Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program
NCT ID: NCT03812848
Last Updated: 2022-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
233 participants
INTERVENTIONAL
2018-01-01
2022-06-05
Brief Summary
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Detailed Description
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This prospective study evaluates the impact of implementing an anticoagulation stewardship program, led by clinical pharmacists, on anticoagulation therapy outcomes during patient hospitalization by the percent of medication errors reduction, percent of adverse drug events reduction, and percent of evidence-based guidelines compliance improvement.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Pre program implementation
All hospitalized patients on therapeutic anticoagulant medication during the pre-implementation period of the anticoagulation stewardship program.
No interventions assigned to this group
Post program implementation
All hospitalized patients on therapeutic anticoagulant medication during the post-implementation period of the anticoagulation stewardship program.
Anticoagulation Stewardship Program
A clinical-pharmacist led anticoagulation stewardship program that includes:
1. Warfarin monitoring and dosing protocol. 1a.Warfarin initial dosing algorithm. 1b.Recommended International normalized ration (INR) target and duration of Warfarin therapy by indication.
1c.Warfarin dosage adjustment algorithms.
1d.Management of high INR values. 2-Heparin weight-based protocol. 3-Perioperative anticoagulation use protocol. 4-Policies that address baseline and ongoing laboratory monitoring for anticoagulants.
5-Protocol for Heparin Induced Thrombocytopenia(HIT) management. 6-Anticoagulation reversal protocol. 7-Booklet for anticoagulant drugs and all of previously prepared protocols. 8-Education programs regarding anticoagulation's therapy for health care team dealing with anticoagulation and patients.
Interventions
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Anticoagulation Stewardship Program
A clinical-pharmacist led anticoagulation stewardship program that includes:
1. Warfarin monitoring and dosing protocol. 1a.Warfarin initial dosing algorithm. 1b.Recommended International normalized ration (INR) target and duration of Warfarin therapy by indication.
1c.Warfarin dosage adjustment algorithms.
1d.Management of high INR values. 2-Heparin weight-based protocol. 3-Perioperative anticoagulation use protocol. 4-Policies that address baseline and ongoing laboratory monitoring for anticoagulants.
5-Protocol for Heparin Induced Thrombocytopenia(HIT) management. 6-Anticoagulation reversal protocol. 7-Booklet for anticoagulant drugs and all of previously prepared protocols. 8-Education programs regarding anticoagulation's therapy for health care team dealing with anticoagulation and patients.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patients who were admitted for less than 24 hours for patient on parenteral anticoagulants and less than 48 hours for patient on warfarin.
3. Patients already admitted for bleeding or thrombosis.
4. Malignancy patients.
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Heba Mohamed El-Bosily
Clinical Pharmacist
Locations
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Faculty of Pharmacy, Ain Shams University
Cairo, , Egypt
Countries
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References
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Broussard M, Bass PF 3rd, Arnold CL, McLarty JW, Bocchini JA Jr. Preprinted order sets as a safety intervention in pediatric sedation. J Pediatr. 2009 Jun;154(6):865-8. doi: 10.1016/j.jpeds.2008.12.022. Epub 2009 Feb 1.
Burnett AE, Trujillo TC. The future of inpatient anticoagulation management. J Thromb Thrombolysis. 2013 Apr;35(3):375-86. doi: 10.1007/s11239-013-0892-1.
Dreijer AR, Kruip MJ, Diepstraten J, Polinder S, Brouwer R, Leebeek FW, Vulto AG, van den Bemt PM. Antithrombotic stewardship: a multidisciplinary team approach towards improving antithrombotic therapy outcomes during and after hospitalisation: a study protocol. BMJ Open. 2016 Dec 20;6(12):e011537. doi: 10.1136/bmjopen-2016-011537.
Fanikos J, Stapinski C, Koo S, Kucher N, Tsilimingras K, Goldhaber SZ. Medication errors associated with anticoagulant therapy in the hospital. Am J Cardiol. 2004 Aug 15;94(4):532-5. doi: 10.1016/j.amjcard.2004.04.075.
Garcia DA, Baglin TP, Weitz JI, Samama MM. Parenteral anticoagulants: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e24S-e43S. doi: 10.1378/chest.11-2291.
Goldspiel B, Hoffman JM, Griffith NL, Goodin S, DeChristoforo R, Montello CM, Chase JL, Bartel S, Patel JT. ASHP guidelines on preventing medication errors with chemotherapy and biotherapy. Am J Health Syst Pharm. 2015 Apr 15;72(8):e6-e35. doi: 10.2146/sp150001. No abstract available.
Levinson, D. R., & General, I. (2010). Adverse events in hospitals: national incidence among Medicare beneficiaries. Department of Health and Human Services Office of the Inspector General. Retrieved from https://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf
Levy JH, Spyropoulos AC, Samama CM, Douketis J. Direct oral anticoagulants: new drugs and new concepts. JACC Cardiovasc Interv. 2014 Dec;7(12):1333-51. doi: 10.1016/j.jcin.2014.06.014.
Hug BL, Witkowski DJ, Sox CM, Keohane CA, Seger DL, Yoon C, Matheny ME, Bates DW. Adverse drug event rates in six community hospitals and the potential impact of computerized physician order entry for prevention. J Gen Intern Med. 2010 Jan;25(1):31-8. doi: 10.1007/s11606-009-1141-3. Epub 2009 Nov 6.
Lysogorski MC, Hassan AK, Lampkin SJ, Geisler R. The impact of pharmacy monitoring and intervention in patients receiving intravenous heparin. Int J Clin Pharm. 2017 Aug;39(4):844-850. doi: 10.1007/s11096-017-0482-y. Epub 2017 May 15.
Padron M, Miyares MA. Development of an anticoagulation stewardship program at a large tertiary care academic institution. J Pharm Pract. 2015 Feb;28(1):93-8. doi: 10.1177/0897190013514091. Epub 2013 Dec 10.
Reardon DP, Atay JK, Ashley SW, Churchill WW, Berliner N, Connors JM. Implementation of a Hemostatic and Antithrombotic Stewardship program. J Thromb Thrombolysis. 2015 Oct;40(3):379-82. doi: 10.1007/s11239-015-1189-3.
Rose, A. (Ed.). (2015). Anticoagulation Management. Cham: Springer International Publishing. https://doi.org/10.1007/978-3-319-22602-6
Sharma M, Krishnamurthy M, Snyder R, Mauro J. Reducing Error in Anticoagulant Dosing via Multidisciplinary Team Rounding at Point of Care. Clin Pract. 2017 Apr 20;7(2):953. doi: 10.4081/cp.2017.953. eCollection 2017 Apr 6.
U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014). Anticoagulants. In National Action Plan for Adverse Drug Event Prevention.
World Health organization, W. H., & others. (2016). Medication Errors: Technical Series on Safer Primary Care ISBN 978-92-4-151164-3. Retrieved from http://apps.who.int/iris/bitstream/10665/252275/1/9789241511650-eng.pdf
Wychowski MK, Ruscio CI, Kouides PA, Sham RL. The scope and value of an anticoagulation stewardship program at a community teaching hospital. J Thromb Thrombolysis. 2017 Apr;43(3):380-386. doi: 10.1007/s11239-016-1455-z.
Related Links
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Institute for Safe Medication Practices. (2010). ISMP's Guidelines for Standard Order Sets.
Institute for Safe Medication Practices. (2014). ISMP list of High-Alert Medications
Institute for Safe Medication Practices (ISMP) Monitoring FDA MedWatch Reports. (2015, September). Quarter Watch (Q 3-4) 2014. Institute for Safe Medication Practices (ISMP).
Institute for Safe Medication Practices (ISMP) ,Quarter Watch (Q4): monitoring FDA MedWatch Reports. (2017, July). Quarter Watch Q4 2016. Retrieved July 13, 2017, from http://www.ismp.org/QuarterWatch/
NCCMERP. (2014, July 18). Types of Medication Errors \[Text\].
Other Identifiers
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165
Identifier Type: -
Identifier Source: org_study_id
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