Treatment of Malnutrition and Heart Failure

Transcription

1 Treatment of Malnutrition and Heart Failure Steven Krueger MD Bryan Heart 216 Bryan Heart Fall Cardiology Conference Disclosure Currently on the speaker bureau s for the following companies related to this talk: Ensure Enlive Abbott All Honoria to Big Heart Initiative charitable fund One Final Disclosure.. Treatment of Malnutrition and Heart Failure A. Introduction B. Preliminary Data C. NOURISH Trial D. Readmissions E. Conclusions 1

2 OBJECTIVES Review the clinical impact of malnutrition and loss of lean body mass (LBM) Discuss the clinical and economic benefits of oral nutrition supplements (ONS) Present new scientific evidence of specialized ONS in the management of malnourished hospitalized patients HOSPITAL ADMISSION HOSPITAL STAY HOSPITAL DISCHARGE HOSPITAL READMISSION 3% to 55% of hospital patients are malnourished upon admission % of severely malnourished patients and 38% of wellnourished patients experience nutritionaldecline 4 Many patients continue to lose weight after discharge 5 Patients with weight loss are at increased risk for readmission 1 1. Tappenden KA et al. JPEN J Parenter Enteral Nutr. 213;37(4): Naber TH et al. Am J Clin Nutr. 1997;66(5): Somanchi M et al. JPEN J Parenter Enteral Nutr. 211;35(2): Braunschweig C et al. J Am Diet Assoc. 2;1(11): Beattie AH et al. Gut. 2;46(6): DISEASE ASSOCIATED MALNUTRITION IS ASSOCIATED WITH ILLNESS, INJURY, AND HOSPITALIZATION Risk of dying increases when food intake is limited by illness or injury 4 Loss of lean body mass delays recovery and impedes rehabilitation 3 Hospitalization itself often worsens nutritionalstatus 2 Anyone who is sick or injured is at risk for malnutrition, especially older people 1 1. Imoberdorf R, et al. Clin Nutr. 21;29: Krumholz HM. N Engl J Med. 213;368: Li HJ, et al. J Adv Nurs. 213;69: Hiesmayr M, et al. Clin Nutr. 29;28:

3 MALNUTRITION NEGATIVELY AFFECTS PATIENT OUTCOMES Malnutrition Hospital Readmissions Wound Healing Infections Complications Convalescence Mortality Treatment Length of Stay (LOS) in Hospital Cost Quality of Life Adapted from Norman K et al. Clin Nutr. 28; 27: Allaudeen N, et al. J Hosp Med. 211;6(2):54-6. MALNUTRITION SARCOPENIA SYNDROME Sarcopenia Frailty Deconditioning Sarcopenic Obesity Cardiac Cachexia Cancer Cachexia ESRD/CKD COPD ICU Acquired Weakness HIV Cachexia Malnutrition Sarcopenia Loss of LBM Protein calorie malnutrition Undernutrition Hospital acquired malnutrition Disease related malnutrition Morbidity Mortality Economic Impact Vandewoude M et al., J Aging Res.212. WHAT IS LEAN BODY MASS (LBM)? Muscles Organs Bone Everything except for fat (fat free mass) LBM accounts for 75% of normal body weight Muscle is the largest component of LBM Functions of LBM include: Mobility Balance Generation of heat (energy) Protein / amino acid pool for skin, immune & digestive systems Survival during periods of stress Wardlaw GM, Kessel M. Perspectives in Nutrition. 5th ed. New York, NY: McGraw-Hill; 22. 3

4 PROGRESSIVE LOSS OF LBM / MUSCLE MASS OCCURS NATURALLY WITH AGE 1% of Muscle Mass 1% Per decade from 4-7 9% 8% 8% loss Per decade after age7 7% 15% loss 6% 5% 4% Age 25 yrs 4 yrs 7 yrs 8 yrs <7%: Zone where risk of death is high Age-related loss of muscle mass, strength and/or functionality is called Sarcopenia 1. Baier S, et al. JPEN J Parenter Enteral Nutr. 29;33(1): Flakoll P, et al. Nutrition. 24;2(5): Grimby G, et al. Acta Physiol Scand. 1982;115(1): Janssen I, et al. J Appl Physiol. 2;89(1): Vandewoude MFJ, et al. Malnutrition-Sarcopenia Syndrome: is this the future of nutrition screening and assessment for older adults. J Aging Res. 212;212: Epub 213 Sep 13. BED REST, AGE AND HOSPITALIZATION INCREASE LOSS OF LBM HealthyYoung 28 Days Inactivity 1 HealthyElders 1 Days Inactivity 2 Elderly Inpatients 3 Days Hospitalization lb/day Pounds Lost Per Day lb/day lb/day -.8 Approximate total loss of LBM 1 lb (28) 2.2 lb (1) 2.2 lb (3) (time in days) 1. Paddon-Jones D et al. J Clin Endocrinol Metab. 24;89: Kortebein P et al. JAMA. 27;297: Paddon-Jones D. Presented at: 11th Abbott Nutrition Research Conference; June 23-25, 29; Columbus, Ohio. INTERVENTIONS TO MITIGATE LBM LOSS Exercise/activity Dietary intervention Dietary Proteins ONS Targeted nutrients amino acids beta-hydroxy-betamethylbutyrate (HMB) 4

5 Treatment of Malnutrition and Heart Failure A. Introduction B. Preliminary Data C. NOURISH Trial D. Readmissions E. Conclusions NUTRITION INTERVENTIONS LEAD TO IMPROVED OUTCOMES Nutrition intervention can produce positive results to improve patient care quality and reduce overall costs. 28% reduction in avoidable readmissions 1 2-day reduction in average length of stay % reduction in pressure ulcer incidence 5 14% reduction in overall complications 6 (e.g., infections, anemia,etc.) ONS use is associated with reduction in mortality in select patients (e.g., elderly malnourished 6 ) 1. Gariballa S, et al. Am J Med 26;119(8): Brugler L et al. J Qual Improv 1999; 25: Somanchi M et al. JPEN 211; 35: Smith PE, et al. Healthcare Financial Management 1997;51: Stratton RJ, Ek AC, Engfer M, et al. Ageing Res Rev. 25;4: Milne AC, et al. Cochrane Database Syst. Rev. 29 APR 16(2):CD3288. DOI:1.12/ ORAL NUTRITION SUPPLEMENTS PROVIDED DURING HOSPITALIZATION WAS ASSOCIATED WITH: 21% decrease in length of stay (2.3 days) 21.6% decrease in episode costs ($4734) 6.7% decrease* in probability of 3-day readmissions Monetary figures are based on 21 US dollars and inflation adjusted. *Readmission defined as return to study hospital for any diagnosis. Data measured delayed readmission and does not include patients not readmitted due to recovery ordeath. In a retrospective health economic study, Philipson T et al. Am J Manag Care. 213;19(2):

6 TARGETED NUTRIENT: ß-HYDROXY ß-METHYLBUTYRATE (HMB) Bioactive metabolite of leucine: Occurs naturally in human muscle cells Found in small amounts in many foods (e.g., avocado, grapefruit, catfish) Exerts its effects through protective, anticatabolic mechanisms and has been shown to: Decrease protein degradation via NFkB downregulation Preserve muscle mass in older adults during extended bed rest Stabilize muscle cell membrane 1. Nissen SL, Abumrad NN. J Nutr Biochem. 1997;8: Wilson. Nutr Metab.28;5:1 3. Eley HL et al. Am j Physiol Endocrinol Metab.28;295:E Deutz et al., Clinical Nutrition 213. EFFECT OF HMB ON LEAN BODY MASS DURING 1 DAYS OF BED REST IN OLDER ADULTS Supplement HMB or Control 5 d 1 d Bed Rest (In patient) 8 Wk Recovery/Resistance Exercise DEXA Isocaloric Diet (All) DEXA DEXA Supplements: 2 sachets/day with 4 g maltodextrine, 2 mg Ca and flavoring agents HMB group: 1.5 g Ca-HMB Controls: no addition Diet stabilization to.8 g protein/kg BW/day and (calculated) energy requirements Bed rest for 1 days with only wheelchair for toileting or showering Prophylacticmeasures D-Dimer test, TED hose and daily checking Constant monitoring by nursing staff and daily physical by physician Rehabilitation for 8 weeks with resistance exercise training - 3 days/week Deutz et al, Clinical Nutrition 213. HMB PRESERVES LBM Change in total lean (kg) Change in Total Lean Mass 1 * -1-2 Control -3 + HMB -4 Bed rest Bed rest+ Rehabilitation Change in legs lean (kg) Change in Total Leg Lean Mass * Control -1.5 HMB Bed rest Bed rest+ Rehabilitation Deutz et al, Clinical Nutrition

7 EFFECT OF HMB ON MUSCLE STRENGTH IN HEALTHY MEN AND WOMEN Leg Extensor Strength, 6 * s Non-exercising Groups p=.4 HMB Placebo Stout JR, et al. Exp Gerontol.213 HMB SAFE AND WELL TOLERATED Review article and meta-analysis of HMB clinical studies published in 213 n=39 articles Conclusions: 3 g/day (CaHMB) efficacious dose Effective in preventing exercise-related muscle damage Effective in preventing muscle loss during chronic diseases No safety concerns Molfino et al., Amino Acids. 213Dec;45(6): Treatment of Malnutrition and Heart Failure A. Introduction B. Preliminary Data C. NOURISH Trial D. Readmissions E. Conclusions 7

8 Readmission and Mortality in Malnourished, Older, Hospitalized Adults Treated With a Specialized Oral Nutritional Supplement: A randomized clinical trial Deutz NE, et al., Clin Nutr; 216, 35 (1): NOURISH STUDY OBJECTIVE NOURISH: Nutrition effect On Unplanned Readmissions and Survival in Hospitalized patients Evaluation of a high-protein oral nutritional supplement containing beta-hydroxy-beta-methylbutyrate (HP-HMB) on post discharge outcomes of non-elective readmission and mortality in malnourished, hospitalized older adults. NOURISH: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER (N=652) STUDY Screen Patients 65y, hospitalized with CHF, AMI, COPD or pneumonia 652 patients with mild severe malnutrition PLACEBO (BID) + standard nutr/medcare D HP-HMB (BID) + standard nutr/medcare PrimaryComposite Outcome: Readmission and mortality through 9 days post-discharge. D3 D6 D9 SecondaryOutcomes: Nutritional Functional Statistical Analysis: Intention-to-treat; p<.5 statistical significance 8

9 SUBJECTIVE GLOBAL ANALYSIS Evaluated nutritional and medical history and changes Validated in healthy and disease populations The gold standard for diagnosing malnutrition Detsky AS, et al. JPEN J Parenter Enteral Nutr ;11(1):8-13. Study Results BASELINE DEMOGRAPHIC AND CLINICAL CHARACTERISTICS SHOWED NO STATISTICAL DIFFERENCE BETWEEN GROUPS 1 Gender and Race Percent Male Female White Non-white Control Placebo HP-HMB Placebo HP-HMB Age (yr, Mean ±SEM) ± ±.47 Charlson Comorbidity Score (Mean ± SEM) 2.5 ± ±.8 Government sponsored insurance, n(%) 278(89%) 276 (89%) Income < $25,/yr, n(%) 13 (42%) 154 (49%) 9

10 BASELINE DEMOGRAPHIC AND CLINICAL CHARACTERISTICS SHOWED NO STATISTICAL DIFFERENCE BETWEEN GROUPS Percent Primary admission Dx Placebo Control HP-HMB CHF AMI PNA COPD Percent SGA B, Mildly-Moderately Malnourished Placebo Control HP-HMB C, Severely Malnourished PRIMARY PATIENT ADMITTING DIAGNOSIS AND COMORBIDITIES Primary admission diagnosis N (%) AM I (n=5 5) CHF (n=15 7) COP D (n=21 4) Pneumoni a (n=195) Comorbidities per Charlson Index Myocardi al infarctio n 55 (1%) 35 (22.3%) 24 (11.2) 19 (9.7) Congestive heart failure (CHF) 13 (23.6%) 157 (1%) 48 (22.4%) 47 (24.1%) Chronic pulmonar y disease 1 (18.2%) 56 (35.7) 214 (1%) 16 (54.4%) PRIMARY COMPOSITE ENDPOINT Kaplan-Meier SurvivalCurve Composite Endpoint of 9-Day Readmission and Mortality Proportion p =.214 Placebo, n HP-HMB, n Placebo HP-HMB Days post-discharge

11 PRIMARY COMPOSITE ENDPOINT Kaplan-Meier Survival Curve Readmission Proportion p =.749 Placebo, n HP-HMB, n Placebo HP-HMB Days post-discharge PRIMARY COMPOSITE ENDPOINT Kaplan-Meier Survival Curve: Mortality Proportion p =.13 Placebo, n HP-HMB, n Placebo HP-HMB Days post-discharge HP-HMB WAS ASSOCIATED WITH 5% REDUCTION IN MORTALITY Percent Mortality p=.18 p= p= Day 3 Day 6 Day 9 Control Placebo HP-HMB Post hoc estimation of the number needed to treat (NNT) to prevent 1 death was 2.3 (95% CI, 1.9 to 121.4). 11

12 HP-HMB IMPROVED NUTRITIONAL STATUS Percent of patients 1% 9% 8% 7% 6% 5% 4% 3% 2% % % Placebo Control HP-HMB Placebo Control HP-HMB Placebo Control HP-HMB Placebo Control HP-HMB n=39 n=313 n=187 n=196 n=161 n=169 n=16 n=167 Baseline Day3 Day6 Day9 SGA-A SGA-B SGA-C By day 9, HP-HMB had higher odds of better nutritional status as assessed by SGA (OR = 2.4,P=.9) HP-HMB IMPROVED WEIGHT GAIN HP-HMB INCREASED SERUM VITAMIN D LEVEL 12

13 NUMBERS WHICH COUNT Deutz et al. showed that 2 patients should be treated to save 1 death [6]. Their decision to provide this information is interesting since it associates nutritional support to pharmacological therapies, and it is relevant since the NNT for this specific ONS is quite encouraging. Indeed, Schork has recently reviewed the NNT for some blockbuster drugs, and it is surprising to note that the NNT for esomeprazole is 24 [8]. Laviano A; Clin Nutr. 216 Feb;35(1):5-6. HMB 35 Cal per 8-fl-oz serving 1.5 grams ofcahmb 2 grams of high-quality protein 12% Daily Value of vitamin D 26 vitamins and minerals Omega-3s (plant-basedala) Antioxidants (vitamins C and E and selenium) 3 grams of fiber SUMMARY Among hospitalized patients, disease associated malnutrition and the loss of lean body mass is prevalent and costly Nutritional interventions including oral nutritional supplements help improve patient outcomes The use of a high-protein oral nutritional supplement containing beta-hydroxy-beta-methylbutyrate is associated with improved clinical and nutritional outcomes in malnourished hospitalized patients with cardio-pulmonary disease 13

14 WHAT CAN YOU DO FOR YOUR MALNOURISHED PATIENTS? Standardize Nutrition Intervention for Improved Patient Care SCREEN All Patients Identify riskof Malnutrition LBM loss INTERVENE Early Recommend two ONS perday Nutrition therapy FOLLOW-UP Compliance Reassess to improve patient outcomes Correia et al., J Am Med Dir Assoc. 214; 15; pp Tappenden et al., JPEN J Parenter Enteral Nutr. 213; 37: Deutz NE, et al., Clin Nutr; 216, 35 (1) pp Sriram K et al., JPEN J Parenter Enteral Nutr 216; 4, pp Treatment of Malnutrition and Heart Failure A. Introduction B. Preliminary Data C. NOURISH Trial D. Readmissions E. Conclusions Optimizing the Nutrition Care Process to Reduce 3-day Readmissions 216 USANENS16179/FEB216 14

15 CMS REDUCES PAYMENTS FOR PREVENTABLE READMISSIONS 2,592 hospitals were penalized by the Centers for Medicare and Medicaid Services (CMS) in fiscal year (FY) Fines estimated by CMS in FY 215 $42 million 1 Penalties increased in FY 215 to 3%: A hospital with $1 million in Medicare payments could be penalized $3 million 1 75% of hospitals subject to the Hospital Readmission Reduction Program are being penalized 1 Hardest hit hospitals are in New Jersey; New York; Washington, DC; Arkansas; Kentucky; Mississippi; Massachusetts; and Illinois 2 1.Rau J. Medicare fines 2,61 hospitals in third round of readmission penalties. Kaiser Health News. January 28, Health Industry Distributors Association (HIDA). 213 Acute Care Market Report. Distributors-Association-HIDA-v2745/Acute-Care /. Accessed January 28, 216. EVIDENCE THAT NUTRITION INTERVENTION DECREASES READMISSIONS Hospital patients who received dietary counseling plus oral nutritional supplements (ONS) experienced significantly fewer readmissions (P=.41) 1 Counseling only ONS 26% 48% 3-Day readmission rates decreased from 16.5% to 7.1% after institution of comprehensive nutrition pathway from inpatient to post discharge 2 Before 16.5% After 7.1% Patients who received ONS ( 995 kcal/day) in addition to food for 6 weeks had fewer readmissions: 29% who consumed ONS vs 4% who ate food only 3 Food only ONS 29% 4% 1. Norman K et al. Clin Nutr. 28;27: Brugler L et al. Jt Comm J Qual Improv. 1999;25: Gariballa S et al. Am J Med. 26;119: REAL WORLD EVIDENCE FOR VALUE OF NUTRITION IN THE NEW HEALTH CARE ENVIRONMENT A Rapid, Comprehensive Oral Nutritional Supplement Quality Improvement Program (QIP) Reduced 3-day Readmission in Malnourished Hospitalized Patients Sriram K et al., JPEN J Parenter Enteral Nutr 216; 4, pp This trial was registered with U.S. National Institutes of Health and U.S. National Library of Medicine on NCT w.ClinicalTrials.gov 15

16 STUDY SETTING: ADVOCATE HEALTH CARE SYSTEM The largest health care provider in Illinois One of the largest accountable care organizations (ACO) in the US 25 sites of care and 12 hospitals Over 2 million patients seen annually Five Level I trauma centers, three Level II trauma centers Not-for-profit, mission-based health system A leader in population health management and coordinated care RESEARCH QUESTION AND PRIMARY ENDPOINT Study Hypothesis: Administration of a rapid, automatic ONS intervention from screening to discharge will decrease 3-day readmission rate by 2% or more and yield superior costeffectiveness compared with existing ONS protocol in patients at risk for malnutrition Primary Endpoint: Incidence of nonelective readmission 3-days post discharge Patient Population: 18+, any primary diagnosis, risk for malnutrition (Malnutrition Screening Tool [MST] score 2) Sriram K et al., JPEN J Parenter Enteral Nutr 216; 4, pp MALNUTRITION SCREENING TOOL (MST) MST is a validated screening tool and evaluates weight loss and appetite as two criteria most indicative of malnutrition risk The set of questions helps to quantify patients malnutrition risk level STEP 1: Screen with the MST Have you recently lost weight without trying? No Unsure 2 If yes, how much weight have you lost? 2-13 lb lb lb 3 34 lb or more 4 Unsure 2 Have you been eating poorly because of a decreased appetite? No Yes Appetite score: 1 Add weight loss and appetite scores MST SCORE: Weight loss score: Ferguson, M et al. Nutrition :

17 DIFFERENCES BETWEEN QIP+ AND QIP Differences of QIP+ and QIP Programs QIP+ QIP MST is a part of EMR RN completesmst ONS selection via automatic drop down menu ONS ordered by MD, RN, orrd RD consultation Time to RD consultation: <24 hours Time to ONS Delivery (onaverage) 1 24 h h Discharge planning instructions Discharge materials including coupons and literature Standard post-discharge phone calls (24-72hours) Nutrition-focused post-discharge questions on phone calls MD, Physician; RN, Registered Nurse; = Yes. Sriram K et al., JPEN J Parenter Enteral Nutr 216;4. RESULTS FOR QIP SITES (N=769) Screening Intervention Education Post discharge Readmission Rate: 2% Readmission Rate: Pre-QIP Nonvalidated screening tool No early intervention No formalized nutrition discharge education No post-discharge reminders about nutrition 16.4% QIP Validated screening tool (MST) integrated into EMR Targeted ONS intervention in hours No formalized nutrition discharge education No post-discharge reminders about nutrition 18% Reduction vs Baseline p<.1 Sriram K et al., JPEN J Parenter Enteral Nutr 216;4. RESULTS FOR QIP+ SITES (N=5) Screening Intervention Education Post discharge Readmission Rate: 2% Readmission Rate: Pre-QIP Nonvalidated screening tool No early intervention No formalized nutrition discharge education No post-discharge reminders about nutrition 15.6% QIP+ Validated screening tool (MST) integrated into EMR Automatic ONS intervention in 24 hours Formalized nutrition discharge education with coupons Follow-up calls encouraging ONS adherence 22% Reduction vs Baseline p<.1 Sriram K et al., JPEN J Parenter Enteral Nutr 216;4. 17

18 RESULTS FOR ALL QIP AND QIP+ SITES ReadmissionRate: 2% ReadmissionRate: 16.4% ReadmissionRate: 15.6% Pre-QIP QIP QIP+ Screening Nonvalidated screening tool Validated screening tool (MST) integrated into EMR Validated screening tool (MST) integrated into EMR Intervention No early intervention Targeted ONS intervention in hours Automatic ONS intervention in 24 hours Education No formalized nutrition discharge education No formalized nutrition discharge education Formalized nutrition discharge education with coupons Post discharge No post-discharge reminders about nutrition No post-discharge reminders about nutrition Follow-up calls encouraging ONS adherence 18% Reduction vs Baseline p<.1 22% Reduction vs Baseline p<.1 Sriram K et al., JPEN J Parenter Enteral Nutr 216;4. ECONOMIC MODEL OF STUDY RESULTS QIP+ SITES (5 patients enrolled) 1 expected 78 observed = 22 prevented readmissions x $18,5 average readmission cost 1 = $47, QIP SITES (769 patients enrolled) 154 expected 126 observed = 28 prevented readmissions x $18,5 average readmission cost 1 = $518, Total 6-Month Savings = $925,* Projected Annual Savings = $1,85, *During the period of this study involving 4 hospitals only. Based ONLY on application of current, limited QIP protocol. 1. Philipson TJ et al. Am J Manag Care. 213;19(2): CONCLUSIONS A comprehensive ONS QIP reduced 3-day unplanned hospital readmissions among hospitalized patients at risk of malnutrition Keys to success: Multidisciplinary team collaboration and follow-up Implementation of a validated nutrition screening tool in EMR Immediate provision of ONS Ongoing patient and care giver education in hospital and at discharge Post-discharge questions related to ONS Ongoing provider education Sustained provider and administrative program support 18

19 Treatment of Malnutrition and Heart Failure A. Introduction B. Preliminary Data C. NOURISH Trial D. Readmissions E. Conclusions Treatment of Malnutrition and Heart Failure Conclusions A. Malnutrition is a big problem in patients with Heart Failure B. Therapy can decrease mortality and readmissions C. We should screen for malnutrition and treat Heart Failure patients that qualify 19