Hospital Pharmacy - July/August 2017 - 496

721105

research-article2017

HPXXXX10.1177/0018578717721105Hospital PharmacyCastelli et al

Article

Effect of a Rivaroxaban Patient
Assistance Kit (R-PAK) for Patients
Discharged With Rivaroxaban:
A Randomized Controlled Trial

Hospital Pharmacy
2017, Vol. 52(7) 496-501
© The Author(s) 2017
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https://doi.org/10.1177/0018578717721105
DOI: 10.1177/0018578717721105
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Michelle R. Castelli1, Catherine A. Saint2, Brandon T. Nuziale3,
Gretchen M. Stern4, Zachary A. Stacy2,5, Andrew J. Crannage2,5,
and Jamie M. Pitlick6

Abstract
Background: The combination of poor health literacy and a complex dosing regimen/transition for rivaroxaban in venous
thromboembolism (VTE) treatment may increase the likelihood of negative clinical outcomes secondary to nonadherence.
Objective: The aim was to determine if a Rivaroxaban Patient Assistance Kit (R-PAK) given at hospital discharge increases
proper dose transition and overall patient adherence. Methods: This prospective, randomized, controlled trial was
conducted at an 859-bed academic medical center. Patients were randomized into 2 groups. In the treatment group, patients
received the R-PAK with counseling at discharge, whereas patients in the control group received discharge counseling alone.
In addition, patients were contacted after 21 days of therapy to assess dose transition, adherence, satisfaction, and safety.
The primary outcome was percentage of patients who properly transitioned to rivaroxaban once daily on day 22. Results:
Twenty-five patients were enrolled; 12 received an R-PAK, whereas 13 comprised the control group. No difference in the
baseline assessment of health literacy status was noted (P = 1.00). Proper transition to daily administration on day 22 was
no different between the groups (P = .891). Adherence was reported in 99.8% of R-PAK patients and 97.65% of control
patients (P = .074). Side effects were rarely reported. Conclusions: The use of an R-PAK for the treatment of VTE was
not associated with an improvement in transition to daily administration; however, both groups had high rates of overall
adherence. Pharmacist counseling/education was provided in both groups and is an important component to include in any
patient discharge, especially for medications with dose transitions.
Keywords
anticoagulant, discharge counseling, patient education, rivaroxaban, transitions of care

Background
Venous thromboembolism (VTE) is a disorder in which
fibrin and red blood cells clot in the veins at sites of blood
stasis and vascular damage, manifesting as a deep vein
thrombosis (DVT) and/or a pulmonary embolism (PE).1
Nearly 30% of patients who experience a VTE event will
have another thrombotic event within 10 years, most commonly occurring within 2 years of the index event.2
Current VTE guidelines recommend treatment with non-
vitamin K oral anticoagulants (NOACs) including dabigatran,
rivaroxaban, apixaban, or edoxaban over the vitamin K antagonist (VKA) warfarin for most patients without cancer.3
Although all of the NOACs come with unique dosing strategies, rivaroxaban requires a transition of dose and frequency
that may affect a patient's ability to use the medication appropriately.4 For VTE, rivaroxaban is dosed at 15 mg by mouth
twice daily for 21 days, and then transitioned to 20 mg
by mouth once daily.3 Patients require 3 or more months of

therapy, depending on patient-specific factors.4 Rivaroxaban
has an onset of action of 1 to 2 hours and a predictable dose
response eliminating the need for bridging with a parenteral
agent and therapeutic drug monitoring required with VKA
treatment. This favorable pharmacokinetic profile may
decrease the overall cost of therapy and improve patient satisfaction.4 In addition, based on the Anti-clot Treatment Scale
1

University of California San Diego Health, La Jolla, CA, USA
Mercy Hospital, St. Louis, MO, USA
3
Oregon School of Pharmacy, Pacific University, Hillsboro, OR, USA
4
Brigham and Women's Hospital, Boston, MA, USA
5
St. Louis College of Pharmacy, St. Louis, MO, USA
6
Drake University College of Pharmacy and Health Sciences, Des Moines,
IA, USA
2

Corresponding Author:
Michelle R. Castelli, University of California San Diego Health, 9300
Campus Point Drive, La Jolla, CA 92037, USA.
Email: Micastel09@gmail.com

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