Hospital Pharmacy - July/August 2017 - 498

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Single Item Screening Tool
How often do you need to have someone help you when you read
instructions, pamphlets, or other written material from your doctor or
pharmacy?
(1) Never (2) Rarely (3) Sometimes (4) Often (5) Always

Figure 1. Single item-screening tool.

education by a pharmacist alone. The R-PAK included a
reminder card stating the dates of dose transition and a customizable pillbox. Patients who received the R-PAK were
taught how to properly fill and utilize the pillbox. All patients
were educated on the indication, dosing regimen, adverse
effects, and monitoring required for rivaroxaban as previously
described. Additional details on the R-PAK and information
provided to each patient has been previously published.12

Follow-up
Using a standardized questionnaire, patients were contacted
via telephone after at least 22 days of therapy to assess the
date of transition based on the date of initiation while hospitalized, medication adherence including missed doses and
doses taken more than 12 hours from appropriate timing,
treatment satisfaction (via ACTS), understanding of dosing
regimen, and side effects. The ACTS is a validated tool used
to assess patient benefit and burden associated with anticoagulation therapy; the burden portion of the scale ranges
from 12 to 60, with higher scores indicating more treatment
hindrance and the benefit portion ranges from 3 to 15, with
higher scores indicating more treatment satisfaction.6 Each
patient's pharmacy was also contacted to obtain a refill history for both strengths of rivaroxaban. Patients were considered lost to follow-up if they were unable to be contacted by
phone after 5 attempts or if greater than 30 days of therapy
had been completed prior to patient contact.

Outcome Assessment
The primary outcome of this trial was the percentage of
patients who properly transitioned to rivaroxaban 20 mg
once daily on day 22. Predefined secondary outcomes
included total adherence, percentage of patients with greater
than 90% adherence, percentage of patients who stopped
rivaroxaban for any reason, patient understanding of correct
dose and timing of medication, and overall satisfaction.
Safety outcomes assessed self-reported side effects including
minor bleeds, events that required contacting physician or
visiting an emergency department, recurrent VTE, and death.

Statistical Analysis
Statistics were run utilizing the per-protocol principal. An
alpha level of 0.05 was set a priori. The primary outcome

Hospital Pharmacy 52(7)
was analyzed using the Fisher exact test to assess the difference between the percentage of patients who properly transitioned to rivaroxaban 20 mg once daily on day 22 within the
treatment and control group. A clinically significant difference was considered greater than or equal to 5% difference
between groups. The Fisher exact test was used for nominal
data, whereas the Mann-Whitney U and Student t tests were
used for ordinal and continuous data, respectively.

Results
From October 2014 through April 2016, a total of 29 patients
underwent randomization (Figure 2). Baseline characteristics, including data on indication and treatment with rivaroxaban, for the patients in this trial are shown in Table 1.
There were no baseline statistical differences noted between
treatment groups (P > .05). Eight (32%) patients enrolled had
an indication of PE with DVT whereas 13 (52%) patients had
a single diagnosis of PE alone; no difference was found
between treatment groups. In addition, 13 (52%) of the
thromboses were thought to be unprovoked in nature.
Patients who were assigned the R-PAK received a median of
4 doses while hospitalized, whereas patients in the control
group received 2 doses (P = .47). Twenty-five patients were
contacted for follow-up; 3 patients were lost to follow-up
and 1 patient declined consent for follow-up after enrollment. One patient in the R-PAK group, who verified full
medication adherence to study investigators, discontinued
therapy prematurely due to recurrent VTE.

Treatment
The primary outcome of proper transition on day 22 was
observed in 67% of R-PAK patients and 69% of control
patients (P = .89; Table 2). When assessed for understanding
of dose and interval, 100% of patients in both arms were able
to verbalize comprehension of the intended dosing regimen
for rivaroxaban. Adherence to the dosing regimen was found
in 99.8% of R-PAK and 97.65% of control patients (P = .07).
Minor bleeding, defined as epistaxis or ecchymosis without
a known cause, was reported in 1 R-PAK patient and 4 control patients (P = .16). No patients involved with the trial
reported bleeding requiring medical attention or death. No
difference was found between patients when reporting benefit or burden of therapy via ACTS (P = .054 and P = .68,
respectively).

Discussion
To the investigators' knowledge, this is the first prospective
study evaluating the implementation of a discharge kit to help
facilitate the appropriate transition of rivaroxaban in the treatment of VTE. Although most patients were diagnosed with a
PE, PE severity index (PESI) scores indicated low mortality
risk among patients in both groups, correlating with the observation of a low number of in-hospital doses administered to

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