Pediatric Patient Safety Symposium
Hospital for Sick Children – Toronto
June 13th, 2013
When the Going Gets Tough, the Tough
Get Data: SCAMPs
James E. Lock, MD
Department of Cardiology
Boston Children’s Hospital
Harvard Medical School
Supported by Hinden Foundation, Boston Children’s Heart Foundation,
Boston Children’s Program for Patient Safety and Quality, and the major insurers of Massachusetts
Declaration of Disclosure
Boston Children’s Hospital is a member of the not-forprofit entity Institute for Relevant Clinical Data Analytics.
The Institute has created a multi-institutional network to
create and develop standardized clinical assessment
and management plans (SCAMPs) around the country,
and plans to license SCAMPs and related technology
and services. It is possible that, in the future, Boston
Children’s Hospital and SCAMP authors will receive
royalties from SCAMPs.
James E. Lock, MD.
Learning Objectives
1. To understand the novel components
behind the SCAMP process
2. To understand how the iterative SCAMP
process can lead to improved clinical
outcomes while identifying unnecessary
resource utilization
3. To show how SCAMPs are similar and,
more importantly, different than
retrospective studies, clinical practice
guidelines and prospective trials
Why is this Important?
• The increase in medical expenditures seems to
be outstripping both the health benefits and the
nation’s financial underpinning to pay
22%
$2
00
21%
Gross Dom estic Product
5,0
00
Health Care in 2018:
• $4.4 Trillion in spending
• >20% of the GDP
$1
0,0
00
Cost (in billions)
$1
20%
19%
18%
$5
17%
,00
0
16%
$0
Percentage of GDP spent on Health Care
0,0
National Health Care Spending
15%
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
Data from the Centers for Medicare and Medicaid Services
Why is this Important Now?
•
What are the options for reducing
medical expenditures?
1. Reduce salaries
2. Improve efficiency for necessary care
3. Reduce unnecessary utilization
4. Ration health care
What do we currently use in clinical medicine to
standardize and improve care?
1. Best clinical judgment
2. Clinical Practice Guidelines: a care plan
created by experts, intended to be followed
until further notice
3. Registries or Retrospective Studies: careful
look backwards
4. Prospective Randomized Controlled Trials:
Meant to provide a definitive and final answer
Current Practice
• 10 Cardiologists (7 different fields) were shadowed with every
significant clinical decision recorded and classified
Results – All Decisions
(n = 1188, ~170 decisions/person/day)
# Decisions
% of Total
•
Experience or anecdote
441
37.1%
•
Arbitrary or instinct
175
14.7%
•
Trained to do it
173
14.6%
•
First principles
146
12.3%
•
General research study
146
12.3%
•
Limited research study
61
5.1%
•
Specific research study
34
2.9%
•
Parental preference
6
0.5%
•
For research
4
0.3%
•
Avoid a lawsuit
2
0.2%
•
Despite the “limited” nature of decision-making in pediatric cardiology, over
18 years, death from 4 “common” defects fell 2.5 fold
Deficiencies of Clinical Practice Guidelines
• Mandated CPGs that have been shown to be
“wrong” by subsequent data1
– Tight control of glucose in ICU
– Normal glucose levels in outpatients
– Recommendations for hip & knee replacements
– Best practices in treatment of congestive heart failure
– Statins in renal failure patients on dialysis
– Outpatient treatment of asthma and hypertension
– Antibiotics within 4 hours of ER visit for pneumonia
• Adherence to a pediatric asthma CPG was
The New York Review, January 2010
between 39% and 53%2 Groopman,
Cabana, Arch Pediatr Adolesc Med, Sept 2001
1
2
Conflicts of Interest for Guideline Authors
Research
Overall
Grants Non-industry Speaker Expert OwnershipConsultant
research
/ Advisory
(industry)
Honoraria Witness Interest
support
Board
Percent with
disclosures
82.4%
55.9%
29.4%
20.6%
5.9%
5.9%
50%
Percent with
significant
financial
relationship
17.6%
14.7%
5.9%
2.9%
0%
2.9%
8.8%
Percent with
no financial
benefit, or
benefit is not
industry
related
17.6%
44.1%
100%
79.4%
79.4%
94.1%
50%
This table shows the percentages and breakdown of financial relationships for
guideline committee members who participated in writing ACCF/AHA clinical
guidelines in 2010
Source: CardioSource WorldNews
Randomized Controlled Trials
Superior Intervention
Outcome 1
Management
1
Standardized
Entry Criteria,
Assessment,
& Management
(Preferred
outcome)
Management
2
Outcome 2
?
?
?
RCT’s only provide answer
for a few patients and for only
1 or 2 outcomes during a
short time period. Even then
are they correct?
?
Outcome 3
(Not measured)
Unnecessary
? Resource
Utilization
Generalization
of Results?
Duration of RCT “Validity”
, usually new RCTs
What About the
Gold Standard?
of RCTs
Summary of the Status Quo
• We make most medical decisions based on instinct,
anecdotes, first principles, or training
• Current tools are demonstrably inadequate to handle the
fact that medicine is changing constantly
Shojania et al. Ann Internal Med 2007
Standardized Clinical Assessment and Management
Plans: SCAMPs
First Principles for SCAMPs:
1. There is no such thing as “best” practice…
only sound practice that is constantly changing.
2. Very few decisions are informed by
conclusive data…
which are hard to acquire and often incorrect.
Changes should be made on persuasive data.
3. Data collection should be targeted based on prior
probabilities…
but not so narrowly that important, unplanned
consequences are missed.
4. Diversions are permitted…
but the reasons must be recorded.
These diversions will accelerate improvement.
Unlike a CPG, a SCAMP is a care plan created by clinicians intended
to continuously improve and promote innovation
SCAMPs
Knowledge or
Innovation
Based
Diversion
“Evidence”
Based Standard
Assessment &
Management
Predicted
Outcome
Unexpected
Outcome
Data analysis and
frequent (q 6 month)
literature review
allows for SCAMP
modification and
improvement
Unnecessary
Resource
Utilization
Selected
Information
Captured In
All Categories
SCAMPs History
• 2006: Effort begun to establish CPGs for outpatient
assessment and management of several conditions
• 2007: Realization that nearly all recommendations for
the CPG would be arbitrary or anecdotal
• 2008: Recognition that SCAMP-like activities have
been very successful in past improvements in care,
creation, and modification of SCAMP prototypes
• 2009: Finalization of the SCAMP approach, creation
of 7 SCAMPs, development of data collection tools, at
Boston Children’s Hospital. First patient enrolled in
March 2009
• 2010: First analysis of SCAMP data with subsequent
SCAMP improvement
• 2011: Spread of SCAMPs to multiple sites, including
BWH
SCAMPs and Research
• The care plan is carefully crafted to be within the boundaries of
"standard of care" and only data relevant to clinical care are
captured
• Analysis conducted with the intent of informing, improving, and
streamlining the health care delivery process and therefore
qualifies as quality improvement
• Retrospective data analysis with the intent of producing
generalizable knowledge comprises human subject research
and therefore requires IRB approval when undertaken
Adult Acute Kidney Injury SCAMP Algorithm
Pediatric SCAMPs in Current Use
Total number of pediatric SCAMPs: 43
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Airway Disorders
Aortic Regurgitation
Aortic Stenosis
AS for Cath Lab
Arterial Switch Operation
Aspiration Pneumonia
Blood Ordering/Cell Salvage
Chest Pain
Coarctation
Cognitive and Headache Management
Critical Asthma
Cytomegalovirus Prevention
Dilated Aorta
Distal Radius Fracture
ECMO Anticoagulation
Fever of Unknown Origin
Food Challenge
Hypertrophic Cardiomyopathy
Hyperparathyroidism
Immune Thrombocytopenia
Interstage Single Ventricle
Lipid Management
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Lipid PCP
Lymphatic Malformations
MS/AA
Myocarditis
Neonatal PDA
Nutrition
Operative Management of TOF/PS
Orthodontic Retention
Papilledema
PICC Line Placement
Polycystic Ovarian Syndrome
PPHN
Pressure Ulcer
Sedated Echo
Sedation and Analgesia for Ventilated Pts
Skin Abscess
Small PDA
Somatoform disorders
Syncope
Ureterocele
Wolff–Parkinson–White syndrome
Adult SCAMPs in Current Use
• Total number of adult SCAMPs: 6
• Examples include:
– Distal radius fracture
– Acute kidney injury
– Breast reconstruction post mastectomy
– Inpatient management of low probability of
acute coronary syndrome
– Lumbar spine fusion
– Discharge management of CHF
exacerbations
Total Patient Encounters at Boston Children’s
Total of 30,922 encounters
(on 11,732 patients)
as of 5/1/2013
The First SCAMP (March 2009)
Transposition of the great arteries after
an arterial switch operation (ASO)
• Background
– ASO is now the preferred operation for
TGA. Remaining issues include lung and
coronary obstruction, a large aorta, and
weakened heart muscle. Sound
assessment and management is unclear.
• Plausible Findings make us collect
relevant data on those 4 areas of
concern
SCAMP Analytics and Actions: ASO
 First review (n=86)
– O2 saturations were invariably normal  Eliminated
– Cardiac MRI at 12 years (n=15) yielded no new relevant clinical data
 Continuing to follow
– Poor compliance with 6 year lipid assessment  Continuing to follow
 Second review (n=173)
– Cardiac MRI at 12 years (n=34) yielded no new relevant clinical data
 Use MRI for high risk patients only
– Continued poor compliance with 6 year lipid assessment  Eliminate
– Sedated echo at 2 years (n=20) unhelpful  Eliminate
 Third review (n=227)
– No new significant cardiac findings after 6 years of age  Reduce
surveillance testing by 50%
How often are SCAMPs followed?
Chest Pain SCAMP Compliance with Testing
CHB
NECCA*
Total
ECG Recommended
357/357 (100%)
99/99 (100%)
456/456 (100%)
Echo Recommended
138/177 (78%)
34/41 (83%)
171/218 (78%)
Echo Not Recommended
161/180 (89%)
44/58 (76%)
205/238 (86%)
0/1 (0%)
0/0
0/1 (0%)
CXR Not Recommended
338/356 (95%)
89/99 (90%)
427/455 (94%)
Total Compliance
93%
90%
92%
Testing Modality
CXR Recommended
includes Mass General Hospital, Connecticut Children’s, Baystate,
Vermont Children's, Dartmouth, Harvard Vanguard, University of
Massachusetts, Maine Medical Center and CHA (Worcester)
*NECCA
SCAMP Diversion Analysis
% of All Diversions
Diversion Analysis for the HCM, AS, and ASO SCAMPs
What is a “Justifiable” Diversion?
Example: A 1 year old presents to clinic with a PDA that is too
small (diameter 1.8 mm, normal LV size) to recommend
cath lab closure according to the PDA SCAMP. Patient is
nonetheless referred to the cath lab for closure.
I.
Reasons for diversion:
- Abnormal Q wave in V6 suggests significant LV volume
load
- LV and LA look considerably larger than RV and RA on
echo.
II.
Findings at Cath:
- Moderate (3 mm) PDA with significant shunt.
II.
Changes to the SCAMP:
- Consider new plausible finding: LV/RV volume ratio is a
better of predictor of PDA size than absolute LV size
SCAMPs and Comorbidities
• Aortic Stenosis and Aortic Regurgitation
SCAMPs recommend no exercise restrictions
• Largest diversion category for both AS and AR
were providers restricting exercise (no
weightlifting). Almost all cases were due to comorbidity of dilated aorta.
• Important and unidentified management issues
related to co-morbidities are recognized
through diversion analysis and are included in
revised version of SCAMPs
SCAMPs Provider Experience Survey
2010 Results
2011 Results
60%
How positive
or negative is
your opinion
of SCAMPs?
60%
48%
50%
50%
41%
40%
27%
30%
30%
20%
15%
20%
10%
13%
10%
10%
0%
6%
2%
0%
Very
Negative
Negative
Neutral
Positive
Very
Positive
0%
Very
Negative
2010 Results
Which
evidencebased method
do you prefer?
37%
40%
80%
70%
60%
46%
50%
40%
30%
30%
20%
11%
13%
10%
0%
0%
CPG
Care Pathway
Clinical
Protocol
SCAMP
Other
Negative
Neutral
Positive
Very
Positive
Patient Experience Survey (Nov 2011)
Claims data from a Massachusetts Insurance Company
Baseline
Evaluation
N
F/U Time (mo)
N
F/U Time (mo)
Δ Standardized
Billed Medical
Charges *
AR
8
69.85
5
37.01
-50%
AS
6
46.74
5
32.26
11%
ASO
21
133.92
14
94.03
-25%
DA
24
173.68
24
152.3
-63%
HCM
14
80.09
23
134.66
-28%
* Per member per month
Chest Pain SCAMP: Reducing Utilization
• An echo is “indicated” only with chest pain on exercise
% of patients with exertional
CP who did not have an echo
% of patients with CP exclusively
at rest who had an echo
50%
50%
40%
40%
33%
30%
30%
20%
17%
29%
20%
14%
10%
10%
0%
0%
His toric al C ontrol (n= 406)
S C A MP P atients (n= 457)
Historical Control (n=406)
SCAMP Patients (n=457)
• Mean patient actual care charges pre-SCAMP = $2,506/pt
• Mean patient actual care charges with SCAMP = $2,068/pt
• Chest Pain SCAMP has lead to ~20% reduction in actual
patient care charges
Catch Lab Aortic Valvuloplasty SCAMP: Improving
Outcomes
Ideal (AS <35 mm Hg, 0 – trace AR)
Adequate (AS <35 mm Hg, mild AR)
Inadequate (AS ≥ 35 mm Hg or ≥
moderate AR)
Freedom from AVR at 10 years:
- Ideal:
~95%
- Adequate:
~80%
- Inadequate:
~65%
Brown et al, JACC 2011.
Catch Lab Aortic Valvuloplasty SCAMP: Improving
Outcomes
Ideal = AS <35 mm Hg, 0 – trace AR
Adequate = AS <35 mm Hg, mild AR)
Inadequate = AS ≥ 35 mm Hg or ≥
moderate AR)
SCAMP Benefits (to whom)
• Cardiology example
– 6 SCAMPs have saved $726,000 in avoided
testing costs
– Testing costs were estimated
• 6 Cardiology SCAMPs
– Direct costs savings of $510,000
• Return on investment if 42%
SCAMPs Benefits for Payor
• 2 SCAMPs with actual single payor cost data
– ASO SCAMP: 37% reduction (vs 11% projected)
– Hypertrophic cardiomyopathy SCAMP: 29%
reduction (vs 20% projected)
• Payor savings on these 2 SCAMPs: $149,000
(not statistically robust)
• Assume this payor has a 20% market share,
then BCH saves payors $745,000 on two
SCAMPs
– Are there savings from factors other than testings?
• Return on investment if 338% (this is a major
effect!)
Pediatric SCAMPs Network
• Boston Children’s Hospital
• New England Congenital Cardiology Association (NECCA)
– Harvard Vanguard
– Hasbro Children’s
– Baystate Medical Center
– University of Mass
– Connecticut Children’s MC
– Mass General Hospital
– Vermont Children’s Hospital
– Maine Medical Center
– Dartmouth Hitchcock
– CHA (Worcester, MA)
• Children’s Hospital of Wisconsin
• Children’s National Medical Center (Washington, DC)
• University of California San Francisco
• Stanford
• Pediatric Endocrine Society
• Hospital for Sick Kids (Toronto, Canada)
• Great Ormond Street (London, United Kingdom)
Adult SCAMPs Network
• Brigham Women’s Hospital
• Lancaster General Hospital
How Will SCAMPS Become an Ongoing, Integral Part
of Medical Care?
1. Institute for Relevant Clinical Data Analytics
established as 501c3 non-profit in 2010
2. Formal Members: Boston Children’s
Hospital, Brigham and Women’s Hospital,
Children’s Hospital of Wisconsin, Children’s
National Medical Center (Washington D.C.),
Lancaster General Hospital, Pediatric
Endocrine Society, NECCA, Toronto Sick
Kids
3. Institutions reviewing contract: Stanford,
Sydney Children’s Hospital (Australia)
How Will SCAMPS Become an Ongoing, Integral Part
of Medical Care?
4. Products:
a. SCAMP content itself
b. Consulting services to help others write and
implement SCAMPs
c. Data generated from SCAMP and modifications
based on that data
d. Software programs
e. Data related to but not directly derived from
SCAMPs (i.e., diversion analyses)
f. Use of SCAMPs for MOC credit
Current Finances of SCAMPs
Impact on Benefit
Creators (Provider
Institutions / Doctors)
1.
2.
3.
1.
Reduced revenue from
reduced unnecessary
2.
care
Increased costs to
$$$
collect and analyze
data to further reduce
unnecessary care
3.
Decreased margin,
because unnecessary
care is the most
profitable care
Impact on Benefit
Recipients
Payers
Patients
– Better care
– Reduced co-pays
– Less time waiting for
unnecessary care
Employers
– Healthier workers
– Reduced premiums
Conclusions and Next Steps
• SCAMPs have successfully and repeatedly, in a
variety of conditions and locations:
– Reduced practice variation
– Iteratively optimized care
– Reduced unnecessary utilization
• SCAMPs build on key principles well-known to
clinicians, permit diversions, and use data to improve
care delivery
• SCAMPs create natural networks to rapidly and
collaboratively improve care delivery
• Expansion of SCAMPs IT support and network is
rapid and inevitable, but will require careful planning