AposTherapy at Montefiore

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AposTherapy at Montefiore Se Won Lee, MD Department of Physical Medicine and Rehabilitation Montefiore Medical Center June 3, 2016

Who We Are Notable Centers of Excellence Children s Hospital at Montefiore Montefiore Einstein Center for Cancer Care Montefiore Einstein Center for Heart and Vascular Care Montefiore Einstein Center for Transplantation Neuroscience Orthopedic Ophthalmology OB/GYN Teaching Research Academic Health System Hospitals Primary & Specialty Care Home Care ~1,323 Residents & Fellows ~420 Allied Health Students ~1,552 Graduate & Undergraduate Nursing ~200 Home Health Aides ~100 Social Workers Clinical Translational Health Services Community 7 Campuses 7 Hospitals 2,200 Beds 150 Skilled Nursing Beds 1 Freestanding ED 3 Urgent Care Sites Advanced Primary Care Sub-specialty Care Dental School Based Health Centers Mobile Health Home Health Programs Primary Care House Call Program ~23,000 Employees ~3,450 Integrated Provider Association Physicians ~1,800 Employed MDs ~4,270 RN/LPN ~3,300 NYSNA RNs ~10,280 SEIU/1199 Workforce Population Health Health Education Community Advocacy Wellness Disease Mgmt. Nutrition Obesity Prevention Physical Activity Reduce Teen Pregnancy Lead Poisoning Prevention Corporate Functions Information Technology Finance Clinical Legal support Planning Network Purchasing applications Compliance Marketing Human Resources CMO Care Management (>300K Covered Lives) Disease Management Care Coordination Telemedicine Pharmacy Education

Impact of Knee Osteoarthritis and Chronic Low Back Pain on Population Health Leading cause of mobility disability Impact a greater proportion of the population than previously appreciated More than 11% of the 40-64 year old population and 14% of the 65-75 year old population sought care related to these conditions during 2014. A review of claims* of patients seeking treatment for knee osteoarthritis (OA) and chronic low back pain (LBP) finds: A high prevalence among the 40-64 and 65-75 year old US populations Higher relative risks of co-morbidities and prescription drug consumption 3-5X higher treatment costs for the knee OA and chronic LBP populations *All patients were continuously enrolled from January 1, 2014 through December 31, 2014 Source: Truven Health Analytics Marketscan US Commercial and Medicare claims

Patients with Knee OA and Chronic LBP have Higher Rates of Co-morbidities and Narcotic use Knee OA 40-64 year olds 65-75 year olds n= 5,924,694 n= 815,464 With knee OA Without knee OA Relative Risk With knee OA Without knee OA 3% 97% 9% 91% Relative Risk Other Associated Conditions Essential hypertension 22% 7% 3.2X 33% 15% 2.2X Disorders of lipid metabolism 15% 7% 2.2X 20% 11% 1.9X Diabetes mellitus 13% 5% 2.9X 21% 11% 2.0X Mood disorders 6% 2% 2.7X 4% 2% 2.6X Obesity 5% 1% 8.7X 3% 0% 7.2X Coronary atherosclerosis & other heart disease 3% 1% 2.6X 9% 5% 1.7X Opioid use 35% 6% 5.6X 33% 8% 4.3X 40-64 year olds 65-75 year olds n= 5,430,384 n= 742,344 Chronic Low Back Pain Without Relative Without Relative With LBP With LBP LBP Risk LBP Risk 17% 83% 22% 78% Other Associated Conditions Essential hypertension 15% 6% 2.4X 29% 14% 2.1X Disorders of lipid metabolism 13% 6% 2.1X 20% 10% 2.0X Diabetes mellitus 9% 4% 2.3X 21% 10% 2.1X Mood disorders 6% 2% 3.7X 5% 1% 4.3X Obesity 2% 0% 4.8X 2% 0% 5.1X Coronary atherosclerosis & other heart disease 2% 1% 2.3X 9% 4% 2.0X Opioid use 28% 4% 6.7X 31% 6% 5.4X

Addressing Knee Osteoarthritis and Chronic Low Back Pain to improve population health Traditional Management of Knee OA and Chronic LBP Education (home exercise program, weight loss) and pharmacological management) Physical therapy and injections (intraarticular and epidural/nerve block etc.) Operative management (total knee arthroplasty) Triple Aims of Successful Management Improving the quality of care provided to patients suffering from knee OA and chronic LBP Lowering the direct and excess costs of care associated with reduced mobility Improving patient satisfaction

What is AposTherapy? Apos (All Phase of Step)Therapy is an innovative biomechanical rehabilitation program that reduces pain, improves function, and improves the mobility of patients with knee OA and chronic LBP Based on two well-established treatment strategies for lower extremity and lower back musculoskeletal conditions Reducing loads from the affected joint by modifying center of pressure (GRF) Retraining the proprioceptive system through perturbation (improve neuromuscular control) Each patient is individually evaluated and calibrated by a specially-trained physical therapist and a 12-month at-home treatment plan is prescribed Patients wear the shoe for about 1 hour a day while conducting routine tasks and come in for 5 follow-up visits over the course of the year

Biomechanical & Neuromuscular Effect 1. Reducing the adductor moment 2. Reducing the compressive forces in the medial Compartment 1. Convexity of pertupod introduces controlled instability that stimulates proprioception 2. Promotes fine modulation of muscles to stabilize the Joint

AposTherapy at Montefiore Montefiore is the first hospital system in the U.S. to offer this innovative treatment Currently provided by Department of Rehabilitation Medicine at the Moses Campus (3199 Bainbridge Avenue, Bronx, NY) Insurance coverage Healthfirst patients Montefiore Empire BCBS benefit plan

Knee OA Pain and WOMAC score between control (conventional PT) and APOS at 2 years (n=38 in treatment & 9 in control) Hip OA Pain, WOMAC, gait parameter after Apos in 12 weeks (N=60, no control) Non specific LBP Gait after AposTherapy in 12 weeks (n=19, no control ) Others Previous Publications After TKA (n=17, no control), THA (n=19, no control), anterior knee pain, knee meniscus (n=34, no control, 12 months FU) and more Biomechanical alignment and perturbation Clinical outcomes Knee OA classification Additional scientific evidence 10 Studies 18 Studies 4 Studies 7 Studies Prevention 8 as a Priority in Value-Based Healthcare

Three Components of AposTherapy Personalized pathway of care Biomechanical system Treatment as part of daily life

AposTherapy Patient Pathway Standard Treatment Plan Initial First Follow Consultation Up Follow Up Follow Up Follow Up Follow Up Customer Care Call 0 3-4 weeks 3-4 Months 6-7 Months 9-10 Months 12 Months Initial Consultation Baseline Report Interim Follow Up Consultation Progress Report Final Follow Up Consultation Progress Report

163 total patients: 71 Healthfirst, 92 Monte Empire New Patients by Payer Monte Empire Healthfirst 40 37 patients 35 30 12 28 patients 25 25 patients 24 patients 24 patients 20 15 10 5 0 9 9 15 16 patients 12 8 25 16 15 13 4 patients 5 patients 12 3 8 3 1 2 Oct Nov Dec Jan Feb Mar Apr May

Preliminary Patient Outcomes Primary complaint: knee pain Outcome measurement: pain and function by WOMAC, quality of life by SF-36, and gait analysis (Optogait) 55 patients with 1 FU 20 patients with 2 FU and 7 patients with 3 FU Primary complaint: back pain Outcome measurement: pain (visual analogue scale), function by Oswestry, quality of life by SF-36, and gait analysis 44 patients with 1 FU and 15 patients with 2 FU

100.00 50.00 0.00 100.00 80.00 60.00 40.00 20.00 0.00 Patients with Knee Pain Preliminary Outcomes: Pain, Stiffness, Function 50.67 53.54 47.72 50.15 49.43 53.18 WOMAC Pain 42.01 23.49 33.43 IE FU1 FU2 FU3 WOMAC Stiffness 39.31 23.31 21.18 IE FU1 FU2 FU3 FU1 Cohort FU2 Cohort FU3 Cohort 100.00 80.00 60.00 40.00 20.00 0.00 53.45 39.54 43.51 WOMAC Function 37.16 31.87 34.36 IE FU1 FU2 FU3 For all cohorts, all results are clinically significant with difference 12% of baseline. For FU1 cohort, all results are statistically significant with p.0.05. For FU2 cohort, pain and stiffness results are statistically significant with p.0.05. 1 Minimum Clinically Important Difference (MCID) = 12% baseline, 6% maximum score 1 Angst F1, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001 Aug;45(4):384-91.

Patients with Knee Pain Preliminary Outcomes: Quality of Life SF-36 Physical SF-36 Mental 100.00 90.00 80.00 70.00 60.00 50.00 40.00 60.16 65.43 49.17 51.59 62.09 46.85 IE FU1 FU2 FU3 FU4 100.00 90.00 80.00 70.00 60.00 50.00 40.00 69.26 73.20 77.25 68.22 72.16 64.72 IE FU1 FU2 FU3 FU4 FU1 Cohort FU2 Cohort FU3 Cohort FU1 Cohort FU2 Cohort FU3 Cohort For FU1 and FU2 cohorts, all results are clinically and statistically significant with: difference 12% of baseline, and p 0.05 For FU3 cohort, with N=7, data not statistically significant 1 Minimum Clinically Important Difference (MCID) = 12% baseline, 6% maximum score 1 Angst F1, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001 Aug;45(4):384-91.

120.00 110.00 100.00 90.00 80.00 70.00 60.00 Patients with Knee Pain Preliminary Outcomes: Gait 91.16 89.30 82.43 100.47 Velocity 45.00 40.00 35.00 30.00 102.50 35.49 35.55 111.86 IE FU1 FU2 FU3 p 0.05 Normal Range: 110-140 cm/sec Single Limb Support 37.32 37.32 60.00 55.00 50.00 45.00 40.00 53.39 52.71 48.51 37.17 56.07 33.79 Normal Range: 38.5-40.5% IE FU1 FU2 FU3 Step Length 57.90 57.11 Normal Range: 55-70 cm IE FU1 FU2 FU3 FU4 p 0.05 p 0.05 *All results are statistically significant with p 0.05 FU1 Cohort FU2 Cohort FU3 Cohort

Patients with Back Pain Preliminary Outcomes: Function and Quality of Life 40.00 35.00 30.00 25.00 20.00 15.00 10.00 5.00 0.00 Oswestry 35.77 29.97 23.90 18.86 IE FU1 FU2 FU3 FU1 Cohort FU2 Cohort 95.00 85.00 75.00 65.00 55.00 45.00 SF-36 Physical 66.90 71.17 60.02 52.55 IE FU1 FU2 FU3 FU1 Cohort FU2 Cohort 95.00 85.00 75.00 65.00 55.00 45.00 SF-36 Mental 74.44 71.31 76.12 66.02 IE FU1 FU2 FU3 FU1 Cohort FU2 Cohort For FU1 cohort, p=0.06. For FU2 cohort, with N=5, data not statistically significant For FU1 cohort, all results are clinically and statistically significant difference 12% of baseline, p 0.05 1 Minimum Clinically Important Difference (MCID) = 12% baseline, 6% maximum score 1 Angst F1, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001 Aug;45(4):384-91.

Patients with Back Pain Preliminary Outcomes: Gait 120.00 110.00 100.00 90.00 80.00 70.00 60.00 113.87 96.87 103.16 92.09 Velocity Single Limb Support IE FU1 FU2 FU3 65.00 60.00 55.00 50.00 45.00 40.00 p 0.05 Normal Range: 110-140 cm/sec 44.00 42.00 40.00 38.00 36.00 34.00 32.00 30.00 Step Length 59.42 54.43 56.85 53.68 Normal Range: 55-70 cm IE FU1 FU2 FU1 Cohort FU2 Cohort 37.60 38.91 37.02 38.91 p 0.05 Normal Range: 38.5-40.5% IE FU1 FU2 FU1 cohort: p 0.05

Summary AposTherapy is a transformative therapy that can improve population health through improving mobility and function while lowering pain in the knee and low back AposTherapy is an effective treatment in our small cohort (of inner city population and hospital employees) and in published papers Innovative treatment Home based Increased compliance and patient satisfaction Possible long term benefit Possible benefit on the general health beyond the knee and low back

Challenges and Next Steps Challenges Change the practice pattern of physicians Education and compliance of the patients Capacity to handle Next steps Randomized control study comparing AposTherapy with conventional treatment in knee OA and chronic low back pain population Strategy for broader insurance coverage o Currently have about 100 patients on a study list that want AposTherapy but don t have coverage Engagement from care managers and other interactive computer program to assist with patient education

Contact information For more information, contact: Dr. Matthew Bartels, Chairman of Rehabilitation Medicine Dr. Se Won Lee, Director of Sports Medicine, Rehabilitation Medicine Dr. Ratnakar Veeramachaneni, Research Fellow, Rehabilitation Medicine Salley Whitman, VP, AposTherapy 718-547-4940 Apostherapy@montefiore.org

Acknowledgements Special thanks to Healthfirst Dr. Bartels, Dr. Morice, Dr. Veeramachanen, Dr. Tiu and Dr. Sutaria AposThearpy team (esp. Ms. Salley Whitman and Dr. Levy) Physical therapists at Moses, Montefiore Staffs in Rehab. medicine Thank You