Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Deep Vein Thrombosis; Mitral Valve Disease
• Interventions: Other: Anticoagulation Stewardship Program

• Registration Number: NCT03812848
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-23
• Primary Completion: 2022-06-05
• Study Completion: 2022-06-05
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Post program implementation	Anticoagulation Stewardship Program	All hospitalized patients on therapeutic anticoagulant medication during the post-implementation period of the anticoagulation stewardship program.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Pharmacy, Ain Shams University; 🇪🇬 Cairo, Egypt