Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implementation of Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program in An Egyptian Tertiary Care Hospital

Conditions
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Deep Vein Thrombosis, Atrial Fibrillation, Mitral Valve Disease

Intervention / Treatment
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* Other: Anticoagulation Stewardship Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All hospitalized patients on therapeutic anticoagulant medication during their hospitalization period. Exclusion Criteria: Patients whose age is less than 18 years old. Patients who were admitted for less than 24 hours for patient on parenteral anticoagulants and less than 48 hours for patient on warfarin. Patients already admitted for bleeding or thrombosis. Malignancy patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Quasi experimental study (separate sample pre-test post-test design)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre program implementation<br>All hospitalized patients on therapeutic anticoagulant medication during the pre-implementation period of the anticoagulation stewardship program. | |
| Experimental: Post program implementation<br>All hospitalized patients on therapeutic anticoagulant medication during the post-implementation period of the anticoagulation stewardship program. | Other: Anticoagulation Stewardship Program<br>* A clinical-pharmacist led anticoagulation stewardship program that includes: 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of medication errors change | 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. | one year and half | 
| percent of adverse drug events change | Detect bleeding and thrombotic-related adverse drug events | one year and half | 
| Percent of evidence-based guidelines compliance improvement | Detect health care providers' adherence to evidence-based guidelines for anticoagulation therapy. | one year and half | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticoagulation, stewardship program, anticoagulants, clinical pharmacist, heparin, warfarin