Making POC Anticoagulation Therapy Work

This article is the second in a two-part series on systematic anticoagulation management at the point of care. In the January issue, Part 1 discussed the benefits of POC PT/INR testing.

Making POC anticoagulation therapy work:
Components of a successful program
Michael Samoszuk, MD

Dr. Michael Samoszuk currently holds the position of Chief Medical Officer with Roche Diagnostics Corporation, maker of CoaguChek products. The views expressed herein are based upon his professional judgment and do not necessarily reflect the views of Roche Diagnostics Corporation.

In contrast to conventional lab-based warfarin therapy, managing anticoagulation therapy at the point of care can shift the focus from labor-intensive administration to personalized patient care – and pave the way for several potential benefits for both patients and physician practices.

By putting patient, physician and test results in the same place at the same time, an approach known as systematic anticoagulation management (SAM) can potentially improve communication and efficiency and thus contribute to better patient care. Multiple studies have shown that SAM, focused at the point of care, may increase the time patients are in range, reduce the risk of adverse events, and be more cost-effective than traditional medical care. 1,2,3,4,5

In light of these benefits, why aren’t more physician practices implementing POC anticoagulation management? One reason may be inefficient office workflow models that make it challenging to manage warfarin patients cost-effectively.1 Another may simply be a misconception of what systematic anticoagulation management at the point of care truly entails.

SAM Program Components
While many criteria have been suggested, the essence of the approach can be represented by four simple components – which, in combination, can bring a new standard of care to a potentially life-saving therapy.6,7

1. Direct, active patient management For several years, clinicians have recognized that the success of anticoagulant therapy depends greatly on the way it is managed – with the goal being a coordinated, controlled approach that brings the patient, caregiver and treatment process into close and continuing contact, to enhance the quality and safety of care.5

That approach is the foundation of the SAM protocol – continuous management of anticoagulation therapy by one qualified, accountable healthcare professional. That caregiver – a nurse, pharmacist, or other licensed provider – has primary responsibility for all aspects of the therapy, from scheduling PT/INR testing to monitoring dosage adjustments to patient education.

The skill set of the ideal candidate would include patient education and counseling, as well as administrative and clinical abilities.

The result of this centralized, direct approach to patient management can be much more effective therapy, shorter decision times, improved compliance, and a reduced risk for adverse events.8,9

2. Patient scheduling and tracking
Accurate PT/INR testing and patient-appropriate warfarin dosage adjustments are obviously critical components of systematic anticoagulation management. But they don’t do much good if the frequency and consistency of patient testing can’t also be closely controlled, tracked and fine-tuned.

A fully integrated system to schedule patient testing, track results, signal missed appointments, and alert staff to out-of-range INR test results is essential to the close control SAM provides. Whether the system is computerized or paper-based, it essentially alerts caregivers to what patients need, when they need it, and whether it’s being provided.1,5,7

Despite the appearance of increased administrative costs, the net financial impact of such a system can be positive for a physician practice. By streamlining the data management and patient care components of warfarin therapy, systematic anticoagulation management may significantly reduce the indirect costs of patient management.1

3. Accessible, accurate, frequent PT/INR testing
Close monitoring of PT/INR test results is the clinician’s primary tool for evaluating the effects of warfarin, adjusting dosage and managing anticoagulation therapy.

One way to increase a patient’s time in range – a major goal of therapy – is to arrange frequent PT/INR testing at an easily accessible site. While off-site laboratories may work in the SAM model, point-of-care testing with fingerstick devices can help speed response and simplify the implementation of SAM. Having immediate access to PT/INR readings enables physicians to make dosage adjustments quickly and communicate with their patients on a face-to-face basis.5,7 Plus, the office-based procedure may be reimbursable under many insurance plans – and most patients prefer fingerstick PT/INR tests with a portable monitor over venous lab draws.10,11

There are a few criteria, however, that physician offices should keep in mind when selecting a point-of-care PT/INR testing system. Accuracy, of course, is primary. There are devices available, such as the CoaguChek S system, with up to a 95% correlation with lab results, as well as automatic calibration and system checks for consistent reliability.10,12,13,14

Other criteria are more practical in nature. A shorter test time and smaller blood sample size can help improve both the efficiency of the process and patient satisfaction; devices are available that require only a 10 L sample and provide results in as little as one minute.14 For practices that use computerized data management systems, it can also be helpful to use devices that can directly download test result data, to help ensure data accuracy and integrity.

4. Patient-specific care
Meeting the physical and emotional needs of each person receiving anticoagulation therapy is a central component of systematic anticoagulation management. The patient-specific approach includes face-to-face interaction with the patient and covers the complete range of therapy parameters – from initial assessment and risk evaluation to an individualized care plan and continued patient education/management.

A significant advantage of establishing SAM at the point of care is that the provider can perform testing, receive and interpret results, adjust dosage, and provide relevant patient education all in a single visit. Regardless of the treatment modality, though, systematic management should include careful documentation of each patient encounter – including anything that might affect therapy, compliance, or patient satisfaction.

One important part of patient-specific care is ongoing education of the patient and other caregivers about medications, diet, testing compliance, and therapy-related warning signs. This can happen one-on-one or in a classroom, but it is essential to communicate the patient’s critical role in his or her own therapy.

By enabling the caregiver to recognize and focus on individual needs and differences, patient-specific support and interaction helps make patients partners in their own care.

Few requirements, many rewards
Adopting systematic anticoagulation management at the point of care may require a small investment of time and resources. But it is not as difficult or as costly as some healthcare professionals may expect – and the benefits can be significant, both for the patients and the practice.

The systematic approach that SAM offers can help healthcare providers manage oral anticoagulant therapy with greater confidence and control and – most importantly – it offers the potential for improved patient outcomes, satisfaction, and safety.1,2,3,7,10

References
1. Wurster M, Doran T. Anticoagulation management: A new approach. Disease Management, 2006;4:201-209. Interventional study conducted with 40 patients receiving chronic anticoagulation therapy in a university-affiliated primary care clinic.
2. Ansell JE, Buttaro ML, Thomas OV, et al., and the Anticoagulation Guidelines Task Force. Consensus guidelines for coordinated outpatient oral anticoagulation therapy management. Ann Pharmacother. 1997;31:604-615
3. Singer DF. Anticoagulation for atrial fibrillation: Epidemiology informing a difficult clinical decision. Proc Assoc Am Physicians. 1996:8(1):29-36
4. Campbell P, Radensky P, Denham C. Economic analysis of systematic anticoagulation management vs. routine medical care for patients on oral warfarin therapy. Disease Management and Clinical Outcomes, 2000;2. Economic analysis of cost impact of systematic anticoagulation management vs. routine medical care for 1000 atrial fibrillation patients on warfarin therapy.
5. Jacobson A, Guilloteau F, Campbell P, Denham C. Comparison of point-of-care testing and standard reference laboratory testing for PT/INR measurements in patients receiving routine warfarin therapy: an engineering work process flow study. Disease Management and Clinical Outcomes, 2000;2. Comparison of prospective analysis of workflow and operational costs of PT/INR testing and retrospective analysis of the utilization of anticoagulation management strategies for two point of care clinics and two control clinics that used standard reference laboratories.
6. Jacobson AK. Patient selection and training for patient self-testing and patient self-management of oral anticoagulation. In Ansell JE, Oertel LB, Wittkowsky AK, eds. Managing Oral Anticoagulation Therapy, second edition. Wolters Kluwer Health, Inc. 2003; 45:1-6
7. Premier Innovation Institute. Systematic Anticoagulation Management: A New Patient Care Path, 2000. The basic structure of the systematic anticoagulation management model was developed by the Premier Innovation Institute.
8. Jacobson AK. In Systematic Anticoagulation Management: A New Patient Care Path. Premier Innovation Institute; 2000.
9. Dunn SG. Ambulatory point of care testing and its role in managed health care. HIDA Educational Foundation, Alexandria, Virginia. 1998.
10. Giles TD, Roffidal L. Results of the Prothrombin Office-Testing Benefit Evaluation (PROBE). CVR&R. 2002;23:27-28, 30, 32-33. Multicenter, prospective design study with 1951 patients (up to 50 consecutive) to assess patient, physician and physician office staff satisfaction with an office-based finger-stick method of PT testing vs. the usual method of testing in an outside laboratory.
11. Williams JR. A cost-saving method for monitoring oral warfarin anticoagulant therapy. Cardiovasc Econ. 1997;9-10. Referenced in Giles TD, Roffidal L. Results of the Prothrombin Office-Testing Benefit Evaluation (PROBE). CVR&R. 2002;23:33.
12. Bussey HI, Chiquette E, Bianco TM, et al. A statistical and clinical evaluation of fingerstick and routine laboratory prothrombin time measurements. Pharmacotherapy. 1997;17(5): 861-866.
13. Kaatz SS, White RH, Hill J, et al. Accuracy of laboratory and portable monitor international normalized ratio determinations. Comparison with a criterion standard. Arch Intern Med. 1995;155:1861-1867.
14. CoaguChek S system package insert. Indianapolis, IN. Roche Diagnostics Corporation, 2002.

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