3. Providers
Assuming
Risk:
• Nationwide, about 120 provider-
sponsored health plans are owned by
hospitals or health systems or are in the
process of applying for a license to own
health plans
• Few provider-owned health plans
participate in exchanges
• About 15% of hospitals had PPOs, 13%
HMOs and 5% fee-for-service products
in 2011, with percentages relatively flat
over a decade, according to AHA’s latest
data
Health Plan Week August 19, 2013 Volume 23 Issue 28
There are limitations for smaller provider
organizations in taking full risk and
becoming an insurance plan, “because
you need large numbers in terms of how
capitated rates are set.”
6. PCORI Determinants of Success in
Involving Patient’s in Research
Are we producing high-quality, timely, useful,
trustworthy information?
Is the information we produce being used?
Are other (funders of) researchers following our
lead?
8. Value Information= Valued Information
• Generate valued information regarding cost-
effectiveness useful to payers and/or policy makers
• Real World Evidence Development
• Follows from clinical findings, real-world
observations
– Retrospective data studies
– Models of care
– Prospective observations
– Measures of Patient Experience(PROs)
“Value is in the eyes
of the Beholder”
11. Using Evidence to Inform
Development of Clinical Trials
• Retrospective Claims and Medical Records Database Analysis
• Analysis of treatment patterns and utilization
• Analysis of prevalence and population trends
• Burden of Illness
• Adherence and persistence assessments
• Economic and resource utilization
• Effectiveness studies and outcomes analysis
• Pharmacoepidemiology
• Prospective Research
• Patient Reported Outcomes
• Treatment patterns and resource utilization
• Quality of Life
• Productivity
12. RWE within the product lifecycle
Pre-launch Product Launch 1 yr post-launch 2+ yrs post-launch
Market
Shaping
• Burden of
Illness
• Gaps in
Care
• RCT
on-label
communication
• Establish
place in
treatment
• Analysis of
clinical trial
subpopulations
• Economic
evaluations
• Budget impact
• CE using RCT data
• PRO Measures of
Patient
Experience
RWD generation
• Adherence/
persistence
• Healthcare
Resource
Utilization
• Clinical Outcomes
• Patient
Satisfaction
13. Real World Evidence:
Efficacy vs. Effectiveness
Example-
Conditions with significant patient subjective symptom
outcome measures (OAB, IBD, migraine)
• RCT data
Extremely high placebo response rates
Difficult to show efficacy for drug compared to placebo
It is essentially all non-pharmacologic therapy compared to
non-pharmacologic therapy + drug
• Real World data
All of the behavioral, non-pharmacologic intervention
associated with the RCT moves over to the drug side of the
ledger
This becomes a comparison of activated, engaged Rx
recipients vs. those with just an Rx
16. How much could we save if
RWE replaced just a single clinical trial?
Cutting Edge Survey
Phase IIIB/IV Clinical Trials 2011
17. Capturing Stakeholder Voices
Uncovering the true needs
• In this changing landscape, they may not have a
clear idea
• Use therapeutic expertise to generate ideas
• Build on those ideas they do have
• But this might not be enough
• May need to actually work together to figure it out
• Collaborative Research
The
“We don’t have
the bandwidth ”
Challenge
18. Complexities of Defining Quality
Measurement Challenges
• Disparate data sources needed
• What data should be reported that will be
useful to stakeholders?
to achieve behavior change
for patient choice
for payer market decisions
• Criteria for Outcome Measures
Risk adjustment
Capture few unintended consequences
The Joint Commission
National Patient Safety Goals 2012
19. Quality Metrics
Benefit from a focused clinical set of proven,
evidenced-based process and outcome
measures that are most likely to drive quality
outcomes and have utility for patients
Tie to the power of payment policies
Appreciate that clinical measures not credible to
clinicians don’t get measured well, nor do they
result in quality improvement
Many measures may not even contain the
information needed to make QI changes
The Joint Commission
National Patient Safety Goals 2012
20. Evidenced Based Solutions
Measurement is not the endpoint
Need to find ways to improve on performance,
using tested proven solutions that are
sustainable because they are imbedded into
practice & are widely accepted
Bring process improvement into solutions
Solutions must be customizable to setting
Improvements must be measurable to know if
they work and at what cost
The Joint Commission
National Patient Safety Goals 2012
21. Performance Improvement Research Collaborative:
Blueprint
Phase I Phase II Phase III Phase IV
Research:
Burden of Illness
Predictive Model
Project Phases
Recruit Health Pilot
Sites
Design Change
Package
Implement
Change Package
in Pilots
Collect Data
Disseminate Best
Practices
Learned
Analyze Align Implement Spread
Partnering to deliver improved care at a reduced cost.
22. Mapping the Patient Journey
Baker GR, Schwartz F
Healthcare Quarterly, 8(3) May
2005.doi:10.12927/hcq.2005.17194
23. Patients newly initiating therapy
Index event captured by HCP Investigator
Patient then engages with Registry and provides ePRO data
throughout the course of 12 month observation period,
independent of whether they:
Remain on treatment
Switch or add on additional treatments
Change or consult with multiple providers
Naïve sites; Weighted PCP representation;
Linkage to multipayer/allpayer claims data of meaningful
scale is still lacking
The Patient Journey-
An Observational Registry
24. Phase 1
• Descriptive analysis (baseline characteristics, treatment
patterns (adherence (primary and secondary),
discontinuation, and switchers) and healthcare resource
use.
• Identify risk factors associated with treatment patterns
Phase 2
• Survey patients newly initiated on therapy who
subsequently Persist, Switch, or Discontinue
Phase 3
• Implement Quality Improvement
intervention using results from Phase II in
Health System Patient population with the
condition
Primary Nonadherence within a
‘Closed’ Healthcare System
25. Performance Improvement within a Health System with
Significant ‘excursions’ of Patient Care Outside the System
• Assess treatment approaches, Explore several measures:
Compare the number of visits during which condition was:
Appears in the problem list
Listed as a diagnosis
A drug was prescribed for the condition
Examine appropriateness of referral patterns:
PCP should try at least one drug for this condition– but only one – before
referring to a specialist
Referrals made without trying any drug or after prescribing more than one
will be classified as potentially inappropriate or suboptimal
Subgroup analysis of referrals from the Health System’s primary care
clinic network vs others
Examine the use of diagnostic testing and imaging
Examine the use and documentation of validated symptom assessment tools.
Compare presentation of treatment options to patients among those that we
can identify via the EHR
26. EMR Based Condition Specific Prompts and
HCP Clinical Decision Support
National Quality Strategy--The Future of Quality Measurement
ONC, AHRQ, CMS Presentation. September 14, 2012
27. EMR Based Condition Specific Prompts and
HCP Clinical Decision Support
• Clinical Decision Support (CDS)
Detect potential safety and quality problems and help prevent them
Detect inappropriate utilization of services, medications, and
supplies
Foster the greater use of evidence-based medicine principles and
guidelines
Organize, optimize and help operationalize the details of a plan of
care
Help gather and present data needed to execute this plan
Ensure that the best clinical knowledge and recommendations are
utilized to improve health management decisions by clinicians and
patients
Osheroff JA, Pifer EA, Teich JM, et al.
Improving Outcomes with Clinical Decision Support: An Implementers' Guide
Chicago: HIMSS; 2005.
28. What Does Good Look Like?
Toward Continued Excellence
• More patient-centered care
• More predictable outcomes
• Low tolerance for unwarranted deviations
from the norm
• Collective Mindfulness
• Greater efficiencies, less waste
• More appropriate/evidence based care
that meets shared expectations
• Evolving “Learning” Systems
The Joint Commission
National Patient Safety Goals 2012
Notes de l'éditeur
The first issue was the fundamental definition of the inception point. The inception point in a randomized trial is the time at which you begin the enrollment of the patient into the study and the clock starts, and you are counting endpoints. Here the issue is do we make the study really broad so that it would be applicable to your average emergency department with all of the vagaries and uncertainties there, or do we really focus in on a very narrow population, trying to select just the people who we are relatively confident would have a benefit.