Putting Patients in the Driver Seat: Warfarin Self Management at KPCO Brandon Simmons, PharmD, BCPS Clinical Pharmacy Specialist in Anticoagulation Kaiser.

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