- Email: [email protected]
Improving Warfarin Management Within the Medical Home: A Health-System Approach
Accepted Manuscript Improving warfarin management within the medical home: a health-system approach Anne E. Rose, PharmD, Erin N. Robinson, PharmD, Joan A. Premo, RN, Lori J. Hauschild, MHA, Philip J. Trapskin, PharmD, Ann M. McBride, MD PII:
S0002-9343(16)31066-X
DOI:
10.1016/j.amjmed.2016.09.030
Reference:
AJM 13750
To appear in:
The American Journal of Medicine
Received Date: 28 October 2015 Revised Date:
23 September 2016
Accepted Date: 27 September 2016
Please cite this article as: Rose AE, Robinson EN, Premo JA, Hauschild LJ, Trapskin PJ, McBride AM, Improving warfarin management within the medical home: a health-system approach, The American Journal of Medicine (2016), doi: 10.1016/j.amjmed.2016.09.030. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Title: Improving warfarin management within the medical home: a health-system
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approach
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Authorship Details:
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Anne E. Rose, PharmD (Corresponding Author)
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Address: 600 Highland Avenue, Madison, WI 53792
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Phone: 608-263-9738
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Fax: 608-263-9494
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Email: [email protected]
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Affiliation: Department of Pharmacy, University of Wisconsin Hospital and Clinics
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Erin N. Robinson, PharmD
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Affiliation: Department of Pharmacy, University of Wisconsin Hospitals and Clinics
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Joan A. Premo, RN
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Affiliation: University of Wisconsin Medical Foundation
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Lori J. Hauschild, MHA
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Affiliation: University of Wisconsin Medical Foundation
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Philip J. Trapskin, PharmD
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Affiliation: Department of Pharmacy, University of Wisconsin Hospital and Clinics
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Ann M. McBride, MD
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Affiliation: Department of Medicine, University of Wisconsin Medical Foundation
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Funding Source: None
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Conflict of Interest Statement: All authors confirm no conflict of interest.
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Verification of Roles: All authors had access to the data and had a role in development
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of the study, access to and evaluation of the study data and in preparation and review of
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the manuscript.
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Article Type: Clinical Research Study
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Key Words: Anticoagulants; patient-centered care; warfarin; primary health care
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Running Head: Warfarin management in the medical home
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Abstract:
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Background: Anticoagulation clinics have been considered the optimal strategy for
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warfarin management with demonstrated improved patient outcomes through increased
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time in therapeutic INR range, decreased critical INR values and decreased
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anticoagulation-related adverse events. However, not all health systems are able to
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support a specialized anticoagulation clinic or may see patient volume exceed available
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anticoagulation clinic resources. The purpose of this study was to utilize an
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anticoagulation clinic model to standardize warfarin management in a primary care clinic
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setting. Methods: A warfarin management program was developed which included
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standardized patient assessment, protocolized warfarin dosing algorithm and electronic
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documentation and reporting tools. Primary care clinics were targeted for training and
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implementation of this program. Results: The warfarin management program was
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applied to over 2,000 patients and implemented at 39 clinic sites. A total of 160 nurses
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and 15 pharmacists were trained on the program. Documentation of warfarin dose and
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date of the next INR increased from 70% to 90% (p<0.0001), documentation occurring
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within 24 hours of the INR result increased from 75% to 87% (p<0.0001), and
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monitoring the INR at least every 4 weeks increased from 71% to 83% (p<0.0001) per
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patient encounter. Time in therapeutic INR range improved from 65% to 75%.
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Conclusions: Incorporating a standardized approach to warfarin management in the
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primary care setting significantly improves warfarin related documentation and time in
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therapeutic INR range.
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Manuscript:
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Background:
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Despite the emergence of direct oral anticoagulants, warfarin continues to be the
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predominant anticoagulant used for the prevention of stroke in non-valvular atrial
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fibrillation and treatment of venous thromboembolism.1-6 The challenges of warfarin
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therapy, are well known, including but not limited to: the need for routine international
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normalized ratio (INR) monitoring, lack of standardized dosing, extensive food and drug
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interactions, and significant morbidity and mortality associated with both subtherapeutic
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and supratherapeutic INRs.7
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In an effort to overcome the challenges of warfarin, management has evolved from
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adjusting the dose based primarily on INR results, to a more comprehensive strategy that
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also incorporates patient assessment. This comprehensive strategy has shown to improve
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patient outcomes but is more labor intensive. To maximize the value of a comprehensive
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approach dedicated anticoagulation clinics have been created to serve patients by
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leveraging efficiencies of skill-mix (i.e. staffing with pharmacists and nurses vs.
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physicians) and expertise. Anticoagulation clinics typically utilize standardized
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processes for patient assessment, documentation, education, transition, and dosing. The
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anticoagulation clinic approach has been demonstrated to improve patient outcomes such
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as: increased time in therapeutic INR range (TTR), decreased critical INR values,
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decreased anticoagulation-related adverse events, decreased emergency room and urgent
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care visits and lower overall anticoagulation-related healthcare costs.8-12
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Despite the demonstrated value of anticoagulation clinics, use of this approach is not
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universally adopted due to fiscal constraints, ability to hire qualified staff, and patient
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preference to streamline care through the medical home. The challenge is to design an
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anticoagulation management strategy that capitalizes on the best practices of
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anticoagulation clinics and efficiency of the medical home without compromising quality
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or safety outcomes.
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We are an integrated health care system comprised of 120 primary and specialty care
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clinics. Throughout the system there are over 2,000 patients receiving warfarin therapy
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in both the primary and specialty clinic settings. Within these ambulatory clinics
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anticoagulation is managed based on one of the following models of care: management
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by the primary care or specialty care physician or physician extender, nurse or pharmacist
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in a primary care or specialty clinic, or a pharmacist-run anticoagulation clinic. The
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specialized anticoagulation clinic manages warfarin therapy for about 500 patients.
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Patient utilization of this clinic is limited by geographical proximity and clinic resources.
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The majority of anticoagulation therapy management within our system occurs within the
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primary care medical home.
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In 2008, an analysis of anticoagulation practices across our system found significant
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variations in: the level of training of clinic staff directing warfarin management,
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workflows, documentation and the quality of management. While the majority of clinics
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did not utilize a warfarin dosing nomogram, there were 5 different warfarin dosing
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nomograms found among those who did. Also identified were 3 documentation systems
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being utilized that included paper charts and documentation within 2 separate electronic
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medical records (EMR). Paper chart documentation was not being scanned into the EMR
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and therefore not available to other providers and documentation in the EMR was not
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standardized or easily accessible to all system providers.
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This analysis was reviewed by clinic operations nursing leadership, the Anticoagulation
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Stewardship Program and Ambulatory Anticoagulation Committee (AAC) who together
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developed recommendations to improve patient care and to remove gaps identified in the
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analysis. Recommendations included utilizing same techniques common to
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anticoagulation clinics by standardizing warfarin management and documentation across
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all primary care clinics and to transition warfarin management from physicians to either a
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trained nurse or pharmacist.
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The primary objectives of the ambulatory improvement project were threefold: 1)
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standardize warfarin management by implementing a delegation protocol for clinic nurses
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and pharmacists, 2) implement an electronic platform to standardize documentation and
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3) develop training materials and competencies for clinic staff working under the
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protocol. Secondary objectives included monitoring quality and safety outcomes data
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and comparing outcomes to a specialized anticoagulation clinic.
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Design and Methods:
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Standardizing Warfarin Management:
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The AAC created a workgroup to spearhead this initiative. The workgroup was led by
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the Anticoagulation Stewardship Program pharmacist and included primary care
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physicians, front line nurses and pharmacists, clinic operations managers, and technical
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system support members.
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The workgroup identified best practices through a comprehensive literature and web
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search of published warfarin management guidelines and protocols. From there a
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delegation protocol was created that allowed physicians to delegate warfarin management
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to either a clinic nurse or pharmacist. The protocol defined roles for each member of the
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clinic team and defined training and competency requirements prior to assuming
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management responsibilities.
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The workgroup was tasked with implementing an electronic platform that would support
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documentation of warfarin management while interfacing with the current active EMR.
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The workgroup attended demonstrations of the anticoagulation platform by the current
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EMR provider and were in agreement to incorporate this platform into the warfarin
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management workflow.
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The workgroup utilized this platform and customized it to drive the protocol requirements
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of documenting warfarin indication, INR goal, dose plans, and INR monitoring
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recommendations. Progress note templates were created to help standardize
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documentation, flow sheets were optimized to trend discrete data, and reporting systems
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were created for monitoring the quality and safety of warfarin management.
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The workgroup defined training requirements, developed training materials and devised a
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method for training protocol users. Each clinic nurse or pharmacist was expected to
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complete training on the protocol and demonstrate competency prior to using the
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protocol. Training was either through attendance of live sessions or via computer based
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training (CBT).
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Monitoring Protocol Adherence and Management Outcomes:
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To determine protocol adherence, retrospective chart reviews were conducted. These
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reviews gathered data on documentation and monitoring requirements as outlined by the
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protocol. It was determined to gather this data in at least 10% of the total warfarin patient
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population and to have representation from a variety of primary care clinic locations.
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Data was collected both pre- and post-protocol implementation in order to compare
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traditional management to protocolized management.
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Warfarin control was calculated using linear interpolation and reported as a TTR
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percentage. This calculation was based off a modified version of the Rosendaal et al.,
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linear calculation.13 For the TTR calculation an INR of 0.1 above or below the target
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range was considered to be within the INR goal. All protocol patients with at least 2
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resulted INRs within the study timeframe were included in the analysis. Any INR
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resulted during a hospitalization was excluded from the calculation. Critical INR results
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were obtained through institution laboratory data.
3 Statistical Analysis:
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For this analysis we used the X2 test to compare completed documentation requirements
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for warfarin management pre- and post-protocol implementation. X2 test was also used to
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compare critical INR values pre- and post-protocol implementation. A p-value <0.05 was
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considered to be statistically significant. All analyses were performed with GraphPad
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Prism Version 6.0 (San Diego, CA).
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Results:
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In the fall of 2009, the AAC workgroup created a delegation protocol for warfarin
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management. It provides step by step instructions on how to initiate a patient on warfarin
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therapy, complete a patient assessment (Figure 1), calculate warfarin dose adjustments,
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monitor an INR, defines what information should be documented in the EMR and
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outlines patient education needs. The protocol was approved for use by our AAC
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Committee, Pharmacy and Therapeutics Committee and Medical Board. The complete
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protocol is available at www.uwhealth.org/anticoagulation.
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Implementation of the electronic documentation platform occurred in 2010. System
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upgrades were completed in phases across our health system with all clinics fully live on
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the new system by October 2010. The new documentation platform created an
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anticoagulation episode of care that linked all telephone encounters, face-to-face
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encounters, laboratory data and documentation for warfarin management including:
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indication, target INR range, weekly warfarin doses, warfarin related labs, progress notes
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and longitudinal dosing flow sheets together in one anticoagulation folder within the
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EMR. The episode of care also allowed for the creation of patient registries and alerting
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systems for when patients are overdue for INR checks.
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Thirty nine sites were targeted for implementation of the warfarin management protocol.
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Two of these sites were the pharmacist-run Anticoagulation Clinic. Thirty-six clinics
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were primary care clinics, two utilized pharmacists and 34 utilized nurses to manage
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warfarin therapy. One clinic was a cardiology specialty clinic that utilized nurses to
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manage warfarin therapy.
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With several clinic sites and a large number of clinic staff requiring training, it was
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agreed to use a “train-the-trainer” approach. Each clinic identified a nurse or pharmacist
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as a protocol champion. The clinic champion was required to attend a live training
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session on the warfarin delegation protocol. The clinic champion has additional
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responsibilities that include serving as the clinical resource on warfarin for their clinic,
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ensuring the completion of training for existing and future clinic staff, and ordering
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patient educational materials for their clinic. The clinic champion also assists with
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assessing the competency of clinic staff. All other nurses or pharmacists were required to
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complete a CBT that closely mirrored the live training sessions.
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Forty nurses and three pharmacists were identified as champions for the 39 clinics. Five
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of the primary care clinic sites selected 2 nurse champions per site based on patient load
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and nurse scheduling. Each clinic champion attended a 3 hour live training session on the
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warfarin management protocol that included both a didactic session and patient case
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reviews in a small group setting. Additional 120 nurses and 12 pharmacists were trained
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via a 1.5 hour CBT module. Each protocol user achieved competency by completing a
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clinical assessment, devising a warfarin management plan and reviewing this plan with
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their clinic champion or lead physician for 5 patients seen within their clinic. Clinics
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were given 6 months to complete training, achieve competencies and implement the
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warfarin management protocol. Thirty-six clinics met the set deadline. All clinics were
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utilizing the warfarin management protocol by December 2010.
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Patient characteristic data for primary care and anticoagulation clinics are described in
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Table 1. This data represents the first full year for patients enrolled in the protocol. To
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avoid duplication, only the primary indication for warfarin was included in the data
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review. The average age for both clinics was similar with 69.3 years in primary care
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clinic and 66.7 years in anticoagulation clinic. Anticoagulation clinic did have a
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significantly higher number of patients in the < 49 years category than compared to the
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primary care clinic setting. No difference was seen in the other age categories between
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the two clinic settings. There were significantly more patients managed by primary care
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with an INR goal of 2.5 – 3.5 than compared to anticoagulation clinic. There were no
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differences seen between the most common indications managed between the clinic
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settings. Significance was seen for the “other” indications in primary care clinic sites.
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Other indications included: cerebral vascular accident, transient ischemic attack,
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thrombosis of unusual site, venous thromboembolism prophylaxis, coagulation disorders,
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and did not reach > 5% per individual indication.
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To evaluate the efficacy of the new electronic documentation system and to evaluate
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protocol adherence of documentation requirements, a sample of patient charts from
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primary care clinics were retrospectively reviewed. Documentation data can be seen in
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Table 2. Additionally, protocol adherence for INR monitoring was also evaluated with
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results reported in Table 2. This data reflects approximately 10% of the total warfarin
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patient population for 6 months prior to protocol implementation and 6 months post
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protocol implementation. The most significant documentation improvements were seen in
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the recording of the warfarin dose and documenting the date of the next INR check.
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There were also significant improvements in monitoring the INR at least once every 4
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weeks and in completing documentation of the warfarin management plan within 24
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hours of the resulted INR.
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Pre-protocol data for traditional warfarin management shows a TTR range of 65% for the
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primary care clinics. Data from 2010 was not reviewed as this year was used for
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transitioning patients from provider management to protocol management. Based on
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previous literature, a TTR of 70% was the target goal for our health system.14 After
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implementation of the protocol the TTR goal has been consistently achieved across the
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primary care clinics as described in Table 3.
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1 A critical INR value is defined in our health system as an INR > 5. Table 4 shows data of
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all critical INR and total INR values between primary care and anticoagulation clinic.
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Overall, the incidence rate of critical INR values was unchanged after implementation of
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the protocol. A comparison between the clinics settings demonstrate significantly lower
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incidence of critical INRs in patients managed through the anticoagulation clinic.
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Our study shows the implementation of a standardized warfarin management program
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across a health system was successful in improving the TTR. Additionally, implementing
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a standardized electronic documentation system also improved the documentation of the
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warfarin management plan including: indication, INR goal, warfarin dose and time to
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next INR and allowed all providers access to the warfarin management information. It
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also provided the opportunity to create real time registries for each clinic and to create
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retrospective reports to monitor adherence to the warfarin protocol and clinic-specific
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outcome measures.
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The unique aspect of this management program was the expansive nature of our protocol.
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We were able to successfully standardize care for over 2,000 patients in 39 clinics
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utilizing both nurse and pharmacist clinicians. Our study demonstrates that with a well-
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structured documentation system and management protocol, most warfarin management
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can occur in the patient’s medical home. To our knowledge this is the first study to
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demonstrate these results on a large scale.
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There are limitations to our study. We were not able to capture additional outcome
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measures on urgent care visits, emergency department visits and hospitalizations due to
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anticoagulation or thrombotic related events. Our health system provides services to
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patients throughout South Central Wisconsin. Because of this wide area of coverage,
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patients may not always present back to an affiliated urgent care center or hospital for
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their emergent needs. Without comprehensive data on emergency department and urgent
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care visits it is difficult to calculate the potential for health care cost savings with our
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management program. However, based on previously published studies we can infer that
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by achieving a target TTR of greater than 70% we can expect less major bleeding events,
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thromboembolic events, urgent care, emergency department visits and hospitalizations
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related to anticoagulation.8-12,14 The INRs used for the TTR calculation includes all
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ambulatory INRs for patients who are managed per the warfarin management program.
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We were unable to exclude INR results for patients who were intentionally being held for
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procedures. To account for this we used a timeframe of 6 months to calculate TTR.
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Additionally, the data for critical INR values and total INRs resulted includes all INR
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values performed for all ambulatory patients. We were not able to exclude INR results
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for patients who are not followed per the warfarin management program. Finally, while
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the EMR used within our system improved all of the documentation parameters in this
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study, it did not achieve 100% as would be expected. This was due to a limitation within
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the system of not requiring the documentation of these parameters.
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The quality of warfarin management is judged by the TTR and pre-protocol
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implementation our TTR was 65%, which would suggest a fairly good INR control. We
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set our TTR goal to achieve a target of > 70% based on data suggesting decreased
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bleeding and thrombotic outcomes associated with good INR control.8-12,14 Post protocol
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implementation the findings of our study are similar to others that show improved TTR
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when warfarin management was transitioned from the traditional care model of
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physician management to either nurse or pharmacist managed warfarin therapy. Other
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studies have additionally compared the difference in warfarin management between
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nurses and pharmacists. In these studies, patients that are managed by pharmacists have a
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higher TTR, less critical INR values and reduced emergency room visits.8-12, 15-17 While
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our data supports the utility of pharmacist-led anticoagulation clinics it also validates that
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with a well-developed management program improvements in TTR can be achieved with
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nurse management. It can also be assumed that improvements would be seen if the
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protocol was utilized by primary care physicians or advanced practice providers.
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It should be mentioned that not all anticoagulation management is equivalent.
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Specialized anticoagulation clinics continue to have a place in providing tailored therapy
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to the specific needs of complicated patients. Anticoagulation clinic providers continue to
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serve as the experts in the rapidly changing field of anticoagulation therapy, providing
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advice and education to patients and providers, and helping to develop and pilot new
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guidelines and protocols that include the growing number of oral anticoagulants. Many
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studies have shown the positive impact that anticoagulation clinics have not only on
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clinical outcomes but also on health care expenditures.8,9,12 Our study also showed a
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higher TTR and lower incidence of critical INRs in the anticoagulation clinic than
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compared to the primary care sites.
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The difference in critical INRs, despite a protocolized approach, may be due to a variety
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of factors. Our anticoagulation clinic is managed by pharmacists who may be able to
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better recognize significant drug interactions thus preventing a critical INR result.18
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Patients may be more proactive with informing the anticoagulation clinic of medication
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and medical changes, as they are consistently reminded to do so by anticoagulation clinic
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pharmacists. Finally, patients may not inform their primary care clinic of changes made
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outside the medical home if there is an assumption that communication is already
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occurring with the primary care provider. However, these are assumptions that will need
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further investigation.
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Our program demonstrates that a standardized approach to warfarin management,
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through the use of a delegation protocol and standardized documentation, significantly
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improves warfarin management. = Utilizing the clinic pharmacists and nurses through
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protocol based warfarin management has increased our time within therapeutic INR
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range. In a time when the medical landscape is changing and resources are limited, our
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warfarin management program model fits within the concept of delivering care in the
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medical home. Health systems with limited financial resources to dedicate to a
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specialized anticoagulation clinic can utilize this model with their current clinical staff
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and see improvements.
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healthcare professionals’ knowledge about warfarin-vitamin K drug-nutrient
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interactions. J Am Coll Nutr. 2000; 19(4):439-45.
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Table 1. Characteristics of patients enrolled in the warfarin protocol Primary Care Clinics
(data from 2011)
N = 2153
Male (%) Age (average)
Anticoagulation Clinics P Value N = 506
1147 (53%)
287 (57%)
69.3
66.7
129 (6%)
56 (11.1%)
NS
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Patient Characteristics
< 49 years
•
50 – 74 years
1253 (58.2%)
274 (54.1%)
NS
•
> 75 years
771 (35.8%)
176 (34.8%)
NS
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•
INR Goal
0.001
2.0 – 3.0
1830 (85%)
433 (85.5%)
NS
•
2.5 – 3.5
218 (8.9%)
31 (6.1%)
0.005
•
Other
132 (6.1%)
42 (8.3%)
NS
1202 (55.8%)
293 (57.9%)
NS
194 (9%)
39 (7.7%)
NS
474 (22.1%)
128 (25.3%)
NS
283 (13.1%)
46 (9.1%)
0.01
Indication (primary)
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Atrial Fibrillation
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Heart Valve Replacement
•
Venous Thromboembolism
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Other
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Table 2. Documentation of Warfarin Management Post – Protocol
N = 395
N = 461
Documenting Indication
95%
96%
Documenting INR Range
86%
90%
INR Checked at least Every 4 weeks
71%
Documenting Dose and Next INR Date Documenting within 24 hours of
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0.09
83%
<0.0001
70%
90%
<0.0001
75%
87%
<0.0001
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P Value
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Table 3. Time Within Therapeutic INR Range Jan – Jun
Jul – Dec Jan – Jun Jul – Dec Jan – Jun
(pre-data)
2011
2011
2012
2012
2013
2013
1435*
1985
2291
2282
2285
2576
2678
2911
65%
74%
74.2%
74.3%
77%
76%
75%
Patients
345
364
TTR
83%
84%
TTR
Anticoagulation Clinic
76%
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Primary Care Clinics
418
463
470
532
84%
84%
82%
81%
81%
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392
*This represents approximately 1/3rd of patients within the health system
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Table 4. Critical INR Values Anticoagulation Clinic
Critical
Total
Event
Critical
Total
INR
INR
Rate/yr (%)
INR
INR
2009*
639
51 ,269
1.2
2011
643
54,372
1.2
18
6,872
2012
661
56,616
1.2
22
2013
703
61,314
1.1
2014
639
53,560
1.2
Rate/yr (%)
7,077
0.3
<0.001
23
7,076
0.3
<0.001
16
7,717
0.2
<0.001
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<0.001
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P value
0.3
*pre-data from 2009 available for primary care clinics
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We implemented an anticoagulation clinic model of care into a primary care setting to achieve improved quality and safety outcomes for warfarin management We utilized existing clinic nurse and pharmacy staff to avoid an increase in health care resources and costs
We utilized the electronic medical record to implement standardized warfarin
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management and documentation.
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S0002-9343(16)31066-X
DOI:
10.1016/j.amjmed.2016.09.030
Reference:
AJM 13750
To appear in:
The American Journal of Medicine
Received Date: 28 October 2015 Revised Date:
23 September 2016
Accepted Date: 27 September 2016
Please cite this article as: Rose AE, Robinson EN, Premo JA, Hauschild LJ, Trapskin PJ, McBride AM, Improving warfarin management within the medical home: a health-system approach, The American Journal of Medicine (2016), doi: 10.1016/j.amjmed.2016.09.030. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Title: Improving warfarin management within the medical home: a health-system
2
approach
3
Authorship Details:
4
Anne E. Rose, PharmD (Corresponding Author)
5
Address: 600 Highland Avenue, Madison, WI 53792
6
Phone: 608-263-9738
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Fax: 608-263-9494
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Email: [email protected]
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Affiliation: Department of Pharmacy, University of Wisconsin Hospital and Clinics
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Erin N. Robinson, PharmD
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Affiliation: Department of Pharmacy, University of Wisconsin Hospitals and Clinics
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Joan A. Premo, RN
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Affiliation: University of Wisconsin Medical Foundation
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Lori J. Hauschild, MHA
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Affiliation: University of Wisconsin Medical Foundation
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Philip J. Trapskin, PharmD
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Affiliation: Department of Pharmacy, University of Wisconsin Hospital and Clinics
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Ann M. McBride, MD
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Affiliation: Department of Medicine, University of Wisconsin Medical Foundation
2
Funding Source: None
3
Conflict of Interest Statement: All authors confirm no conflict of interest.
4
Verification of Roles: All authors had access to the data and had a role in development
5
of the study, access to and evaluation of the study data and in preparation and review of
6
the manuscript.
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Article Type: Clinical Research Study
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Key Words: Anticoagulants; patient-centered care; warfarin; primary health care
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Running Head: Warfarin management in the medical home
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Abstract:
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Background: Anticoagulation clinics have been considered the optimal strategy for
3
warfarin management with demonstrated improved patient outcomes through increased
4
time in therapeutic INR range, decreased critical INR values and decreased
5
anticoagulation-related adverse events. However, not all health systems are able to
6
support a specialized anticoagulation clinic or may see patient volume exceed available
7
anticoagulation clinic resources. The purpose of this study was to utilize an
8
anticoagulation clinic model to standardize warfarin management in a primary care clinic
9
setting. Methods: A warfarin management program was developed which included
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standardized patient assessment, protocolized warfarin dosing algorithm and electronic
11
documentation and reporting tools. Primary care clinics were targeted for training and
12
implementation of this program. Results: The warfarin management program was
13
applied to over 2,000 patients and implemented at 39 clinic sites. A total of 160 nurses
14
and 15 pharmacists were trained on the program. Documentation of warfarin dose and
15
date of the next INR increased from 70% to 90% (p<0.0001), documentation occurring
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within 24 hours of the INR result increased from 75% to 87% (p<0.0001), and
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monitoring the INR at least every 4 weeks increased from 71% to 83% (p<0.0001) per
18
patient encounter. Time in therapeutic INR range improved from 65% to 75%.
19
Conclusions: Incorporating a standardized approach to warfarin management in the
20
primary care setting significantly improves warfarin related documentation and time in
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therapeutic INR range.
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Manuscript:
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Background:
3
Despite the emergence of direct oral anticoagulants, warfarin continues to be the
4
predominant anticoagulant used for the prevention of stroke in non-valvular atrial
5
fibrillation and treatment of venous thromboembolism.1-6 The challenges of warfarin
6
therapy, are well known, including but not limited to: the need for routine international
7
normalized ratio (INR) monitoring, lack of standardized dosing, extensive food and drug
8
interactions, and significant morbidity and mortality associated with both subtherapeutic
9
and supratherapeutic INRs.7
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In an effort to overcome the challenges of warfarin, management has evolved from
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adjusting the dose based primarily on INR results, to a more comprehensive strategy that
13
also incorporates patient assessment. This comprehensive strategy has shown to improve
14
patient outcomes but is more labor intensive. To maximize the value of a comprehensive
15
approach dedicated anticoagulation clinics have been created to serve patients by
16
leveraging efficiencies of skill-mix (i.e. staffing with pharmacists and nurses vs.
17
physicians) and expertise. Anticoagulation clinics typically utilize standardized
18
processes for patient assessment, documentation, education, transition, and dosing. The
19
anticoagulation clinic approach has been demonstrated to improve patient outcomes such
20
as: increased time in therapeutic INR range (TTR), decreased critical INR values,
21
decreased anticoagulation-related adverse events, decreased emergency room and urgent
22
care visits and lower overall anticoagulation-related healthcare costs.8-12
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Despite the demonstrated value of anticoagulation clinics, use of this approach is not
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universally adopted due to fiscal constraints, ability to hire qualified staff, and patient
3
preference to streamline care through the medical home. The challenge is to design an
4
anticoagulation management strategy that capitalizes on the best practices of
5
anticoagulation clinics and efficiency of the medical home without compromising quality
6
or safety outcomes.
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We are an integrated health care system comprised of 120 primary and specialty care
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clinics. Throughout the system there are over 2,000 patients receiving warfarin therapy
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in both the primary and specialty clinic settings. Within these ambulatory clinics
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anticoagulation is managed based on one of the following models of care: management
12
by the primary care or specialty care physician or physician extender, nurse or pharmacist
13
in a primary care or specialty clinic, or a pharmacist-run anticoagulation clinic. The
14
specialized anticoagulation clinic manages warfarin therapy for about 500 patients.
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Patient utilization of this clinic is limited by geographical proximity and clinic resources.
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The majority of anticoagulation therapy management within our system occurs within the
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primary care medical home.
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In 2008, an analysis of anticoagulation practices across our system found significant
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variations in: the level of training of clinic staff directing warfarin management,
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workflows, documentation and the quality of management. While the majority of clinics
22
did not utilize a warfarin dosing nomogram, there were 5 different warfarin dosing
23
nomograms found among those who did. Also identified were 3 documentation systems
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being utilized that included paper charts and documentation within 2 separate electronic
2
medical records (EMR). Paper chart documentation was not being scanned into the EMR
3
and therefore not available to other providers and documentation in the EMR was not
4
standardized or easily accessible to all system providers.
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This analysis was reviewed by clinic operations nursing leadership, the Anticoagulation
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Stewardship Program and Ambulatory Anticoagulation Committee (AAC) who together
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developed recommendations to improve patient care and to remove gaps identified in the
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analysis. Recommendations included utilizing same techniques common to
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anticoagulation clinics by standardizing warfarin management and documentation across
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all primary care clinics and to transition warfarin management from physicians to either a
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trained nurse or pharmacist.
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The primary objectives of the ambulatory improvement project were threefold: 1)
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standardize warfarin management by implementing a delegation protocol for clinic nurses
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and pharmacists, 2) implement an electronic platform to standardize documentation and
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3) develop training materials and competencies for clinic staff working under the
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protocol. Secondary objectives included monitoring quality and safety outcomes data
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and comparing outcomes to a specialized anticoagulation clinic.
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Design and Methods:
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Standardizing Warfarin Management:
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The AAC created a workgroup to spearhead this initiative. The workgroup was led by
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the Anticoagulation Stewardship Program pharmacist and included primary care
3
physicians, front line nurses and pharmacists, clinic operations managers, and technical
4
system support members.
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The workgroup identified best practices through a comprehensive literature and web
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search of published warfarin management guidelines and protocols. From there a
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delegation protocol was created that allowed physicians to delegate warfarin management
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to either a clinic nurse or pharmacist. The protocol defined roles for each member of the
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clinic team and defined training and competency requirements prior to assuming
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management responsibilities.
12 Electronic Documentation Support:
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The workgroup was tasked with implementing an electronic platform that would support
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documentation of warfarin management while interfacing with the current active EMR.
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The workgroup attended demonstrations of the anticoagulation platform by the current
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EMR provider and were in agreement to incorporate this platform into the warfarin
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management workflow.
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The workgroup utilized this platform and customized it to drive the protocol requirements
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of documenting warfarin indication, INR goal, dose plans, and INR monitoring
22
recommendations. Progress note templates were created to help standardize
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1
documentation, flow sheets were optimized to trend discrete data, and reporting systems
2
were created for monitoring the quality and safety of warfarin management.
3 Training Materials and Competencies:
5
The workgroup defined training requirements, developed training materials and devised a
6
method for training protocol users. Each clinic nurse or pharmacist was expected to
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complete training on the protocol and demonstrate competency prior to using the
8
protocol. Training was either through attendance of live sessions or via computer based
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training (CBT).
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Monitoring Protocol Adherence and Management Outcomes:
12
To determine protocol adherence, retrospective chart reviews were conducted. These
13
reviews gathered data on documentation and monitoring requirements as outlined by the
14
protocol. It was determined to gather this data in at least 10% of the total warfarin patient
15
population and to have representation from a variety of primary care clinic locations.
16
Data was collected both pre- and post-protocol implementation in order to compare
17
traditional management to protocolized management.
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Warfarin control was calculated using linear interpolation and reported as a TTR
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percentage. This calculation was based off a modified version of the Rosendaal et al.,
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linear calculation.13 For the TTR calculation an INR of 0.1 above or below the target
22
range was considered to be within the INR goal. All protocol patients with at least 2
23
resulted INRs within the study timeframe were included in the analysis. Any INR
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1
resulted during a hospitalization was excluded from the calculation. Critical INR results
2
were obtained through institution laboratory data.
3 Statistical Analysis:
5
For this analysis we used the X2 test to compare completed documentation requirements
6
for warfarin management pre- and post-protocol implementation. X2 test was also used to
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compare critical INR values pre- and post-protocol implementation. A p-value <0.05 was
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considered to be statistically significant. All analyses were performed with GraphPad
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Prism Version 6.0 (San Diego, CA).
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Results:
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In the fall of 2009, the AAC workgroup created a delegation protocol for warfarin
13
management. It provides step by step instructions on how to initiate a patient on warfarin
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therapy, complete a patient assessment (Figure 1), calculate warfarin dose adjustments,
15
monitor an INR, defines what information should be documented in the EMR and
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outlines patient education needs. The protocol was approved for use by our AAC
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Committee, Pharmacy and Therapeutics Committee and Medical Board. The complete
18
protocol is available at www.uwhealth.org/anticoagulation.
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Implementation of the electronic documentation platform occurred in 2010. System
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upgrades were completed in phases across our health system with all clinics fully live on
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the new system by October 2010. The new documentation platform created an
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anticoagulation episode of care that linked all telephone encounters, face-to-face
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encounters, laboratory data and documentation for warfarin management including:
2
indication, target INR range, weekly warfarin doses, warfarin related labs, progress notes
3
and longitudinal dosing flow sheets together in one anticoagulation folder within the
4
EMR. The episode of care also allowed for the creation of patient registries and alerting
5
systems for when patients are overdue for INR checks.
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Thirty nine sites were targeted for implementation of the warfarin management protocol.
8
Two of these sites were the pharmacist-run Anticoagulation Clinic. Thirty-six clinics
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were primary care clinics, two utilized pharmacists and 34 utilized nurses to manage
10
warfarin therapy. One clinic was a cardiology specialty clinic that utilized nurses to
11
manage warfarin therapy.
12
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With several clinic sites and a large number of clinic staff requiring training, it was
14
agreed to use a “train-the-trainer” approach. Each clinic identified a nurse or pharmacist
15
as a protocol champion. The clinic champion was required to attend a live training
16
session on the warfarin delegation protocol. The clinic champion has additional
17
responsibilities that include serving as the clinical resource on warfarin for their clinic,
18
ensuring the completion of training for existing and future clinic staff, and ordering
19
patient educational materials for their clinic. The clinic champion also assists with
20
assessing the competency of clinic staff. All other nurses or pharmacists were required to
21
complete a CBT that closely mirrored the live training sessions.
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Forty nurses and three pharmacists were identified as champions for the 39 clinics. Five
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of the primary care clinic sites selected 2 nurse champions per site based on patient load
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and nurse scheduling. Each clinic champion attended a 3 hour live training session on the
4
warfarin management protocol that included both a didactic session and patient case
5
reviews in a small group setting. Additional 120 nurses and 12 pharmacists were trained
6
via a 1.5 hour CBT module. Each protocol user achieved competency by completing a
7
clinical assessment, devising a warfarin management plan and reviewing this plan with
8
their clinic champion or lead physician for 5 patients seen within their clinic. Clinics
9
were given 6 months to complete training, achieve competencies and implement the
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warfarin management protocol. Thirty-six clinics met the set deadline. All clinics were
11
utilizing the warfarin management protocol by December 2010.
12
Patient characteristic data for primary care and anticoagulation clinics are described in
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Table 1. This data represents the first full year for patients enrolled in the protocol. To
15
avoid duplication, only the primary indication for warfarin was included in the data
16
review. The average age for both clinics was similar with 69.3 years in primary care
17
clinic and 66.7 years in anticoagulation clinic. Anticoagulation clinic did have a
18
significantly higher number of patients in the < 49 years category than compared to the
19
primary care clinic setting. No difference was seen in the other age categories between
20
the two clinic settings. There were significantly more patients managed by primary care
21
with an INR goal of 2.5 – 3.5 than compared to anticoagulation clinic. There were no
22
differences seen between the most common indications managed between the clinic
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settings. Significance was seen for the “other” indications in primary care clinic sites.
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Other indications included: cerebral vascular accident, transient ischemic attack,
2
thrombosis of unusual site, venous thromboembolism prophylaxis, coagulation disorders,
3
and did not reach > 5% per individual indication.
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To evaluate the efficacy of the new electronic documentation system and to evaluate
6
protocol adherence of documentation requirements, a sample of patient charts from
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primary care clinics were retrospectively reviewed. Documentation data can be seen in
8
Table 2. Additionally, protocol adherence for INR monitoring was also evaluated with
9
results reported in Table 2. This data reflects approximately 10% of the total warfarin
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patient population for 6 months prior to protocol implementation and 6 months post
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protocol implementation. The most significant documentation improvements were seen in
12
the recording of the warfarin dose and documenting the date of the next INR check.
13
There were also significant improvements in monitoring the INR at least once every 4
14
weeks and in completing documentation of the warfarin management plan within 24
15
hours of the resulted INR.
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Pre-protocol data for traditional warfarin management shows a TTR range of 65% for the
19
primary care clinics. Data from 2010 was not reviewed as this year was used for
20
transitioning patients from provider management to protocol management. Based on
21
previous literature, a TTR of 70% was the target goal for our health system.14 After
22
implementation of the protocol the TTR goal has been consistently achieved across the
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primary care clinics as described in Table 3.
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1 A critical INR value is defined in our health system as an INR > 5. Table 4 shows data of
3
all critical INR and total INR values between primary care and anticoagulation clinic.
4
Overall, the incidence rate of critical INR values was unchanged after implementation of
5
the protocol. A comparison between the clinics settings demonstrate significantly lower
6
incidence of critical INRs in patients managed through the anticoagulation clinic.
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9
Our study shows the implementation of a standardized warfarin management program
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across a health system was successful in improving the TTR. Additionally, implementing
11
a standardized electronic documentation system also improved the documentation of the
12
warfarin management plan including: indication, INR goal, warfarin dose and time to
13
next INR and allowed all providers access to the warfarin management information. It
14
also provided the opportunity to create real time registries for each clinic and to create
15
retrospective reports to monitor adherence to the warfarin protocol and clinic-specific
16
outcome measures.
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The unique aspect of this management program was the expansive nature of our protocol.
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We were able to successfully standardize care for over 2,000 patients in 39 clinics
20
utilizing both nurse and pharmacist clinicians. Our study demonstrates that with a well-
21
structured documentation system and management protocol, most warfarin management
22
can occur in the patient’s medical home. To our knowledge this is the first study to
23
demonstrate these results on a large scale.
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There are limitations to our study. We were not able to capture additional outcome
2
measures on urgent care visits, emergency department visits and hospitalizations due to
3
anticoagulation or thrombotic related events. Our health system provides services to
4
patients throughout South Central Wisconsin. Because of this wide area of coverage,
5
patients may not always present back to an affiliated urgent care center or hospital for
6
their emergent needs. Without comprehensive data on emergency department and urgent
7
care visits it is difficult to calculate the potential for health care cost savings with our
8
management program. However, based on previously published studies we can infer that
9
by achieving a target TTR of greater than 70% we can expect less major bleeding events,
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thromboembolic events, urgent care, emergency department visits and hospitalizations
11
related to anticoagulation.8-12,14 The INRs used for the TTR calculation includes all
12
ambulatory INRs for patients who are managed per the warfarin management program.
13
We were unable to exclude INR results for patients who were intentionally being held for
14
procedures. To account for this we used a timeframe of 6 months to calculate TTR.
15
Additionally, the data for critical INR values and total INRs resulted includes all INR
16
values performed for all ambulatory patients. We were not able to exclude INR results
17
for patients who are not followed per the warfarin management program. Finally, while
18
the EMR used within our system improved all of the documentation parameters in this
19
study, it did not achieve 100% as would be expected. This was due to a limitation within
20
the system of not requiring the documentation of these parameters.
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The quality of warfarin management is judged by the TTR and pre-protocol
23
implementation our TTR was 65%, which would suggest a fairly good INR control. We
14
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set our TTR goal to achieve a target of > 70% based on data suggesting decreased
2
bleeding and thrombotic outcomes associated with good INR control.8-12,14 Post protocol
3
implementation the findings of our study are similar to others that show improved TTR
4
when warfarin management was transitioned from the traditional care model of
5
physician management to either nurse or pharmacist managed warfarin therapy. Other
6
studies have additionally compared the difference in warfarin management between
7
nurses and pharmacists. In these studies, patients that are managed by pharmacists have a
8
higher TTR, less critical INR values and reduced emergency room visits.8-12, 15-17 While
9
our data supports the utility of pharmacist-led anticoagulation clinics it also validates that
10
with a well-developed management program improvements in TTR can be achieved with
11
nurse management. It can also be assumed that improvements would be seen if the
12
protocol was utilized by primary care physicians or advanced practice providers.
13
It should be mentioned that not all anticoagulation management is equivalent.
14
Specialized anticoagulation clinics continue to have a place in providing tailored therapy
15
to the specific needs of complicated patients. Anticoagulation clinic providers continue to
16
serve as the experts in the rapidly changing field of anticoagulation therapy, providing
17
advice and education to patients and providers, and helping to develop and pilot new
18
guidelines and protocols that include the growing number of oral anticoagulants. Many
19
studies have shown the positive impact that anticoagulation clinics have not only on
20
clinical outcomes but also on health care expenditures.8,9,12 Our study also showed a
21
higher TTR and lower incidence of critical INRs in the anticoagulation clinic than
22
compared to the primary care sites.
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The difference in critical INRs, despite a protocolized approach, may be due to a variety
2
of factors. Our anticoagulation clinic is managed by pharmacists who may be able to
3
better recognize significant drug interactions thus preventing a critical INR result.18
4
Patients may be more proactive with informing the anticoagulation clinic of medication
5
and medical changes, as they are consistently reminded to do so by anticoagulation clinic
6
pharmacists. Finally, patients may not inform their primary care clinic of changes made
7
outside the medical home if there is an assumption that communication is already
8
occurring with the primary care provider. However, these are assumptions that will need
9
further investigation.
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Our program demonstrates that a standardized approach to warfarin management,
12
through the use of a delegation protocol and standardized documentation, significantly
13
improves warfarin management. = Utilizing the clinic pharmacists and nurses through
14
protocol based warfarin management has increased our time within therapeutic INR
15
range. In a time when the medical landscape is changing and resources are limited, our
16
warfarin management program model fits within the concept of delivering care in the
17
medical home. Health systems with limited financial resources to dedicate to a
18
specialized anticoagulation clinic can utilize this model with their current clinical staff
19
and see improvements.
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References:
2 1. Ruff C, Giugliano R, Braunwald E, et al. Comparison of the efficacy and safety of
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new oral anticoagulants with warfarin in patients with artial fibrillation: a meta-
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analysis of randomised trials. Lancet. 2014;383:995-962.
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2. You J, Singer D, Howard P, et al. Antithrombotic Therapy for Atrial Fibrillation:
Antithrombotic Therapy and Prevention of Thrombosis, 9th ed. American College of
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Chest Physicians Evidence Based Clinical Practice Guidelines. CHEST.
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2012;141:e531s-575s.
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3. Van der Hulle T, Kooiman J, den Exter P, Dekkers O, Klok F, and Huisman M.
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Effectiveness and safety of noval oral anticoagulants compared with vitamin K-
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antagonists in the treatment of acute symptomatic venous thromboembolism – a
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systemic review and meta-analysis. J Thromb Haemost. 2013;12:320-328.
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4. Eliquis® [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2013.
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5. Pradaxa® [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2013.
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6. Xarelto® [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2013.
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7. Ageno W, Gallus AS, Wittkowsky A, et al. Oral anticoagulation therapy:
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antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST. 2012;
141:e44s-e88s.
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8. Hall D, Buchanan J, Helms B, et al. Health care expenditures and therapeutic
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outcomes of a pharmacist-managed anticoagulation service versus usual medical care.
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Pharmacotherapy. 2011; 31:686-694
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9. Chiquette E, Amato M, and Bussey H. Comparison of an anticoagulation clinic with usual medical care. Arch Intern Med. 1998; 158:1641-1647.
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10.Garwood C, Dumo P, Baringhaus S, and Laban K. Quality of anticoagulation care in patients discharged from a pharmacist-managed anticoagulation clinic after
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stabilization of warfarin therapy. Pharmacotherapy. 2008; 28:20-26.
11. Nichol M, Knight T, Dow, T, et al. Quality of anticoagulation monitoring in
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novavluar atrial fibrillation patients: comparison of anticoagulation clinic versus
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usual care. Ann Pharmacother. 2008; 42:62-70.
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management services with usual medical care. Pharmacotherapy. 2010; 30:330-338.
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12. Rudd K and Dier J. Comparison of two different models of anticoagulation
13. Rosendaal F, Cannegieter S, Van der Meer F, and Briet E. A method to determine the optimal intensity of oral anticoagulation. Thromb Haemost. 1993;69:236-239. 14. White H, Gruber M, Feyzi J, et al. Comparison of outcomes among patients
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randomized to warfarin therapy according to anticoagulant control. Arch Intern Med.
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2007;167:239-245.
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15. Levine M, Shao W, and Klein D. Monitoring of international normalized ratios: comparison of community nurses with family physicians. Can Fam Physician. 2012;58:e465-71
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16. Entezari-Maleki T, Dousti S, Hamishehkar H, Gholami K. Systematic review on
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comparing 2 common models for management of warfarin therapy; pharmacist-led
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service versus usual medical care. 17. Gupta V, Kogut SJ, Thompson S. Evaluation of difference in percentage of
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international normalized ratios in range between pharmacist-led and physician-led
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anticoagulation management services. J Pharm Pract. 2015; 28(3):249-55
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18. Couris RR, Tataronis GR, Dallal GE, Blumberg JB, Dwyer JT. Assessment of
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healthcare professionals’ knowledge about warfarin-vitamin K drug-nutrient
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interactions. J Am Coll Nutr. 2000; 19(4):439-45.
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Table 1. Characteristics of patients enrolled in the warfarin protocol Primary Care Clinics
(data from 2011)
N = 2153
Male (%) Age (average)
Anticoagulation Clinics P Value N = 506
1147 (53%)
287 (57%)
69.3
66.7
129 (6%)
56 (11.1%)
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Patient Characteristics
< 49 years
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50 – 74 years
1253 (58.2%)
274 (54.1%)
NS
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> 75 years
771 (35.8%)
176 (34.8%)
NS
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INR Goal
0.001
2.0 – 3.0
1830 (85%)
433 (85.5%)
NS
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2.5 – 3.5
218 (8.9%)
31 (6.1%)
0.005
•
Other
132 (6.1%)
42 (8.3%)
NS
1202 (55.8%)
293 (57.9%)
NS
194 (9%)
39 (7.7%)
NS
474 (22.1%)
128 (25.3%)
NS
283 (13.1%)
46 (9.1%)
0.01
Indication (primary)
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Atrial Fibrillation
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Heart Valve Replacement
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Venous Thromboembolism
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Other
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Table 2. Documentation of Warfarin Management Post – Protocol
N = 395
N = 461
Documenting Indication
95%
96%
Documenting INR Range
86%
90%
INR Checked at least Every 4 weeks
71%
Documenting Dose and Next INR Date Documenting within 24 hours of
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0.09
83%
<0.0001
70%
90%
<0.0001
75%
87%
<0.0001
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Table 3. Time Within Therapeutic INR Range Jan – Jun
Jul – Dec Jan – Jun Jul – Dec Jan – Jun
(pre-data)
2011
2011
2012
2012
2013
2013
1435*
1985
2291
2282
2285
2576
2678
2911
65%
74%
74.2%
74.3%
77%
76%
75%
Patients
345
364
TTR
83%
84%
TTR
Anticoagulation Clinic
76%
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418
463
470
532
84%
84%
82%
81%
81%
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*This represents approximately 1/3rd of patients within the health system
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Table 4. Critical INR Values Anticoagulation Clinic
Critical
Total
Event
Critical
Total
INR
INR
Rate/yr (%)
INR
INR
2009*
639
51 ,269
1.2
2011
643
54,372
1.2
18
6,872
2012
661
56,616
1.2
22
2013
703
61,314
1.1
2014
639
53,560
1.2
Rate/yr (%)
7,077
0.3
<0.001
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7,076
0.3
<0.001
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7,717
0.2
<0.001
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<0.001
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P value
0.3
*pre-data from 2009 available for primary care clinics
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We implemented an anticoagulation clinic model of care into a primary care setting to achieve improved quality and safety outcomes for warfarin management We utilized existing clinic nurse and pharmacy staff to avoid an increase in health care resources and costs
We utilized the electronic medical record to implement standardized warfarin
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management and documentation.
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