observers in engaging with specialty colleagues in reducing practice variationMedical staff involvementCollegial physician-physician communication
Increased transparency of local and regional utilization patterns is coming and can potentially reduce ineffective or marginally effective utilization
Eplerenone in Patients with CHF and Mild Symptoms2737 patients with NYHA Class II CHF and EF ≤
35%Hospitalized within the last 6 months or increased
BNPRandomized to eplerenone titrated to 50 mg qd
vs. placeboStarted 25 mg qd and increased to 50 mg qd at 4
weeksIf CrCl 30-49 ml/min started 25 mg qod and titrated
to qd if K+ ≤ 5.0Dose decreased if K+ 5.5-5.9Drug stopped for K+ ≥ 6.0, remeasured after 72
hours and restarted if K+ < 5.0
NEJM 2011 ;364:11-21
Eplerenone in Mild CHFEplerenone Placebo
CV death or CHF Hospitalization
18.3% 25.9%
Overall mortality or CHFHospitalization
19.8% 27.4%
Hospitalization for worsening renal function
0.7% 0.6%
Aldosterone Antagonists in CHFObservational analysis of 43,625 patients
admitted with CHF and discharged home242 hospitals participating in the Get With The
Guidelines-HF Program12,565 patient eligible for aldosterone antagonist
therapyEF ≤ 35%Serum potassium ≤ 5.0 mEq/LSerum creatinine ≤ 2.5 mg/dl in menSerum creatinine ≤ 2.0 mg/dl in women
34.5% eligible patients received aldosterone antagonist
10.55% inappropriate or potentially inappropriate use
JAMA 2009 302;1658-1665
Aldosterone Antagonists in CHFPatients admitted for CHF may have
multiple medication changesClinician concern about initiating multiple
interventions may be a barrier to initiating treatment
Dose intensification of multiple medications is generally needed in CHF patients
Clinical inertia may be a barrier to optimal care in CHF
Need for specialty/PCP role clarification
Population Based Prostate Cancer Screening Trial- Goteberg Trial20,000 age 50-64 randomized to PSA every
2 years vs. no screeningScreening discontinued at age 69Elevated PSA, defined as 2.5-3, offered DRE,
ultrasound and biopsyMen with negative evaluation re-screened
every 2 years and biopsied for repeat PSA elevation
Primary endpoint- prostate cancer specific mortality
Median follow-up 14 years
Lancet Oncol. 2010 Aug;11(8):725-32
Control Invited to screen
Attendees
Non-attendees
Prostate CAdiagnosed
7.2% 11.4% 13.8% 3.9%
Low risk 2.0% 6.1% 7.8% 0.6%
Moderate risk
2.5% 3.6% 4.5% 1.0%
High Risk 1.3% 1.0% 1.0% 0.8%
Advanced 0.9% 0.3% 0.2% 0.5%
Low risk: T1, Gleason score ≤ 6, PSA <10Moderate risk: T1-2, Gleason score ≤ 7, PSA <20High risk: T1-4, Gleason score ≥ 8, PSA <100
# invited to screen to prevent one death= 293# diagnosed to prevent one death= 12
Co-Morbidity and Mortality Results From the PLCO Trial
J Clin Oncol 2010 29:355-61
Men with minimal or no
Significant co-morbidity examples: CAD, MI, DM, HTN, CVA, BMI > 30, COPD, chronic bronchitis
Men with ≥ 1 significant co-morbidity
Determinants and Outcome of Watchful Waiting in Men with Prostate CancerHealth Professionals Follow-up Study
Cohort 51,529 men3331 diagnosed with prostate cancer 1986-2007342 chose watchful waiting
51% remained untreated after 7.7 yearsTreatment delayed average of 3.9 years in
those undergoing treatmentNo difference in prostate cancer death or
metastatic disease (about 10 per 1000 pt-years)
Age, tumor size, Gleason score, PSA level predicted future treatment
PSA ≤ 10, Gleason <7 Stage 1 and 2
PSA 10.1-20 or Gleason 7, Stage 1 or 2
PSA > 20 or Gleason >7, or Stage 3
Radical Prostatectomy vs. Watchful Waiting in Early Prostate Cancer695 men age < 75, life expectancy > 10 years,
T1 or T2 tumor randomized to RP or WWOnly 12% non-palpable T1c tumors at enrollment5% diagnosed by screening≈ 75% T2 tumors> 45% with PSA >10
RP patients received hormonal therapy for recurrence
WW patients underwent TURP for obstructive symptoms
Median follow-up 12.8 years
NEJM 2011 364:1708-117
NCCN GuidelinesActive surveillance reasonable option for
men withStage T1-2a, Gleason score ≤ 6, PSA < 10
Active surveillancePSA at least every 6 monthsDRE at least every 12 monthsBiopsy 6 months if initial bx. < 10 coresBiopsy 18 months if initial bx. ≥ 10 cores
www.nccn.org accessed 10/29/10
Prostate Cancer Screening-ConclusionsPSA screening may provide small survival benefit
Pre-screening, contamination, biopsy threshold and treatment differences limits data interpretation
Survival curves start to diverge at about 10 yearsSignificant benefit may take longer
Overdiagnosis is a serious health hazardOver 1 million treatedSide effects immediateImpact of overdiagnosis could be dramatically
reduced if active surveillance was initial treatment strategy in appropriate patients
Shared decision making should emphasize delayed benefit, short term risk, baseline health and option for delayed curative treatment
Collaboration with urology community to determine treatment options is essential
USPTF Grade D recommendation
Mobile Diabetes Intervention StudyRandomly assigned 26 primary care
practices to 4 study groups No academic affiliation > 10% patients had diabetesEnrolled 163 commercially insured patients,
HgBA1C ≥ 7.5%No mental health diagnoses, substance abuse, must
have internet accessInterventions
Usual CareCoachCoach + Patient PortalCoach + Portal +Decision Support
Diabetes Care published online 7/25/2011
Mobile Diabetes Intervention Study
Usual Care
Coaching CoachingPortal
CoachingPortalDecision Support
BaselineHgBA1C
9.2% 9.3% 9.0% 9.9%
12 monthHgBA1C
8.5% 7.7% 7.9% 7.9%
Mean change
- 0.7% - 1.6% 1.2% 1.9%
Txt2stop Trial: Smoking Cessation Support via Mobile Phone Text Messaging5800 patients aged ≥ 16 willing to attempt
to quit smoking within 1 monthParticipants socioeconomically diverse, 44%
left school ≤ age 16Participants responded to ads via text or
onlineAll participants allowed to participate in any
other smoking cessation program and all provided helpline numbers
Lancet 2011:378:49-55
Txt2stop Trial: Smoking Cessation Support via Mobile Phone Text MessagingIntervention group received 5 texts daily x 5
weeks, then 3 texts weekly for 26 weeksCore program of 186 standard messages and 713
personalized messagesMessages selected from algorithm based on
patient specific dataMessages provided motivation and behavior
change techniquesControl group received text message every 2
weeks thanking them for study participationBiochemically verified 6 month quit rate 10.7%
vs. 4.9%
Randomized Trial of DepressionFollow-Up Care by On Line Messaging208 patients with newly prescribed antidepressant
depression in 9 primary clinics in Group Health CooperativePatients already enrolled in on line messagingExcluded patients with anti-depressant within 270 days, with
bi-polar disorder or any previous mood stabilizer, anti-psychotic
Randomized to usual care in primary care setting (including psychotherapy, medication, online messaging) vs. usual care plus nurse based outreach via online messagingOutreach included PHQ-9, medication adherence, side effects,
facilitated visits, referral as needed3 contacts plus additional patient initiated contactScripted response and algorithm based on questionnaire,
tight coordination with PCPReview with supervising psychiatrist, did not provide direct
care
JGIM 2011 26(7):698-704
Randomized Trial of DepressionFollow-Up Care by On Line Messaging
Intervention Control
Adherence 81% 61%
Second medication 22% 16%
Mental health specialistvisit
32% 31%
50% improvement indepression score
55% 41%
Very satisfied with depression treatment
53% 33%
Care Transitions Intervention (CTI)Quasi-experimental prospective cohort
study of FFS Medicare patients in 6 Rhode Island hospitalsAssess generalizability of previous RCT
Intervention consisted of health coachingVisit in hospital before dischargeHome visit within 3 daysTelephone call within 7-10 daysFinal telephone call by day 30
Coaches worked 18-24 hours per week and carried case loads of 12-15 patients
Arch Int Medicine 2011;171:1232-37
InterventionEnsure medications taken matched those prescribed
and patients can describe which meds to take and how often
Identify health conditions and maintain a personal health record
Discuss/practice how to schedule a follow-up appointmentPatients make their own appointments
Help the patient recognize “red flags” that should prompt a telephone call or urgent appointment with provider
Enrolled patients in state-wide HIEDiscussed and encouraged completion of advanced
directive
Readmission Rates
Intervention Group 12.7%
External Control (eligible for CTI not approached)
20%
Internal Control (declined CTI or lost to follow up before home visit)
18.6%
Decline 18.6%
Lost to follow up 18.7%
Simplified approach to treat HTN
45 Canadian family practices able to enroll 30 patients with uncontrolled hypertension randomized to algorithm or guideline based care
Uncontrolled HTN define as ≥ 140/90 or diabetics ≥ 130/80
Mean age 61, 15% diabeticsAlgorithm consisted of:
Step 1- fixed dose ACE/diuretic or ARB diuretic with up titrationi.e. lisinopril 10/12.5 HCTZ; max dose 20/25
Step 2 calcium channel blocker with up titrationStep 3 add α blocker, β blocker, or spironolactone
BP Control at 6 months:
Algorithm 64.7%
Guideline 52.7%
Effectiveness of Home BP Monitoring, Web Based Communication, and Pharmacist Care on BP Control
778 patients with uncontrolled hypertension randomized to Usual careHome BP monitoring and Web servicesHome BP monitoring, Web services,
pharmacist care management Outcomes were changes in BP and %
patients controlled 12 month follow-upGoal BP 135/85
JAMA 2008;299:2857-67
Effectiveness of Home BP Monitoring, Web Based Communication, and Pharmacist Care on BP Control
Usual Care
Home BP +Web
Home BP +pharmacist
Systolic BP drop
-5.3 mm -8.2 mm -14.2 mm
Diastolic BP
-3.5 mm -4.4 mm -7.2 mm
% control 31% 36% 56%
# E-Mail contacts
2.4 3.3 22.3
# BP meds 1.69 1.94 2.16No difference in primary care visitsModest decline in specialist visits
Intensive Blood Pressure Control in Diabetic Patients- ACCORD BP 4733 patients with HgBA1C ≥ 7.5%
Age ≥ 40-79 with CVDAge ≥ 55-79 at high risk for CVDSystolic BP 130-180 taking ≤ 3 BP drugsCreatinine ≤ 1.5 mg/dl or < 1 gm proteinuria
Intensive treatment- Goal BP ≤ 120 mm Hg monthly visits x4, then q2mo
Control group- Goal BP ≤ 140 mm Hg visits month 1 and 4, then q4mo
1° outcome- non-fatal MI, CVA, CV deathMean follow-up 4.7 years
NEJM 2010 362: 1575-85
2.1 meds
3.4 meds
Similar use of ACEI/ARB, thiazides, beta blocker, calcium channel blocker
ACCORD BP TrialIntensive TherapyEvents %/yr
Standard TherapyEvents %/yr
Primary Outcome 1.87 2.09 (NS)
CVA 0.32 0.53 (NNT x 5 yr 89)
Non-fatal MI 1.13 1.28
Death 1.28 1.19
ACCORD BP TrialIntensive Therapy Standard Therapy
Serious adverse events
3.3% 1.27%
Dizziness on standing
44.3% 40.3%
Macroalbuminuria(protein excretion ≥ 300 mg/d
6.6% 8.7%
Consider periodic monitoring urinary protein for overt nephropathy
INVEST TrialObservational secondary analysis involving
6400 diabetic patients with HTN and CADPatients randomized to calcium channel
blocker vs. beta blocker strategy to achieve BP <130/85Added ACEI and thiazide
Patients categorizedTight control systolic BP <130Usual control systolic BP 130-139Uncontrolled systolic BP ≥ 140
Primary outcome- mortality, non-fatal MI, CVA
JAMA 2010:304;61-68
INVEST TRIALBP < 130 BP 130-139 BP ≥ 140
Primary Outcome
12.7% 12.6% 19.8%
Total Mortality 11.0% 10.2% 15.4%
Non-fatal MI 1.3% 1.7% 3.1%
Non-fatal CVA 1.0% 1.3% 2.4%
Amer J Med 2010 123:719-726
INVEST TRIAL- BP Control in CAD
HypertensionA simple algorithm may improve BP control3-4 drugs may be necessaryPatients with uncontrolled hypertension
require therapeutic intensification and efforts to improve adherence
Team based care and frequent patient/provider contact increases BP control
Carefully consider target BP based on patient characteristics
Apixiban for Atrial Fibrillation-ARISTOTLE Trial18,201 patients with atrial fibrillation and one
additional risk factor for strokeRandomized to a apixiban (Direct Factor Xa
inhibitor) 5 mg po bid vs. warfarinDose reduced to 2.5 mg if 2 of the following
Age ≥ 80Weight ≤ 60 kgCreatinine ≤ 1.5 mg/dl
Median duration of follow-up 1.8 yearsPrimary outcome ischemic/hemorrhagic stroke
or systemic embolismSecondary outcome major bleeding, death
NEJM 2011;365:981-92
ApixibanEvent Rate%/year
WarfarinEvent Rate%/year
Hazard Ratio
CVA or Systemic embolism
1.27 1.60 0.79
Hemorrhagic CVA
0.24 0.47 0.51
Total Mortality 3.52 3.94 0.89
CVA, MI, systemicEmbolism or death
4.85 5.45 0.88
CVA, systemicEmbolism, death, or major bleeding
6.13 7.20 0.85
INR median time in therapeutic range 66%ARR for any bleeding 7.7%/year
New Anticoagulants in Atrial Fibrillation- SummaryApixiban, dabigitran, and rivoroxaban all reduce
hemorrhagic stroke, major bleedingDabigitran only drug to reduce ischemic strokeApixiban reduces rate of major bleeding and total
mortalityCost an issue, especially for Medicare patients or
other coverage with greater cost share for drugsPatients well controlled on warfarin may not require
med changeBeneficial when difficult to control or monitor in
adherent patients. Cannot extrapolate to non-adherent patients due to
shorter half life
The National Lung Screening Trial53,454 patients age 55-74 with ≥ 30 pack year
smoking history, current smoker or quit within 15 years
Randomized to yearly low dose chest CT vs. CXR for 3 years
Median follow-up 6.5 years18,146 positive tests in CT group
96.4% false positive 5,043 positive tests in CXR group
94.5% false positiveMost diagnostic evaluations were f/u imaging4% CT group underwent a surgical procedure
NEJM 2011;365:395-409
CT Group
Radiology Group
Major complication after diagnostic evaluation
11.6%N=75
8.6%N=95
Intermediate complication after diagnostic evaluation
14.6%N=24
12.5%N=35
309/100,000Patient-years
247/100,000Patient-years
6.7% reduction in total mortality
Conclusions- CT screening for lung cancerIn this trial, CT screening resulted in a 20%
reduction in lung cancer death and 6.7% reduction in overall mortality
Complications uncommon but higher in screened group
Areas of uncertaintyOverdiagnosis rateImpact of newer technology (i.e. greater mortality
reduction vs. more false positives)Cost-effectivenessDuration and interval of screeningTarget patient population
Authors recommended policy makers wait for additional data
Tiotropium vs. Salmeterol to prevent COPD Exacerbation7376 patients with moderate to very severe COPD
90% Stage II-III Gold CriteriaPatients continued other medications
>50% used inhaled corticosteroids, short acting bronchodilators
Primary outcome- time to first exacerbationSecondary outcomes
Risk of severe exacerbationsExacerbations requiring inhaled steroids and/or
antibioticsDiscontinuation due to adverse effects
Follow-up 1 year
NEJM 2011;364:1093-1103
Probability of COPD exacerbation
Time to first exacerbation decreased by 42 days
Probability of severe COPD exacerbation
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