Clinical Research Redesign Proposal

Joe Adams, Michael Chen, Lindsay Kaplan, Tracy Nunnery, Shujen Yeh MMI 498-DL Spring 2013

Project Overview
Goal: To create a plan for an academic health system for embedding clinical research functions into an existing EHR.
o Assess the current state o Propose future state o Define a strategy and process

Topics to address:
o o o o o o o o o Benefits and challenges Ethical and legal issues Technical requirements Recommended Terminology standards Implementation and system integration Timeline Training requirements Budget considerations ROI

AHS Overview
Anytown Hospital System (AHS)
o Not-for-profit physicians health group. o Physicians and specialists include more than 300 providers and 25 specialties across 80 locations. o AHS provides a complete, coordinated and comprehensive sphere of care for the region it serves. o The broad array of services includes emergency medicine, cardiology, obstetrics/gynecology, pediatrics, oncology, surgery, neurology as well as laboratory, radiology and pathology. o Intensive care facilities provide critical care, pediatric, neonatal, coronary care and post-op ICU.

Clinical Research & Informatics

Clinical research processes where opportunities exist for informatics solutions:
Identifying Potential Study Participants Screening and Enrolling Participants in a Clinical Study Scheduling and Tracking Study-Related Participant Events Executing Study Encounters and Associated Data Collection Tasks Ensuring the Quality of Study Data Regulatory and Sponsor Reporting and Administrative Tracking/Compliance o Budgeting and Fiscal Reconciliation o Human Subjects Protection Reporting and Monitoring (Payne, 2012) o o o o o o

Proposed Solution for AHS

Fully integrated with existing EHR Improved Efficiencies

Interoperable

A Comprehensive Clinical Trial Management System (CTMS)

Streamlined Processes

Standards-Based

Customizable Functions

Benefits and Challenges

Improvement of recruitment efficiency and success rate in trial enrollment Time/labor saving and errors reduction Easier monitoring of adverse events protects participants safety Conformance to standards makes data sharing easier Usability of interface design Integrating and streamlining workflow Stakeholders buy-in Unstructured data elements

AHS Stakeholders
Stakeholder Involvement
o Consider research goals and AHS vision o Utilizing CTMS allows for increased size of studies and number of studies o Effective CTMS = Backbone of Clinical Development Efforts (Tyson & Lynch, 2008)

Recommended Stakeholder Strategies

o CTMS Steering Committee appointment o Development of common CTMS vision

Create Buy-In from all CTMS users

o Implementation flounders if non-engaged stakeholders fail to use system effectively (Tyson & Lynch, 2008) o Broad buy-in facilitates fully functional and effective CTMS

Current State

Current State

Future State

Use Case: Study Enrollment

Current workflow for study enrollment

Labor-intensive Time-consuming Lack of coordination Not automated Introduces opportunities for error Does not leverage existing data efficiently Relies on physician to follow-up

Use Case: Study Enrollment

Proposed workflow for study enrollment

Core processes are automated Reduces time-toenrollment Provides more complete study candidates Reduces opportunities for error Uses integrated data Does not rely heavily on physician interaction

Eligibility Alerts

Budget
Type Initial software acquisition and setup Analysis Software installation, hardware and other infrastructure improvements, and inhouse staff may be required. Larger organizations need more accessibility and more users, which may affect licensing costs. Ongoing subscription costs must be negotiated carefully based on the needs of the organization. Costs can come from a per case basis or a fixed support cost. These costs are ongoing and will continue throughout the lifecycle of the software use. Contracting for 24/7 support is also an option that will increase cost Exhaustive training requires hiring of personnel to train staff, but lower cost training may result in lower proficiency or higher employee commitment. Cost is also determined by loss of productivity during training. Interfacing with the existing software (EHR, HR, Accounting, Billing) and migrating pertinent data must be done for the system to work properly Though not an initial cost, a CTMS will require ongoing contractual commitment to a vendor. The initial cost is daunting, but the return on investment could be much more. For larger organizations, the low-end estimates may not be attainable. Estimated Cost $30,000 - $200,000 Licensing $1,500 annual per-user fee

Support and Maintenance

$25,000 $50,000

Training

$10,000 - $50,000

Data Migration

$50,000 - $150,000

Contract Commitment Total

$200,000 - $500,000

ROI
Improvement Area Billing Improved materials management and tracked billing of sponsor. Reduced burden on research staff Year 2 Return $25,000 $50,000 Rationale No more missed billing opportunities $50,000 $75,000 Research has more time to commit to research rather than manual cataloguing and procedural duties. Potential to reduce staff and increase amount of studies CTMS can reduce the number of studies missed due to participant issues. The ability to quickly determine which studies AHS is capable of undertaking and producing the most equitable contract will improve the number of studies and the reimbursements from sponsors Other organizations have reported improvements well past this conservative estimate for return within the first year. One organization reported a staggering $2M increase in annual clinical trial revenue in a few years (Miller, 2006)

Increased study participation Improved negotiation and contracting

$100,000 $300,000 $0 - $100,000

Total

$175,000 $525,000

Two-year Comparison

CTMS: Core Functionality

Recruitment and enrollment management integrated with existing EHR Integrated electronic data capture minimizing rekeying and minimizing data capture on paper Systematic, standard-conforming database management and transmission Data extraction and the ability to generate reports

CTMS: EHR Enhancements

Expansion of structured data capture Clinical encounter data are less structured and have a higher likelihood of missing data A good percentage of trial required data elements are already available in EHR but may not be as rigorously structured Trial eligibility alerts and initial intent response mechanism to CTMS Applicable elements of CDISC standards Toward standardized clinical terminology suitable for research

CTMS: Streamlined Workflows

Recruitment and enrollment management integrated with existing EHR Integrated electronic data capture minimizing re-keying and minimizing data capture on paper Systematic, standard-conforming data base management and transmission Data extraction and ability to generate reports

CTMS: Patient Portal

Improved recruitment efforts Enhanced patient participation and satisfaction Patients have ability to:
o Seek out studies o Determine eligibility for studies o Ask about inclusion in studies

Active Research Participants:

o Fill out surveys/questionnaires o Report vital information immediately o Easily communicate with physicians and study coordinators

CTMS: Clinical Implementation

Phased Implementation Plan
o Complex clinical research processes o Wide range of informatics needs o Diverse AHS stakeholder involvement

Benefits of a multi-phased realization

o o o o o Reduces business and operational risks Reduces short-term initial resource and financial burdens Initial returns invested in future phases Minimizes disruption in workflow Increases user-acceptance

Benefits of an integrated system can be reaped with a limited set of well-designed, highly usable functionalities.

CTMS: Project Timeline

CTMS: Training
Training plan developed with AHS Project Sponsor On-site, instructor-led training for each USER Goals of Training
o o o o o o Familiarizing users with system functions Teaching tools to start using CTMS right away Focus on system navigation Knowing system features Using real-life scenarios/AHS research data as examples Maintaining open environment for questions/feedback (Pfotenhauer, 2012)

CTMS: Support
Following CTMS Implementation
o 24/7 software support as negotiated in software package o Continued feedback from users/responses to questions

Capstone Consulting Connections page

Accessed via Capstone Consulting webpage Free access to online video training materials Frequently Asked Questions (FAQs) page Online forum Customer feedback page Live, internet-based support

Ethical and Legal Considerations

HIPAA Privacy Rule
o CTAs enable point-of-care recruitment o CTMS facilitates the collection of PHI using both de-identified data sets and limited data sets

HIPAA Security Rule & FDA 21 CFR Part 11

o o o o o Authorized access only Audit trail Consistent use of clinical terminology Isolate identifiable information Guard against data loss

OHRP Common Rule, FDA Protection of Human Subjects & Institutional Review Boards
o Informed Consent storage, tracking, and re-consenting management o Combine with Privacy Rule Authorization o Facilitate IRB Review

Technical Architecture
SaaS SOA STDM XML Integration of legacy data and systems WSDL ODM

Operational Data Model

Integrated Flexible Standards-based System-agnostic Leverages STDM and XML Enables reuse of metadata

(Verplancke, 2007)

Terminology Standards
Standard CDASH Description The [CDASH] standard describes the basic recommended data collection fields for 18 domains (CDISC CDASH, 2013). CDISC-developed standard specification defining requirements for interchange of laboratory data. The Standard for Exchange of Nonclinical Data is a standardized format which defines the structure and format of nonclinical datasets for purposes of exchange. The Analysis Data Model is used to facilitate the transfer of datasets between research organizations, (CDISC ADaM, 2013). The Logical Observation Identifiers Names and Codes is a database and standard for measuring laboratory results. The Systemized Nomenclature of Medicine-Clinical Terms is a standard used to cross-map to other international standards. Standard RxNorm Description RxNorm provides normalized names for clinical drugs and links its names to many of the drug vocabularies. DICOM is designed to create interoperability of systems used to produce, store, retrieve and view medical images. HL-7 provides a framework and for the exchange, integration, sharing, and retrieval of electronic health information (Health Level 7 International). A continuity of care document is an electronic summary of all of a patients clinical information. ICD-9-CM is the official system of assigning codes to diagnoses and procedures associated with hospital utilization in the United States. (CDC, 2012) CPT codes are used to report medical procedures and services under public and private health insurance programs. LAB DICOM

SEND

HL-7

ADaM

CCD

LOINC

ICD-9-CM

SNOMEDCT

CPT