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Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03812848
Recruitment Status : Active, not recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Heba Mohamed El-Bosily, Ain Shams University

Brief Summary:
This study aims at evaluating the implementation of clinical-pharmacist-led anticoagulation stewardship program in Egyptian tertiary hospital to promote a culture of safety around anticoagulants.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Atrial Fibrillation Mitral Valve Disease Other: Anticoagulation Stewardship Program Not Applicable

Detailed Description:

One of the high-alert medication categories that may cause significant patient harm if not used correctly is anticoagulants. It is not clear if medication errors are more common with this category in specific compared to other medication categories, but the ramifications of a medication error with the use of anticoagulation agents is without a doubt detrimental to the patient's health and more serious than most of other drug categories.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Quasi experimental study (separate sample pre-test post-test design)
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation of Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program in An Egyptian Tertiary Care Hospital
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
No Intervention: Pre program implementation
All hospitalized patients on therapeutic anticoagulant medication during the pre-implementation period of the anticoagulation stewardship program.
Experimental: Post program implementation
All hospitalized patients on therapeutic anticoagulant medication during the post-implementation period of the anticoagulation stewardship program.
Other: 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.





Primary Outcome Measures :
  1. Percent of medication errors change [ Time Frame: one year and half ]
    Detect the medication error according to (National Coordinating Council for Medication Errors Reporting and Prevention NCC MERP) Index for Categorizing Medication Errors using NCC MERP Index for Categorizing Medication Errors Algorithm.

  2. percent of adverse drug events change [ Time Frame: one year and half ]
    Detect bleeding and thrombotic-related adverse drug events

  3. Percent of evidence-based guidelines compliance improvement [ Time Frame: one year and half ]
    Detect health care providers' adherence to evidence-based guidelines for anticoagulation therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All hospitalized patients on therapeutic anticoagulant medication during their hospitalization period.

Exclusion Criteria:

  1. Patients whose age is less than 18 years old.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812848


Locations
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Egypt
Faculty of Pharmacy, Ain Shams University
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams University

Additional Information:
Publications:
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
Lucado, J., Paez, K., & Elixhauser, A. (2010). Statistical brief# 109. Journal of General Internal Medicine, 25(1), 31-38.
Rose, A. (Ed.). (2015). Anticoagulation Management. Cham: Springer International Publishing. https://doi.org/10.1007/978-3-319-22602-6
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

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Responsible Party: Heba Mohamed El-Bosily, Clinical Pharmacist, Ain Shams University
ClinicalTrials.gov Identifier: NCT03812848    
Other Study ID Numbers: 165
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not clear according to the clinical research guidelines at Faculty of Pharmacy, Ain Shams University.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heba Mohamed El-Bosily, Ain Shams University:
anticoagulation
stewardship program
anticoagulants
clinical pharmacist
heparin
warfarin
Additional relevant MeSH terms:
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Warfarin
Atrial Fibrillation
Thrombosis
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Anticoagulants