Clinical trial NCT03575936: Enhanced Pharmacist-Managed Anticoagulation Service in a University-based Family Medicine Clinic
Official title: Enhanced Pharmacist-Managed Anticoagulation Service in a University-based Family Medicine Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anticoagulation
Home INR Monitoring
Keywords: Pharmacists Intervention
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction:

The ambulatory care pharmacist service is a vision that is supported by several national pharmacy associations and expected by many clinical environments. However, pharmacists practicing in such settings often lack the data to demonstrate their value for the services they provide. Consequently, clinical services provided by pharmacists are not viewed as a billable expense and reimbursements are bundled with drug dispensing. Thus, if a pharmacy service is to sustain for the long-term, it is imperative to develop a value model to support monetary compensation for the cognitive services provided.

Background and Significance:

Anticoagulation with warfarin is a high risk therapy involving complex dosing, monitoring, and ensuring adherence to outpatient therapy. Monitoring anticoagulation intensity utilizing the prothrombin time (PT) and the international normalized ratio (INR) is used to determine the effectiveness of anticoagulation therapy. The proportion of time the INR is within the therapeutic range (TTR) is considered a surrogate measure of anticoagulation control and is associated with lower rates of major bleeds and thromboembolism.

Pharmacist managed anticoagulation clinics eliminate the waiting period between lab work from an external facility and decisions from physicians. Pharmacists practicing in anticoagulation clinics with point-of-care INR testing usually practice under a collaborative agreement, which allows them to adjust and reverse warfarin dosing based on established protocols. This reduces the wait time and is expected to increase patient satisfaction. Despite the wide acceptance of pharmacist-managed anticoagulation clinics, there is inconsistent evidence to support prevention of major bleeding.

Methods:

This is an IRB-approved prospective, unblinded randomized controlled trial of the clinical impact of home anticoagulation monitoring. The study will enroll all patients (who meet eligibility criteria) who require long-term anticoagulation therapy from a pharmacist-managed anticoagulation clinic.

Expected Outcomes:

The purpose of this study is to evaluate if self- monitoring in addition to pharmacist review will increase the TTR. This will allow university- based pharmacists to provide care for more patients effectively in addition to their academic duties.


Eligibility criteria: Inclusion Criteria:

* Established patients within the USF Morsani Center Family Medicine department
* Adults over the age of 18 years
* Long-term (\> 12 months) warfarin therapy
* Taking warfarin for at least 90 days prior to enrollment
* Willing and able to perform home INR monitoring with correct technique (or caregiver)

Exclusion Criteria:

* Failure by either the patient or caregiver to demonstrate successful INR monitoring technique
* Issues with mental and/or physical dexterity as evaluated and determined by the pharmacist
* Unwillingness to take full financial responsibility for costs not covered (by patient's insurance and/or grant money) incurred with home INR monitoring

Primary outcomes:
measure: INR
timeFrame: 12 months
Secondary outcomes:
measure: Patient Satisfaction and Quality of Life with Anticoagulation utilizing the Duke Anticoagulation Satisfaction Scale (DASS)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: