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

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.

Thrombolytic Therapy in Wake-Up Stroke Patients.

OBJECTIVE: The aim of the study is to review existing and ongoing trial data on wake-up stroke (WUS) patients for thrombolytic therapy. METHODS: A literature search was conducted in PubMed (conception-October 2016) using the terms wake-up stroke, acute ischemic stroke, wake-up thrombolysis, computed tomography imaging in wake-up stroke, and magnetic resonance imaging in wake-up stroke. Ongoing trials were found using the ClinicalTrials.gov website. RESULTS: The search yielded 61 articles in PubMed and 7 ongoing trials. After removing duplicate/irrelevant articles, 33 articles and relevant references were reviewed; of these, 6 articles and 3 ongoing trials were included. Two retrospective studies evaluating the characteristics between WUS and known-onset stroke were identified; the only significant difference between groups was the ability to receive treatment with tissue plasminogen activator (tPA). One study suggested that perfusion brain imaging may be useful to identify patients that may benefit from tPA. In addition, 3 studies have evaluated WUS treatment; all used different methods to identify potential patients. Two of 3 studies showed that treatment with tPA is associated with better outcomes when controlling for baseline National Institutes of Health Stroke Scale. No difference in safety outcomes was seen between groups for all 3 studies. CONCLUSIONS: Available data suggest promising strategies to identify WUS patients who may benefit from thrombolysis. Once on-going trials are complete, there may be sufficient information to redefine tPA eligibility for previously excluded patients.

Conception of a Personalized Medication Adherence Discharge Kit for Rivaroxaban.

Purpose: Due to a lack of necessary monitoring with rivaroxaban, patients have fewer opportunities for education, adherence reinforcement, and follow-up. If rivaroxaban is taken incorrectly, patients are at increased risk for adverse events. The objective was to create personalized rivaroxaban patient adherence kits (R-PAKs) to enhance successful transition from 15 mg twice daily to 20 mg once daily on day 22 of venous thromboembolism (VTE) treatment. Summary: A review of rivaroxaban drug information and existing medication adherence tools was completed to increase understanding of ways to improve adherence. Clinical pharmacists identified several concerns the R-PAK should address, including patient understanding of correct dose, administration timing, serious adverse effects, and importance of compliance, along with loss to follow-up by a health care provider. In the pilot phase, 100 R-PAKs were created. Each kit includes an educational handout describing adverse effects, administration, and monitoring; a reminder card with dosing information, date to transition, and emergency contact information; and a personalized 28-day pill organizer containing customized dividers to correlate with the first 21 days of treatment. Color-coded stickers denote the first day of starting twice-daily therapy upon discharge and the day of transition to once-daily dosing. The items were distributed in tote bags at discharge along with pharmacist education. Conclusion: The R-PAKs are being used at a community teaching hospital for patients newly diagnosed with VTE who are discharged on rivaroxaban. The concept of a personalized medication box could be modified for any medication that requires high compliance or dose transitions.