Detailed Proposal

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1. Proposed Profile: Retrieve Protocol for Execution

  • Proposal Editor: Landen Bain, CDISC
  • Profile Editor: Diane Wold, Glaxo Smith Klein; Peter Villiers, SAS; Daemon Whittenburg, Greenway Medical
  • Date: November 18, 2008
  • Version: 1.0
  • Domain: Quality, Research, and Public Health

Summary

Many healthcare sites supplement their core patient care activities by participating in clinical trials. Currently, the tasks required for clinical research participation are served by systems entirely separate from the site's EHR. The ITI profile Retrieve Form for Data-capture (RFD), along with its complementary content profile Clinical Research Data-capture, have set a path towards integrating site-based clinical research workflow into the task manager of an electronic health record. This new profile, Retrieve Protocol for Execution, expands the scope of workflow integration between clinical research and EHR systems.

CDISC's Protocol Representation team intends to develop a standard protocol document, derived from the BRIDG, a RIM-linked data model. This protocol representation includes the Trial Design Model a standard structure for representing the planned sequence of events and the treatment plan of a trial. This planned sequence of events includes many tasks that could be executed by an EHR's workflow engine. The 'schedule of activities' section of the trial design includes clinical trial activities such as interventions (e.g., administering drug, surgery) and study administrative activities (e.g,. obtaining informed consent, distributing clinical trial material & diaries, randomization) as well as assessments. The time is ripe to insert these executable workflow tasks into the EHR for execution within the site's normal way of doing business.

2. The Problem

Research protocols are complex instruction sets that guide the conduct of trials. A subset of the protocol pertains to the activities of the healthcare provider site that participates in the trial. This instruction set specifies the data to be captured, tests to be ordered, inclusion and exclusion criteria for subjects, number and type of visits, etc. These instructions currently reside in hard copy binders which provide guidance for study coordinators at research sites. What is desired is a way to insert protocol instructions into an EHR for automatic completion.

3. Key Use Case: Investigational New Drug Clinical Trial

The setting for the clinical trial use case is a physicians’ practice where patient care is delivered side-by-side with clinical research. The site, Holbin Medical Group, is a multi-site physician practice, employing over 100 physicians in a variety of specialties. Holbin’s CEO encourages the physicians to participate as site investigators for pharmaceutical-sponsored clinical trials; Holbin provides support for clinical research activities in the form of a Research Department of twelve dedicated study coordinators, mostly RNs, along with clerical and data-entry support personnel. Holbin Medical Group uses an Electronic Health Record (EHR) and a number of sponsor-provided Electronic Data Capture (EDC) systems for documenting clinical trial activities.

Holbin’s involvement in a clinical study begins when the Research Department receives a request for proposal from PharmaGen, a biopharma research sponsor. A Study Coordinator, Patricia Zone, RN, evaluates the RFP for business viability and clinical appropriateness, provides the requested documentation back to the sponsor, and agrees to participate. After being approved as a site for the PharmaGen #1234 trial, and providing the required regulatory documentation to the sponsor, the physician identified as the Principal Investigator and other study personnel receive protocol-specific training from the sponsor, including training in use of the SynerGen EDC system.

During the trial set-up period, Patricia takes a number of steps that require interaction with the EHR. At this juncture, searches are at an aggregate level:

  1. ensures that the appropriate system security is in place for this protocol;
  2. recruits patients to participate as subjects according to inclusion and exclusion criteria described in the study protocol;
  3. creates a visit type for 1234 patient visits;
  4. reviews CRFs for data capture and data entry;
  5. pre-orders labs and other assessments;
  6. performs all the attendant financial tasks.

Following set up, Patricia contacts Corey Jones, a patient at Holbin, about participating in the trial, and Corey agrees to participate as a subject. A number of tasks deal with this individual patient:

  1. register Corey in the EHR as a subject in trial #1234, using the EHR’s patient index.
  2. She also registers Corey as a subject in the EDC system.
  3. She schedules Corey’s study visits using the EHR scheduling module, and flags the visits as pertaining to the trial #1234.
  4. initiates clinical trial care and trial-specific documentation.

4. Standards & Systems

  • CDISC's Protocol Representation
  • CDSIC's Trial Design Model
  • CDISC's CDASH definition of Case Report Form data elements
  • IHE ITI's Retrieve Form for Data-capture
  • IHE QRPH's Clinical Research Data-capture
  • Business Processing Management standards (OASIS BPEL)
  • PIX/PDQ for patient identification

5. Technical Approach

The technical approach to RPE takes RFD as a point of departure. Like RFD, RPE will go to great lengths to buffer the EHR participants from extraordinary development requirements. And workflow enablement pre-supposes that the human actor will retain a role when necessary. The actors of RPE take their name and some notion of their roles from RFD:

  • Protocol Executor resembles Form Filler, the EHR-based actor that receive the task instruction and executes it
  • Protocol Manager (or Study Manager) resembles Forms Manager
  • Protocol Recorder resembles the Forms Receiver

Transactions also resemble RFD's transactions:

  • Retrieve activity
  • Event notification

Existing actors

Retrieve Form for Data-capture Form Filler, Form Manager, Form Receiver, Form Archiver

New actors

Event Executor, Study Manager, Protocol Recorder


Existing transactions

RFD Retrieve Form

New transactions (standards used)

Retrieve Event for Enactment

Impact on existing integration profiles

Extends and modifies RFD

6. Support & Resources

  • RFD scenario teams:
    • Sponsors: Pfizer, Lilly, Novartis, Genzyme
    • EHRs: Cerner, Allscripts, Greenway, Epic
    • eClinical: Outcome Sciences, Nextrials, IPL, Phoenix Data Systems
  • Lisa Chatterjee, DIFZ, chair of CDISC’s Protocol Representation team
  • Diane Wold, GSK, chair of CDISC’s Trial Design team
  • Peter Villiers, SAS, developer of ODM extensions to express Schedule of Activities
  • Daemon Whittenburg, Greenway Medical
  • Dan Levy, Outcome Sciences
  • Jane Griffin, Cerner
  • Amar Das, Stanford Professor
  • Chris Connor, Phoenix Data Systems / Bio-Imaging Technologies

7. Risks

Cross-system workflow integration is a relatively new area for IHE.

The EHRs risk encountering the clinical research regulatory environment 21 CFR part 11.

8. Open Issues

Similar issues are addressed in the Performance Measurement Data Element Structured for EHR Extraction white paper. What relation does RPE have with quality initiatives?

How to deal with protocols amendments taken during the study?

How does RPE relate to RFD. Is RPE essentially a content profile using RFD infrastructure? Or does RFD create new RFD-like transactions.

How much automation of protocol events is within grasp? How to executable tasks get conveyed to the Protocol Executor (Enabler? Enactor?)

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