Update in Outpatient Medicine. Robert A Gluckman, MD, FACP Chief Medical Officer, Providence Health Plans December

Transcription

1 Update in Outpatient Medicine Robert A Gluckman, MD, FACP Chief Medical Officer, Providence Health Plans December

2 Disclosures Stock holdings Proctor and Gamble Abbvie Abbott Bristol Myers Squibb Pfizer

3 Topics Low dose CT screening for lung cancer Impact of colonoscopy on colorectal cancer incidence New agents for VTE Systems of care and BP targets for hypertension New lipid guidelines Treatment of depression and reduced mortality Alcohol screening Obesity treatment

4 Reduced Lung Cancer Mortality with Low Dose CT Screening 53,454 patients high risk for lung cancer Age Current or former smoker with 30 pack year history If former smoker, quit within 15 years Randomized to annual low dose CT or CXR x 3 Screening performed at specialized centers Radiation dose averaged 1.5 msv; Diagnostic CT averages 8mSv NEJM 2011;365:

5 Reduced Lung Cancer Mortality with Low Dose CT Screening Non-calcified nodules 4 mm classified as suspicious for lung cancer If nodule stable for three rounds classified as minor abnormalities rather than positive >27% CT scans classified as positive in T1, T2 16.8% CT scans classified as positive screen T3 39.1% of patients in CT group had at least 1 positive screen > 90% positive tests had further evaluation, mostly further imaging 96.4% positive CT results were false positives

6 T0 T1 T2 Total Positive tests (% pts screened) Imaging (% pos tests) Biopsy (% pos tests) 7,191 (27.3%) 6,901 (27.9%) 4,054 (16.8%) 18,146 5,717 (81.1%) 2520 (37.4%) 2009 (51.3%) 10, 246 (57.9) 155 (2.2%) 74 (1.1%) 93 (2.4%) 322 (1.8%) Bronchoscopy (% pos tests) 306 (4.3%) 178 (2.6%) 187 (4.8%) 671 (3.8%) Surgery (% pos tests) 297 (4.2%) 197 (2.9%) 219 (5.6%) 713 (4.0%)

7 Cumulative Numbers of Lung Cancers and of Deaths from Lung Cancer. Lung cancer mortality reduced 62/100,000 patient-years RR 20% NNS to prevent one Lung cancer death= 320 Total mortality RRR 6.7% The National Lung Screening Trial Research Team. N Engl J Med 2011;365:

8 Reduced Lung Cancer Mortality with Low Dose CT Screening Complication rates low and minor (overall 1.4%) 0.06% of patients without lung cancer 11.2% of patients with lung cancer Mortality for surgical resection of lung cancer 1%-2% NLST centers 4% national average NLST data included mediastinoscopy, thoracoscopy Generalizability of this trial dependent on equivalent performance Reporting essential

9 Targeting of Low-Dose CT Screening According to risk of Lung Cancer Death Post-hoc analysis of NLST Prediction model externally validated with patients from PLCO Trial Risk defined as 5 year risk for lung cancer Quintile 1 and % Quintile 3 thru %- > 2% NEJM 2013;369:245-54

10 Lung Cancer Risk Calculator

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12 Quintile 5 yr risk of Lung CA Death # False Positives per Lung CA Death Prevented NNS

13 Low Dose CT for Lung Cancer Screening Reduces lung cancer mortality and total mortality Benefit related to baseline risk 88% of benefit preserved and 36% of false positives can be avoided by limiting screening to patients in top 3 risk quintiles A simple risk calculator can inform patients Smoking cessation should be part of screening programs Rate of false positives should be tracked Patients should only be referred to centers with benchmark performance

14 Long Term Colorectal Cancer Incidence and Mortality After Colonoscopy Analysis of 88, 902 patients from the Nurses Health Study and Health Professionals Follow-up Study Age at midpoint analysis ranged from year follow-up Biennial questionnaire queried if patients had colonoscopy, sigmoidoscopy, or no screening NEJM 2013; 369:

15 Long Term Colorectal Cancer Incidence and Mortality After Colonoscopy

16 Long Term Colorectal Cancer Incidence and Mortality After Colonoscopy Polypectomy (n= 2740) Stage I or II Negative Colonoscopy (n= 7535) Stage III Stage IV 7 26

17 Long Term Colorectal Cancer Incidence and Mortality After Colonoscopy Incidence rate of CRC reduced 58% in patients with a single negative colonoscopy Incidence rate of CRC is further reduced in patients with > 1 negative colonoscopy Reduction in incidence rate and mortality rate in patients with negative colonoscopy undergoing repeat surveillance exam is unknown and costly FIT would find many of these cancers at curable stage

18 In patients with VTE, are new anticoagulants more effective in preventing recurrence or reducing complications?

19 Oral Rivaroxaban for the Treatment of Symptomatic PE-EINSTEIN-PE 4832 patients with acute symptomatic PE randomized to rivaroxban 15 mg twice daily x 3 weeks followed by 20 mg once daily vs. LWMH plus warfarin Primary outcome was symptomatic recurrent VTE Primary safety outcome was major or clinically relevant non-major bleeding Major bleeding- HgB drop of 2 g/dl, transfusion of 2 or more units PRBC s or critical site NEJM 2012;366:

20 Oral Rivaroxaban for the Treatment of Symptomatic PE-EINSTEIN-PE Recurrent VTE Major bleeding Non-major bleeding Major or non-major bleed Rivaroxaban Usual Therapy 2.1% 1.8% NS 1.1% 2.2% NNT=91 9.5% 9.8% NS 10.3% 11.4% NS

21 Oral Apixiban for Treatment of VTE AMPLIFY Trial 5395 patients with acute VTE randomized to 10 mg twice daily x 7 days then 5 mg twice a day vs. SQ LWMH followed by warfarin Treatment continued 6 months 65% DVT, 25% PE, 9% both 89% unprovoked VTE Excluded patients on DAPT, ASA > 165 mg qd, CRCl, 25 ml/min, Hgb <9 Primary outcome- recurrent symptomatic VTE or death due to VTE NEJM 2013;369:

22 Apixiban Usual Care Recurrent VTE 2.3% 2.7% NS Major bleeding 0.6% 1.8% 83 Relevant Non-major bleeding Major or non-major bleeding 3.8% 8.0% % 9.7% 19

23 PHP Member Adherence 8/1/2010-7/31/2011 8/1/2011-7/31/2012 8/1/2012-7/31/2013 Denominator # of Adherent Members Rate Denominator # of Adherent Members Rate Denominator # of Adherent Members Rate warfarin 4,014 2, % 3,971 2, % 4,142 2, % dabigitran % % % rivoraxaban % % % apixiban % Adherence Rate: Proportion of Days Covered (PDC) = Covered Days / Measurement Period

24 In the past Year: 69.3% > 80% 50.8% > 90% 12.5% = 100%

25 Considerations in Choosing Treatment for VTE Patient choice, cost considerations Patient selection- fewer patients with cancer, renal failure. DAPT, need for ASA > 165 mg excluded Potential drug interactions-inducers or inhibitors of P-glycoprotein, cytochrome P450 enzyme 3A4 Compliance- recommend treatment contract Apixiban with short half life, Rivoroxaban is qd Continue follow-up/monitoring Post discharge calls, follow-up appointments

26 Improved BP Control with a Large Scale Hypertension Program 652, 763 patients in KPNC registry compared to other California insurers participating in NCQA 5 components to program Development of a registry Sharing of performance metrics Evidence based guidelines MA BP visits Single pill combination therapy (diuretic plus ACE) JAMA 2013;

27 Improved BP Control with a Large Scale Hypertension Program 4 step drug therapy Thiazide or Thiazide plus ACEI Thiazide plus ACEI CCB (i.e. amlodipine) Spironolactone or beta blocker MA visit 2-4 weeks after med change No co-pay Allowed more rapid treatment intensification JAMA 2013;310:

28 PHP %

29 Home Blood Pressure Telemonitoring and Pharmacist Management of Blood Pressure 450 adults with uncontrolled BP from 16 clinics in a large multi-specialty group Patients received a home BP monitor that transmits clinic and told to transmit 6 times per week Patients met with pharmacist in person once and then phone call every 2 weeks until BP controlled x 6 weeks. Treatment intensified if < 75% readings at target Monthly call until month 6, then every 2 months At 12 months, telemonitor returned and intervention ended. BP control at 18 months 71.8% vs. 57.1% JAMA 2013;310:46-56

30 BP pressure and mortality in CKD Cohort study of 651, 749 US veterans with CKD 34% with hypertension 62.3% CKD Stage 3A (egfr ml/min) 24.1% CKD Stage 3B (egfr ml/min) Mean age % DM, 42.6% CAD Ann Int Med 2013;

31 BP pressure and mortality in CKD Insert figure 1

32 Hypertension Management-Conclusions A standardized reproducible process is required to achieve optimal blood pressure control across a population Non-physician staff with physician oversight can achieve optimal blood pressure control and create primary care capacity Consider diastolic BP while trying to achieve BP targets in the elderly or patients with chronic conditions

33 New ACC/AHA Lipid guidelines Focus on ASCVD risk reduction- 4 statin benefit groups New perspective on LDL-C and non-hdl-c treatment goals- emphasis on statin intensity Global risk assessment for primary preventionhighly controversial new risk calculator Safety recommendations Role of biomarkers and noninvasive tests Accessed on line 11/30/2103

34 New ACC/AHA Lipid guidelines 4 major statin groups Established ASCVD Primary elevations of LDL-C 190 mg/dl Diabetes age with LDL-C 70 to 189 md/dl and without clinical ASCVD Patients without ASCVD or DM, LDL-C 70 to 189 mg/dl and estimated 10 year ASCVD 7.5% Highly controversial risk calculator Use high intensity statin if age 75 DM may use moderate intensity statin if 10 year risk < 7.5%

35 New ACC/AHA Lipid guidelines New perspective on LDL-C and non-hdl-c Treat with maximally tolerated statin based on guideline LDL levels used to monitor adherence Surveillance CK or hepatic function only if symptoms Addition of niacin, fibrates, or eztemibe Grade IIB recommendation based on level C evidence LDL targets will likely be replaced for performance measurement

36 New ACC/AHA Lipid guidelines High intensity statin Atorvastatin mg Rosuvastatin mg Moderate intensity statin Atorvastatin mg Rosuvastatin 10 mg Simvastatin mg Pravastatin mg Lovastatin 40 mg Fluvastatin 40 mg BID Fluvastatin XL 80 mg Pitavastatin 2-4 mg

37 Long term effect of depression care management on mortality in older adults 1226 patients from 20 primary care practices, screened and tested positive for depression Randomized to intervention consisting of depression care manager, PCP and family education vs. usual care Care managers had on demand psychiatrist consultation and weekly supervision Care managers titrated meds at 6 weeks and changed meds at 12 weeks if no response BMJ 2013;346:f2570 doi: /bmj.f2570 published 5 June 2013

38 Long term effect of depression care management on mortality in older adults Intervention Usual care Remission at 4 months 40.0% 22.5% Remission at 24 months 45.4% 31.5%

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40 Long term effect of depression care management on mortality in older adults- PROSPECT is the first trial to demonstrate long term mortality benefits for treating depression Effective management of depression requires systematic assessment/follow-up of treatment response and population based psychiatric oversight

41 Screening and Behavioral Counseling Interventions to Reduce Alcohol Misuse USPTF Recommendation Statement Alcohol Misuse- Risky Use Men- > 4 drinks in a day or 14 drinks per week Women- > 3 drinks in a day or 7 drinks per week Harmful Use- pattern of drinking that causes harm to physical or mental health Alcohol Abuse- Drinking that leads to recurrent failure in major home, work school responsibilities, use in physically hazardous situations, alcohol related legal or social problems Annals of Intern Med 2013;159:

42 Screening and Behavioral Counseling Interventions to Reduce Alcohol Misuse USPTF Recommendation Statement Evaluated 3 screening tools AUDIT 10 questions takes 3-5 minutes Sensitivity 84%-85%, Specificity 77%-84% AUDIT-C 3 questions takes 1-2 minutes Sensitivity 74-76%, Specificity 80-83% Single question screen < 1 minute Sensitivity 82-87%, Specificity 61-79% SBIRT- CCO performance metric Initial screen 1 alcohol question, 1 drug use question, PHQ- 2 depression screen Positive screens followed up by AUDIT, DAST, PHQ-9 as warranted has all the materials

43 Screening and Behavioral Counseling Interventions to Reduce Alcohol Misuse USPTF Recommendation Statement Brief, multicontact behavioral counseling best 12% ARR in binge drinking 11% ARR in patients not exceeding recommended limits 9% ARR in patients > 65 not exceeding limits Effectiveness for patients with harmful alcohol use or alcohol abuse less certain

44 Behavioral Treatment for Weight Gain Prevention in Primary Care 194 overweight or Class 1 obese (BMI ), African American women, age from 6 community health centers 79.7% < college education, 74.3% income < $30K, 71.4% employed Recruited by mail and follow up phone call Randomized after attending a baseline visit Usual care patients received a newsletter every 6 mo Intervention patients informed goal was overall health and maintenance of current body image JAMA Int Med 2013;173:

45 Behavioral Treatment for Weight Gain Prevention in Primary Care 5 components to intervention Patient self selection of behavioral goals (i.e. no sugar sweetened beverages or fast food) Goals replaced every 2 months Weekly self monitoring via interactive voice response calls- tailored feedback Monthly 20 minute phone calls with dietician Tailored training materials Free YMCA gym membership

46 Behavioral Treatment for Weight Gain Prevention in Primary Care Intervention Usual Care Weight change (kg) 12 months % at or below baseline 12 months Weight change (kg) 18 months % at or below baseline 18 months % 45.4% % 38.5%

47 An Economic Analysis of Traditional and Technology-Based Approaches to Weight Loss 197 sedentary overweight or obese adults randomized to 4 groups Self directed weight loss Group based program (GWL)-14 sessions Arm band- provided feedback on energy expenditure, time engaged in physical activity, steps Arm band plus GWL Mean BMI 33.3, 81% women. 32% African- American Excluded conditions that limited physical activity 9 month follow-up Am J Prev Med 2012;43(2):

48 An Economic Analysis of Traditional and Technology-Based Approaches to Weight Loss Intervention Total cost per patient Weight loss (kg) Cost per kg lost Usual Care $ Group Class $ $ Armband $ $51.43 Group Class + Arm Band $ $55.42

49 Obesity-Treatment Efforts to prevent and treat obesity are an urgent public health priority Traditional approaches require considerable staff and recidivism is high Leveraging technology may be cost effective and provide low cost, long term approaches Community resources to promote and facilitate adoption of healthy behaviors essential