This quality improvement project resulted in clinically and statistically significant improvements in percent TTR of INR values for patients receiving warfarin management at Roxboro Medical Associates. This project adds to the current body of knowledge regarding implementation of a warfarin dosing protocol and its usefulness in primary care. The results are transferable to most primary care practices who could use this project and report as a guide for implementing a warfarin dosing protocol in their specific setting. Rural primary care settings may particularly benefit from this project and report as they are more likely to manage their patient’s warfarin therapy given the lack of available anticoagulation clinics in rural areas. The results of this project support the recommendation to follow EBP guidelines for warfarin
management that include use of a warfarin dosing protocol. This project validates evaluation of practice to identify problems that can be improved using EBP guidelines and quality
improvement methods.
Sustainability
This project should be highly sustainable as consideration was made to incorporate ideas that would increase the likelihood of sustainability from project conception to completion as stated throughout this report. It did not require extra personnel or new equipment. Sustaining the practice change should remain low cost with no foreseeable additional costs in the future.
Positive feedback was received with each PDSA cycle throughout project implementation, resulting in no changes to the original protocol plan. This positive feedback could indicate an
increased likelihood of sustainability. The PDSA method could be continued indefinitely at variable intervals to maintain the practice change in the future. Providers are also likely to continue using the protocol given the statistically and clinically significant improvement in percent TTR demonstrated in the primary and post-hoc analyses.
Future Changes
If this quality improvement project was repeated at the host site or was to be replicated at another site, consideration should be made for the following changes:
Consider extending the implementation phase beyond 13 weeks. The 13-week duration was relatively short and, although statistically significant results were obtained, this time frame may make it difficult to gauge long-term results. A time frame of six months or more for post-intervention data collection may provide more information regarding protocol effectiveness and sustainability. In this case, the pre-intervention comparative data collection time frame would also be extended in the same manner for the prior year. Consider formal interval meetings for evaluation and feedback discussions. Informal
meetings were used in this project with nurses and providers stopped randomly during their normal daily patient care schedules and respondents may have felt rushed to speak so they may not have put much thought into their responses.
Consider the option of anonymous feedback. Nurses and providers may have been uncomfortable providing negative feedback given that they knew the project leader obtaining the information. They were encouraged to speak to the nurse or physician on the project team instead of the project leader if desired, but they may have hesitated to do that as well.
Consider creating an electronic version of the protocol or somehow integrating the protocol into the EMR but be sure to determine stakeholder preference beforehand. The providers at the host site for this project did not want an electronic version but their paper version created duplicate documentation for the nurses. An electronic version that could be incorporated into the EMR could prevent this duplication and perhaps be more readily available for the providers and nurses who are already using the EMR for every patient visit. An electronic version could also streamline data availability and retrieval, making it more feasible to monitor the practice change on an ongoing basis.
Further Study
This project could be expanded in the future to include issues with warfarin management beyond simple provider dose adjustments. Future projects could include a dosing protocol along with standardized warfarin patient education that may improve adherence to warfarin dose changes, INR testing, and a warfarin friendly diet, and possibly result in an additional increase in TTR of INR values. Additional clinical decision-making tools could be added to the dosing protocol used for this project that may include, for example, recommended dose adjustments when prescribing specific antibiotics for patient’s taking warfarin, guidance on warfarin management for patients receiving hemodialysis, or computer-assisted dose adjustment calculations.
This project, and the warfarin dosing protocols used within it, could be incorporated in most primary care settings, and they could easily be expanded for further study and to fit the specific needs of different practice sites.
APPENDIX A: SEARCH TERM COMBINATIONS
1. warfarin OR coumadin OR anticoagula* AND protocol OR nomogram OR algorithm
2. warfarin OR coumadin OR anticoagula* AND dosing OR administration
3. warfarin OR coumadin OR anticoagula* AND time within therapeutic range OR TTR
4. warfarin OR coumadin OR anticoagula* AND International Normalized Ratio OR INR
5. warfarin OR coumadin OR anticoagula* AND outpatient OR primary care OR ambulatory care
6. warfarin OR coumadin OR anticoagula* AND outpatient OR primary care OR
ambulatory care AND dosing OR administration AND time within therapeutic range OR TTR AND outpatient OR primary care OR ambulatory care AND International
APPENDIX B: PRISMA FLOW DIAGRAM Records identified through database searching (PubMed=58) (CINAHL=11) (Embase=53) (Cochrane database = 1) S cr ee n in g In cl u d ed E li gi bi li ty Id en ti fi ca ti
on Additional records identified through
other sources (n=2 - articles identified
from reference list of another article)
Records after duplicates removed (n=116)
Records screened (n=116)
Records excluded after title and abstract
screening (n=106)
Full-text articles assessed for eligibility
(n=10)
Full-text articles read and excluded, with reasons (n=2: different outcome
measure)
Studies included (n=8)
35
APPENDIX D: WARFARIN DOSING PROTOCOL FOR THERAPEUTIC INR RANGE 2.0-3.0
36
APPENDIX E: WARFARIN DOSING PROTOCOL FOR THERAPEUTIC INR RANGE 2.5-3.5
*used with permission from The University of North Carolina General Internal Medicine Clinic Signature:
Internal Medicine Clinic Director
Chest. 2012 Feb;141(2 Suppl);e1S-801S. Copyright 2012. UNC Center for Excellence in Chronic Illness Updated August 2012
Major bleed:
• Hold Warfarin and admit patient to hospital
• Rapid reversal of anticoagulation with four-factor prothrombin complex concentrate rather than plasma
• Additionally use vitamin K 5-10 mg administered by slow IV injection
APPENDIX F: PATIENT THROUGHPUT AND WORKFLOW
Patient arrives for INR testing
FRONT OFFICE STAFF
Registers patient & adds patient to provider schedule (reason for visit entered as “INR”) Changes patient status in EMR to “checked in”
Directs patient to main waiting area
LAB TECH
Sees “checked in” status for patient needing INR testing in EMR Retrieves patient from main waiting area & escorts to lab Obtains point-of-care INR blood lab by finger stick Enters INR result in EMR
Escorts patient to lab waiting area & notifies nurse that patient is ready
NURSE
Retrieves patient from lab waiting area & escorts to nursing station
Obtains patient vital signs (blood pressure, heart rate) & documents in EMR Verifies medication list with patient & updates in EMR
Documents changes in diet, current symptoms, side effects of warfarin therapy, & compliance with current warfarin dosing schedule using the warfarin documentation EMR template
Verifies clinical indication for warfarin (updating EMR if needed)
Establishes patient’s therapeutic INR range (i.e. Afib/DVT/PE = 2.0 - 3.0, valve replacement = 2.5 - 3.5) Reviews INR result & uses the appropriate warfarin dosing protocol to determine if a dose change is
needed
Calculates new warfarin dosage, if indicated, and completes the “Warfarin Dosing” form
Discusses with provider the patient’s clinical indication for warfarin, current INR result, and protocol dose adjustment recommendation & gives the provider the “Warfarin Dosing” form
PROVIDER
Reviews patient’s EMR
Determines if a compelling reason to deviate from the protocol recommendation exists
Informs nurse of decision to follow protocol recommendation or not, and reason for protocol deviation if applicable and desired
Legend: INR= International Normalized Ratio; EMR = Electronic Medical Record; Afib = atrial fibrillation; DVT = deep vein thrombosis; PE = pulmonary embolism
NURSE
Enters dose adjustment & recheck time frame in EMR using documentation template as follows: Warfarin strength, dosing directions, recheck time frame (Ex: warfarin 5mg, take 1 tab daily, recheck in 2 weeks) Enters whether protocol recommendation was or was not followed and, if not, reason for deviation if
given as follows: Per protocol OR not per protocol due to [enter reason] Prints office visit summary & gives to patient
Informs patient of visit completion & directs patient to exit Changes patient status in EMR as “checked out”
APPENDIX G: INTERVAL POST-INTERVENTION DATA Data
Point Date Protocol Use TTR Protocol To-date
Use To-date TTR Yes No % Yes No % 1 July 1 – July 14, 2018 16 1 94.1% 11 6 64.7% 2 July 15 – July 28, 2018 23 0 100% 19 4 82.6% 97.5% 75% 3 July 29 – Aug 11, 2018 22 1 95.7% 14 9 60.9% 96.8% 69.8% 4 Aug 12 – Aug 25, 2018 25 1 96.2% 21 5 80.8% 92.1% 73% 5 Aug 26 – Sept 8, 2018 21 1 95.5% 15 7 68.2% 96.4% 72% 6 Sept 9 – Sept 30, 2018 35 0 100% 24 11 68.6% 97.3% 71.2%
Legend. TTR=Time within the Therapeutic Range
52.79 57.79 62.79 67.79 72.79 77.79 82.79 87.79 Baseline 1 2 3 4 5 6 % T TR Data Point
Post-Intervention TTR Change Over Time
Pre-intervention %TTR Interval %TTR Linear Trend
APPENDIX H: RESULTS WITH STATISTICAL ANALYSIS Primary Analysis
(Original Therapeutic Range) (Expanded Therapeutic Range) Post-hoc Analysis
Pre-Intervention (n=247) Yes 137 155 No 110 92 TTR 55.5% 62.8% Post-Intervention (n=146) Yes 104 119 No 42 27 TTR 71.2% 81.5% Difference TTR ↑ 15.7% ↑ 18.7% Chi-square analysis α = 0.05 α = 0.05 p=0.019 p=0.0000923
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