Clinical Pharmacist Anticoagulant Stewardship

Safety Issues Clinical Trial

Official title:

Clinical Pharmacist Led Hospital-Wide Direct Oral Anticoagulant Stewardship Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03527615
• Other study ID #: DOACPHARM-HMO-CTIL
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2018
• Source: Hadassah Medical Organization
• Contact: Amichai Perlman, Pharmd
• Phone: 972505172768
• Email: amichaip[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anticoagulant Toxicity
• Safety Issues

Intervention

Other:
• Clinical Pharmacist Medication Review
Programmatic review of physician orders for direct anticoagulants by clinical pharmacists.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of clinical pharmacist consultations accepted by attending physician.	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	Percent of clinical pharmacist consultations accepted by attending physician.	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