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
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis Atrial Fibrillation Mitral Valve Disease||Other: Anticoagulation Stewardship Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||234 participants|
|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|
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:
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.
- 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.
- percent of adverse drug events change [ Time Frame: one year and half ]Detect bleeding and thrombotic-related adverse drug events
- 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.
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
|Faculty of Pharmacy, Ain Shams University|
|Cairo, Egypt, 11566|