Download Managing the Anticoagulation Clinic IJN Experience

Managing the
Anticoagulation Clinic
IJN Experience
Dr Emily Tan Lay Koon
Cardiologist
IJN
Incidence per 100 patient-years
Adverse Event Rate
The Perils of Oral
Anticoagulation Management
INR
Adapted from Jacobson, AK, modification of Cannegeiter SC, N Eng J Med 1995
Impact on Health Care Delivery
Cost Effectiveness
Adapted from Eckman, MH et al. Chest 1998
3 Basic Models of Oral
Anticoagulation Management
Usual Medical
Care (UMC)
Care provided by a
physician or physician
group as part of
routine care of the
patient
Family Physician (GP),
Physician, Physician
Specialist
(Cardiologist,
Hematologist)
Anticoagulation
Clinic (AC)
Patient Self
Testing (PST)
Care provided by a
team of physician,
pharmacist, nursing and
healthcare staff in a
specialized
comprehensive care
facility
Patients are trained to
perform own INR
testing using
approved coagulation
monitoring devices
Provides comprehensive
anticoagulation care
Results reported to
healthcare provider
who gives specific
instructions for follow
up care
Ansell J et al. Chest 2001;119(suppl):22s-38s
Summary of trials involving
Anticoagulation Clinic (AMS) and
Usual Medical Care (UC)
Ansell et al. Chest 2008;133;160s-198s
Cohort comparison between AC and UMC
328 newly anticoagulated patients, 4 years follow up
UMC
AC
INR in range (2-3)
37%
40%
INR in range (2.5-4.5)
35%
50.4%
Bleeding
35%
8.1%
Thromboembolic
events
11.8%
3.3%
Mortality rate
2.9%
0%
Annual warfarin
related hospitalization
19%
5%
ED visits
22%
6%
Annual health care
cost reduction
$132,086 per 100
patients
E Chiquette et al. Arch Intern Med 1998;158:1641-1647
Randomized controlled trial
comparing management by AC and
by Family Physician
221 patients, follow up 3 months, 2 centres (Ontario,
London)
AC
FP
P value
Percentage of time INR within range
82%
76%
0.034
Percentage or patients with INR <1.5 or
>5.0 (high risk values)
30%
40%
0.005
Mean number of INR measurements
11
13
0.001
Major bleeding events
2%
1%
NS
Thromboembolic events
1%
2%
NS
Deaths
4%
6%
NS
Patient satisfaction
96%
84%
0.001
S Wilson et al. CMAJ 2003;169(4):293-8
Cohort Comparison of Clinical
Pharmacy AC and UMC
6645 patients, follow up 6 months
30
63.5% of AC group in target range; 55.2% of UMC group
in target range; P<0.001
% of patients
25
20
AC
UMC
15
10
5
0
0-20
21-40
41-60
61-80
81-100
% time spent in therapeutic INR range
M Witt et al. Chest 2005;127;1515-1522
Cohort Comparison of Clinical
Pharmacy AC and UMC
6645 patients, follow up 6 months
Kaplan-Meyer survival analysis of
anticoagulation therapy-related complications
1.000
Proportion experiencing
complications
AC group 39% less likely to experience
any anticoagulation therapy-related
complication
AC
UMC
0.970
1
Time (days)
181
M Witt et al. Chest 2005;127;1515-1522
American College of Chest
Physicians Evidence-Based Clinical
Practice Guidelines (8th Edition)
Recommendations
4.1.1 For health-care providers who manage
oral anticoagulation therapy, we recommend
that they do so in a systematic and
coordinated fashion, incorporating patient
education, systematic INR testing,
tracking, follow-up care and good patient
communication of results and dosing
decisions as occurs in an anticoagulation
clinic service.
Ansell et al. Chest 2008;133;160s-198s
Role of Anticoagulation
Clinic
Coordinate and optimize delivery of
oral anticoagulant therapy
– Determining appropriateness of therapy
– Managing warfarin dosing
– Continuous monitoring of patient’s INR
results, dietary factors, concomitant
medications and interfering disease state
Comprehensive education and good
communication links
Planning an Anticoagulation
Clinic Service
Identify a need
Set up a multi-disciplinary steering group
– Planning a safe and effective service clinically
and financially
– Minimal disruption to organization
– Estimate impact on workload and staffing
Estimate Cost
–
–
–
Space/room
Staff, training
Equipment (furniture, computers/software,
laboratory machines etc)
Setting up an Anticoagulation
Clinic
Location and operating hours
Identify all patients on warfarin and with
indications for anticoagulation
Designate a clinical lead –
Doctor/Pharmacist/Nurse
Develop protocols and standard operating
procedures
Staff training
Procurement of equipment
Quality Assurance – parameters for
evaluation
Monitoring of
patients
Counseling
Cardiologist
Staff Nurses
Coordinate patient’s
care
Monitoring of
patients
Counseling
Pharmacist
Anticoagulation
Clinic
Multidisciplinary
Team
Titration and dispensing
of warfarin
Monitoring of patients
Counseling
Dietician
Laboratory Technician
Phlebotomist
Diet counseling
INR check
Work Flow at INR Clinic
Laboratory
Blood Testing
For INR
Lab Technician
Ascertain possible/probable reason
Counseling and Education
Pharmacist/Nurse
No
INR within range
?
Dosage adjustment
According to
Established protocol
Compliance
Medications
Supplements
Diet changes
Exercise
Recent illness
Alcohol
Bleeding
Pharmacist/Doctor
Yes
Pharmacist/Nurse prescribe warfarin dosage
Physician standing order
Medication collection
Follow up appointment
Dietician counseling
Personnel Training
Training
– Work environment
– Formal didactic or experiential training
programme
– Self-study
Formal anticoagulant therapy
management training programme
– Singapore General Hospital
Garcia et al. Ann Pharmacother 2008;42:979-88
Anticoagulation Therapy
Training Programmes
Certified Anticoagulation Provider
– The National Certification Board for Anticoagulation Providers to formally
recognise anticoagulation providers meeting educational and patient-care
experiential requirements
Research Institute of the American College of Clinical
Pharmacy Anticoagulation Training Program
– 4 to 6 weeks intensive training program provided through the University
of Texas and the Anticoagulation Clinics of North America
American Society of Health-System Pharmacists Foundation
Antithrombotic Pharmacotherapy Traineeship
– Curriculum consists of self study program and a 5-day experiential
program
University of Southern Indiana College of Nursing and Allied
Health Professionals Anticoagulant Therapy Management
Certificate Program
– Interactive 6 week, 40 hour internet certificate program for nurses,
pharmacist and physicians
www.clotcare.com; www.acforum.org
Garcia et al. Ann Pharmacother 2008;42:979-88
Personnel Responsibility
Collaborative practice agreement
– Assigning day-to-day responsibility for
anticoagulation management
– Responsibilities, accountability and job
descriptions
– In IJN, nurses and pharmacist manage
warfarin dosing
Garcia et al. Ann Pharmacother 2008;42:979-88
Policies, Protocol and Procedures
Policies and procedures serve as clinical tool and
quality assurance mechanism to reduce variability
in delivery of care
Address common and/or controversial issues that
may arise
Reviewed, updated as evidence becomes available
and approved regularly by appropriate committees
Widely disseminated throughout the organization
Available for review within the clinic at all times
Reduce fragmentation of care by facilitating
communication and transitions between healthcare
team members
Garcia et al. Ann Pharmacother 2008;42:979-88
Anticoagulation Management
Issues for which established
policies and procedures may be
useful
Assessing risks and benefits of therapy
Documenting patient’s understanding
Indications and specific target INR
Planned duration of therapy
Initiating therapy
Managing therapeutic and non therapeutic INR
Monitoring intervals and other lab parameters
Defining and documenting adverse events
Mechanism by which missed appointments be flagged
Managing nonadherence to blood tests or clinic visits
Managing transitions between care settings
Defining criteria for discharging patients from dedicated AC
Defining quality measures
Interrupting anticoagulation for invasive procedures
Managing anticoagulation therapy during pregnancy
Coordination of anticoagulation therapy during travel
Defining eligibility criteria and follow up requirements for patient self testing
Garcia et al. Ann Pharmacother 2008;42:979-88
Documentation
Accurate and easily
accessible
documentation
system
Computer software
programs or paper
forms
Demographics
Treatment
Indications for anticoagulation therapy
Target INR
Start date
Anticipated duration of therapy
Tablet strength(s) of vitamin K antagonist
Risk factors for bleeding and clotting
Communication
Documentation of patient education processes
Miscellaneous
Complications
Missed appointments
Plans for interrupting anticoagulation therapy
Garcia et al. Ann Pharmacother 2008;42:979-88
Computer Software
Programmes
Documentation
Dosage adjustment and management
Statistical analysis
Randomized controlled trial evaluating
software showing at least comparable
if not superior outcome compared with
manual dose titration
Computer Software Programme
Software Product
Vendor/Contact info
Web address/email
ANTHEMA
e-MedicalMonitor, Spain
www.e-medicalmonitor.com
Anticoagulation Management
Program(AMP)
Telehealth Systems Inc, 877490-6161
[email protected]
www.telehlthsys.com
Clever Clog
Clever Clog, England
www.clevclog.freeserve.co.uk
CoagCare Management
System
ZyCare Inc, 919-419-7228
www.zycare.com
CoagClinic
Standing Stone Inc, 800-6489877
www.standingstoneinc.com
CoumaCare Patient
Management System (v5.1a)
Bristol-Myers Squibb
Pharmaceuticals, 800-3287709
www.coumacare.com
DAWN AC Anticoagulation
Therapy Software v.6.03
4S Information Systems Ltd,
UK, 011-44-15395-63091
www.4s-dawn.com
DoseResponse
Keystone Therapeutics Inc,
Pittsburg, 800-633-8642
www.doseresponse.com
[email protected]
DrugCalc
Therapeutics Technologies
www.clinpharmacologist.bigs
tep.com
Intelligent Dosing System
248-321-0971
[email protected]
Adapted from Ansell et al. Managing Oral Anticoagulation Therapy:Clinical and Operational Guidelines 2003
Patient Education and
Counseling
Patient safety is enhanced when
patients are actively involved in,
understand and take responsibility for
their care
Verbal, written, internet
Discussion
Allow time for questions
All team members
Evaluation and Quality
Assurance (QA)
Time in therapeutic range (TTR)
– Fraction of INR within therapeutic range (eg. No
of INRs in range divided by total no of INR
tests).
– ‘Cross-section of the files’ – assessing fraction of
patients with INR in range at one point in time
compared to the total no of patients tested.
– ‘Linear interpolation’ – linear relationship exists
between 2 INR values and allocates a specific
INR value to each day between tests for each
patient.
Number of adverse outcomes – hemorrhage
(major, minor), thromboembolic event
Patient Self Testing and
Monitoring
Self monitoring – self test and self adjust
treatment according to a predetermined
dose schedule
Self test – self test and call a clinic to
receive the appropriate dose adjustment
Convenience, better treatment compliance,
more frequent monitoring, fewer
thromboembolic and hemorrhagic
complications, improving quality of life
Cost effective
Ansell et al. International J of Card 2005;37-45
Comparison of Anticoagulation
Management Models
Adapted and modified from Ansell JE, J Thrombosis and Thrombolysis, 1998
Patient Self Monitoring – better
INR within target range
Meta-analysis of 14 randomized trial
Heneghan et al. Lancet 2006;367:404-11
Patient Self Monitoring – lower
thromboembolic events
Meta-analysis of 14 randomized trial
Heneghan et al. Lancet 2006;367:404-11
Patient Self Monitoring – lower
major haemorrhage
Meta-analysis of 14 randomized trial
Heneghan et al. Lancet 2006;367:404-11
Patient Self Monitoring
Selection of patient
Patients on long term anticoagulation
therapy
Most patients who are able to lead an
independent and self supporting life
Intellectual ability – able to understand the
concept of oral anticoagulation therapy and
its potential risks
Willingness to actively participate in
treatment, sufficient manual dexterity and
acuity of vision
No previous experience is necessary
Training required
Ansell et al. International J of Card 2005;37-45
Patient Self Monitoring
Coagulometers
Ansell et al. International J of Card 2005;37-45
Medic Alert
The MedicAlert Foundation
– Non-profit company founded in 1956 in
California
Maintains a database of members’ medical
information that is made available to
medical authorities in the event of an
emergency
Members wear a distinctive metal bracelet
or necklace at all times
Medic Alert
Medical conditions and medications
Anticoagulants
Asthma
Diabetes
Epilepsy
Blood Group
Allergies
Special needs – pacemaker, organ donor
Medic Alert Application
Yayasan MedicAlert
Malaysia
c/o University Malaya
Medical Centre,
59100 KL
Tel/Fax :
+603-79601355
24-hour Hotline :
+603-79575111
www.ummc.edu.my
Take Home Message
Warfarin has a narrow therapeutic range and
therefore requires effective monitoring to reduce
adverse outcomes.
Proper management of anticoagulation by a
multidisciplinary team of healthcare workers in a
dedicated anticoagulation clinic is cost effective and
improves patient’s quality of life by delivery of
optimum anticoagulation care.
Patient self testing and monitoring provides a
convenient and reasonable reliable alternative to
attending an anticoagulation clinic.
“The successful use of oral anticoagulation
depends on an essential triad :
A Vigilant physician
A Cooperative patient
A readily available, reliable
laboratory”
……Askey and Cherry
JAMA 1950; 144:97-100