Putting Patients in the Driver Seat: Warfarin Self Management at KPCO Brandon Simmons, PharmD, BCPS...
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Transcript of Putting Patients in the Driver Seat: Warfarin Self Management at KPCO Brandon Simmons, PharmD, BCPS...
Putting Patients in the Putting Patients in the Driver Seat:Driver Seat:
Warfarin Self Management at Warfarin Self Management at KPCOKPCO
Brandon Simmons, PharmD, BCPSBrandon Simmons, PharmD, BCPS
Clinical Pharmacy Specialist in Clinical Pharmacy Specialist in AnticoagulationAnticoagulation
Kaiser Permanente ColoradoKaiser Permanente Colorado
The PlanThe Plan
• Background Patient Self Management (PSM)
• Kaiser Permanente Colorado PSM– Rationale– Design
• Results
• Future direction
Self-monitoring of oral anticoagulation: Self-monitoring of oral anticoagulation: systematic review and meta-analysis of systematic review and meta-analysis of
individual patient data.individual patient data.
• Pooled results of individual patient data of anticoagulation therapy PSM
• 11 randomized, controlled trials– 2000 to 2010– 6417 participants– 12,800 person-years of follow-up
• Modest improvements in INR control – 5.13% mean improvement in time in
therapeutic INR range (TTR)
• Reductions in thromboembolic events– HR 0.42; 95% CI 0.28–0.65
• Nonsignificant differences in – Major bleeding (HR 0.86, 95% CI 0.56–1.31) – All-cause mortality (HR 0.75, 95% CI 0.42–
1.33)
Self-monitoring of oral anticoagulation: Self-monitoring of oral anticoagulation: systematic review and meta-analysis of systematic review and meta-analysis of
individual patient data.individual patient data.
Patient Self Management (PSM) Patient Self Management (PSM) for warfarin managementfor warfarin management
• All warfarin PSM studies to date utilized self testing (PST) with point of care (POC) devices– Similar accuracy to venipuncture INR
Current PracticeCurrent Practice
Previous Self ManagementPrevious Self Management
CPAAS Self ManagementCPAAS Self Management
KP.ORGKP.ORG
• KPCO patients can choose to have an active kp.org account– Secure, on-line system– Facilitates communication with providers – Displays information, including lab values
Why use not use POC?Why use not use POC?
• Requires additional patient training– Technique dictates accuracy
• POC is much more expensive – Cost of the POC machine– Cost of testing supplies
• PSM w/ POC devices also require weekly testing– CPAAS protocol allows up to 8 weeks
ProcessProcess
2 Hour Class2 Hour Class
• 1st hour was basics on self management– How warfarin works– How to adjust dose– How to pick a recheck date
• Break out practice session
• 2nd half focused on common anticoagulation issues– Drug interactions– Diet changes– Health changes– Complications
• Bleeding• Clotting
2 Hour Class2 Hour Class
5 Step Process of Managing 5 Step Process of Managing WarfarinWarfarin
1. Add up your total weekly warfarin dose in milligrams (mg)
2. Determine how much to adjust dose and when to recheck using Table 1. “Dosage Management Card”
3. Determine new weekly dose based on Table 2. “Dosage Adjustment Card”
4. Determine new dosing schedule by finding your new weekly dose on Table 3. “Weekly Schedule Card”
5. Send message to Clinical Pharmacy Anticoagulation Service
PT INR Value Dosage Adjustment RecheckINR
If Next INR Unchanged (Stays in Same Row)
Less than 1.5
Increase WEEKLY dose by 15 to 20%
7 days If next INR still less than 1.5 removed from the study
1.5 – 1.7Increase WEEKLY dose by
5 to 10% 14 days
If next INR still 1.5 to 1.7 increase WEEKLY dose by 10 to 15% and recheck in 7 days
1.8 – 1.9 No Change 7 daysIf next INR still 1.8 to 1.9 increase WEEKLY dose by 5
to 10% and recheck in 14 days
2.0 – 3.0 No Change 14 days If next INR still 2.0 to 3.0 recheck in 28 days
3.1 – 3.2 No Change 7 daysIf next INR still 3.1 to 3.2 reduce WEEKLY dose by 5 to
10% and recheck in 14 days
3.3 – 4.0Reduce WEEKLY dose by 5
to 10%14 days
If next INR still 3.3 to 4.0 decrease WEEKLY dose by 10 to 15% and recheck in 7 days
4.1 – 4.5Hold 1 dose then reduce WEEKLY dose by 10 to
15% 7 days
If next INR still 4.1 to 4.5 hold 1 dose then decrease WEEKLY dose by 15 to 20% and recheck in 7 days
Greater than 4.5
Hold 2 doses 2 days If next INR still greater than 4.5 removed from the study
Table 1: Dosage Management Card
Table 2: Dosage Adjustment CardMinus 20% Minus 15% Minus 10% Minus 5%
Current Weekly Dose
Plus 5% Plus 10% Plus 15% Plus 20%
Unable to continue using 5mg tablets 17.5 20 20 22.5 22.5
15 17.5 17.5 17.5 20 22.5 22.5 25 25
17.5 17.5 20 20 22.5 25 25 30 30
20 20 22.5 22.5 25 27.5 27.5 30 30
22.5 22.5 25 25 27.5 30 30 32.5 32.5
25 25 27.5 27.5 30 32.5 32.5 35 37.5
25 27.5 30 30 32.5 35 35 37.5 40
27.5 30 32.5 32.5 35 37.5 40 40 42.5
30 30 32.5 35 37.5 40 40 42.5 45
32.5 35 35 37.5 40 42.5 45 45 47.5
32.5 35 37.5 40 42.5 45 47.5 50 52.5
35 37.5 40 42.5 45 47.5 50 52.5 55
37.5 40 42.5 45 47.5 50 52.5 55 57.5
40 42.5 45 47.5 50 52.5 55 57.5 60
42.5 45 47.5 50 52.5 55 57.5 60 62.5
45 47.5 50 52.5 55 57.5 60 62.5 65
47.5 50 52.5 55 57.5 60 62.5 65 70
47.5 52.5 55 57.5 60 62.5 65 70 72.5
50 55 57.5 60 62.5 65 67.5 70 75
52.5 55 60 62.5 65 70 72.5 75 80
55 57.5 60 65 67.5 70 75 77.5 82.5
55 60 65 67.5 70 Unable to continue using 5mg tablets
Table 3: Weekly Schedule CardWeekly Dose (mg)
Sundaymg (tablets)
Mondaymg (tablets)
Tuesdaymg (tablets)
Wednesdaymg (tablets)
Thursdaymg (tablets)
Fridaymg (tablets)
Saturdaymg (tablets)
17.5 2.5 (1/2 tab) 2.5 (1/2 tab) 2.5 (1/2 tab) 2.5 (1/2 tab) 2.5 (1/2 tab) 2.5 (1/2 tab) 2.5 (1/2 tab)
20 2.5 (1/2 tab) 2.5 (1/2 tab) 2.5 (1/2 tab) 5 (1 tab) 2.5 (1/2 tab) 2.5 (1/2 tab) 2.5 (1/2 tab)
22.5 2.5 (1/2 tab) 5 (1 tab) 2.5 (1/2 tab) 2.5 (1/2 tab) 2.5 (1/2 tab) 5 (1 tab) 2.5 (1/2 tab)
25 2.5 (1/2 tab) 5 (1 tab) 2.5 (1/2 tab) 5 (1 tab) 2.5 (1/2 tab) 5 (1 tab) 2.5 (1/2 tab)
27.5 5 (1 tab) 2.5 (1/2 tab) 5 (1 tab) 2.5 (1/2 tab) 5 (1 tab) 2.5 (1/2 tab) 5 (1 tab)
30 5 (1 tab) 2.5 (1/2 tab) 5 (1 tab) 5 (1 tab) 5 (1 tab) 2.5 (1/2 tab) 5 (1 tab)
32.5 5 (1 tab) 5 (1 tab) 5 (1 tab) 2.5 (1/2 tab) 5 (1 tab) 5 (1 tab) 5 (1 tab)
35 5 (1 tab) 5 (1 tab) 5 (1 tab) 5 (1 tab) 5 (1 tab) 5 (1 tab) 5 (1 tab)
37.5 5 (1 tab) 5 (1 tab) 5 (1 tab) 7.5 (1 & 1/2 tab) 5 (1 tab) 5 (1 tab) 5 (1 tab)
40 5 (1 tab) 7.5 (1 & 1/2 tab) 5 (1 tab) 5 (1 tab) 5 (1 tab) 7.5 (1 & 1/2 tab) 5 (1 tab)
42.5 5 (1 tab) 7.5 (1 & 1/2 tab) 5 (1 tab) 7.5 (1 & 1/2 tab) 5 (1 tab) 7.5 (1 & 1/2 tab) 5 (1 tab)
45 7.5 (1 & 1/2 tab) 5 (1 tab) 7.5 (1 & 1/2 tab) 5 (1 tab) 7.5 (1 & 1/2 tab) 5 (1 tab) 7.5 (1 & 1/2 tab)
47.5 7.5 (1 & 1/2 tab) 5 (1 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 5 (1 tab) 7.5 (1 & 1/2 tab)
50 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 5 (1 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab)
52.5 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab)
55 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 10 (2 tabs) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab)
57.5 7.5 (1 & 1/2 tab) 10 (2 tabs) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 7.5 (1 & 1/2 tab) 10 (2 tabs) 7.5 (1 & 1/2 tab)
60 7.5 (1 & 1/2 tab) 10 (2 tabs) 7.5 (1 & 1/2 tab) 10 (2 tabs) 7.5 (1 & 1/2 tab) 10 (2 tabs) 7.5 (1 & 1/2 tab)
62.5 10 (2 tabs) 7.5 (1 & 1/2 tab) 10 (2 tabs) 7.5 (1 & 1/2 tab) 10 (2 tabs) 7.5 (1 & 1/2 tab) 10 (2 tabs)
65 10 (2 tabs) 7.5 (1 & 1/2 tab) 10 (2 tabs) 10 (2 tabs) 10 (2 tabs) 7.5 (1 & 1/2 tab) 10 (2 tabs)
67.5 10 (2 tabs) 10 (2 tabs) 10 (2 tabs) 7.5 (1 & 1/2 tab) 10 (2 tabs) 10 (2 tabs) 10 (2 tabs)
70 10 (2 tabs) 10 (2 tabs) 10 (2 tabs) 10 (2 tabs) 10 (2 tabs) 10 (2 tabs) 10 (2 tabs)
Competency Test CompositionCompetency Test Composition• 70% required to achieve passing score• 4 multiple choice questions that assessed:
– Knowledge of Vitamin K’s effect on INR– Managing drug interactions– Distinguishing serious from common bleeding– Managing missed doses
• 6 short-answer questions that assessed:– Ability to adjust dose based on low, slightly
elevated and significantly elevated INRs– Knowledge of when to have follow-up INR based
on previous INR results
Short-answer questionsShort-answer questions• Use the following information to answer questions
5 and 6:• Mr. Alfredo takes 30 mg of warfarin weekly as
follows:
• His INR on Tuesday is 1.7.• 5. What changes, if any, should he make to his
warfarin dose?
• 6. When should he check his next INR?
Sunday Monday Tuesday Wednesday Thursday Friday Saturday
5 mg 2.5 mg 5 mg 5 mg 5 mg 2.5 mg 5 mg
Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Competency Test - ValidationCompetency Test - Validation
• Based on pre-validated tests– The Oral
Anticoagulation Knowledge Test
– Anticoagulation Knowledge Assessment Questionnaire
Target PopulationTarget Population
• Age > 18 years
• Atrial fibrillation w/ target INR is 2.5 (range 2.0 to 3.0)
• 5 mg warfarin tablets
506 Screened
116 Failed inclusion criteria: Not active on kp.org: 49< 6 months on warfarin: 40Not on 5 mg tablets: 24Other: 3
223 Met exclusion criteria: >1 missed INRs last 6 mo: 143Staff recommendations: 26Planned time away: 20Planned procedure: 17Residing at care facility: 10Other: 7
123 Declined participation: No reason given: 77Time Conflicts: 21Prefers status quo: 19Other: 6
44 Enrolled
39 Completed
3 Withdrew consent1 Failed competency exam1 Withdrawn
167 Eligible
28 Continued PSM
Patient DispositionPatient Disposition
Test ResultsTest Results
Competency Test (n=43)
Pre-Education Score, mean (SD) 55.8% (19.5)
Post-Education Score, mean (SD) 88.8% (13.5)
Change in Score, mean (SD) 33.0% (19.2) p < 0.001
Patients with passing score
Pre-Education (n=15) 34.9%p <0.001
Post-Education (n=41) 95.3%
PSM ResultsPSM Results90 day pre-PSM phase
90 day PSM phase
p value
TTR 82.9% 81.2% p=0.65
Average #
INRs
2.97 4.38 p<0.01
# Bleed / Clot Events
3/1 0 p=0.24
•210 warfarin PSM dosing decisions•208 (99.0%) implemented unchanged by CPAS pharmacists
Individual TTR ChangesIndividual TTR Changes
Study ProblemsStudy Problems
Study ProblemsStudy Problems
Study Limitations Study Limitations
• Stringent enrollment criteria– Strong internal validity– Not very generalizable
• Not powered to show effect on INR– Main objective was to demonstrate feasibility – Pilot study
• Short follow up interval
• Dosing algorithm not validated
Future Research Future Research
• Larger study randomized – multiple disease states and warfarin strengths
• Reduced restrictions w/exclusion criteria
• Possible 3 arm trial– Regular Care– PSM– Attend Class only
Future directionFuture direction
• Creation of dosing algorithm program
• Direct feeds into DAWN AC
• Sub-feature of DAWN with direct patient access
What Questions Do You Have?What Questions Do You Have?
Thank You for Coming!Thank You for Coming!
Putting Patients in the Putting Patients in the Driver Seat:Driver Seat:
Warfarin Self Management at Warfarin Self Management at KPCOKPCO
Brandon Simmons, PharmD, BCPSBrandon Simmons, PharmD, BCPS
Clinical Pharmacy Specialist in Clinical Pharmacy Specialist in AnticoagulationAnticoagulation
Kaiser Permanente ColoradoKaiser Permanente Colorado