i will not discuss off label use and/or investigational use in my presentation. i have financial...
TRANSCRIPT
I will not discuss off label use and/or investigational use in my presentation.
I have financial relationships to disclose:
Employee of: Fresenius Medical ServicesConsultant for: N/AResearch support from: Amgen and AbbottHonoraria from: N/A
Presenter Disclosure Information
Raymond M. Hakim, M.D., Ph.D.April 25, 2009
ESRD: State of the Art ESRD: State of the Art Charting the Challenges for the Charting the Challenges for the
FutureFuture
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 Mortality1990 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
Co-Morbidity• Age• Nutritional Status• Diabetes• Cardiovascular Disease• LVH• Depression
Reversible Risk Factors• Anemia• Low albumin• High Phosphorus• High catheter rate
Reversible Risk Factors• Anemia• Low albumin• High Phosphorus• High catheter rate
Risk Factors• Unplanned start
(w/o permanent access)• Short (<4 months) prior
nephrological care• Low residual renal output
Risk Factors• Unplanned start
(w/o permanent access)• Short (<4 months) prior
nephrological care• Low residual renal output
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
Month 1
Month 2
Month 3
Month 4+
56 62 6278
0
20
40
60
80
100
Perc
en
t
URR > 70%N=562
41
5971
78
0
20
40
60
80
100
Perc
en
t
Hct > 33%
N=682
5158
6579
0
20
40
60
80
100
Perc
en
t
Albumin > 3.7 g/dL
N=696
1 2 3 4+ 1 2 3 4+
1 2 3 4+
RightStart® GoalsDefined goals for each healthcare team memberGeneral Goals Ongoing individualized Patient Education & Self-Care,
Medication Reviews, care plans, recommendation for a liberal diet
Protocol-driven outcomes
Specific Goals Week 2: URR >=70% Weeks 3-4: Target EDW
Hct >=30%, T. Sat >=20%Transplant referral & permanent
access planning Weeks 5-6: Stable BP Weeks 7-8: Hct >=33%
PO4 3.5-5.5 mg/dLUse Permanent Access
Weeks 9-10: Review Goal Achievement Weeks 11-12: HgbA1C <=7%
Albumin >=3.7 g/dL PTH 150-300 (BiPTH 75-150)
Week: 1/2 3/4 5/6 7/8 9/10 11/12
GoalsM.D.NursingS.W.R.D.
RightStart® Grid
Enrollment ProcessRightStart®, 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=1,047Retrospective 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-test2 = Chi-square
Laboratory Parameters
Percent of Patients with Hematocrit >33%
Percent of Patients with Albumin >3.5 g/dL
63.9
84.287.1 85.6
82.5 83.4
40.436.8
50.1
74.279 79.2 79.6 78.2
0
20
40
60
80
100
0 1 2 3 4 6 12
Months
% P
atie
nts
Me
etin
g T
arg
et
RightStart Control
63.9
84.287.1 85.6
82.5 83.4
40.436.8
50.1
74.279 79.2 79.6 78.2
0
20
40
60
80
100
0 1 2 3 4 6 12
Months
% P
atie
nts
Me
etin
g T
arg
et
RightStart Control
63.6
72.375.4 74.6
80.785
55.752.7
60.265.9
70.374.6
79.183.3
0
20
40
60
80
100
0 1 2 3 4 6 12
Months
% P
atie
nts
Me
etin
g T
arg
et
RightStart Control
63.6
72.375.4 74.6
80.785
55.752.7
60.265.9
70.374.6
79.183.3
0
20
40
60
80
100
0 1 2 3 4 6 12
Months
% P
atie
nts
Me
etin
g T
arg
et
RightStart Control
paricalcitolPTH>300
Supplementson HD
Alb < 3.7
megesterolAlb < 3.2
Teaching(Eat, Eat, Eat!)
BindersPhos >5.5
Renal Dietitians
Star PlanRightStart
URR and Vascular Access OutcomesPercent Reduction
of CathetersPercent of Patients with
URR >70%
58.8 58.361.8 64.2
73.5
82
51.348.8
52.8 5457.6
61.266.8
75.9
0
20
40
60
80
100
0 1 2 3 4 6 12
Months
% P
atie
nts
Me
etin
g T
arg
et
RightStart Control
23.1
54.2
69.2
7.84.9
27.3
48.1
65.8
0
20
40
60
80
100
Base toMO1
Base toMO3
Base toMO6
Base toMO12
Pe
rce
nt o
f Pa
tien
ts
RightStart Control
23.1
54.2
69.2
7.84.9
27.3
48.1
65.8
0
20
40
60
80
100
Base toMO1
Base toMO3
Base toMO6
Base toMO12
Pe
rce
nt o
f Pa
tien
ts
RightStart Control
What Do Patients Say They Want?(I CARE)
InformationCompassionAttitudeResponsivenessExpertise
28.5 30
.8 35.1 37
.1 39.1
37.3 39
.3
39.8
35.1
0
20
40
60
Wk 1 Wk 2 Wk 3-4 Wk 5-6 Wk 7-8 Wk 9-10 Wk 11-12 Mo 6 Mo 12
% o
f P
atie
nts
All RS
Right Start Outcome DataPercent of Patients Physically Active
All PatientsKDQOL by Weeks
Average Mental Component Score (MCS)
46.0 52
.0
49.0
52.0 63
.0
47.0
0
20
40
60
80
100
Wk 5-6 Wk 7-8 Wk 9-10 Wk 11-12 Month 6 DOPPS
Ave
rage
MC
S
Survival Curve, 1st 365 DaysAdjusted Cox-proportional hazards regression model
4003002001000
risk_days_365
1.00
0.95
0.90
0.85
0.80
Cu
m S
urv
iva
l
RightStart
Controlgroup_number
Survival Function for patterns 1 - 2
P<0.001 by Cox Log-rank, Breslow, and Tarone-Ware testsat 90, 180, and 365 day exposure levels.
RightStart®
Control
Adjusted by age, race, gender, diabetes
Mortality Hazard Ratios
Mortality Period
Unadjusted Hazard Ratio1
(95% CI)
Adjusted2
Hazard Ratio1
(95% CI)
P Value (Adj.
Hazard Ratio)
RightStart® (deaths per 100 pt yrs)
Control (deaths per 100 pt yrs)
90-days0.52
(0.35-0.76)
0.60
(0.37-0.97)
0.037 0.20 0.39
180-days0.55
(0.40-0.75)
0.60
(0.40-0.91)
0.015 0.18 0.33
365-days0.60
(0.46-0.79)
0.66
(0.46-0.95)
0.026 0.17 0.30
1 = Control used as reference group2 = Adjusted for age, gender, race, diabetes
Hospital Days per Patient Yr at Risk
14.513.3
13.4
18.3 18.5
17
0
5
10
15
20
Mo 1-3 Mo 1-6 Mo 1-12
Hos
pit
al D
ays/
Pt
Yr
at R
isk
RightStart Control
14.513.3
13.4
18.3 18.5
17
0
5
10
15
20
Mo 1-3 Mo 1-6 Mo 1-12
Hos
pit
al D
ays/
Pt
Yr
at R
isk
RightStart Control
Summary
1. Patients initiating dialysis present with several co-morbidities 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
• 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
RSCM (follow pts x4 months)
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 criteriaSame facilityAge, gender, diagnosisControl started dialysis before RightStart
program was started in that facilityControl 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 TimeNutritionDialysis AdequacyVascular AccessFoot ChecksSurvival
Cycle Time:Efficiency of Epogen Management
Time (Days) from Date of 1st Outpatient Dialysis to Date of 1st Epogen Order
Components MeasuredDays to 1st Lab DrawDays to 1st EPO Order
Days to First Lab Draw for Incident Patients
8
5
0
2
4
6
8
10
Per
cen
t
Control RightStart
8
5
0
2
4
6
8
10
Per
cen
t
Control RightStart
**p<0.0001
**
Days to First EPO Order for Incident Patients
14.6
10
0
5
10
15
20
25
30
Per
cen
tControl RightStart
14.6
10
0
5
10
15
20
25
30
Per
cen
tControl RightStart
**p<0.0001
**
Percent of Pts with Epogen Orders at 120 Days
95.9 98.9
0
20
40
60
80
100
Per
cen
tControl RightStart
95.9 98.9
0
20
40
60
80
100
Per
cen
tControl RightStart
**p<0.0001
***
Percent of Pts with T. Sat 20-50% at 120 Days
58.8 61.1
0
20
40
60
80
100
Per
cen
t
Control RightStart
58.8 61.1
0
20
40
60
80
100
Per
cen
t
Control RightStart
**p<0.0001
**
Percent of Pts with Hgb 11-12 g/dL at 120 Days
18.7
24.8
0
5
10
15
20
25
30
Per
cen
t
Control RightStart
18.7
24.8
0
5
10
15
20
25
30
Per
cen
t
Control RightStart
*p<0.001
*
Percent of Pts with Albumin >=3.5 g/dL at 120 Days
62.872.9
0
20
40
60
80
100
Per
cen
t
Control RightStart
62.872.9
0
20
40
60
80
100
Per
cen
t
Control RightStart
**p<0.0001
**
Percent of Pts with Phosphorus 3.5-5.5 mg/dL at 120 Days
51.3 56.5
0
20
40
60
80
100
Per
cen
t
Control RightStart
51.3 56.5
0
20
40
60
80
100
Per
cen
t
Control RightStart
*p=0.02
*
Percent of Pts with spKt/V >=1.4 at 120 Days(eKt/V >=1.2 for FMS pt group)
65.275.2
0
20
40
60
80
100
Per
cen
t
Control RightStart
65.275.2
0
20
40
60
80
100
Per
cen
t
Control RightStart
**p=0.0001
**
Percent of Pts with AV-Fistula at 120 Days
25.2
34.4
0
10
20
30
40
50
Per
cen
t
Control RightStart
25.2
34.4
0
10
20
30
40
50
Per
cen
t
Control RightStart
**p<0.0001
**
Average Number of Foot Checks Done During First 120 Days (diabetic pts only)
0.6
1.9
0
0.5
1
1.5
2
Per
cen
tControl RightStart
0.6
1.9
0
0.5
1
1.5
2
Per
cen
tControl RightStart
**p<0.0001
**
One Year Survival of RightStart Pts vs. Case-Control matching, All Pts n=approx 8,000
120 Days
Hazard Ratios at 120 days: 0.66At 1 year: 0.78
RightStart Patients
Matched non-RightStart patients
P<0.0001
Mortality Hazard Ratios for RightStart vs. Matched Controls, All Pts
0.780.66
0
0.2
0.4
0.6
0.8
1
1.2
120 Days 1 year
Per
cen
t
0.780.66
0
0.2
0.4
0.6
0.8
1
1.2
120 Days 1 year
Per
cen
t
**p<0.0001
****
Ref. (matched controls)
Top 10 Lessons Learned from RightStart for Incident Dialysis Patients
1. Reduce cycle timea) Lab panel on 1st treatmentb) Lab follow-up by MD and RN next (2nd) treatment
2. Make early “emotional” connection with new pt. Recognize grieving process and empathize, support pt to reach acceptance phase & empowerment/self-management
3. Delay heavy (intensive) teaching until 2-3 weeks after start4. Team-driven “curriculum”5. Emphasize good nutrition- “Eat well and we’ll dialyze you well”6. Provide oral nutritional supplements early on7. Get rid of catheters ASAP8. Include family members or next of kin in education9. Focus on pt as most important team member10. Assure TOPS program participation before starting dialysis
Advantages of the RightStart Program1. 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 treatmentIncident hemodialysis patients
Year
Adoption of RightStart in the Nephrology Community
1. CJASN Manuscript, Nov 20072. DaVita IMPACT Program
Incident Management of Pts Actions Centered on Treatment
3. NKF Booklets4. Kidney Times 5. Canadian Trial6. CMS Pt Ed Regulations7. KCP goal of reducing 1st
year morality of 20% in 3 years
RightReturn
Re-Hospitalization after discharge from Hospital(Medicare fee-for-service)
(N=3 million)
Medical Discharges
% Cumulative Re-Hospitalizations
0-30 days 21.1%
30-60 days 30.3%
61-90 days 36.6%
91-180 days 47.9%
181-365 days 59.4%
S. Jencks et al, NEJM 360, 1418, 2009
Predictors of Re-HospitalizationAge <55 yr 1.0 (ref)
55-69 yr 0.99
70-79 1.07
ESRD 1.42
No of Re-Hospitalization 0 1.0
1 1.37
2 1.75
≥3 2.5
S. Jencks et al: NEJM 360, 1418, 2009
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 EducationVascular Access (surgeon appt 1st mo. if catheter)MedicationsNutritionFacilitate overall medical careRehab/SW referralsPhysical activity programSelf-CareCollaborate with staffDocumentation
Advantages of the RightStart Program2. To FMS
Relative increase in (incident) patient growth rate (2/33) 6.4%
Absolute increase in (incident+prevalent) patient growth rate (2/120)
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)
$110 M
Increase in EBIT from RightStart (0.17 x Revenue) $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 StoriesLouise Gene
Current RightStart Participation by Business UnitsNumber of Case Managers
BU RSCMs
CBU 10
NEBU 1
SBU 6
SEBU 5
SWBU 3
WBU 5
ALL 30
Mortality Hazard Ratios for RightStart vs. Matched Controls by Business Unit
0.78 0.800.85
0.94
0.79
00.10.20.30.40.50.60.70.80.9
11.11.2
Central West South SE SW
Haz
ard
Rat
io 0.78 0.800.85
0.94
0.79
00.10.20.30.40.50.60.70.80.9
11.11.2
Central West South SE SW
Haz
ard
Rat
io
**
Ref. (matched controls)
NE excluded due to small # of pts
Mortality Hazard Ratios for RightStart vs. Matched Controls, All Pts
0.780.66
0
0.2
0.4
0.6
0.8
1
1.2
120 Days 1 year
Per
cen
t
0.780.66
0
0.2
0.4
0.6
0.8
1
1.2
120 Days 1 year
Per
cen
t
**p<0.0001
****
Ref. (matched controls)
One Year Survival of SPIDER Pts vs. Case-Control matching, All Pts n=approx 8,000120 Days
Hazard Ratios at 120 days: 0.66At 1 year: 0.78