UPMC Cancer Center Model

UPMC Cancer Center Model • Hub for UPCI Research and UPMC Cancer Centers Hillman Cancer Center Potter Mercer Elk Venango Jefferson Clarion Lawrence Butler Clearfield Armstrong Beaver Indiana Cambria Hillman Cancer Center Blair Westmoreland Washington Greene Fayette Somerset Bedford The Clinical Network • UPCI clinical network founded 1996 • Faculty and clinical faculty ~ 120 – Med Onc in network ~ 51 • Clinical trials at 16 locations • Infrastructure – Pitt IRB/CTO works with central IRB – Clinical Research Services hires, trains, places and monitors CRCs and CRAs. • ~25,000 new patients/year – Small % enter clinical trial Network Accruals Year Therapeutic Accruals 2003 2004 310 328 2005 373* (projected) *65% of accruals by 20% of physicians Update on Projects • PDA – Access to clinical trials – Hyperlink to clinical pathways • Application of Toyota Management System/Toyota Production System (TMS/TPS) to conduct of clinical trials • Synthetic Interview Providing PDA-based Clinical Trial Listings to Oncologists Background • UPMC Cancer Center physicians are encouraged to consider clinical trials for their patients. • Currently, over 230 trials are open for accrual. • However, the status of these trials changes frequently. Challenge • How can we provide our physicians with clinical trial information that is: – Up-to-date – Comprehensive – Easy to access – Easy to use • Hyperlink to clinical pathways Technology PDA-based Clinical Trials Listings 1. Pharmaceutical approval for content 2. Short titles 3. Summaries 4. Specific network site and HCC Presented at American Medical Informatics Association Annual Symposium, 2005 Early Feedback “Quick”, “fast” “Convenient”, “at fingertips”, “ mobile” “Accurate information” Clinical Pathways • Uniform treatment across UPMC Cancer Centers – Quality, Predict costs, Evaluate outcomes – Emphasis on clinical trials Patient Name_______________ DOB___________________ Non -Small Cell Lung Cancer STAGE III Unresectable PS=0,1 1) UPCI 02-015 Carboplatin/Taxol/RT with or without Thalidomide If not chosen provide reason________________________________ 2) Carboplatin AUC+2 Taxol 45mg/m 2 q week with concurrent Radiation followed by Taxotere 75mg/m 2 q 3 weeks x 3 cycles If not chosen provide reason_________________________________ PS=2 with little comorbidity Carboplatin AUC=2 Taxol 45mg/m 2 q week with concurrent Radiation If not chosen provide reason_________________________________________ PS=2 with significant comorbidity Taxol 45mg/m2 q week with concurrent Radiation If not chosen provide reason________________________________________ Barriers to Successful Conduct of Clinical Trials • Physician awareness and access to clinical trial – Assuring that trial can be conducted at site, e.g., resources such as CRC/CRA, centrifuge, EKG machine, institutional account for research samples/scans, etc • Identify all possible subjects • HIPAA • Obtaining informed consent – How is explanation given, content – Delivery • Face to face, via telephone, adequate time to answer questions • Timely, complete, accurate data collection So much to do and so little time • Monitoring patients progress – – – – – – – – Complete collection and verification of all lab samples Writing and verifying chemotherapy orders Appropriate dose adjustment and recording of same Grading toxicity and adverse events with completion and verification of case report forms and reporting of SAEs to PI, Protocol Office, Sponsor, regulatory bodies Scheduling imaging, verifying and recording results Performing and recording tumor measurements Completion of Case Report Forms Recording and verifying information in database A serious adverse event goes unreported to the protocol office •WHAT DO YOU DO? Usual TMS/TPS 1. 2. 3. 4. 5. Yell at CRC Set up committee meeting Set up second meeting to discuss further Try to solve by committee Move on to next crisis Reward the reporting Get expert advice Determine how it happened Study where/how the problem arose, where are other latent related problems 5. Seek corrections from those doing the work, local level, sustainable fixes, one problem at a time 1. 2. 3. 4. TMS/TPS: Central Line Infection (CLI) • At a large Pittsburgh hospital CLI rate dropped from 37 in 2003 to 6 in 2004 • Deaths dropped from 19 to 1 • Direct cost reduction $1.4 million • How – Investigated each infection as it is discovered – See why it happened – root cause –learning line – Corrective actions learned from these processes – Remove all femoral lines w/i 24 hours – Prohibit rewiring of dysfunctional lines – Remove all catheters from transferred patients – Use biopatch dressings for lines that are expected to be in place for > 2 weeks Spear, S.J .Harvard Business Review, Sep.2005 Benefits TMS/TPS • Commitment to culture of improving, learning and enjoying what we do • More complete identification of subjects who may benefit from a clinical trial • Increase accrual to clinical trials • Complete data collection, fewer queries from sponsor • Timely entry of data into database Plans • Secured funding to test TMS/TPS at one of our sites Providing Clinical Trial Information to Patients: A Synthetic Interview Approach Limitations of Traditional Approach • Information scope – e.g., short booklets • Access – only viewed one time in evaluation study • Media format – text only – video only • Content – material presents facts about trials but not patient experiences What do patients want? A recent interview study with patients who had declined to participate in a clinical trial found that these patients reported having “high levels of information need” and wanted “a more gradual introduction to the research process, with shorter pieces of information being given over a longer period.” Stevens T, Ahmedzai S. Why do breast cancer patients decline entry into randomised trials and how do they fell about their decision later: a prospective, longitudinal, in-depth interview study. Patient Education and Counseling 2004;52:341-348 Addressing Previous Limitations • Information scope – Our SI has over 200 question/answer pairs • Access – Available 24/7 via the Internet • Media format – Provides video and text-based responses – Interview can be printed for future sharing and review • Content – Expert information PLUS clips with clinical trial participants Current Status • Reconfiguring interface to avoid question/answer mismatches that can occur • Editing existing clips • Grant submitted to Komen Foundation to evaluate the impact of the SI on patient clinical trial knowledge, attitudes, decisional conflict, and decision satisfaction Evaluate SI in Randomized Clinical Trial • Two groups – Pamphlet describing adjuvant breast cancer therapy and clinical trials OR – Online SI about adjuvant breast cancer and clinical trials + pamphlet Key Eligibility • Newly diagnosed Stage I or II breast cancer • Eligible for adjuvant clinical trial • Tumor size greater than 1.5 cm or any positive nodes • Access to computer and email, and willingness to check for email messages daily Endpoints • To evaluate impact of SI on clinical trial decisional conflict and decision satisfaction • To assess impact of SI on patients’ knowledge of clinical trials and adjuvant therapy and attitudes regarding clinical trials The Team • • • • • Valerie Monaco, PhD Mary Beth Simon, RN,MSN Kenneth S. McCarty, Jr. MD,PhD Suzanne Pozzani Aab M. Arnold, BA