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Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program

Primary Purpose

Deep Vein Thrombosis, Atrial Fibrillation, Mitral Valve Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Anticoagulation Stewardship Program
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Deep Vein Thrombosis focused on measuring anticoagulation, stewardship program, anticoagulants, clinical pharmacist, heparin, warfarin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Pharmacy, Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre program implementation

Post program implementation

Arm Description

All hospitalized patients on therapeutic anticoagulant medication during the pre-implementation period of the anticoagulation stewardship program.

All hospitalized patients on therapeutic anticoagulant medication during the post-implementation period of the anticoagulation stewardship program.

Outcomes

Primary Outcome Measures

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.
percent of adverse drug events change
Detect bleeding and thrombotic-related adverse drug events
Percent of evidence-based guidelines compliance improvement
Detect health care providers' adherence to evidence-based guidelines for anticoagulation therapy.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2019
Last Updated
September 19, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03812848
Brief Title
Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program
Official Title
Implementation of Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program in An Egyptian Tertiary Care Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 5, 2022 (Actual)
Study Completion Date
June 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Atrial Fibrillation, Mitral Valve Disease
Keywords
anticoagulation, stewardship program, anticoagulants, clinical pharmacist, heparin, warfarin

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Quasi experimental study (separate sample pre-test post-test design)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre program implementation
Arm Type
No Intervention
Arm Description
All hospitalized patients on therapeutic anticoagulant medication during the pre-implementation period of the anticoagulation stewardship program.
Arm Title
Post program implementation
Arm Type
Experimental
Arm Description
All hospitalized patients on therapeutic anticoagulant medication during the post-implementation period of the anticoagulation stewardship program.
Intervention Type
Other
Intervention Name(s)
Anticoagulation Stewardship Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of medication errors change
Description
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.
Time Frame
one year and half
Title
percent of adverse drug events change
Description
Detect bleeding and thrombotic-related adverse drug events
Time Frame
one year and half
Title
Percent of evidence-based guidelines compliance improvement
Description
Detect health care providers' adherence to evidence-based guidelines for anticoagulation therapy.
Time Frame
one year and half

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Pharmacy, Ain Shams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not clear according to the clinical research guidelines at Faculty of Pharmacy, Ain Shams University.
Citations:
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URL
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Description
Institute for Safe Medication Practices. (2010). ISMP's Guidelines for Standard Order Sets.
URL
http://www.ismp.org/recommendations/high-alert-medications-acute-list
Description
Institute for Safe Medication Practices. (2014). ISMP list of High-Alert Medications
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Description
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http://www.nccmerp.org/types-medication-errors
Description
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Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program

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