6/28/2006
Alternative Methods for
PracticePractice-Based Evidence
Outline of Presentation
Harnessing Natural Variation for
• Brief description of PBEPBE-CPI, a practicepractice-based
evidence approach, and how it differs from
Effectiveness Research
PracticePractice-Based Evidence for Clinical Practice Improvement
other study methodologies
• PBEPBE- CPI examples showing breadth of
by
Susan D. Horn, Ph.D
findings from comprehensive data sets
Institute for Clinical Outcomes Research
699 East South Temple, Suite 100
Salt Lake City, Utah 84102
801801-466466-5595 (V) 801801-466466-6685 (F)
shorn@isisicor.com
www.isisicor.com
• Application to pressure ulcer prevention in LTC
1
PracticePractice-Based Evidence for
Clinical Practice Improvement Study Design
2
PracticePractice-Based Evidence for
Clinical Practice Improvement Study Design
Improve/Standardize:
Analyzes the content and timing of individual
Process Factors
•Management Strategies
•Interventions
•Medications
steps of a health care process, in order to
determine how to achieve:
Control for:
• superior medical outcomes for the
Patient Factors
•Psychosocial/demographic Factors
•Disease(s)
•Severity of Disease(s)
• least necessary cost over the
Measure:
Outcomes
•Clinical
•Health Status
•Cost/LOS/Encounters
› physiologic signs and symptoms
• continuum of a patient’
patient’s care
•Multiple Points in Time
3
4
PracticePractice-Based Evidence for
Clinical Practice Improvement Study Design
Outcomes Research
• PBEPBE-CPI goes beyond outcomes research by
Uses large administrative databases to
evaluate effectiveness of
- identifying outcomes
• specific treatment methodologies
- examining detailed process steps
• medical technologies
- adjusting for severity of illness
• providers
5
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PracticePractice-Based Evidence for
Clinical Practice Improvement Study Design
Example from Stroke Guideline
• PBEPBE-CPI goes beyond guidelines, which
often are
- not decidable:
decidable: give a vague description of
patients
- not executable:
executable: give a menu of process
steps to follow
- not connected to outcomes
Stroke patients with diagnosed depression
should be offered a course of treatment with
antidepressant drug therapy.
7
8
PracticePractice-based Evidence for Clinical Practice Improvement
PracticePractice-based Evidence for Clinical Practice Improvement
(PBE(PBE-CPI) compared to
Randomized Controlled Trial (RCT)
(PBE(PBE-CPI) compared to
Randomized Controlled Trial (RCT)
PBEPBE-CPI
I. Select Key Conditions
to Study
PBEPBE-CPI
RCT
I. Define Study
RCT
II. Data Collection
II. Data Collection
A. Patient Variables
- Patient eligibility and
A. Patient Variables
- Patient eligibility and
stratification factors
- Use severity of illness to
measure:
- comorbidities
- disease severity
- All patients qualify
stratification factors
- Eliminate patients who could
bias results:
- comorbidities
- more serious disease
~ 15% of patients qualify
9
10
PracticePractice-based Evidence for Clinical Practice Improvement
PracticePractice-based Evidence for Clinical Practice Improvement
(PBE(PBE-CPI) compared to
Randomized Controlled Trial (RCT)
(PBE(PBE-CPI) compared to
Randomized Controlled Trial (RCT)
PBEPBE-CPI
RCT
II. Data Collection
II. Data Collection
B. Process Variables
B. Process Variables
- Treatment Protocol
- Methods for Stabilization
- Measure all processes and use
analysis findings to develop
protocol associated with better
outcomes
PBEPBE-CPI
III. Data Analysis
Outcome Variables
- Specify explicitly every
important element of the
process of care for both
treatment and control
arms
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AcademyHealth CPI Workshop June
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- Dynamic improvement
based on fact
IV. Result
-
Effectiveness research
RCT
III. Data Analysis
Outcome Variables
- Change based on fact
IV. Result
- Efficacy research
12
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PracticePractice-based Evidence for Clinical Practice Improvement
PracticePractice-based Evidence for Clinical Practice Improvement
(PBE(PBE-CPI)
(PBE(PBE-CPI)
• Led by transtrans-disciplinary team that
• PBEPBE-CPI is a comprehensive analysis of
¾Develops and frames questions
patient, process, and outcome variables
¾Gathers data
¾Interprets findings
• PBEPBE-CPI studies are based on everyday
¾Implements findings
• Results in more generalizable and transportable
clinical practice, not controlled
circumstances.
findings
13
14
PBE-CPI vs. RCT
PBE-CPI vs. RCT
• RCTs are considered to be evidence of the
highest grade.
Results from 2 NEJM studies
• Observational (CPI) studies are viewed as
having less validity because they
reportedly overover-estimate treatment
effects.*
“Average results of the observational
studies were remarkably similar to those of
the randomized, controlled trials.”
trials.”
* New England Journal of Medicine 2000; (June 22, 2000)
2000) 342:1878342:1878-92.
* New England Journal of Medicine 2000; (June 22, 2000) 342:1887342:1887-92.
15
16
PBE-CPI vs. RCT
PBE-CPI vs. RCT
Results from JAMA Study
Conclusions
Comparing results on 45 topics with binary
outcomes, found "very good correlation …between
summary odds ratios of randomized and nonnonrandomized studies"
r = 0.75, p < .001 for all studies,
r = 0.83, p < .001 for prospective studies.
JAMA (Aug 2001) 286;7:821286;7:821-830
* New England Journal of Medicine 2000; (June 22, 2000) 342:1887342:1887-92.
17
AcademyHealth CPI Workshop June
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WellWell-designed observational studies do not
systematically overover-estimate the magnitude
of the effects of treatment as compared
with those in randomized, controlled trials
on the same topic.*
18
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PBE-CPI and RCT
Assigned vs. Assumed Causality
• Assigned causality:
causality: RCT
•
– Known confounders are eliminated
Assumed causality:
causality: PBEPBE-CPI
– No added confounders cause the significant
association to disappear
– A change in outcomes follows a change in
treatment as predicted by the PBEPBE-CPI model
– Repeated studies on the same topic yield the
same findings
RCT
Progenitor of
RCTs
Practice effects
of RCT results
PBEPBE-CPI
19
Experimental Designs
20
PBE-CPI
RCT
•Hypothesis many and vague
•Hypothesis clear
feasible to evaluate complex
•Alternatives not discrete
•Alternatives discrete
interventions in the real world.
•Local knowledge
contributes
•Not depend on local
knowledge
Experimental designs are rarely
21
PBE-CPI
PBE-CPI offers opportunities to
RCT
•Confounders affect
outcomes and are
interesting
•Confounders not
interesting
•Effects large
•Effects small
22
• Focus on clinical reality
• Discover best practices
• Test clinical questions and intermediate
outcomes
• Gain some control over variable patient,
process, and outcome data
Dr. Don Berwick, HSR, April 2005
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24
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Criteria for Selection
of a Severity Indexing System
PracticePractice-based Evidence for Clinical Practice Improvement
(PBE(PBE-CPI)
• Connects outcomes with detailed process
steps
• Adjusts for severity of illness
•
DiseaseDisease-specific
•
Independent of treatments
•
Comprehensive (i.e., all diseases)
•
Clinically credible
•
Able to measure severity at multiple points in the
care process
•
Statistically valid in explaining costs/outcomes
25
Comprehensive Severity Index
(CSI®)
Comprehensive Severity Index CSI®
Severity Systems
Diagnostic/Procedure Based
Systems
Physiologic/Clinically Based
Systems
•AIM by Iameter
•Apache
•Disease Staging by MedStat
•Atlas by Mediqual
26
•APR DRGs by 3m
•Patient Management
Categories
CSI®
z
Over 2,200 individual criteria subdivided into more than
5,500 diseasedisease-specific groups
z
No treatments used as criteria
z
Computes diseasedisease-specific and overall severity levels on a
scale of 00-4 and continuous
z
Fixed times for inpatient reviews
- Admission review-first 24 hours
review--first
- Maximum review-any time during stay
review--any
- Discharge review-last 24 hours
review--last
27
28
How Does PBE-CPI Differ?
Pneumonia Criteria Set
480.0480.0-486; 506.3; 507.0507.0-507.1; 516.8; 517.1; 518.3; 518.5; 668.00668.00-668.04; 997.3; 112.4; 136.3; 055.1
1
2
3
C a rd io v a s c u la r
C ATEG OR Y
• p u ls e ra t e 5 1 -1 0 0 ; S T
s e g m e n t c h a n g e s -E K G ;
s y s t o lic B P ≥ 9 0 m m H g
• p u ls e r a t e 1 0 0 -1 2 9 ;
4 1 -5 0 ; P A C s , P A T ,
P V C s -E K G ;
s y s t o lic B P 8 0 - 8 9 m m H g
• p u ls e r a t e ≥ 1 3 0 ; 3 1 -4 0 ;
s y s t o lic B P 6 1 - 7 9 m m H g
• p u ls e r a te ≤ 3 0 ;
a s y s to le , V T , V F ,
V flu tte r ;
s y s to lic B P ≤ 6 0 m m H g
F ever
• 9 6 .8 -1 0 0 .4 a n d /o r c h ills
• 1 0 0 .5 -1 0 2 .0 o r a l;
9 4 .0 -9 6 .7
• 1 0 2 .1 -1 0 3 .9 ; 9 0 .1 - 9 3 .9
a n d /o r r ig o r s
• ≥ 1 0 4 .0
≤ 9 0 .0
Labs
ABGs
• p H 7 .3 5 - 7 .4 5
• p H > 7 .4 6 7 .2 5 -7 .3 4
• p H 7 .1 0 - 7 .2 4
• p H ≤ 7 .0 9 ;
H e m a to lo g y
• p O 2 5 1 -6 0 m m H g
•pO 2 ≤ 50m m Hg
• W B C 1 1 .1 -2 0 .0 K / c u m m ;
2 .4 -4 .4 K /c u m m ;
b a n d s 1 0 -2 0 %
• W B C 2 0 .1 -3 0 .0 K / c u m m ;
1 .0 -2 .3 K /c u m m ;
b a n d s 2 1 -4 0 %
• W B C ≥ 3 0 .1 K /c u m m ;
< 1 .0 K /c u m m ;
ba nds > 4 0%
• c h r o n ic c o n fu s io n
•p O 2 ≥61m m Hg
• W B C 4 .5 - 1 1 .0 K / c u m m ;
ban ds < 10% ;
4
• a c u te c o n fu s io n
• u n re s p o n s iv e
• 9 -1 1
• 6 -8
• ≤5
R a d io lo g y C h e s t
X -R a y o r C T
Scan
• in f ilt r a t e a n d /o r
c o n s o lid a t io n in ≤ 1
lo b e ; p le u r a l e f fu s io n
• in f iltr a te a n d /o r
c o n s o lid a t io n in > 1 b u t
≤ 3 lo b e s ;
• in filt r a t e a n d /o r
c o n s o lid a t io n in > 3
lo b e s ; c a v ita tio n o r
lu n g n e c ro s is
R e s p ira t o ry
• d y s p n e a o n e x e r t io n ;
s t r id o r ; r a le s ≤ 5 0 % /< 3
lo b e s ; d e c r e a s e d b re a th
s o u n d s ≤ 5 0 % /< 3 lo b e s ;
p o s it iv e fo r fr e m it u s ;
s t r id o r
• h e m o p ty s is N O S ;
b lo o d tin g e d o r p u r u le n t
o r fr o th y s p u tu m
• c y a n o s is p r e s e n t
• d y s p n e a a t r e s t ; r a le s
> 5 0 % / ≥ 3 lo b e s ;
d e c re a s e d b r e a th
s o u n d s > 5 0 % / ≥ 3 lo b e s
•ap nea
a b s e n t b re a th s o u n d s
> 5 0 % / ≥ 3 lo b e s
N e u ro S t a t u s
L o w e s t G la s g o w
c o m a s c o re
• ≥ 12
• w h ite , th in , m u c o id
sp u tu m
©
• Severity adjustment methodology
• ThreeThree-dimensional, comprehensive
measurement framework: patient, process, and
outcomes
• Balance of rigorous science with a pragmatic
operational focus
• f ra n k h e m o p ty s is
29
30
Copyright 1998. Susan D. Horn. All rights reserved. Do not quote, copy or cite without permission.
AcademyHealth CPI Workshop June
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6/28/2006
Nursing Home Study (NPULS)
1996-1997
NPULS Outcomes
• 6 longlong-term care provider organizations
• Developed pressure ulcers
• Healed pressure ulcers
• Hospitalization
• 109 facilities
• 2,490 residents studied
• 1,343 residents with pressure ulcer; 1,147 at risk
• 70% female, 30% male
• Systemic infections
• Average age = 79.8 years
Funded by Ross Products Division, Abbott Laboratories31
32
Bladder Incontinence Management
in Long Term Care
Effects of Nutritional Support
in Long Term Care
Treatments
Nutritional
Treatment Strategies
Oral Supplement / Standard Medical
Nutritional
Enteral Formula
N
Pressure
Ulcer
Develop Rate
134
21.6%
210
23.8%
Fluid Order
396
25.0%
Snacks, House Shakes
No Nutritional Risk -No Nutritional Treatment
At Nutritional Risk -No Nutritional Support
403
27.3%
195
27.2%
323
35.6%
34.2%
23.6%
23.9%
26.3%
29.1%
29.5%
32.1%
51.3%
26.3%
34
Medications from NPULS Study
Optimal Medications
Dementia & Agitation n = 803
• Use fewest number of medications possible
(OBRA 1987)
No Psych Meds
AntiAnti-psychotics
AntiAnti-depressants
AntiAnti-anxiety
• Minimize use of benzodiazepines
• Use atypical over typical antipsychotics
• Use SSRIs over tertiary amine antidepressants
AcademyHealth CPI Workshop June
27,2006
PU Develop Rate
33
LongLong-Term Care Residents with Agitation in Dementia
Recommended Practice
• Avoid combination therapy
N
Incontinent-Use one or more of following treatments: 1,441
Briefs, disposable
501
Toileting program
549
Briefs, reusable
118
Topical Treatment
1,159
Bed pads, disposable
193
Bed pads, reusable
221
Use of catheter
195
Continent-No incontinence treatment
209
35
32.5%
31.5%
34.6%
34.9%
Combinations in 42% of treated residents
36
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6/28/2006
Long Term Care CPI Results
Medication Use and Outcomes for Elderly
with Dementia with Agitation
Medication
Outcome: Develop Pressure Ulcer
% Hospital +
ER
% Restraints
% Pressure
Ulcers
No Psych Medications
20.0
19.9
37.2
Monotherapy
17.2
24.0
24.0**
General
Assessment
+ Age ≥ 85
9.9**
12.3*
12.6**
Monotherapy includes antipsychotic only, antidepressant only, or antianxiety only
SSRI + antipsychotic medications concurrently.
*p<
*p<.05 **p<
**p<.01
Horn, Drug Benefit Trends 2003; 15 (Supplement 1, December): 1212-18
Interventions
+Static pressure
reduction: protective
device
+ History of PU
- Disposable briefs
+ Dependency in
>= 7 ADLs
- Toileting Program
+Positioning: protective
device
+ Severity of Illness
Staffing
Interventions
Pressure Relief
+ Mechanical devices for
the containment of urine
(catheters)
+ Male
SSRI + Antipsychotic
Incontinence
Interventions
- RN hours per resident
day >=0 .25
- CNA hours per resident
day >= 2
-LPN hours per resident
day >=0.75
+ Diabetes
Medications
+ History of tobacco use
- SSRI + Antipsychotic
37
38
Long Term Care CPI Results
AHRQ Partnership for Quality
Outcome: Develop Pressure Ulcer
RealReal-time Optimal Care Plans for Nursing Home QI
¾Integrate sustainable quality improvement into daily operations
Nutritional
Assessment
Nutritional
Interventions
+ Dehydration signs and
symptoms: low systolic blood
• Incorporate practicepractice-based evidence for pressure ulcer prevention
• Integrate into daily work versus ‘addadd-on’
on’ project
¾Focus on critical data elements and information flow
- Fluid Order
•
•
•
•
- Nutritional Supplements
pressure, high temperature,
• standard medical
dysphagia,
dysphagia, high BUN, diarrhea,
dehydration
- Enteral Supplements
+ Weight Loss: >=5% in last 30
days or >=10% in last 180 days
• diseasedisease-specific
• high calorie/high
protein
Eliminate redundant documentation
Reduce paperwork and streamline documentation
Improve accuracy of information
Improve communication among transtrans-disciplinary care teams
¾ Translate documentation into data & data into transtrans-disciplinary
clinical reports
Horn et al, J. Amer Geriatr Soc March 2004
39
40
41
42
Results
™ Decrease Pressure Ulcer Development on average 33%
™ Increase Adherence to Best Practices
™ Increase Staff Accountability and Satisfaction
–
–
–
Inclusion of frontfront-line workers in QI efforts
Comprehensive documentation at point of care more complete
Communication among care team improved
™ Reduce Inefficiencies
–
–
–
–
# documentation forms for CNAs decreased 50% or more
CNA time looking for documentation book decreased
Time to compile reports for State Regulators and MDS decreased
Time for Wound RN to summarize and report data decreased
™ Improve State Survey Process
™ Establish a foundation for EMR
AcademyHealth CPI Workshop June
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Value of Nurses
DEVELOP PRESSURE ULCER by RN Time
Logistic Regression: DEVELOP PU-PU-- RN/LPN/CNA Time and Other Effects
40%
35%
Parameter
38.1%
% Pressure Ulcers
30%
31.8%
25%
25.1%
20%
15%
10%
9.4%
5%
0%
<10 min
10 - <20 min
20 - <30 min
30 - <40 min
RN Time Per Resident Per Day
ChiChi-Square
Pr > ChiSq
ADLs_78
CSI Severity
MDS PU_hx
PU_hx
Wt loss
Oral_eat prob
Catheter
Entcalpr
Ent_
Ent_dis
Fluid order
Estimate
0.28
0.01
0.75
0.34
0.39
0.78
-0.55
-0.98
-0.43
4.68
18.19
15.00
6.04
9.33
16.98
6.77
6.00
8.43
0.0305
<.0001
0.0001
0.0140
0.0023
<.0001
0.0093
0.0143
0.0037
RN 1010-20m
RN 2020-30m
RN 3030-40m
CNA >2.25h
LPN >=45m
-0.41
-0.62
-1.86
-0.64
-0.64
7.84
13.12
42.82
5.76
8.74
0.0051
0.0003
<.0001
0.0164
0.0031
C = 0.727
ChiChi-Square (6 df) = 50.86, p<.0001, n=1,376
43
% Hospitalization
HOSPITALIZATION by RN Time
20%
18%
16%
14%
12%
10%
8%
6%
4%
2%
0%
44
Effects of RN Time
Horn SD, et el. Assoc. between registered nurse staffing time and
and outcomes of longlong-stay nursing home
residents. Amer J Nursing (Nov 2005 to appear)
RN time of 3030-40 min/resident/day
18.4%
is associated with
•
•
•
•
11.1%
9.6%
6.1%
<10 min
10 - <20 min
20 - <30 min
30 - <40 min
RN Time Per Resident Per Day
Fewer UTIs
Fewer catheterizations
Less weight loss
Less decline in ADLs
• More nutrition supplements
ChiChi-Square (4 df) = 35.17, p<.0001, n=1,376
45
Societal Perspective
Economic Value of Nurses
46
PostPost-Stroke Rehabilitation Study
Dorr DA, Horn SD, Smout RJ. Cost analysis of nursing home registered nurse staffing times. J American Geriatrics Society 2005; 53:65653:656-661
Cost/Benefit Analysis of More RN Time
$ Per 100 atat-risk residents per year (FY2001 dollars)
Savings in avoided PU treatment cost
Cost of additional 30 min
RN care per resident day
$242,426
Savings in avoided hospitalizations
$518,627
$472,814
Savings in avoided UTI costs
30,882
Net Savings $319,121
Assumptions: $1,727 wtd avg to treat PU across stages,
$8,523 avg for Medicare hospitalization, $53,900K RN salary & FB/yr
AcademyHealth CPI Workshop June
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STUDY QUESTIONS
1. Which patient characteristics are associated
with improved postpost-stroke outcomes?
2. Controlling for patient characteristics,
which treatment interventions or
combinations are associated with improved
outcomes?
48
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PostPost-Stroke Rehabilitation Study
PostPost-Stroke Rehabilitation Study
STUDY QUESTIONS
Project Clinical Team
•
•
•
•
•
3. What is the optimal intensity and duration of
various postpost-stroke treatment interventions?
4. What staffing characteristics are associated with
better outcomes?
Physicians
Nurses
Social Workers
Psychologists
Physical Therapists
• Occupational Therapists
• Recreation Therapists
• Speech/Language
Pathologists
49
50
PostPost-Stroke Rehabilitation Study
PostPost-Stroke Rehabilitation Study
Examples of OUTCOME VARIABLES
Patient Characteristics
•
Change in FIM score
•
Deep vein thrombosis
•
Length of rehab stay
•
Major bleeding
•
Discharge disposition
•
Pulmonary embolism
52% Male: 58% White, 26% Black
•
Contracture
•
Pressure ulcer
66.0 Mean age (18.6 - 95.5 yrs)
•
Death
•
Pneumonia
1,161 U.S. Patients
51
•
•
•
•
•
52
PostPost-Stroke Rehabilitation Study
PostPost-Stroke Rehabilitation Study
Examples of PROCESS VARIABLES
DEVELOP WORKABLE INSTRUMENTS
Medications
•
Intensity, frequency, and
duration of OT
interventions
•
Intensity, frequency, and
duration of SLP
interventions
Nutritional process
Pain management
Time to first rehab
Intensity, frequency, and
duration of PT
interventions
•
Other therapy
interventions and dosage
53
AcademyHealth CPI Workshop June
27,2006
MULTIPLE AXES
•
FUNCTIONAL ACTIVITIES
¾TaskTask-specific approach
•
THERAPY INTERVENTIONS
¾Organized around core functional activities
•
TIME SPENT
¾Interventions in activities, formal assessment, home evaluation54
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Post-Stroke Physical Therapy Form
PostPost-Stroke Rehabilitation Study
P hysical Therapy Rehabilitation Activities
PT FUNCTIONAL ACTIVITIES
•
•
•
•
•
•
PrePre-Functional
Bed Mobility
Sitting
Transfers
•
•
•
•
•
SitSit-toto-Stand
Wheelchair Mobility
6 649
/
/
Time session begins:
:
Gait
Advanced Gait
Community Mobility
Intervention not related to
functional activity
55
Predicting Outcomes
Severe Stroke - CMGs 112+114
LOS
Date of Therapy Session:
Therapist:
PrePre-gait
Outcome
Patient ID:
S a m p l e
INTERVENTION CODES
Duration of Activity:
Neuromuscular Interventions:
Enter in 5 minute increments.
01. Balance training
02. Postural awareness
Pre-Functional Activity
03. M otor learning
04. PNF
Bed Mobility
05. NDT
06. Gait with body w eight support
07. Involved upper extremity addressed
Sitting
08. Constrained induced movement therapy
M usculoskeletal Interventions:
09. Strengthening
Transfers
10. M obilization
11. PROM /Stretching
12. M anual Therapy
Sit-to-Stand
13. M otor Control
Cardiopulmonary Intervention:
14. Breathing
Wheelchair Mobility
15. Aerobic/Conditioning exercises
Cognitive/Perceptual/Sensory Interventions:
16. Cognitive training
Pre-gait
17. Perceptual training
18. Visual training
G ait
19. Sensory training
Education Interventions:
20. Patient
Advanced Gait
21. Family/Caregiver
22. Staff
Equipment Interventions:
Community Mobility
23. Prescription/Selection
24. Application
25. Fabrication
Intervention not related
26. Ordering
M odality Interventions:
27. Electrical Stimulation
28. Biofeedback
29. Ultrasound
Pet Therapy:
30. Use of dog
31. Use of other animal
Assistive Device:
32. Ankle dorsi flex assist
33. Cane - Large base
34. Cane - Small base
35. Cane - Straight
36. Crutches - Axillary
37. Crutches - Forearm
38. Crutches - Small base forearm
39. Dowel
40. Grocery cart
41. Hemirail
42. Ironing board
43. KAFO
44. Lite gait
45.
46.
M irror
Parallel bars
Interventions:
Enter one intervention code per group of boxes.
to functional activity
Intervention #2 not related
to functional activity
Platform (parallel bars
or FW W)
48. Standing fram e
49. Steps (various heights)
50. Step ladder
51. Swedish knee cage
52. Swiss ball
53. Tray table
54. Walker - FWW
55. Walker - Hem iwalker
56. Walker - Rising Star
57. Walker - Standard
58. Wheelchair
O ther:
59.
Co-Treat:
47.
Area Involved/non-functional:
60. Upper Extremity
61. Lower Extrem ity
62. Trunk
63. Head/Neck
Disciplines:
No. of minutes:
Patient Assessment:
Formal A ssessm ent (initial, re-evaluation, discharge):
minutes
minutes
Hom e Evaluation:
minutes
W ork Site Evaluation:
Physical Therapy T ime:
Physical Therapist
PT Assistant
PT Aide/Tech
PT Student
minutes
minutes
minutes
minutes
Group Physical Therapy T ime:
PT Group/Dovetail:
minutes
Enter the number of each that participated in the Group PT:
Patients
Therapists
Assistants
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Students
Aides/Techs
Predicting Outcomes
Severe Stroke - CMGs 112+114
Discharge
Home
Discharge
Total FIM
Outcome
Discharge
Motor FIM
Patient Variables alone
R2 = .39
c = .70
Patient Variables alone
R2 = .64
R2 = .58
Add Total PT&OT Time/LOS
R2 = .39
c = .70
Add Total PT&OT Time/LOS
R2 =
.64
R2 = .59
Instead add PT&OT - Specific
Activity Time/LOS
R2 = .61
c = .85
Instead add PT&OT - Specific
Activity Time/LOS
R2 = .78
R2 = .76
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PostPost-Stroke Rehabilitation Outcomes Project
Outcome: Increase in Motor FIM CMGs 112+114
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PostPost-Stroke Rehabilitation Study
General Care
General
Assessment
– Age
– Adm Severity of Illness
+ No dysphagia
+ Chronic confusion
General
Interventions
– Days onset to rehab
+ Rehab length of stay
+ Enteral feeding
OT
Interventions
PT
Interventions
12 papers published in
Supplement to Archives of Physical Medicine and
+ Home mgt time in 1st 3 hrs
+ Gait time in 1st 3 hrs
+ Comm integr in 1st 3 hrs
+ Adv gait time in 1st 3 hrs
– Bed mobility time in 1st 3
hrs
– Bed mobility time in 1st 3
hrs
December 2005
– Wheelchair time in 1st 3
hrs
Opening the “Black Box”
Box” of Stroke Rehabilitation
+ Monoplegia or Normal
Medications
And What It Means for Rehabilitation Research
– Old SSRIs
– AntiAnti-Parkinsons
8 additional papers in other journals
– Modafinil
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Rehabilitation
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CPI Model - Length of Stay
Abdominal Surgery Nutrition Study
Bowel surgery
Disease CSI Score
PROCESS OF CARE
Assessment
+ Admission
CSI
(severity)
+ COPD
Surgery
+ Bowel PrepPrep- GoGoLightly
Pain
Management
Wound
Management
Nutrition
PT / RT
Discharge
+ Discharge
to SNF
+ PostPost-op TPN
+ Skin to skin
+ Drain - JP
+ Drain - Penrose
Intervention Subgroup
N
Mean
Early & Sufficient
Not Early & Not Sufficient
Not Early & Sufficient
Early & Not Sufficient
42
61
25
55
50.7
49.3
48.8
41.8
61
62
Abdominal Surgery Nutrition Study
Abdominal Surgery Nutrition Study
Nutrition CSI Score (Deaths and Transfers Removed)
Length of Stay (Deaths and Transfers Removed)
Intervention Subgroup
N
Mean
Intervention Subgroup
N
Mean
Early & Sufficient
Not Early & Not Sufficient
Not Early & Sufficient
Early & Not Sufficient
29
47
21
43
9.8
7.7
8.0
7.7
Not Early & Not Sufficient
Not Early & Sufficient
Early & Not Sufficient
Early & Sufficient
47
21
43
29
14.8
14.6
13.3
11.9
63
64
Abdominal Surgery Nutrition Study
Intended and Unintended
Consequences of HMO
Cost-Containment Strategies
Total Charges (Deaths & Transfers Removed)
Intervention Subgroup
N
Mean
Not Early & Sufficient
Not Early & Not Sufficient
Early & Not Sufficient
Early & Sufficient
13
35
35
20
39,883
38,578
36,542
34,602
Results from the Managed Care Outcomes Project
American Journal of Managed Care
March 1996
Neumayer LA, et al. Journal of Surgical Research 2001;95:1:732001;95:1:73-77
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Managed Care Outcomes Project
Main Study Question
This represented more
than:
Patient Population:
“When one looks across multiple managed care
organizations at a year’
year’s worth of actual data on
the care of thousands of typical patients treated by
their regular doctors, how is the amount of health
Nearly 13,000 patients
were included in the
study:
•99,000 office visits
•480 emergency room visits
•1,000 hospitalizations
•240,000 prescriptions
•1,309 - 3,938 patients
for each disease group
•1,876 - 2,663 patients
studied at each HMO site
care services used associated with costcostcontainment efforts by the HMO?”
HMO?”
Length of study period:
•One year
67
68
Managed Care Outcomes Project
Managed Care Outcomes Project
Study controlled for patient, costcost-containment practice, and HMO
site variables
Patient variables
With increased formulary restrictiveness, the study found:
CostCost-Containment
Practice Variables
HMO Site Variables
•SecondSecond-opinion
requirements
•Strictness of site’
site’s
gatekeeper
•Strictness of case mgt.
•Drug and visit coco-pays
•Restrictions of
formulary
•Extent of generic
drug use
•Severity of patient
illness
•Age and gender
•Time in study
•Number of
physicians seen by
patient
Findings
•Physician payment
• More patient visits to physicians
method
•HMO profit status
• More emergency room visits
•Geographical
• More hospitalizations
location
• Greater estimated cost of prescriptions per year
• Greater number of prescriptions per year
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Managed Care Outcomes Project
Managed Care Outcomes Project
Cost of Prescriptions for Arthritis
% Formulary
Limitation
50
48.4
45
40
39.1
35
35.8
30
24
26.3
20
16.9
15
10
34.6
29 28.3
25
8.4
11.4 10.9
18
46.1
Si te 1
(0%)
Site 2
(65.2%)
Site 3
(65.2%)
Site 4
(75%)
Site 5
(76.1%)
Cost of Prescriptions
Per Patient Per Year
Number of Prescriptions Per
Patient Per Year
Number of Prescriptions for Asthma
%
Formulary
Limitation
$1,400
1285
1236
$1,200
$1,000
1010
858
$800
726
$600
501
$400
332 344
$200
132
8.8
587 604
159
628
486
245
Site 1
(0%)
Site 2
(42.5%)
Site 3
(47.5%)
Site 4
(55%)
Site 5
(62.5%)
$0
5
0
Low Sev e rity
Medium Sev e rity
Low Severity
High Se ve rity
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M edium Severity
High Severity
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CostCost-Containment Measure
Managed Care Outcomes Project
Formulary Limitation
Number of Visits Per Patient
Per Year
Number of Visits for Ulcers
12
11.7 11.9
11.0
10
9.5
8.4
8
6.8
6
6.2
5.9
5.0 5.0
4
3.0 3.3
2
1.9
3.9
3.6 3.8
2.3
2.9
H y p e rte n s io n
n=3477
D is e a s e G ro u p
A rth ritis
n=2632
R xC o un t
+ 0 .2 8 0 (0 .1 5 )
+ 0 .2 7 0 (0 .7 9 )
+ 1 .4 6 0 ***
E p ig a s tric
P a in / U lc e r
n=1511
+ 1 .6 0 0 **
+ 0 .8 0 0 *
Site 1
(0%)
D is G p R x C t
+ 0 .2 7 0 (0 .1 9 )
+ 2 .3 9 0
+ 1 .1 2 5 ***
+ 1 .0 0 0 (0 .0 9 )
+ 0 .5 5 0 (0 .1 7 )
Site 2
(12.5%)
R xC ost
+ 0 .7 8 0
*
+ 2 .5 9 0 (0 .1 6 )
+ 1 .4 2 0 *
+ 2 .2 8 0 *
+ 0 .4 2 0 (0 .4 9 )
D is G p R x C s t
+ 2 .8 4 0
***
+ 2 .6 5 0 (0 .8 4 )
+ 4 .8 0 0 ***
+ 3 .7 9 0 **
V is its
+ 0 .3 2 0 (0 .3 5 )
-3 .7 4 0 (0 .0 9 )
+ 0 .7 4 0 (0 .3 9 )
+ 2 .1 3 0
Site 5
(25%)
E D V is its
+ 0 .1 2 5 ***
-1 .2 8 0
***
+ 0 .2 9 0 ***
+ 0 .2 8 7 ***
+ 0 .2 8 9 ***
Site 6
(37.5%)
H osp A dm s
+ 0 .4 1 9
-2 .3 5 0
***
+ 1 .0 2 0 ***
+ 0 .4 9 0
+ 0 .4 3 1 **
% Formulary
Limitation
Site 3
(12.5%)
Site 4
(25%)
O u tc o m e s
***
O titis M e d ia
n=3862
**
A s th m a
n=1290
+ 0 .5 3 0 (0 .5 5 )
**
***
+ 1 .1 1 0
(0 .3 1 )
0
Low Severity
M edium Severity
High Severity
Shaded cells represent unexpected direction
*** indicates p <0.001
73
+ indicates increased utilization
** indicates 0.001<p<0.01
- indicates decreased utilization
74
* indicates 0.01<p<0.05
Summary of Findings
Limitations of PBEPBE-CPI Studies
Curtailing access to medications via
costcost-control mechanisms can adversely
affect other healthcare utilization:
• Additional office visits for dose titration/
monitoring
• ER/hospital visits
• Concomitant medications
and increase total healthcare costs.
75
Do not scientifically
prove causality of
underlying relationships
- “Association is not
causation.”
causation.”
•
Incidence and type of test
ordering and availability
of information is not
uniform across sites
•
Accuracy and
completeness of current
documentation
•
Complexity of analysis
•
LaborLabor-intensive manual
data abstraction
76
Comprehensive Approaches to Care Save
30% to 50% of Health Costs
Limitations of CPI Studies
•
•
Improve/Standardize
The strength of an observational study depends
Process Factors
•Management Strategies
•Interventions
•Medications
on the study’
study’s ability to control for patient
differences that would otherwise be addressed
through randomization. There is always the
Control for:
chance that some unknown critical variable
Patient Factors
•Psychosocial/demographic Factors
•Disease(s)
•Severity of Disease(s)
may have been overlooked
Measure:
Outcomes
•Clinical
•Health Status
•Cost/LOS/Encounters
› physiologic signs and symptoms
•Multiple Points in Time
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