Claude D Pepper Older Americans Independence Center at

Claude D. Pepper Older Americans Independence Center at Mount Sinai Icahn School of Medicine at Mount Sinai

Mission • To bridge the specialties of geriatrics and palliative care by focusing on the relationship of pain and other symptoms to independence and quality of life in elders with serious illness • To identify, recruit, and train leaders in aging and palliative care research To establish research infrastructure to: a) support research in aging and palliative care by providing expertise in research design, measurement, and analysis, b) apply to aging research, methods not currently in widespread use (e. g. item response theory, propensity score methods) but which are highly applicable to gerontology • 2

Geriatrics and Palliative Care Well Older Adults Cancer Gait Disorders Preventive care AIDS Cancer (<65) Stroke Genetic/ Developmental Disorders Advanced Organ Failure Stable chronic dx Chronic Critical Illness Geriatric syndromes Pediatric Oncology Frailty Peri-operative care Cystic Fibrosis Dementia Osteoporosis TBI

OAIC LEADERS Albert L. Siu, M. D. – PI and Leadership Administrative Core Leader R. Sean Morrison, M. D. – Research Career Development Core Leader Kenneth Boockvar, M. D. – Pilot and Exploratory Studies Core Leader Joan Penrod, Ph. D / Melissa Carlson, Ph. D - Research Design and Analysis Core Leader Jeanne Teresi, Ph. D – Measurement and Data Management Core Leader 4

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Programs Linked to the Pepper Center ▶ ▶ ▶ ▶ Brookdale Department of Geriatrics and Palliative Medicine Hertzberg Palliative Care Institute Division of Diabetes and Experimental Aging Friedman Brain Institute at Mount Sinai GRECC and HSR&D Program Jewish Home Research Program Hebrew Home Research Division Visiting Nurse Service of NY Center for Home Care Research Center to Advance Palliative Care (CAPC) National Palliative Care Research Center (NPCRC) Martha Stewart Center for Living (MSCL) Mount Sinai Visiting Doctors VISN 3 Palliative Care Program

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Pilot and Exploratory Core o Pilot studies: o Descriptive Analysis of Hospice Care for Older Patients with Heart Failure – PI: L. Gelfman o Goal: examine the Medicare population with heart failure who enrolls with hospice, the predictors of hospice referral for Medicare patients with HF, and the impact of hospice enrollment on 30 -day re-hospitalization rates for HF patients o Uses an existing Medicare dataset of all Medicare beneficiaries with at least one home health claim from 2009 and 2010 who were hospitalized for HF in a one-year period o Reducing symptom burden for chronically ill homebound patients through homebased primary care intervention – PI: K. Orenstein o Goal: describe the caregiving needs of homebound patients and interventions used by home-based programs to reduce pain and other symptoms in this population o Follows 100 patients with documented moderate/severe symptom burden at baseline to monitor change in symptom severity and corresponding treatment plans o Elder Life Program to Prevent Delirium in Long-term Care – PI: K. Boockvar, W. Hung o Goal: evaluate a delirium-prevention intervention in the nursing home by providing during acute illness standardized assessment and treatment for delirium risk factors o Design is a single facility clustered, controlled trial 8

Pilot and Exploratory Core o Cohort study of patients with ventricular assist devices (VADs) to determine symptoms of patients and their caregivers – PI: N. Goldstein o Goal: evaluate prevalence and change over time of physical and psychological symptoms in patients with VADs and describe psychological symptoms in caregivers o Enrolls 100 patients immediately after VAD implantation at 4 academic medical centers and follow them for up to 12 months o Couples-focused symptom management intervention for older lung cancer patients and their spousal caregivers – PI: H. Badr o Goal: develop and pilot test a couple-focused intervention for older lung cancer patients and their partners that educates them about lung cancer symptoms, effective symptom management, and skills to problem-solve cancer-related concerns and coordinate care o Uses focus groups and a small RCT o Treating subthreshold depression in nursing home residents with serious chronic illness using Problem Solving Therapy (PST) – PI: J. Reinhardt o Goal: test feasibility of Problem Solving Therapy (PST) among 40 nursing home patients to treat subsyndromal depression in patients with serious life-threatening conditions who reside in long term care facilities o Uses small RCT 9

National Palliative Care Research Center (www. npcrc. org) ▶ ▶ Directed by R. Sean Morrison, MD Mission is to improve quality of care for patients with serious illness and promote palliative care research and its translation into clinical practice. Research Grants Program to date has received ~600 letters of interest and has awarded 17 pilot project grants to experienced investigators and 27 career development awards to junior faculty (total close to $6. 7 million dollars in research funding. NPCRC has supported and funded two conferences of experts in dementia research led by Susan Mitchell, MD, to establish a research agenda for this population.

Research Career Development Core Selected Accomplishments o Career Development Awards o NIH Career Development Award – M. Carlson (K 99) & U. Hwang (K 23) o VA Research Career Development Award and National Palliative Care Research Center (NPCRC) – M. Garrido o American Cancer Society (ACS) – C. Grudzen o Paul Beeson Award – A. Kelley o NIH Research Training Grant (T 32) o L. Gelfman o CTSA KL 2 Scholars Award – o F. Ko & C. Smith 11

n n Aim: Examine the relationship between functional status and hospital use in the last 6 months of life. Methods: Two-part regression model of total hospital days among Health and Retirement Study decedents (n= 2, 493), adjusting for patient characteristics, regional resources and local hospital care intensity (HCI). Results: Decedents with severe disability or decline had more regression-adjusted hospital days (range 3. 47 -9. 05, depending on category), compared to those without decline. Conclusions: To improve care and reduce costs, health care programs and policies should address specific needs of patients with functional decline and disability. 12

n n Aim: Explore the determinants of Medicare expenditures in the last 6 months of life. Methods: Multi-level regression models of total Medicare Expenditures among Health and Retirement Study decedents (n= 2, 394), adjusting for patient characteristics, regional resources and local Medicare spending patterns. Results: Patient characteristics: functional decline, race/ethnicity, chronic disease, and nearby family, are important determinants of Medicare costs, independent of regional factors. Conclusions: Future studies must determine when and if high-cost treatment is inconsistent with patient preferences or indicative of inappropriate, poor quality medical care. 13

Ko Research program ▶ Research goals: – Determine and modify post-operative molecular mechanisms that increase risk for poor surgical outcomes in aged-mice (immediate goal) – Translate findings from mice to humans by implementing mechanismdriven interventions in vulnerable older surgical patients in order to prevent, attenuate or reverse surgery-related adverse outcomes (longterm goal) ▶ Mouse studies: – Determine molecular mechanisms mediating laparotomy-induced adverse metabolic responses including anorexia and immobility – Determine whether targeted attenuation of post-operative inflammation results in decreased adverse post-surgical metabolic responses ▶ Human studies: – Determine whether peri-operative inflammatory and oxidative stress mediators predict adverse metabolic, functional and cognitive outcomes in older adults who receive abdominal and hip fracture surgeries

Research Design and Analysis Core ▶ Randomized, controlled trials of interventions for older patients with complex, multiple conditions are sometimes not appropriate or possible; ▶ Sophisticated analytic methods for observational data, including propensity score methods, instrumental variables estimation and competing risks analysis, strengthen investigators’ ability to make causal inferences with such data; ▶ The major goal of this core is to help investigators apply these methods 15

Core Integration o Selected externally funded Projects o Palliative Care in Hospitalized Cancer Patients - PI: D. Meier (NCI – R 01) o Improving Pain and Function in Hip Fracture – PI: R. Morrison (NIA – R 01) o An Intervention to Improve ICD Deactivation Conversations – PI: N. Goldstein (NHLBI – R 01) o Implementing a Regional Data Exchange Tool to Improve Medication Use and Safety – PI: K. Boockvar (VA IIR) o Readmissions among Older Home Health Patients with Congestive Heart Failure– PI: C. Murtaugh (AHRQ - R 01) o The Impact of Hospice Preferred Practices on Patient Outcomes and Hospice Costs –PI: M. Carlson (NINR/NIH-R 01) 16

External Projects Palliative Care for Hospitalized Cancer Patients (PI: Meier, NCI/NINR funded) ▶ This is a 5 -hospital study of 6500 subjects with advanced cancer. The purpose of this study is to evaluate the clinical outcomes of palliative care consultation teams (PCCTS) on the care of hospitalized patients with advanced cancer. ▶ The study will examine the effect of the intervention on care processes (analgesic prescribing, symptom assessment, goals of care discussions, care transition management, and advance care planning) and on pain, symptom intensity and satisfaction with care. 17

Rationale for Measurement Core ▶ A major barrier to conducting palliative care research has been the burden of measurement. ▶ Issues may be ameliorated by using measures derived using item response theory, and by developing an item bank for domains important in palliative care. – Item banks contain questionnaire items that define and quantify a trait (e. g. , pain). – Each item is calibrated on a common metric using models based on IRT. – Ideally, the items are also well characterized in regards to differential item functioning. – Calibrated item banks can be used to create a standard static instrument or tailored measures, a short form, or to perform computerized adaptive testing. 18

Measurement and Data Management Core Tasks include: ▶ ▶ ▶ ▶ Develop electronic data collection software; Setup and implementation of randomization process Routine data monitoring and data cleaning; Data processing and statistical analyses Quality control Preparing for IRT analyses Preparing for item banking of NCI data set. 19

Item response analysis of scale for family satisfaction with advanced cancer care ▶ The FAMCARE is a commonly used 20 -item scale used to measure family satisfaction with advanced cancer care. A shorter measure may lessen burden of participation for family members. ▶ We explored the psychometric properties of the FAMCARE using exploratory factor analysis and item response theory (IRT) in an ethnically diverse sample of caregivers of hospitalized cancer patients. (n=1983) ▶ FAMCARE is a unidimensional measure. Item functioning measures can be used to create a short form scale if desired ▶ Future work will examine differential item functioning (DIF ) of FAMCARE based on age, gender, race/ethnicity, and education 20

Research Priorities for Geriatric Palliative Care Conference Goal – commission state of the science papers from experts who bridge the fields of geriatrics and palliative care to serve as a model for a new focused area of research that has typically not been well addressed by either the geriatrics or palliative care alone – lead to improve geriatric palliative care for older adults and help guide NIA and NIH funding priorities in the field of geriatric palliative care. Findings 1. Needs/Understanding – Prospective longitudinal study on non-cancer/dementia serious illness that includes patients and caregivers – “Multimorbidity” 2. Interventions - Symptom interventions that transcend disease-specific approaches 3. Design/Methods - Bring rigorous analytic approaches to quasi-experimental and observational data (Propensity Scores – selection bias, missing data) 4. NIH Technical Fixes – RFAs/PAs/Review Process - Inclusion of cognitively impaired and frail in all studies ; Requirement of cost analysis in intervention studies 21

Mount Sinai Pepper Center Summary ▶ Goal is to establish a sustainable infrastructure to support the development of new investigators in geriatric palliative care research, and develop or adapt instruments, designs, and analytic methods for research on improving care for seriously ill older adults ▶ In the last 3 years, RCDC has supported the development of investigators many of whom now have CDAs and some of whom have advanced to independent investigators ▶ RCDC has leveraged the NPCRC to support research in the Pepper Center and elsewhere ▶ PESC is supporting investigators in development of R 01 s ▶ Two research cores have advanced methods (e. g. , in use of propensity score methods and in IRT) while assisting investigators in new and ongoing research ▶ LAC with the NPCRC has worked to advance research at the intersection of geriatrics and palliative care at a national level 22