Transcript Update in outpatient internal medicine

Update in Outpatient Internal
Medicine
Robert A. Gluckman, MD, FACP
Regent, American College of Physicians
Chief Medical Officer- Providence Health Plans
Navy Chapter-American College of Physicians
October 8,2011
Goals
 Using evidence to promote accountable care
 Practice variation in cardiac care
 Using evidence to promote shared decision making
 PSA screening and treatment of early prostate cancer
 Using “consumer” technology to improve chronic disease
management
 Systems of care
 Hypertension
 Hospital discharge
 “Potpourri”
 New agents for stroke prophylaxis in atrial fibrillation
 CT screening for lung cancer
 Treatment choices in COPD
Appropriate Use of PCI
 Multicenter 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 indication
 17 member expert panel developed appropriateness criteria
 Classified as appropriate, uncertain, inappropriate
 Acute interventions 98.6% appropriate
 Inappropriate procedures largely stable patients, > 12 hours
from symptom onset
JAMA 2011; 306:53-61
Appropriate Use of PCI
 Non-acute PCI
 50.4% appropriate
 38% uncertain
 13.4%% had CCS Class III-IV angina
 5.1% documented high risk ischemia on non-invasive testing
 2.7% > 2 meds (83.5% on 0-1 med)
 11.6% inappropriate
 53.8% no symptoms
 68.7% documented low risk ischemia on non-invasive testing
 42.3% no meds, 53.5% 1 med
Optimal Medical Therapy in Patients
Undergoing PCI
 Data 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 contraindications
 Analyzed % patients receiving OMT pre and post publication of
the COURAGE Trial.
JAMA 2011;305:1882-1889
Medication Prescription Rates Before PCI
Before COURAGE
9/1/2005-3/25/2007
After COURAGE
7/1/2007-6/30/2009
43.5%
44.7%
Anti-platelet agent 88.8%
88.3%
Beta blocker
62.0%
63.1%
Statin
62.4%
63.0%
OMT
Medication Prescription Rates After PCI
Before COURAGE
9/1/2005-3/25/2007
After COURAGE
7/1/2007-6/30/2009
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%
OMT
Appropriateness of Diagnostic Angiography
 Retrospective analysis of 565,504 patients without previous
MI or revascularization from 2005-2008 undergoing elective
coronary angiography
JACC 2011;58:801-809
Low CAD Rate
Hospital
High CAD Rate
Hospital
Beta Blocker Use
38%
50%
Low Framingham
Risk
High Framingham
Risk
Atypical CP
33%
21%
14%
21%
45%
27%
Stable Angina
33%
42%
Positive Stress Test
66%
71%
Mean PCIVolume
562/yr
802/yr
Patients’ and Cardiologists’ Perceptions of
the Benefits of PCI in stable CAD
 Survey 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 week
 41% had activity limited by angina
 77% who received PCI reported angina
 Cardiologists’ reported angina in 98% of these patients
Annals 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 government
State expenditures (all states), 2006
25%
20%
15%
10%
5%
0%
Medicaid
K-12
HigherEd
T ransport
Nat’l Assoc of State Budget Officers, 2007
Corrections
Practice Variation in the Use of Cardiac
Procedures- Summary
 The ACC is leading the way for specialty society efforts to
reduce inappropriate procedures
 General internists should be active collaborators rather than
passive observers in engaging with specialty colleagues in
reducing practice variation
 Medical staff involvement
 Collegial 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 Symptoms
 2737 patients with NYHA Class II CHF and EF ≤ 35%
 Hospitalized within the last 6 months or increased BNP
 Randomized to eplerenone titrated to 50 mg qd vs. placebo
 Started 25 mg qd and increased to 50 mg qd at 4 weeks
 If CrCl 30-49 ml/min started 25 mg qod and titrated to qd if
K+ ≤ 5.0
 Dose decreased if K+ 5.5-5.9
 Drug stopped for K+ ≥ 6.0, remeasured after 72 hours and
restarted if K+ < 5.0
NEJM 2011 ;364:11-21
Eplerenone in Mild CHF
Eplerenone
Placebo
CV death or CHF
Hospitalization
18.3%
25.9%
Overall mortality or
CHF
Hospitalization
19.8%
27.4%
Hospitalization for
worsening renal
function
0.7%
0.6%
Aldosterone Antagonists in CHF
 Observational analysis of 43,625 patients admitted with CHF
and discharged home
 242 hospitals participating in the Get With The Guidelines-HF
Program
 12,565 patient eligible for aldosterone antagonist therapy




EF ≤ 35%
Serum potassium ≤ 5.0 mEq/L
Serum creatinine ≤ 2.5 mg/dl in men
Serum 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 CHF
 Patients admitted for CHF may have multiple medication




changes
Clinician 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 Trial
 20,000 age 50-64 randomized to PSA every 2 years vs. no





screening
Screening discontinued at age 69
Elevated PSA, defined as 2.5-3, offered DRE, ultrasound and
biopsy
Men 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 CA
diagnosed
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 <10
Moderate risk: T1-2, Gleason score ≤ 7, PSA <20
High 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
Men with minimal or no
J Clin Oncol 2010 29:355-61
Men with ≥ 1 significant co-morbidity
Significant co-morbidity examples: CAD, MI, DM, HTN, CVA, BMI > 30,
COPD, chronic bronchitis
Determinants and Outcome of Watchful
Waiting in Men with Prostate Cancer
 Health Professionals Follow-up Study
 Cohort 51,529 men
 3331 diagnosed with prostate cancer 1986-2007
 342 chose watchful waiting
 51% remained untreated after 7.7 years
 Treatment delayed average of 3.9 years in those undergoing
treatment
 No 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 > 20 or Gleason >7, or Stage 3
PSA 10.1-20 or Gleason 7,
Stage 1 or 2
PSA ≤ 10, Gleason <7
Stage 1 and 2
Radical Prostatectomy vs. Watchful
Waiting in Early Prostate Cancer
 695 men age < 75, life expectancy > 10 years, T1 or T2
tumor randomized to RP or WW
 Only 12% non-palpable T1c tumors at enrollment
 5% 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 Guidelines
 Active surveillance reasonable option for men with
 Stage T1-2a, Gleason score ≤ 6, PSA < 10
 Active surveillance
 PSA at least every 6 months
 DRE at least every 12 months
 Biopsy 6 months if initial bx. < 10 cores
 Biopsy 18 months if initial bx. ≥ 10 cores
www.nccn.org accessed 10/29/10
Prostate Cancer Screening-Conclusions
 PSA 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 years
 Significant benefit may take longer
Overdiagnosis is a serious health hazard
 Over 1 million treated
 Side effects immediate
 Impact 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 Study
 Randomly assigned 26 primary care practices to 4 study
groups
 No academic affiliation
 > 10% patients had diabetes
 Enrolled 163 commercially insured patients, HgBA1C ≥ 7.5%
 No mental health diagnoses, substance abuse, must have internet access
 Interventions




Usual Care
Coach
Coach + Patient Portal
Coach + Portal +Decision Support
Diabetes Care published online 7/25/2011
Mobile Diabetes Intervention Study
Usual Care
Coaching
Coaching
Portal
Coaching
Portal
Decision Support
Baseline
HgBA1C
9.2%
9.3%
9.0%
9.9%
12 month
HgBA1C
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 Messaging
 5800 patients aged ≥ 16 willing to attempt to quit smoking
within 1 month
 Participants socioeconomically diverse, 44% left school ≤ age
16
 Participants responded to ads via text or online
 All 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 Messaging
 Intervention group received 5 texts daily x 5 weeks, then 3
texts weekly for 26 weeks
 Core program of 186 standard messages and 713 personalized
messages
 Messages selected from algorithm based on patient specific data
 Messages provided motivation and behavior change techniques
 Control group received text message every 2 weeks thanking
them for study participation
 Biochemically verified 6 month quit rate 10.7% vs. 4.9%
Randomized Trial of Depression
Follow-Up Care by On Line Messaging
 208 patients with newly prescribed antidepressant depression in 9
primary clinics in Group Health Cooperative
 Patients already enrolled in on line messaging
 Excluded 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 messaging
 Outreach included PHQ-9, medication adherence, side effects, facilitated
visits, referral as needed
 3 contacts plus additional patient initiated contact
 Scripted response and algorithm based on questionnaire, tight
coordination with PCP
 Review with supervising psychiatrist, did not provide direct care
JGIM 2011 26(7):698-704
Randomized Trial of Depression
Follow-Up Care by On Line Messaging
Intervention
Control
Adherence
81%
61%
Second medication
22%
16%
Mental health specialist
visit
32%
31%
50% improvement in
depression 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 hospitals
 Assess generalizability of previous RCT
 Intervention consisted of health coaching
 Visit in hospital before discharge
 Home visit within 3 days
 Telephone call within 7-10 days
 Final 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
Intervention
 Ensure 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 appointment
 Patients 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 HIE
 Discussed and encouraged completion of advanced directive
Intervention Group
Readmission
Rates
12.7%
External Control (eligible for CTI
not approached)
Internal Control (declined CTI or
lost to follow up before home visit)
Decline
20%
Lost to follow up
18.7%
18.6%
18.6%
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% diabetics
 Algorithm consisted of:
 Step 1- fixed dose ACE/diuretic or ARB diuretic with up titration
 i.e. lisinopril 10/12.5 HCTZ; max dose 20/25
 Step 2 calcium channel blocker with up titration
 Step 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 care
 Home BP monitoring and Web services
 Home BP monitoring, Web services, pharmacist care
management
 Outcomes were changes in BP and % patients controlled
 12 month follow-up
 Goal 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
Diastolic BP
-5.3 mm
-8.2 mm
-14.2 mm
-3.5 mm
-4.4 mm
-7.2 mm
% control
31%
36%
56%
# E-Mail
contacts
# BP meds
2.4
3.3
22.3
1.69
1.94
2.16
No difference in primary care visits
Modest decline in specialist visits
Intensive Blood Pressure Control in
Diabetic Patients- ACCORD BP
 4733 patients with HgBA1C ≥ 7.5%




Age ≥ 40-79 with CVD
Age ≥ 55-79 at high risk for CVD
Systolic BP 130-180 taking ≤ 3 BP drugs
Creatinine ≤ 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 death
 Mean 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 Trial
Intensive Therapy
Events %/yr
StandardTherapy
Events %/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 Trial
Intensive 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 Trial
 Observational secondary analysis involving 6400 diabetic
patients with HTN and CAD
 Patients randomized to calcium channel blocker vs. beta
blocker strategy to achieve BP <130/85
 Added ACEI and thiazide
 Patients categorized
 Tight control systolic BP <130
 Usual control systolic BP 130-139
 Uncontrolled systolic BP ≥ 140
 Primary outcome- mortality, non-fatal MI, CVA
JAMA 2010:304;61-68
INVEST TRIAL
BP < 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%
INVEST TRIAL- BP Control in CAD
Amer J Med 2010 123:719-726
Hypertension
 A simple algorithm may improve BP control
 3-4 drugs may be necessary
 Patients 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 FibrillationARISTOTLE Trial
 18,201 patients with atrial fibrillation and one additional risk
factor for stroke
 Randomized to a apixiban (Direct Factor Xa inhibitor) 5 mg po
bid vs. warfarin
 Dose reduced to 2.5 mg if 2 of the following
 Age ≥ 80
 Weight ≤ 60 kg
 Creatinine ≤ 1.5 mg/dl
 Median duration of follow-up 1.8 years
 Primary outcome ischemic/hemorrhagic stroke or systemic
embolism
 Secondary outcome major bleeding, death
NEJM 2011;365:981-92
Apixiban
Event Rate
%/year
Warfarin
Event 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, systemic
Embolism or death
4.85
5.45
0.88
CVA, systemic
Embolism, 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- Summary
 Apixiban, dabigitran, and rivoroxaban all reduce hemorrhagic





stroke, major bleeding
Dabigitran only drug to reduce ischemic stroke
Apixiban reduces rate of major bleeding and total mortality
Cost an issue, especially for Medicare patients or other coverage
with greater cost share for drugs
Patients well controlled on warfarin may not require med change
Beneficial when difficult to control or monitor in adherent
patients.
 Cannot extrapolate to non-adherent patients due to shorter half life
The National Lung Screening Trial
 53,454 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 years
 18,146 positive tests in CT group
 96.4% false positive
 5,043 positive tests in CXR group
 94.5% false positive
 Most diagnostic evaluations were f/u imaging
 4% CT group underwent a surgical procedure
NEJM 2011;365:395-409
CT Group
Radio
logy
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
247/100,000
Patient-years
309/100,000
Patient-years
6.7% reduction in total mortality
Conclusions- CT screening for lung
cancer
 In 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 uncertainty
 Overdiagnosis rate
 Impact of newer technology (i.e. greater mortality reduction vs.
more false positives)
 Cost-effectiveness
 Duration and interval of screening
 Target patient population
 Authors recommended policy makers wait for additional data
Tiotropium vs. Salmeterol to prevent
COPD Exacerbation
 7376 patients with moderate to very severe COPD
 90% Stage II-III Gold Criteria
 Patients continued other medications
 >50% used inhaled corticosteroids, short acting bronchodilators
 Primary outcome- time to first exacerbation
 Secondary outcomes
 Risk of severe exacerbations
 Exacerbations requiring inhaled steroids and/or antibiotics
 Discontinuation 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