Transcript RightStart Program

Presenter Disclosure Information
I will not discuss off label use and/or investigational use in
my presentation.
I have financial relationships to disclose:
Employee of: Fresenius Medical Services
Consultant for: N/A
Research support from: Amgen and Abbott
Honoraria from: N/A
ESRD: State of the Art
Charting the Challenges for the Future
Raymond M. Hakim, M.D., Ph.D.
April 25, 2009
Background
 ESRD patients <65 years old do not receive Medicare
coverage until 91 days of ESRD therapy. In order to make
results comparable across age groups, USRDS reports
mortality rates for all patients after 90 days of ESRD
therapy.
 Several studies have highlighted multiple co-morbidities
and risk factors that are present in the majority of
patients starting dialysis therapies. Nevertheless, few
studies have focused on the mortality of dialysis patients
during these initial 90 days, or on processes to reduce it.
Published Data for Initial 90 Day Mortality
 1990 USRDS (Held et al): reported a 12% mortality rate
in the initial 90 days (48 deaths/100 pt years at risk) in
patients starting dialysis.
 Khan et al (AJKD 1995): reported a 12.6% mortality rate
during the initial 90 days (50 deaths per 100 pt years at
risk).
 Soucie and McClellan (JASN 1996): reported avg
mortality rate of 24 deaths per 100 pt yrs at risk, based
on data supplied by facility staff.
 RCG has reported a 10% mortality during that initial 90
day period of time, or an annualized 40 deaths per 100
pt years at risk; this compares to 20 deaths per 100 pt
years at risk for prevalent patients.
Co-Morbidities and Risk Factors
Associated with Early Mortality
 Risk Factors
 Co-Morbidity
• Age
• Nutritional Status
• Diabetes
• Cardiovascular Disease
• LVH
• Unplanned start
(w/o permanent access)
• Short (<4 months) prior
nephrological care
• Low residual renal output
• Depression
 Reversible Risk Factors
•
•
•
•
Anemia
Low albumin
High Phosphorus
High catheter rate
At Initiation of Dialysis in the U.S.
 57% had albumin concentration below lower
limit of normal
 80% of patients with Hct <28% were not
receiving EPO
 50% had no visit with dietitian (21% had one
visit)
 25% had a permanent access 30 days before
starting dialysis
 33% used temporary access 60 days after
initiation
Outcomes for Patients Initiating Dialysis
URR > 70%
100
80
Hct > 33%
N=562
56
100
78
62
80
62
60
40
60
40
20
20
0
1
2
N=682
3
78
59
41
0
4+
71
1
2
3
4+
Albumin > 3.7 g/dL
100
80
60
79
N=696
51
58
65
Month 1
Month 2
Month 3
40
Month 4+
20
0
1
2
3
4+
RightStart® Goals
Defined goals for each healthcare team member
General Goals
 Ongoing individualized Patient Education & Self-Care, Medication
Reviews, care plans, recommendation for a liberal diet
 Protocol-driven outcomes
Specific Goals
 Week 2:
 Weeks 3-4:
 Weeks 5-6:
 Weeks 7-8:
 Weeks 9-10:
 Weeks 11-12:
URR >=70%
Target EDW
Hct >=30%, T. Sat >=20%
Transplant referral & permanent access planning
Stable BP
Hct >=33%
PO4 3.5-5.5 mg/dL
Use Permanent Access
Review Goal Achievement
HgbA1C <=7%
Albumin >=3.7 g/dL
PTH 150-300 (BiPTH 75-150)
®
RightStart
 Week:
 Goals
 M.D.
 Nursing
 S.W.
 R.D.
1/2
3/4
5/6
7/8
Grid
9/10 11/12
Enrollment Process
 RightStart®, N=923
 Prospective enrollment of ALL new patients within one to
three weeks of dialysis initiation
 Exclusions:
 Seasonal or transient patients
 Nursing home residents
 Patients with cognitive dysfunction that precludes
ability to learn
 Time-Concurrent Control Group, N=1,047
 Retrospective data retrieval of all new patients in non-
RightStart® clinics in same geographic area for one year
concurrent with the RightStart® program
Demographics
Variable
RightStart®
Control
Group
p Value
Age (years)
61.8 + 16.0
62.0 + 17.2
NS1
Male/Female
45.8%/54.2%
46.6%/53.4%
NS2
Diabetes (I & II)
53.8%
53.8%
NS2
Caucasian
57.2%
47.8%
P<0.052
AA/Hispanic
36.5%
36.2%
NS2
Other
6.3%
16%
NS2
1 = Student’s t-test
2 = Chi-square
Laboratory Parameters
Percent of Patients with
Albumin >3.5 g/dL
Percent of Patients with
Hematocrit >33%
RightStart
Control
RightStart
100
87.1
84.2
80
85.6
79
74.2
83.4
82.5
79.6
78.2
79.2
63.9
60
40
50.1
40.4
36.8
20
0
% Patients Meeting Target
% Patients Meeting Target
100
Control
80
60
75.4
72.3
55.7
52.7
63.6
60.2
65.9
80.7 79.1
85 83.3
74.6 74.6
70.3
40
20
0
0
1
2
3
Months
4
6
12
0
1
2
3
Months
4
6
12
Teaching
(Eat, Eat,
Eat!)
megesterol
Alb < 3.2
Renal
Supplements
on HD
Dietitians Alb < 3.7
RightStart
Star Plan
Binders
Phos >5.5
paricalcitol
PTH>300
URR and Vascular Access Outcomes
Percent Reduction
of Catheters
Percent of Patients with URR
>70%
RightStart
RightStart
Control
Control
100
82
80
60
75.9
73.5
51.3
48.8
58.8
58.3
54
52.8
61.8
66.8
64.2
61.2
57.6
40
20
Percent of Patients
% Patients Meeting Target
100
80
69.2
65.8
60
54.2
48.1
40
23.1
20
27.3
7.8
4.9
0
0
0
1
2
3
Months
4
6
12
Base to
MO1
Base to
MO3
Base to
MO6
Base to
MO12
What Do Patients Say They Want?
(I CARE)
Information
Compassion
Attitude
Responsiveness
Expertise
Right Start Outcome Data
Percent of Patients Physically Active
All RS
39.8
Wk 11-12
Mo 6
35.1
39.3
37.3
39.1
37.1
35.1
30.8
40
28.5
% of Patients
60
20
0
Wk 1
Wk 2
Wk 3-4
Wk 5-6
Wk 7-8
Wk 9-10
Mo 12
All Patients
KDQOL by Weeks
Average Mental Component Score (MCS)
49.0
52.0
Wk 7-8
Wk 9-10
Wk 11-12
47.0
52.0
60
46.0
Average MCS
80
63.0
100
40
20
0
Wk 5-6
Month 6
DOPPS
Survival Curve, 1st 365 Days
Adjusted Cox-proportional
Survival Function forhazards
patterns 1 - 2regression model
Adjusted by age,
race,
Control gender,
RightStart
diabetes
group_number
1.00
Cum Survival
0.95
RightStart®
0.90
Control
0.85
P<0.001 by Cox Logrank, Breslow, and
Tarone-Ware tests
at 90, 180, and 365
day exposure levels.
0.80
0
100
200
risk_days_365
300
400
Mortality Hazard Ratios
Unadjusted Adjusted2
Hazard
Mortality
Hazard
Ratio1
Period
Ratio1
(95% CI)
(95% CI)
P Value
(Adj.
Hazard
Ratio)
RightStart®
(deaths per
100 pt yrs)
Control
(deaths
per 100
pt yrs)
90-days
0.52
(0.35-0.76)
0.60
(0.370.97)
0.037
0.20
0.39
180-days
0.55
(0.40-0.75)
0.60
(0.400.91)
0.015
0.18
0.33
365-days
0.60
(0.46-0.79)
0.66
(0.460.95)
0.026
0.17
0.30
1 = Control used as reference group
2 = Adjusted for age, gender, race, diabetes
Hospital Days per Patient Yr at Risk
RightStart
Hospital Days/Pt Yr at Risk
20
Control
18.5
18.3
17
15
13.4
14.5
13.3
10
5
0
Mo 1-3
Mo 1-6
Mo 1-12
Summary
1.
Patients initiating dialysis present with several comorbidities and risk factors, and knowledge deficits that
are associated with a high initial 90-day mortality rate,
(generally not reflected in published data).
2.
Several of these risk factors can be attenuated or reversed
more rapidly with an intensive team effort during the
initial 90 days of therapy.
3.
The RightStart® program, consisting of focused attention
on reversible risk factors and patient education, resulted
in a significant reduction in mortality and hospitalization
during those initial 90 days, which extended up to 1 year
following initiation of dialysis.
Combine RightStart and Diabetes Programs Primary Areas of Patient Care
RSCM (follow pts x4 months)
•
•
•
•
•
Patient Education/Modality Options
Vascular Access
Medication Reviews
Nutrition
Rehab/SW referrals
• Foot Exams/Shoes
• Glucose control – home records
• Prevention (eye exams)
• Case Follow-up and input
• Self-Care
• Electronic Documentation/Outcomes
All Patients Included
• Nursing home pts
• Non-English speaking
pts
• Spouse/significant other
for confused pts
Preventing Infection and Amputations
Facts About the Diabetic Foot1
 ESRD pts with diabetes have 10X the rate of amputations as
normal population
 Up to 86% of amputations start from a minor injury i.e. blister,
callus, poorly fitting shoes
 Amputations linked to decreased survival rate
- 51% of ESRD pts survive 1 yr after amputation
- 34% of ESRD pts survive 2 yrs after amputation
1Eggers
et al. Kidney International
Diabetes Foot Check Procedure
 INITIAL FOOT CHECK- (Annually) includes:
 Observation of shoes, skin condition, integrity, temperature
 Check Pedal Pulses
 Sensory testing
 Patient Education
 ROUTINE FOOT CHECK – (Monthly) includes:
 Observation of shoes, skin condition, integrity, temperature
 Reinforce Patient Education
2008 RightStart Analysis: Case Control Matching
 2 Patient DataSets Analyzed: RCG (aka AMI) Clinics
(5/2004 – 5/2008) and FMS Clinics (3/2006 – 5/2008)
 Incident HD pts in facilities that agreed to participate
in the RightStart Program
 Each case matched to a non-RightStart pt (control) per
the following criteria
 Same facility
 Age, gender, diagnosis
 Control started dialysis before RightStart program
was started in that facility
 Control survived # of days it took to enroll matched
pt into RightStart
RightStart vs. Case-Control Matching: Demographics
Variable
Control
RightStart
p Value
AMI Patient Group
# of Pts
3,392
3,392
Age (years)
63.1 + 0.24
62.6 + 0.25
NS
Male (%)
55.9 + 0.56
55.7 + 0.56
NS
Diabetes (1 & 2)
51.8 + 0.58
57.0 + 0.58
p<0.0001
FMS Patient Group
# of Pts
1,042
1,042
Age (years)
63.4 + 0.44
63.3 + 0.46
NS
Male (%)
56.7 + 1.1
54.7 + 1.1
NS
Diabetes (1 & 2)
64.3 + 1.1
65.9 + 1.0
NS
Avg + Standard Error
Outcomes Analysis
 Anemia/Cycle Time
 Nutrition
 Dialysis Adequacy
 Vascular Access
 Foot Checks
 Survival
Cycle Time:
Efficiency of Epogen Management
 Time (Days) from Date of 1st Outpatient Dialysis to
Date of 1st Epogen Order
 Components Measured
 Days to 1st Lab Draw
 Days to 1st EPO Order
Days to First Lab Draw for Incident Patients
Control
RightStart
10
8
Percent
8
**
6
5
4
2
0
**p<0.0001
Days to First EPO Order for Incident Patients
Control
RightStart
30
25
Percent
20
14.6
**
15
10
10
5
0
**p<0.0001
Percent of Pts with Epogen Orders at 120 Days
Control
95.9
*
100
Percent
80
60
40
20
0
**p<0.0001
RightStart
98.9
**
Percent of Pts with T. Sat 20-50% at 120 Days
Control
RightStart
100
80
Percent
58.8
60
40
20
0
**p<0.0001
61.1
**
Percent of Pts with Hgb 11-12 g/dL at 120 Days
Control
RightStart
30
24.8
25
18.7
Percent
20
15
10
5
0
*p<0.001
*
Percent of Pts with Albumin >=3.5 g/dL at 120 Days
Control
RightStart
100
**
80
72.9
Percent
62.8
60
40
20
0
**p<0.0001
Percent of Pts with Phosphorus 3.5-5.5 mg/dL
at 120 Days
Control
RightStart
100
80
Percent
*
60
51.3
40
20
0
*p=0.02
56.5
Percent of Pts with spKt/V >=1.4 at 120 Days
(eKt/V >=1.2 for FMS pt group)
Control
RightStart
100
**
75.2
80
Percent
65.2
60
40
20
0
**p=0.0001
Percent of Pts with AV-Fistula at 120 Days
Control
RightStart
50
40
**
Percent
34.4
30
25.2
20
10
0
**p<0.0001
Average Number of Foot Checks Done
During First 120 Days (diabetic pts only)
Control
**
1.9
2
Percent
RightStart
1.5
1
0.6
0.5
0
**p<0.0001
One Year Survival of RightStart Pts vs. CaseControl matching, All Pts n=approx 8,000
120 Days
RightStart Patients
Matched non-RightStart patients
P<0.0001
Hazard Ratios
at 120 days: 0.66
At 1 year: 0.78
Mortality Hazard Ratios for RightStart vs. Matched
Controls, All Pts
1.2
Ref. (matched controls)
1
**
Percent
0.8
0.66**
0.78
0.6
0.4
0.2
0
120 Days
**p<0.0001
1 year
Top 10 Lessons Learned from RightStart for
Incident Dialysis Patients
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Reduce cycle time
a) Lab panel on 1st treatment
b) Lab follow-up by MD and RN next (2nd) treatment
Make early “emotional” connection with new pt. Recognize
grieving process and empathize, support pt to reach acceptance
phase & empowerment/self-management
Delay heavy (intensive) teaching until 2-3 weeks after start
Team-driven “curriculum”
Emphasize good nutrition- “Eat well and we’ll dialyze you well”
Provide oral nutritional supplements early on
Get rid of catheters ASAP
Include family members or next of kin in education
Focus on pt as most important team member
Assure TOPS program participation before starting dialysis
Advantages of the RightStart Program
1. To the Patient
Number of new (incident) patients in US
100,000
Number of new (incident) patients in FMS
33,000
Current 1st Year Mortality (USRDS)
25.4%
Number incident pts at end of 1st year without
RightStart
24,618
Expected 1st Year Mortality with RightStart (HR =
0.75)
19.0%
Number incident pts at end of 1st year with
RightStart
26,730
Lives Saved/Lives Extended from RightStart
~ 2100 pts/Yr
Mortality Rates, by modality & year of treatment
Incident hemodialysis patients
Year
Adoption of RightStart in the
Nephrology Community
CJASN Manuscript, Nov 2007
2. DaVita IMPACT Program
Incident Management of Pts Actions Centered on Treatment
3. NKF Booklets
4. Kidney Times
5. Canadian Trial
6. CMS Pt Ed Regulations
7. KCP goal of reducing 1st
year morality of 20% in 3 years
1.
RightReturn
Re-Hospitalization after discharge from Hospital
(Medicare fee-for-service)
(N=3 million)
Medical Discharges
0-30 days
% Cumulative Re-Hospitalizations
21.1%
30-60 days
61-90 days
91-180 days
30.3%
36.6%
47.9%
181-365 days
59.4%
S. Jencks et al, NEJM 360, 1418, 2009
Predictors of Re-Hospitalization
Age
<55 yr
1.0 (ref)
55-69 yr
0.99
70-79
1.07
ESRD
No of Re-Hospitalization
S. Jencks et al: NEJM 360, 1418, 2009
1.42
0
1.0
1
1.37
2
1.75
≥3
2.5
Impact of hospitalization on hemoglobin, albumin, and weight by
length of stay
Impact of hospitalization on the prevalence of EPO and vitamin D
usage by length of stay
Hazard ratios for repeat hospitalization within the specified number of days
after discharge from hospital
Laboratory Outcomes Following Initiation of Dialysis (N = 7,658)
HCFA Data from Q4, 1997
6
Months
6-12
mo
12-24
mo
24
mo
% with URR > 65%
43
68
76
78
Median Dialysis Time (min)
210
210
210
210
% patients with
HCT > 33%
41
58
60
59
% of patients
with Albumin > 3.5
63
81
86
87
Rocco: AJKD, 2001
A Special Group: New Patients Have Special Needs
New HD Pts Arrive:
 Anemic
 Malnourished
 Underdialyzed (uremic)
 With catheter
 Inflammatory state (catheter)
 Inactive
 Jobs threatened
 Overwhelmed
 More likely to be hospitalized
 More likely to die
RightStart Pilot Program –
Primary Areas of Patient Care










Patient Education
Vascular Access (surgeon appt 1st mo. if catheter)
Medications
Nutrition
Facilitate overall medical care
Rehab/SW referrals
Physical activity program
Self-Care
Collaborate with staff
Documentation
Advantages of the RightStart Program
2. To FMS
Relative increase in (incident) patient growth rate (2/33)
Absolute increase in (incident+prevalent) patient growth
rate (2/120)
6.4%
1.7%
Cost of RightStart Implementation
1 Case Manager/200 Pts/Yr x 60K (including benefits)
$9.9 M
Return on Investment
Increase in revenues from RightStart (2100 pts x
$350/tx x 150 tx/yr)
Increase in EBIT from RightStart (0.17 x Revenue)
$110 M
$18.7 M
? Increase in revenue from earlier start of EPO & Vit D
?
CFC Mandated ‘Patient Ed’ Related Nursing Time
(10 hr/pt)
((10 x 33000) / 2080)
$8.0 M
Patient Stories
Louise
Gene
Current RightStart Participation by Business Units
Number of Case Managers
BU
RSCMs
CBU
10
NEBU
1
SBU
6
SEBU
5
SWBU
3
WBU
5
ALL
30
Hazard Ratio
Mortality Hazard Ratios for RightStart vs. Matched
Controls by Business Unit
1.2
1.1
Ref. (matched controls)
0.94
1
0.85
0.9
0.79
0.80
0.78
0.8
**
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
Central West
South
SE
SW
NE excluded due to small # of pts
Mortality Hazard Ratios for RightStart vs. Matched
Controls, All Pts
1.2
Ref. (matched controls)
1
**
Percent
0.8
0.66**
0.78
0.6
0.4
0.2
0
120 Days
**p<0.0001
1 year
One Year Survival of SPIDER Pts vs. Case-Control
matching, All Pts n=approx
8,000
120 Days
Hazard Ratios
at 120 days: 0.66
At 1 year: 0.78