# Presentation: 110133

## PBRN Resource Center Defining Shared IT Interests Among PBRN’s

- Atif Zafar, M.D.
- Indiana University

## Overview of Presentations

- Introduction
- A Taxonomy of IT Functionality
- Security and Confidentiality: *IRB’s and HIPPA*
- Questions and Answers
- Small Group Session: 1-3:30 pm
*Portable Computing: Technology and Trends*
*Demonstrations*
*Patient Education Materials Using a Touch Screen Interface*
*Wireless, Web-based Data Collection on Tablet PC Devices*

## 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 PBRN’s 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 PBRN’s have been *observational *in nature.

## Introduction to PBRN Research

## 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

## 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 PBRN’s lack one or more of these expertise.

## Introduction to PBRN Research

- In order to empower PBRN’s with the necessary IT infrastructure to be able to accomplish the tasks mentioned, it is necessary to asses what each of the PBRN’s 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 PBRN’s 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 PBRN’s to complete.

## 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 PBRN’s 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 PBRN’s with:
- Research Methodology Expertise
- Electronic Communications Capability
- Electronic Data Collection Capability
- Repository of Current Research, Research Methods, Tools and Tutorials

## Characterization of New PBRN Efforts (2002 RFA)

## Characterization of New PBRN Efforts (2002 RFA)

- Given these interests of the 36 PBRN’s, 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 PBRN’s
- _Electronic Medical Records_
- Provide assistance with TRIP activities
- Help with the care of the underserved populations
- IU’s 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

## 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 (EMR’s)
- Data Management (report generation, clinical care, billing, etc.)

## 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

## 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)***

## 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 PC’s
- Other Handheld Devices (Cell phones, etc.)

## 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

## 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

## 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

## 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:  VitalNetTM, EKG data, ICU data

## 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 *DON’T* have EMR’s!)
- Typed
- Speech Recognition
- Dictation/Transcription
- Above technologies with templates for CODED data capture.

## 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 A1C’s > 9) into practice guidelines and protocols

## 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*

## 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.**

## IT Resources: A Compendium

- _Hardware: Major Categories_
- Desktop Compute Device
- Hand-Held Device
- Communications
- Network
- Printing
- Display
- Peripheral
- Telemedicine

## IT Resources: A Compendium

| FEATURE | CATEGORY |
| --- | --- |
| Telephone | Communications |
| Fax | Communications |
| Modem | Communications |
| Digital Sender | Communications |
| Infra-Red Device | Communications |
| Printer | Printing |
| Scanner | Printing |
| Network Interface Card | Network |
| Wireless Network Adapter | Network |

## IT Resources: A Compendium

| FEATURE | CATEGORY |
| --- | --- |
| Router | Network |
| Server | Network |
| Hub | Network |
| Firewall | Network |
| Repeater | Network |
| Wireless Antenna | Network |
| CDROM or DVD-ROM | Peripheral |
| Hard Disk | Peripheral |
| Memory | Peripheral |

## IT Resources: A Compendium

| FEATURE | CATEGORY |
| --- | --- |
| Microphone or Sound Card | Peripheral |
| Monitor | Display |
| LCD | Display |
| Video Card | Display |
| Video Capture Card | Display |
| Desktop Computer | Desktop Device |
| PDA | Hand-Held Device |
| 2-Way Pager | Hand-Held Device |
| Cell Phone | Hand-Held Device |

## IT Resources: A Compendium

| FEATURE | CATEGORY |
| --- | --- |
| Digital Camera | Hand-Held Device |
| Tablet PC | Hand-Held Device |
| Laptop | Hand-Held Device |
|  |  |
|  |  |
|  |  |
|  |  |
|  |  |
|  |  |

## IT Resources: A Compendium

- _Software: Major Categories_
- Office Application
- Organizer
- Database
- Statistics
- Data Mining
- Graphics
- Visualization

## IT Resources: A Compendium

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

## IT Resources: A Compendium

| FEATURE | CATEGORY |
| --- | --- |
| Email Software | Communication |
| Web Browser | Web Software |
| Web Server | Web Software |
| Web Page Designer | Web Software |
| Word Processor | Office Application |
| Spreadsheet | Office Application |
| Presentation | Office Application |
| Speech Recognition | Office Application |
| Reference Management | Office Application |

## IT Resources: A Compendium

| FEATURE | CATEGORY |
| --- | --- |
| Database | Database |
| Database Server | Database |
| Organizer | Organizer |
| File Management | Organizer |
| Groupware | Groupware |
| Network Management | Networking |
| Statistics Package | Statistics |
| Data Mining Software | Data Mining |
| Visualization Package | Visualization |

## IT Resources: A Compendium

| FEATURE | CATEGORY |
| --- | --- |
| Drawing Package | Graphics |
| Painting Package | Graphics |
| 3D Modeling Package | Graphics |
| Image Editing | Graphics |
| CD / DVD Authoring | Graphics |
| References | Tutorials |
| Electronic Training | Tutorials |
| Physician Order Entry | EMR |
| Billing System | EMR |

## IT Resources: A Compendium

| FEATURE | CATEGORY |
| --- | --- |
| Registration System | EMR |
| Decision Support | EMR |
| Pharmacy | EMR |
| Lab | EMR |
| Radiology | EMR |
| Results Display | EMR |
| Scheduling | EMR |
|  |  |
|  |  |

## IT Resources: A Compendium

- _Web Software: Major Categories_
- General/Information
- Tutorial
- Collaboration
- File Sharing
- E-Business
- Online Searching

## IT Resources: A Compendium

| FEATURE | CATEGORY |
| --- | --- |
| Email | Collaboration |
| Discussion Lists | Collaboration |
| Listserv’s | Collaboration |
| Bulletin Boards | Collaboration |
| Shared Document Creation | Collaboration |
| Web Conferencing | Collaboration |
| Shared Calendar | Collaboration |
| News Display | General/Information |
| Information Display | General/Information |

## IT Resources: A Compendium

| FEATURE | CATEGORY |
| --- | --- |
| E-Zine/E-Newsletter | General/Information |
| Web Casting | General/Information |
| Online Sales/Auction | E-Business |
| Web Based Training | Tutorial |
| Survey Software | Data Entry |
| Online Directory | Online Searching |
| File Sharing | File Sharing |
| Instant Messaging | Collaboration |
| Chat Rooms | Collaboration |

## IT Resources: A Compendium

- _Human Resources: Major Categories_
- Research Support
- Administration
- Computer Support

## IT Resources: A Compendium

| FEATURE | CATEGORY |
| --- | --- |
| Data Manager | Research |
| Statistician | Research |
| Research Assistant | Research |
| Research Manager | Research |
| Network Support | Computer Support |
| Systems Support | Computer Support |
| Computer Security | Computer Support |
| Financial Officer | Administration |
| Secretarial/Clerical  Support | Administration |

## 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***

## 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.

## 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.

## 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 14**__**th**__** 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”

## 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

## 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

## 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

## 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

## 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 EMR’s, this is *not *a trivial exercise.

## 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!

## PBRN IT Systems

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

## PBRN IT Systems

- Useful References
- Physician IT Surveys:
- _[http://www.rnpalm.com/HIMSS_survey.htm](http://www.rnpalm.com/HIMSS_survey.htm)_
- _[http://www.mcareol.com/mcolsecw/webpages/survy950.htm](http://www.mcareol.com/mcolsecw/webpages/survy950.htm)_
- _[http://www.pwcglobal.com/healthcare](http://www.pwcglobal.com/healthcare)_
- _[http://www.modernphysician.com](http://www.modernphysician.com/)_
- PBRNs
- _[http://www.racgp.org.au](http://www.racgp.org.au/)_

## PBRN IT Systems

- Useful References
- USDA guidelines for computerized clinical trial systems
- _[http://](http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm)__[www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm](http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm)_
- Useful Online Survey Software
- Perseus Software: SurveySolutionsTM
- _[http://www.perseusdevelopment.com](http://www.perseusdevelopment.com/)_
- Ultimate Software: UltimateAppsTM
- _[http://www.ultimateapps.com](http://www.ultimateapps.com/)_
- Raosoft: EZSurveyTM
- _[http://www.raosoft.com](http://www.raosoft.com/)_

## Questions and Answers