Clinical Pharmacist Anticoagulant Stewardship

May 16, 2018 updated by: Hadassah Medical Organization

Clinical Pharmacist Led Hospital-Wide Direct Oral Anticoagulant Stewardship Program

Initiative to improve direct anticoagulant utilization involving programmatic review by clinical pharmacists in collaboration with multidisciplinary team.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Hadassah Hebrew University Medical Centers' Clinical Pharmacy team initiated a hospital-wide program, in collaboration with the institutions' coagulation specialists, including two hematologists and a clinical pharmacologist, for monitoring and promoting safe and effective prescription of direct oral anticoagulants (DOAC) during hospitalization. Electronic medical records throughout the hospital are screened for DOAC orders. All DOAC orders are assessed by a clinical pharmacist for potentially-inappropriate prescribing. When potentially-inappropriate prescribing or a drug-related problem is identified, the clinical pharmacist provided consultation on management options. In specific cases, additional guidance is provided by coagulation specialists. Consultations are recorded in the electronic medical record. Performance measures are collected and summarized.

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah Medical Organization, Jerusalem, Israel
        • Principal Investigator:
          • Mordechai Muszkat, MD
        • Sub-Investigator:
          • Amichai Perlman, PharmD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in Hadassah Medical Center with a physician's order for direct oral anticoagulants.

Description

Inclusion Criteria:

Patients hospitalized in Hadassah Medical Center with a physician's order for direct oral anticoagulants (apixaban, rivaroxaban, or dabigatran).

Exclusion Criteria:

Patients hospitalized in departments without computerized physician order entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of clinical pharmacist consultations accepted by attending physician.
Time Frame: At forty-eight months
Calculated by dividing the number of clinical pharmacist consultations accepted, by the number of clinical pharmacist consultations given, during the period. Data for consultation counts will be obtained from patient electronic medical record.
At forty-eight months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of clinical pharmacist consultations accepted by attending physician.
Time Frame: At six months
Calculated by dividing the number of clinical pharmacist consultations accepted, by the number of clinical pharmacist consultations given, during the period. Data for consultation counts will be obtained from patient electronic medical record.
At six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Mordechai Muszkat, MD, Hadassah University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

April 16, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 17, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • DOACPHARM-HMO-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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