Unleash Healthcare Information Technology for Successful Sites, Investigators and Subjects Timothy J. Kelly, MS, MBA Vice President Dialog Medical Who has heard the term Who has heard the term meaningful use? ACRP 2011 Seattle, WA Page 1
Who has heard the term cash for clunkers? Both Are/Were Both Are/Were Programs Under the American Recovery and Reinvestment Act of 2009 ACRP 2011 Seattle, WA Page 2
Cash for Clunkers <$3 billion Meaningful Use (Healthcare Information Technology) ~$36 billion Grassley seeks accounting of 'Cash for Clunkers' costs. The Washington Post. January 7, 2010. Rock and a hard place: An analysis of the $36 billion impact from health IT stimulus funding. Price Waterhouse Coopers. April 2009. Meaningful Use, or more appropriately, the emerging national investment in HIT will have an unprecedented impact on clinical studies. ACRP 2011 Seattle, WA Page 3
Agenda Review of Available Healthcare Information Technology (HIT) HITECH Act and EHRs Other HIT and the Data from Those Systems Strategies Site Selection Investigator Identification Subject Recruitment Roadmap for Unleashing HIT for Your Studies HITECH Act The Health Information Technology for Economic and Clinical Health Act (Part of the ARRA of 2009) ACRP 2011 Seattle, WA Page 4
HITECH Act Earmarked significant incentive funds for Electronic Health Record (EHR) adoption and use Hospitals and Eligible Providers (physicians) will both be eligible for incentives different rules apply HITECH Act Congress did not simply want adoption of EHRs they wanted to ensure that there would be meaningful use of these systems After significant input from various constituencies, proposed rules, and public comment, the Final Meaningful Use rules were published by CMS in the Federal Register on July 28, 2010 ACRP 2011 Seattle, WA Page 5
Meaningful Use Objectives Eligible Providers 25 Objectives 15 are core objectives 5 of the remaining 10 may be deferred ( menu objectives ) Hospitals 24 Objectives 14 are core objectives 5 of the remaining 10 may be deferred ( menu objectives ) ACRP 2011 Seattle, WA Page 6
Meaningful Use Menu Objective Objective Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach Measure Generate at least one listing of patients with a specific condition ACRP 2011 Seattle, WA Page 7
EHRs, and associated HIT Systems that meet Meaningful Use objectives, will be excellent sources of data and potential vehicles for enhancing recruitment Are EHRs Alone the Answer? A study of 21 Canadian investigators 100% found that fewer 80% of the top 60% performing 40% investigators had an EHR 20% Keown S. The Monitor 2010;24(6):11-15. 0% Percent of Sites That Have an EHR Top 5 Best- Performing Investigators Remaining 16 Investigators ACRP 2011 Seattle, WA Page 8
In research, we too need to practice Meaningful Use of these systems! EHRs Electronic Health Records Inpatient Outpatient Practice-based systems 491 EHR Vendors exhibited at the HIMSS 2011 Conference in February ACRP 2011 Seattle, WA Page 9
Other HIT Systems ADT Systems Patient Registration Systems Scheduling Systems Visit OR Pharmacy Lab PACS Informed Consent Systems Data Facility historical data Diagnoses (ICD-9/10), procedures (CPT, HCPCS) National Databases NNIS, NSQIP, MEDPAR, HEDIS Billing data Providers cases completed Patients diagnosis, co-morbidities, planned procedures ACRP 2011 Seattle, WA Page 10
Example Typical EHR Data elements Data elements are granular and mineable ACRP 2011 Seattle, WA Page 11
Mineable Data Patient Information Name Age Medical Record Number Email Provider Information ACRP 2011 Seattle, WA Page 12
Mineable Data ICD-9 Code 719.46 Pain in joint involving lower leg ICD-9 Code 715.16 Osteoarthrosis localized primary involving lower leg HCPCS Code J3301 Injection, Triamcinolone Acetonide, 10mg Mineable Data Education Materials Arthritis Total Knee Medications Skelaxin Vicodin ACRP 2011 Seattle, WA Page 13
Site Selection Site Selection Database of information from multiple sites or information for a single site 28 ACRP 2011 Seattle, WA Page 14
Site Selection Information may be available in different formats or from different points in the care continuum ACRP 2011 Seattle, WA Page 15
Site Selection Analyze Analyze performance of a particular site ACRP 2011 Seattle, WA Page 16
Site Selection Compare Compare performance of sites over time ACRP 2011 Seattle, WA Page 17
Investigator Identification ACRP 2011 Seattle, WA Page 18
Investigator Identification Analyze investigator performance over time Example: Lung procedures that might be predictive of prolonged intubation ACRP 2011 Seattle, WA Page 19
Subject Recruitment (The ultimate Meaningful Use of HIT) Typical Subject Recruitment Strategy? ACRP 2011 Seattle, WA Page 20
Subject Recruitment Meaningful Use of HIT Passive Notifications Real-Time Active Alerts Real-Time Subject Recruitment Identify potential subjects in realtime On-site Prior to a procedure accessible ACRP 2011 Seattle, WA Page 21
Note or Alert Explaining the Study Effectively the same information as what might appear on a recruitment poster ACRP 2011 Seattle, WA Page 22
Real-Time Subject Recruitment Tie studies to: Medical history Diagnosis Vital signs Medications Planned treatment Instructions or education ACRP 2011 Seattle, WA Page 23
Note or Alert Explaining the Study Other implementations include: Automatic email alert Flag set in the EHR ACRP 2011 Seattle, WA Page 24
Roadmap (Unleash HIT for Successful Sites, Investigators and Subjects) ACRP 2011 Seattle, WA Page 25
Roadmap Look for systems that touch each patient Identify resources CIO CMIO Informatics Group CACs EHR Project Manager Explore the Meaningful Use Objective: Generate lists of patients by specific conditions to use for research Roadmap Watch-Outs Ensure that databases do not contain PHI before reviewing data for either sites or investigators Consult local Privacy Officer as appropriate Obtain an appropriate HIPAA waiver or other instrument from your IRB prior to employing any recruitment strategies Consider adding study recruitment language to existing HIPAA disclosures ACRP 2011 Seattle, WA Page 26
Looking Ahead HITECH Act Physician EHR adoption incentives through 2015 Hospital EHR adoption incentives through 2016 The Patient Protection and Affordable Care Act (Healthcare Reform) Accountable Care Organizations (ACOs) Health Information Exchanges (HIEs) The Bottom Line: The opportunities to unleash HIT will continue to increase Additional Resources www.dialogmedical.com/research-consents-and-study-recruitment Links to key resources: HITECH Act, Meaningful Use Blumenthal D and Tavenner M. N Engl J Med 2010;363(6):501-504. HIMSS resources on Meaningful Use Articles on research consents and study recruitment Timothy J. Kelly, MS, MBA Dialog Medical www.dialogmedical.com tkelly@dialogmedical.com ACRP 2011 Seattle, WA Page 27