1. EHR Stakeholder Workshop: Toward New Interaction Models The Nuts and Bolts of Patient Recruitment…from a (nearly) non-technical perspective “What’s right is what’s left when you’ve done everything else wrong.” – Robin Williams “For every 25% increase in complexity, there is a 100% increase in effort” – Scott Woodfield Charles N Mead, MD, MSc Chief Technology Officer National Cancer Institute Washington, DC (USA) Senior Associate Global Health Group Booz Allen Hamilton

2. 1 An Exemplar Scenario… A Trial Sponsor has developed a new intervention for Type I diabetes and has developed a clinical trial protocol to test this new intervention. A repository containing the Electronic Health Records (EHRs) for a number of patients is available to the Sponsor as a possible source of subjects for the protocol. The Trial Sponsor would like to compare the protocol’s inclusion/exclusion (I/E) criteria against patient-specific data in the EHR repository to see how many patients could be potentially eligible to participate in the intervention study.

3. 2 This should be easy except for issues of…  Security and Access to EHR repository  Consent of individual patient (not necessarily the same as the previous point)  Non-standard expression of I/E criteria  Non-standard expression of patient-specific data

4. 3 And those were just the ‘easy’ limitations. Also there are…  Many additional steps involved in ‘recruiting a subject for a trial’ including  More finely granulated analysis of data (beyond I/E criteria) –Lack of standards for automating this analysis, i.e. every recruitment is a one- off process  Multitude of regulatory hurdles to cross –Local/State/regional –National/International  Multiple stakeholders (with multiple value propositions) working from within multiple systems. For each system involved: –Who mandates a system? –Who pays for a system? –Who uses (primary and secondary) the system? –Who builds the system? –Who regulates the system?  Differing levels of organization maturity

5. 4 Complexity  “Complicated”, “Multi-faceted”, “Multi-factorial”, “Multi-layered”  Ivar Jacobson (paraphrase): “A multi-leveled, vertically hierarchical organization whose products of value are produced through one or more horizontal processes that cross vertical organizational lines.”  With cross-organization processes – whether they involve people or systems – syntactic and semantic problems occur at the vertical boundaries.  Cumulative experience in industry, art, and (cognitive) science has repeatedly shown that the best way to deal with complexity is through abstraction, layering, and the use of standards.

6. 5 The Communication Pyramid Communication ` Free-text Documents Structured Documents ad hoc Drawings Non-standard Graphics Discussions Standardized Models (UML) Problem Space Solution Space Implementation-Independent Implementation-Specific Abstraction

7. 6 “Protocol” – a ‘commonly used’ term… Source: John Speakman Symbol “Protocol” “We need to sign off on the protocol by Friday” Concept 1 Thing 1 (Document) “Protocol XYZ has enrolled 73 patients” Concept 2 Thing 2 (Study) “Per the protocol, you must be at least 18 to be enrolled” Concept 3 Thing 3 (Plan) Ogden/Richards (Mead/Speakman)

8. 7 A New Interaction Model  What is “An Interaction Model”?  Candidate definition (CNM): A formal representation of a a set of activities and deliverables that occur as the result of one or more participating entities requesting or responding to well-defined events in a control flow. A given interaction has well-defined –pre- and post-conditions –Inputs and outputs  If this sounds like empiric process and/or software engineering, it is… –…but only because software engineering addresses complexity management in situations of equivalent complexity to the proposed goals of this conference  Best represented in visual diagrams augmented by text (rather than the inverse)

9. 8 Use Case 2 – Load Lab Data A Formal Representation of an Interaction

10. 9 A New Interaction Model: Critical Components  Identify stakeholders by role –Capability, Capacity, Competency –Stakeholders can be systems, organizations, or persons –Many-to-many relationships are common –Five ‘types’ of stakeholders, multiple instances of each type  Apply ongoing risk management strategies –Static identification on a regular (e.g. weekly) basis –Integration of risk mitigation strategies into project planning  Proceed iteratively and incrementally –Apply project management Best Practices and avoid the Waterfall RUP Agile Scrum Etc.

11. 10 Summary  The problem we are trying is the embodiment of a (hyper) complex system  apply the appropriate tools, techniques, expertise, etc. –“You can’t build a skyscraper by nailing together doghouses.”  The problem will not be solved ‘bottom up’ – a meaningful solution will require top-down mandates to focus bottom-up and middle-out efforts – they will not succeed on their own  Success will only occur iterative and incrementally – any attempt to solve this problem with Waterfall approaches is doomed to failure  Think architecture: business first, technology second  Success in a layered, I/I approach involves –Continuous risk identification and management –Multi-disciplinary teams Identification of discipline-specific value propositions for all stakeholders –Prioritization of project goals and realistic expectation settting  The is a hard problem, but it is a solvable one if approached correctly

12. QUESTIONS & ANSWERS

13. 12 Cumulative experience in industry, art, and (cognitive) science has repeatedly shown that the best way to deal with complexity is iteratively, using abstraction and layering  Complex problems require the application of complex cognitive processes in order to achieve meaningful solutions  Cognitive processes must apply layering and chunking (“the law of 7 +- 2”)  All disciplines that routinely deal with complex problems develop either formal or de facto approaches to Layering and Chunking –Cyclical application of core process of definition, discovery, intervention, (re)evaluation (re- definition)  “iterative/incremental process” The Nursing Process as a model of complex problem solving http://www.chambers.com.au/glossary/chunk.htm

14. 13 Organizational Maturity  Level 1: Heroism and Passion (no defined process)  Level 2: A Set of Directions (minimal ability to deal with unexpected)  Level 3: A Map (unexpected events can be managed)  Level 4: Gathering Process Variance (parallel process improvement)  Level 5: Using Process Variance data to drive Process Improvement  Everyone wants to be Level 5  Progression to the ‘next level’ is stepwise  Level 1 does not mean incompetence! It just doesn’t scale well over time

15. 14 Complexity  “Complicated”, “Multi-faceted”, “Multi-factorial”, “Multi-layered”  Ivar Jacobson (paraphrase): “A multi-leveled, vertically hierarchical organization whose products of value are produced through one or more horizontal processes that cross vertical organizational lines.”