PBRN Resource Center Defining Shared IT Interests Among PBRNs

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PBRN Resource Center Defining Shared IT
Interests Among PBRNs

• Atif Zafar, M.D.
• Indiana University

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Overview of Presentations

• Introduction
• A Taxonomy of IT Functionality
• Security and Confidentiality IRBs and HIPPA
• Questions and Answers
• Small Group Session 1-330 pm
• Portable Computing Technology and Trends
• Demonstrations
• Patient Education Materials Using a Touch Screen
  Interface
• Wireless, Web-based Data Collection on Tablet PC
  Devices

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Introduction to PBRN Research

• Motivation to understand what can be done with
  Information Technology (IT) stems from the fact
  that some major barriers exist to performing
  research in PBRNs and the realization that IT is
  a fundamental capability necessary in order to
  break down these barriers
• The Necessary Data is scattered
• Geographically Different practices in a network
  may keep different records
• Formats Data is often stored in disparate
  systems that cannot talk to each other and in
  many cases the data is not even in electronic
  form
• Data abstraction thus requires expensive data
  manager or research assistant time
• Data may also be incomplete or inaccurate, which
  necessitates a data quality control step
• Physicians do not have the time or skills to
  extract and analyze this data
• Requires knowledge of underlying systems and
  databases
• Requires fluency with statistical analysis
  systems
• Requires expertise on research methodology and
  study design
• As a consequence, most studies done to date in
  PBRNs have been observational in nature.

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Introduction to PBRN Research
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Introduction to PBRN Research

• What are some of the tasks that are required in
  collaborative research and how can IT help with
  development of the ability to accomplish these
  tasks?
• Ability to design an appropriate study from a
  clinical question
• identify and describe potential subjects for
  grant applications
• for funded studies to ask physicians for
  verification of the disease and permission to
  contact, generate lists of potential subjects
  with scheduled appointments (for recruitment)
• identify patients who say "don't ever ask me
  again to be in a research project"
• to store information on which study a patient is
  in, and
• provide descriptive and outcome data for enrolled
  subjects and comparable patients not enrolled (if
  needed).
• Electronic Medical Records (EMR) provide a
  solution to these problems

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Introduction to PBRN Research

• Tasks required for collaborative studies cont.
• Ability to plan the logistics of the study within
  a busy clinical setting. This requires an
  organizing body, a PBRN!
• Ability to collect the relevant data efficiently
  with minimal interruption to clinical workflow by
  knowledgeable individuals who often cohabit the
  same space as clinicians. This necessitates
  mobile electronic data collection.
• Ability to quickly alter the design if necessary
  with minimal loss as data is generated and
  problems arise.
• Ability to analyze the data using appropriate
  statistical methods. Statistical Software, used
  by knowledgeable people is the key
• Ability to communicate the results to others and
  change practice appropriately. A Web-based
  collaborative workspace augmented by an EMR is
  the answer here.
• Many of the existing PBRNs lack one or more of
  these expertise.

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Introduction to PBRN Research

• In order to empower PBRNs with the necessary IT
  infrastructure to be able to accomplish the tasks
  mentioned, it is necessary to asses what each of
  the PBRNs are capable of, I.e. what stage of
  development they are in
• First phase was to define and characterize the
  practices within the PBRN in order to asses their
  data generation capability. Preliminary effort
  came in the form of the PRINS I and PRINS II
  Surveys completed in September 2002.
• Define what types of data are being collected?
• Who is collecting this data?
• Where is it being collected?
• Who is paying for this data collection.
• Second phase will be to characterize the
  information technology (IT) capacities of the
  PBRNs in order to collect data electronically
  and engage in meaningful, collaborative research
  requiring data sharing. This is the IT-Survey
  about to be revealed by AHRQ for all PBRNs to
  complete.

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Introduction to the PBRN Resource Center

• In order to address these issues, AHRQ
  established in September 2002 the PBRN Resource
  Center, as a means to assist those PBRNs that
  lack the essential knowledge and tools, some
  basic level of expertise in order to engage in
  meaningful collaborative research.
• The Specific Objectives are to provide PBRNs
  with
• Research Methodology Expertise
• Electronic Communications Capability
• Electronic Data Collection Capability
• Repository of Current Research, Research Methods,
  Tools and Tutorials

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Characterization of New PBRN Efforts (2002 RFA)
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Characterization of New PBRN Efforts (2002 RFA)

• Given these interests of the 36 PBRNs, the need
  for 2 IT solutions arises
• Mobile Web-Based Data Collection and
  Communication Systems
• Collect study data in busy clinical environments
• Communicate between investigators and PBRNs
• Electronic Medical Records
• Provide assistance with TRIP activities
• Help with the care of the underserved populations
• IUs Kenya Program developed a simple MS Access
  based EMR that has had a tremendous impact in the
  care of underserved Kenyans, especially those
  afflicted with HIV

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A Taxonomy of IT Functionality

• What are some basic functions at the level of the
  PBRN and the Practice that IT must support?
• I. PBRN Level
• Communication (investigator to investigator)
• Data Collection (Research Data, Surveys, etc.)
• Data Management (data extraction, data analysis)
• II. Practice Level
• Communication (doctor-patient, doctor-doctor)
• Data Collection (EMRs)
• Data Management (report generation, clinical
  care, billing, etc.)

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A Taxonomy of IT Functionality

• IA. Communication (PBRN Level)
• Active Communication between Investigators
• Synchronous (two-way)
• Conference Calls
• Cell Phone Calls
• Instant Messaging
• Video Conferencing
• Chat Rooms
• Asynchronous (one-way)
• Email
• Discussion Lists
• Editing Shared Documents
• Digital Message Pagers

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A Taxonomy of IT Functionality

• IA. Communication (PBRN Level)
• Acquiring Information Passively
• Reading News and Reviews Online
• Looking up Prior Research
• Watching and Listening to Webcasts
• Engaging in Web-Based Training (WBT)

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A Taxonomy of IT Functionality

• IB Data Collection (PBRN Level)
• Telephone Interviews
• Paper-Based Surveys
• Hybrid Paper-Electronic Methods
• Scanned forms
• Teleforms (fax)
• Electronic Means
• Computer systems (laptops, desktops)
• PDA Devices
• Tablet PCs
• Other Handheld Devices (Cell phones, etc.)

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A Taxonomy of IT Functionality

• IC Data Management (PBRN Level)
• Extracting Data from Databases
• Analyzing Data
• Statistics
• Data Mining
• Data Transformation
• GIS methods
• Data Reporting
• Visualization Methods

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A Taxonomy of IT Functionality

• IIA Communication (Practice Level)
• Patient-Doctor Communication
• Telephone calls
• Notes from Nurse Triage
• Letters
• Email (38 by HIMMS survey)
• Doctor-Doctor Communication
• Encounter Notes
• Letters
• Email
• Telephone calls

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A Taxonomy of IT Functionality

• IIA Communication (Practice Level)
• Acquiring Information Passively
• Extracting knowledge from knowledge sources
• PDA based References (Drugs, Harrisons, Ferry )
• CDROM based References (UpToDate, SciAm Medicine)
• Online Literature Searching (PubMed, Yahoo
  Health)
• Automatic content delivery (BOTS, SPIDERS,
  AGGREGATORS)
• Understanding Past Experiences of others
• Attending seminars, conferences, CME (online)
• Listening to Web Broadcasts

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A Taxonomy of IT Functionality

• IIB Data Collection (Practice Level)
• Different domains of data
• Encounter data
• Billing and Administrative Data
• Lab/Radiology/Pathology Data
• Demographics Data
• Pharmacy Data
• Registration Data
• Some electronic systems can capture some of this
  data automatically VitalNet, EKG data, ICU data

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A Taxonomy of IT Functionality

• IIB Data Collection (Practice Level)
• Medical Record Encounter Data
• Paper-based charts
• Handwritten
• Template-based (checkboxes etc.)
• Electronic (almost 75 of ambulatory practices by
  the HIMMS survey state they DONT have EMRs!)
• Typed
• Speech Recognition
• Dictation/Transcription
• Above technologies with templates for CODED data
  capture.

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A Taxonomy of IT Functionality

• IIB Data Management (Practice Level)
• Coding and Billing
• Converts bullet points into billable codes
• Data Understanding Clinical Decision Making
• Convert lab and imaging data into diagnoses
• Quality Improvement
• Use outcome data ( people with Hgb A1Cs gt 9)
  into practice guidelines and protocols

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Types of IT

• An understanding of what is available and what it
  can do will help you match your requirement with
  the correct IT solution
• Will describe IT resources in 4 areas
• Hardware
• Software
• Web Functions
• Support (Human Resources)
• Each is then broken down into category and
  feature

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Types of IT

• MS Access Database Taxonomy of IT.MDB
• Can be downloaded from the Extranet
• Allows you to catalog your IT functionality
• Records data in terms of 4 categories (HW, SW,
  Web, Support)
• Has fields for VENDOR, PRICE, DESCRIPTIONS,
  CATEGORY, FEATURE etc.
• Has a built-in data entry form
• PLEASE NOTE This is a preliminary
  hierarchy which is by no means all inclusive or
  complete. I encourage you to make changes and
  additions as you see fit. It is in a form that is
  easily modifiable and manageable.

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IT Resources A Compendium

• Hardware Major Categories
• Desktop Compute Device
• Hand-Held Device
• Communications
• Network
• Printing
• Display
• Peripheral
• Telemedicine

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IT Resources A Compendium
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IT Resources A Compendium
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IT Resources A Compendium
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IT Resources A Compendium
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IT Resources A Compendium

• Software Major Categories
• Office Application
• Organizer
• Database
• Statistics
• Data Mining
• Graphics
• Visualization

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IT Resources A Compendium

• Software Major Categories Cont.
• Groupware
• Communication
• Networking
• Hand-Held Device
• Tutorial
• Web Software
• Electronic Medical Records

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IT Resources A Compendium
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IT Resources A Compendium
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IT Resources A Compendium
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IT Resources A Compendium
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IT Resources A Compendium

• Web Software Major Categories
• General/Information
• Tutorial
• Collaboration
• File Sharing
• E-Business
• Online Searching

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IT Resources A Compendium
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IT Resources A Compendium
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IT Resources A Compendium

• Human Resources Major Categories
• Research Support
• Administration
• Computer Support

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IT Resources A Compendium
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Security and Confidentiality

• ALL research activities must meet strict federal
  regulations in terms of security of the data
  obtained and preservation of patient/subject
  confidentiality
• There are 2 steps that need to be taken to assure
  that this is done properly
• IRB Approval
• Adherence to HIPAA Regulations

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Security and Confidentiality

• IRB Institutional Review Board
• Task is to ensure that the rights of Human
  Subjects are protected in any research endeavor
• Requires a separate application process
• Involves 2 written components
• Summary Safeguard Statement Describes the study
  and provides assurances that certain guidelines
  are being followed
• Informed Consent A signed agreement from the
  subject informing them of the risks and benefits
  of participating in a study
• All participants involved in human subjects
  research must pass a certification course on
  human subjects as of 2001. This is a mandate from
  HHS.

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Security and Confidentiality

• Guidelines for obtaining IRB Approval
• Be as detailed and specific as you can, leaving
  nothing for guessing. Remember, many of the
  people reviewing your application are not experts
  in your field!
• Include all possible contingencies. If you cannot
  account for all possibilities, say so.
• Use language consistent with an 8th grade
  education. EXPLAIN ALL MEDICAL TERMS!
• Include as much statistical design information as
  you can. Many applications are rejected on the
  basis of improper design because the board
  feels that the relevant outcomes may not be
  studied properly using the methodology stated.
  Get help from a biostatistician when you write
  the application.

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Security and Confidentiality

• HIPAA Health Insurance Portability and
  Accountablity Act (2003)
• Requires healthcare providers to protect
  patients privacy through appropriate policies,
  procedures and staff training
• Deadline for compliance with privacy rules is
  APRIL 14th 2003!
• Penalties for infringement of rules includes
  fines and even jail terms! However, process is
  designed to be smooth, so unless you plan to
  break the rules, you should not have to fear
  fines or jail terms.
• Process will be complaint-driven, rather than a
  game of gotcha

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Security and Confidentiality

• HIPAA
• Provides 3 core provisions
• Standardizing Electronic Data Interchanges
• Tightening Privacy Practices
• Beefing up Data Security
• These can be summarized under 3 headings
• Transactions and Code Sets
• Privacy
• Security

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Security and Confidentiality

• HIPAA
• Transactions and Code Sets
• Law requires the healthcare industry (including
  all research endeavors) to agree upon common
  standards for electronic transmission of clinical
  data
• Supposed to begin testing your system on April
  16, 2003, two days after the deadline. Date for
  full compliance is October 16, 2003 (if you filed
  for an extension)
• Goal is to lower healthcare costs by enabling
  providers and payers to save money on back-office
  functions such as billing

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Security and Confidentiality

• HIPAA
• Privacy
• Standard transactions and code sets may make it
  too easy to share data electronically, so this
  privacy rule sets the ethical limits
• Core concept is that protected health information
  (PHI) should be disclosed only to those in need
  (payers and providers of care)
• Doctors need information and patients have the
  right to see anything in their own records.
  Anyone else is restricted unless consent is given
  by the patient

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Security and Confidentiality

• HIPAA
• Security
• If privacy and data integrity are the whys, then
  security is the how.
• Thus, data must be protected at the points of
  collection, transmission and storage.
• The specific technology that is used to
  accomplish this is left up to the discretion of
  the institution

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Security and Confidentiality

• HIPAA What it means for PBRN IT Systems
• Essentially 3 things
• Need a Login/Password to access sensitive
  information and only authorized users are given a
  login and password
• Transmission of sensitive information must be
  encrypted
• Computers housing sensitive information must be
  located in a secure, locked area
• Given the web-centric nature of many EMRs, this
  is not a trivial exercise.

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Security and Confidentiality

• HIPAA
• Other management tasks
• Remove a login/password for someone who leaves
  the institution (staff, students, etc.).
• Install a system for Intrusion Detection. This is
  not trivial, given how easy it is to break into
  systems and the fact that a fully secure
  network can cost up to 20,000/month to maintain!

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PBRN IT Systems

• Useful References
• HIPAA
• http//snip.wedi.org/public/articles/HIPPASolution
  .pdf
• Conferences on IT
• HIMSS (Health Information and Management Systems
  Society)
• http//www.himss.org
• AMIA (American Medical Informatics Association)
• http//www.amia.org

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PBRN IT Systems

• Useful References
• Physician IT Surveys
• http//www.rnpalm.com/HIMSS_survey.htm
• http//www.mcareol.com/mcolsecw/webpages/survy950.
  htm
• http//www.pwcglobal.com/healthcare
• http//www.modernphysician.com
• PBRNs
• http//www.racgp.org.au

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PBRN IT Systems

• Useful References
• USDA guidelines for computerized clinical trial
  systems
• http//www.fda.gov/ora/compliance_ref/bimo/ffinalc
  ct.htm
• Useful Online Survey Software
• Perseus Software SurveySolutions
• http//www.perseusdevelopment.com
• Ultimate Software UltimateApps
• http//www.ultimateapps.com
• Raosoft EZSurvey
• http//www.raosoft.com

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Questions and Answers