1. NDARC Annual Symposium
Embedding Evaluation and Learning into the Delivery of Routine Services
Louis Fiore MD, MPH
NDARC Annual Symposium
8 October 2018

2. Roadmap Learning versus discovery Requirements for learning
Examples of learning healthcare system activities
Lessons learned

3. Chapter 1: Learning versus Discovery

5. Traditional Observational Health Research
Cohort
Identification
Data
Cleaning
Data
Collection
Data
Analysis
Healthcare System
Research Enterprise
Knowledge
Generation
Publication
Translation Gap

6. Local Learning for Care Optimization

7. Local Learning with Implementation
Cohort
Identification
Data
Collection
Data
Cleaning
Data
Analysis
Knowledge
Generation
Patient Specific
Decision Support
Prediction
Algorithm
Results
Individual
Patient Data

9. Chapter 2: Requirements for Learning
Engagement of care providers
“Bottom Up”
Data availability and provenance
Of critical data elements only
Data science
The easy part
Ability to experiment
Randomization in usual care
Implementation
Implement as you learn

10. Chapter 2: Requirements for Learning
Engagement of care providers
“Bottom Up”
Data availability and provenance
Of critical data elements
Data science
The easy part
Ability to experiment
Randomization in usual care
Implementation
Implement as you learn

11. The VA VistA/CPRS National EHR
RDW
RDW
RDW
CDW
RDW

13. Chapter 2: Requirements for Learning
Engagement of care providers
“Bottom Up”
Data availability and provenance
Of critical data elements
Data science
The easy part
Ability to experiment
Randomization in usual care
Implementation
Implement as you learn

14. Chapter 2: Requirements for Learning
Engagement of care providers
“Bottom Up”
Data availability and provenance
Of critical data elements
Data science
The easy part
Ability to experiment
Randomization in usual care
Implementation
Implement as you learn

15. Point of Care (Embedded) Clinical Trials
Cohort
Identification
Enroll
& Consent
Randomize
Intervention
Decision Support
Data Capture
Study DB
Analysis

16. Point of Care Clinical Trial
A clinical trial with a substantial portion of its operations conducted by clinical staff in the course of providing patient/subject’s routine clinical care and where the choice of treatment is between two “equivalent” options

17. POCR Advantages
Pragmatic qualities address issues of Clinical Effectiveness
Faster (immediate) Integration of results into practice thereby lowering the T2 translation barrier
Enhanced acceptance by providers (locally selfish)
Conversion to a decision support node
Improved logistics – scalable

18. Use of EHR Application Layer

19. Chapter 2: Requirements for Learning
Engagement of care providers
“Bottom Up”
Data availability and provenance
Of critical data elements
Data science
The easy part
Ability to experiment
Randomization in usual care
Implementation
Clinicians generate knowledge and implement change in care delivery
Decision support modules

20. Chapter 3: Examples of Learning Healthcare System Activities
Weight-based versus sliding scale insulin administration
Diuretic comparison study
Phenobarbital versus benzodiazepines for alcohol withdrawal syndrome
Precision Oncology Program
Spinal Stenosis Registry and SOLID study

21. LBP with
Spinal Stenosis
Conservative Therapy
Surgery
55%
45%
Spondylolisthesis
18%
82%
No Spinal
instability
Spinal Instability
No Spondylolisthesis
Randomize
POC-CT
Decompression
with fusion
Objective 1:
Observational Study
Decompression
with fusion
Decompression alone
Re-operation
No re-operation
Re-operation
No re-operation
( %)
( %)

22. Chapter 3: Examples of Learning Healthcare System Activities
Weight-based versus sliding scale insulin administration
Diuretic comparison study
Phenobarbital versus benzodiazepines for alcohol withdrawal syndrome
Precision Oncology Program
Spinal Stenosis Registry and SOLID study
Each of these projects addresses compelling clinical issues and was proposed by clinical staff (not researchers).

23. Chapter 4: Lessons Learned
Learning activities should be supported by clinical care services (not research services)
Engaged clinicians must have a strong voice in determining the questions that are addressed (not researchers or regulators)
Answers to the questions must be meaningful to providers and patients (not regulators)
‘Patient centric’
Researchers are critical partners but not owners of the process

24. Chapter 4: Lessons Learned continued…
Experimentation (randomization) critical to validate important findings
Should be designed to minimally perturb the clinical ecosystem
Interventions studied must be proof-tested for implementation before study starts
It is hard work to move the needle for issues relating to human subjects protection:
Informed consent
Engagement in research
Patient privacy

25. Let’s start destroying those silos
Clinical
Hospital Administration
Clinical Research
Pharma

26. Avoid bedside-to-bookshelf activities

27. The Free Rider Dilemma