UPMC Cancer Center Model

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UPMC Cancer Center Model

• Hub for UPCI Research and UPMC Cancer Centers

Hillman Cancer Center
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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

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Network Accruals
65 of accruals by 20 of physicians
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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

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Providing PDA-based Clinical Trial Listings to
Oncologists
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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.

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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

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Technology
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PDA-based Clinical Trials Listings

• Pharmaceutical approval for content
• Short titles
• Summaries
• Specific network site and HCC

Presented at American Medical Informatics
Association Annual Symposium, 2005
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Early Feedback

• Quick, fast
• Convenient, at fingertips, mobile
• Accurate information

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Clinical Pathways

• Uniform treatment across UPMC Cancer Centers
• Quality, Predict costs, Evaluate outcomes
• Emphasis on clinical trials

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Patient Name_______________
DOB___________________ Non -Small Cell Lung
Cancer STAGE III Unresectable PS0,1 1) UPCI
02-015 Carboplatin/Taxol/RT with or without
Thalidomide If not chosen provide
reason________________________________ 2)
Carboplatin AUC2 Taxol 45mg/m2 q week with
concurrent Radiation followed by Taxotere
75mg/m2 q 3 weeks x 3 cycles If not chosen
provide reason_________________________________ P
S2 with little comorbidity Carboplatin AUC2
Taxol 45mg/m2 q week with concurrent Radiation
If not chosen provide reason____________________
_____________________ PS2 with significant
comorbidity Taxol 45mg/m2 q week with
concurrent Radiation If not chosen provide
reason________________________________________
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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

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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

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(No Transcript)
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A serious adverse event goes unreported to the
protocol office

• WHAT DO YOU DO?

• Usual
• Yell at CRC
• Set up committee meeting
• Set up second meeting to discuss further
• Try to solve by committee
• Move on to next crisis

• TMS/TPS
• Reward the reporting
• Get expert advice
• Determine how it happened
• Study where/how the problem arose, where are
  other latent related problems
• Seek corrections from those doing the work, local
  level, sustainable fixes, one problem at a time

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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 gt 2 weeks

Spear, S.J .Harvard Business Review, Sep.2005
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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

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Plans

• Secured funding to test TMS/TPS at one of our
  sites

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Providing Clinical Trial Information to
PatientsA Synthetic Interview Approach
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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

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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
200452341-348
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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

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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

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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

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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

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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

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The Team

• Valerie Monaco, PhD
• Mary Beth Simon, RN,MSN
• Kenneth S. McCarty, Jr. MD,PhD
• Suzanne Pozzani
• Aab M. Arnold, BA