VA Cmparative Effectiveness Research Jel Kupersmith, MD Chief Research & Develpment Officer
VA Missin VA Missin t care fr him wh shall have brne the battle and fr his widw, and his rphan A. Lincln, 2 nd Inaugural VA Research Missin: T discver knwledge and create innvatins that advance the health and care f veterans and the natin. Veterans first, last and always in all we d
Attributes fr Cmparative Effectiveness Research VA attributes fr Cmparative Effectiveness Research fr the benefit f veterans Large healthcare system Outstanding research prgram embedded in healthcare system - Intramural Infrastructure fr clinical trials Vehicles fr translatin and implementatin f research int the health care system
Large Healthcare System Large system $36.3 Billin budget (FY2007) 5.5 millin patients/yr, 7.8 millin enrllees >1200 Sites f Care 153 Medical Centers 737 Cmmunity-based Outpatient Clinics 225 Readjustment Cunseling Centers Electrnic Health Recrd
Intramural Research Prgram Intramural research system - a unique strength Researchers must be emplyed by VA >70% f VA investigatrs are clinicians Links researchers directly veterans needs Facilitates implementatin f research results Unique research resurces als include Electrnic Health Recrd Cperative Studies Prgram Clinical Trials Health Services Research Rehabilitatin
Intramural Research Prgram 117 VAMCs have Federal Wide Assurances fr research Cmmunity f 3000 VA researchers Published 46,149 articles in past 7 years Publish in the best jurnals 2000 VA funded prjects Best buy in gvernment
Rich 60 Year Histry 3 Nbel Laureates, 6 Lasker Award Winners Many imprtant discveries and inventins Cardiac Pacemaker, First liver transplant, Radiimmunassay, CT Scanner Clinical Trials TB First large scale clinical trial Cperative Studies Prgram Trials strngly influence medical practice
VA Prgrams in Cmparative Effectiveness Research
Cmparative Effectiveness Research Definitin Research evaluating the clinical effectiveness, risks and benefits f 2 r mre medical treatments and/r services Speaker s previus interest in the tpic Kupersmith at al, Jurnal f Investigative Medicine, 2005
VA Cmparative Effectiveness Research Research Clinical trials Cperative Studies Prgram Health Services Research health system riented reserach Rehabilitatin Implementatin Quality Enhancement Research Initiative prgram Evidence Based Synthesis prgram
VA Cperative Studies Prgram Large VA clinical trials prgram Majr vehicle fr Cmparative Effectiveness Research Organizatin Headquarters Central Office, under Office f R & D 5 Data and Statistical Crdinating Centers 4 Epidemilgy Research Centers Pharmacy Crdinating Center Health Ecnmics Resurce Center Pharmacgenmics Analysis Labratry
VA Cperative Studies Prgram Methd f funding prjects Letter f intent submitted Prject review by experts wh cllabrate with the prpser Review includes plicy cnsideratins Participatin f Patient Care Services Ecnmic review f issue in VA healthcare system Cllabratin with NIH and thers in many trials
VA Cperative Studies Prgram -- Examples Cmputerized Tmgraphy vs Psitrn Emissin Tmgraphy in slitary pulmnary ndule (PET better) Jurnal f Nuclear Medicine, 2008 Stll vs Amidarne in atrial fibrillatin (similar) New England Jurnal f Medicine, May 5, 2005 Standard care with & withut Phlebtmy in stable peripheral artery disease (n sign difference) Jurnal f the American Medical Assciatin, February 14, 2007 Medical therapy vs Crnary revascularizatin prphylaxis prir t elective vascular surgery (n sign difference) New England Jurnal f Medicine, December 30, 2004
VA Cperative Studies Prgram -- Examples Percutaneus crnary interventin/ptimal medical therapy vs Optimal medical therapy alne (COURAGE) (n sign difference) New England Jurnal f Medicine, March 27, 2007 Open mesh vs Laparscpic mesh repair fr inguinal hernia (pen mesh better) New England Jurnal f Medicine, April 29, 2004 Care mdel (patient s self-management, cntinuity f care, infrmatin via nurse care crdinatr) vs Standard care in Biplar Disrder (care mdel better fr mst end pints) Psychiatric Services, July 2006 Prlnged Expsure Therapy vs Patient-Centered therapy in PTSD (PET better) Jurnal f the American Medical Assciatin, Feb 28, 2007
VA Cperative Studies Prgram - Onging Clnscpy at 2-3 and 5 years vs 5 years nly in asymptmatic subjects with small clrectal plyps Radical Prstatectmy vs Palliative Expectant Management fr lcalized Prstate Cancer Intensive vs Standard glycemic cntrl in diabetes Hme mnitring vs High quality anti-cagulatin clinic in atrial fibrillatin and/r mechanical heart valve CABG vs Percutaneus crnary interventin with stents in diabetes Rbtic assisted training in upper extremity mvement vs Intensive stretching and range f mtin exercise via trained therapist vs Usual care in strke Self-management (educatin, actin plan & case management) vs Standardized care in severe Chrnic Obstructive Lung Disease
Health Services Research - Onging Health systems riented prjects Labratry based vs Hme evaluatin f sleep apnea Examples f studies vs usual care cntrl Plain language decisin aid fr patient decisin making in prstate cancer Cllabrative care using primary care physician, RN and PharnD fr hypertensin/diabetes t implement strike risk management Patient preference tailred infrmatin cncerning cln cancer screening Training caregivers wih a Hme Safety Tlkit in Alzheimer s Disease
Interrgatin f Electrnic Health Recrd Besides clinical trials, interrgatin f EHR represents an apprach t Cmparative Effectiveness Research Cmpare treatments and appraches t care in clinically rich data in EHR Using EHR data prvides Immediacy f results Less cstly studies Hwever, there are still methdlgic issues E.g. are grups cmparable? Text recgnitin
Interrgatin f Electrnic Health Recrd VA examples EHR diabetes chrt database shws n difference in mrtality amng ral antidiabetic drugs Diabetes Care, July 2007 Cmparisn f besity care practices NSAID prescriptin strategies Carvedill vs Cntrlled-release Metrpll in heart failure
Implementatin/Translatin Quality Enhancement Research Initiative Evidence-Based Synthesis' Prgram
Quality Enhancement Research Initiative QUERI Prgram
QUERI Prgram Missin - Systematically implement/ translate evidencebased clinical practices & research findings int rutine clinical practice Steps in QUERI prcess Identify gap in Evidence Based Practice Develp and implement a strategy fr change Test strategy Single site pilt Small scale implementatin pilt Large scale, multi-regin implementatin trial System-wide rll-ut Dcument system imprvements Dcument utcmes & QOL imprvements
Spinal Curt Injury Natinal Vaccinatin Prject VA perfrmance measures: SCI Veterans w/sci Survey Flu PPV Flu PPV 1997 25% 20% NA NA 1998 26% 25% NA NA 2000 28% 40% NA NA 2001 33% 50% 57% NA 2002 62% 78% 62% 60% 2003 61% 79% 68% 75% 2004 68% 88% 79% 82% 2005 65% 82% 72% NA
Implementatin f System Change Cllabrative Care f Depressin Depressin Cllabrative Care Mdel VISN 10 Black Hills Twin Prts Siux Falls Akrn Cantn Yungstwn Beaumnt Pensacla Lufkin Depressin symptms Depressin severity Anti-depressant meds Outpatient utilizatin Patient satisfactin Hspitalizatin rates Barriers t cllabratin Cllabrative care csts Implementatin fidelity 2 nd -generatin sites BRIDGE t Natinal Rllut 1 st -generatin sites Sustainability in 1 st -generatin sites Single 3 VISNs 18-30 sites Natinal site 9 sites 4 VISNs Rllut
Evidence Based Synthesis Prgram
Evidence Based Synthesis Prgram Reviewing the evidence n a tpic Plicy riented synthesis f evidence t infrm medical practice and health systems planning Infrmed by plicy cnsideratins with input by Patient Care Services Recent tpics Drug management f BPH Led t Frmulary change Osteprsis Incrprated int Guideline n screening male veterans Pain in Plytrauma Need mre research
Syntheses f the Evidence n Tw Aspects f Pain Finds Little t Guide Clinicians The HSR&D Evidence-Based Synthesis Prgram (ESP) was established t prvide timely and accurate syntheses f targeted health care tpics f particular imprtance t VA managers and plicymakers and t disseminate these reprts thrughut VA. Recently, investigatrs at the Prtland VA Medical Center cnducted tw systematic and cmprehensive literature reviews fcusing n pain. Pain in Patients with Plytrauma In a review f the literature (published 1950 July 2008), and a survey f active research, investigatrs sught t: address the assessment and management f pain in patients with plytraumatic injuries, identify
Cnclusins VA has many attributes t undertake and implement Cmparative Effectiveness Research Intramural research prgram in a large healthcare system Infrastructure fr clinical studies VA has a strng nging prgram and many accmplishments in the service f veterans in Cmparative Effectiveness Research Besides clinical trials, interrgatin f the Electrnic Health Recrd will als be an apprach t Cmparative Effectiveness Research