Transcript CRUSADE Operations Training

MAINTAIN CRUSADE:
Medication Applied and Sustained
Over Time
A Longitudinal Follow-Up Study of the CRUSADE
Quality Improvement Initiative
Duke Clinical Research Institute
Durham, NC
Topics
 Project Overview
 Why MAINTAIN?
 Inclusion Criteria and Patient Identification
 Data Collection
 Enrollment and Follow-up Procedures
 Site Reimbursement
 Summary
MAINTAIN Project Overview
 A longitudinal substudy of CRUSADE that
examines:
- Medication adherence post- ACS at 3 and 12
months
- LDL-C goal attainment at 12 months (and
associated lipid-lowering regimen)
- Patient outcomes at 12 months including
rehospitalization and functional status
Why MAINTAIN?
 Majority of research in ACS focuses on inpatient
setting; little is known about outpatient care over the
following year
• What do patients do at home?
• If not adherent, why not?
• Are process measures limiting success?
 More data needed linking long-term adherence and
outcomes
• How strong is the relationship?
• Is low adherence or lack of LDL-C goal attainment associated
with more events?
Long-Term Risk
Unstable Angina/NSTEMI
Cumulative Yearly Mortality After
UA/NSTEMI Discharge
25
22.6
19.1
20
% Mortality
Cause of Deaths Through
4 Years After UA/NSTEMI Discharge
16
15
14.4
15
Re-MI
50
10.2
Other CV
Cancer
Non-CV
19
10
5
70% of deaths are
cardiovascular
0
1
2
3
4
Year
Taneja AK, Eur Heart J 2004;25:2013-18
HOPE: Long-Term Results by Treatment
% Death, MI, or Stroke
ACE Inhibitors for Vascular Disease and Normal EF
0.2
Ramipril
Placebo
0.15
p<0.001
0.1
0.05
0
0
500
1000
1500
Days of Follow-up
HOPE Investigators, N Engl J Med 2000;342:145-53.
PROVE-IT: Long-Term Results
0.25
0.15
0.20
LDL>=70,Age>=70
21.5%
LDL<70,Age>=70
13.5%
0.10
LDL>=70,Age<70
10.4%
0.05
LDL<70,Age<70
8.1%
0.0
% Death, MI, UA req. Hosp
0.30
By LDL-C Attainment at 30 days
0
200
400
600
800
Time after 30 days post entry into trial (days)
CURE: Long-Term Results by Treatment
Clopidogrel Following NSTE ACS
Any Revascularization
0.20
RR: 0.80 (0.69-0.92)
0.15
Placebo
0.10
0.05
Clopidogrel
0.0
0
100
200
300
Days of Follow-up
Death, MI, or Stroke Hazard Rates
Death, MI, or Stroke Hazard Rates
Medical Management
0.20
RR: 0.82 (0.69-0.96)
0.15
Placebo
0.10
0.05
Clopidogrel
0.0
0
100
200
300
Days of Follow-up
Fox KAA, Circulation, 2004;110:1202-8
ACC/AHA Guidelines for UA/NSTEMI:
Discharge/Post-Discharge Medications
I IIa IIb III
ASA, if not contraindicated
Clopidogrel, when ASA contraindicated
Aspirin + Clopidogrel, for 9 months
-blocker, if not contraindicated
Lipid  agents + diet, if LDL >130 mg/dL*
ACE Inhibitor: CHF, EF < 40%, DM, or HTN
*LDL <70 mg/dl may be beneficial
Braunwald E, J Am Coll Cardiol 2002;40:1366-74
Successful Transition From Acute
Care to Long-Term Management
Cardiology
GUIDELINES
Acute Care
Outpatient
Secondary
Prevention
PATIENT !!
Adapted from Cannon CP. Cardiology. 2002;8
(special edition):29-37.
Patient Factor: Medication Adherence
 Adherence is the extent to which a
patient’s behavior coincides with medical
advice
 Influenced by patient and provider factors
Consistent Use In Patients with CAD
DDCD 1995-2002
100
Percentage
80
60
40
71
46
20
43
36
21
0
ASA
BB
Patients with only one clinical follow up excluded
Lipid
ASA + BB
ASA+BB+
Lipid
Long-Term Beta Blocker Compliance:
Even with Drug Benefits
% Meeting 75% Adherence
In 15,070 patients post-MI in Managed Care
Organizations
100
90
80
70
60
50
40
30
20
10
0
62
3 Month
56
6 Month
49
46
9 Months
12 Months
Kramer JM, JACC 2004;43:415A.
Medication Adherence
Implications
% 1 y death
 Medication nonadherence is associated with
increased mortality and rehospitalization
16
14
12
10
8
6
4
2
0
13.6%
RR = 2.4 (1.1 to 5.6)
5.6%
nonadherence
adherence
(Gallagher EJ, JAMA1993)
Why MAINTAIN?
 Medication adherence is likely to be low
• Understand reasons for non-adherence over time
 Medication adherence and LDL goal attainment are
likely to impact clinical outcomes
• Functional and Health status at 1 year
 Understanding variation and predictors of
adherence may help improve patient behaviors
• Site specific feedback on outpatient adherence
over time
CRUSADE
Inclusion Criteria and Patient Identification
Ischemic symptoms lasting ≥10 minutes at rest in
prior 24 hours and one of the following:
• Positive cardiac markers
• ST Segment ECG changes
• If transferred, must arrive at CRUSADE hospital
within 24 hrs of presentation
CRUSADE MAINTAIN
Inclusion Criteria and Patient Identification
In addition, CRUSADE MAINTAIN patients must:
a. Have a lipid panel drawn during index hospitalization
b. Community-dwelling (not in a nursing home)
c. English-speaking and cognitively intact
Target Enrollment: 2,500 patients
Enrollment period: 8-10 months
MAINTAIN
Enrollment Procedures
 Patients prospectively identified and consented
 Baseline lipid panel drawn
 Home and discharge medication form
 Patient contact information form
 Complete and enter CRUSADE DCF
 All baseline forms to the DCRI
MAINTAIN
Home and Discharge Medication Form
MAINTAIN
Coordinating Center Follow-Up
 Phone interview at 3 and 12 months
 Lipid study patients will have lipid panel at 12
months:
–at the site
–at home by personnel from a central laboratory
–at a designated clinic
• Patients may consent to interview follow-up without
having their lipid values monitored
MAINTAIN
3 and 12 Months Phone Interview
 Domains
•
•
•
•
•
•
Current Medications
Measures of adherence
Patient-Provider Communication
Health Assessment/ Functioning
Medical Care/Secondary Prevention
Socioeconomic Information
MAINTAIN
Site Reimbursement
 Sites will receive the following MAINTAIN payments:
• Up to $1500.00 for Internal Review Board fees
• $50.00 for patient enrollment:
•Submit medication form to DCRI via fax ($20)
•Submit consent and contact info to DCRI via fax ($30)
• $30.00 for 12 month lipid draw if done at site.
 ALSO, $20 standard CRUSADE DCF payment
Summary
 This study will provide valuable information regarding
outpatient treatment, medication adherence and
outcomes
 Sites will receive feedback reports (at 3 and 12
months) on their patients’ adherence and lipid levels
 Increased awareness will provide opportunities for
improving patient care
Contact Us!
Any Questions?
Call Jennifer Poteat at
919-668-8709
Email [email protected]
OR
Page the Site Manager On Call at 877-513-1976
(8:30am – 5:00pm ET M-F,
except holidays)
OR
Email us at
[email protected]