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

Abstract

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. 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. 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. 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 ( = 1.00). Proper transition to daily administration on day 22 was no different between the groups ( = .891). Adherence was reported in 99.8% of R-PAK patients and 97.65% of control patients ( = .074). Side effects were rarely reported. 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.

Patient-focused interventions to support vulnerable people using oral anticoagulants: a narrative review

“…We identified only six studies 47,59,60,70–72 describing interventions that specifically targeted older persons and two studies of interventions that specifically targeted those with limited health literacy. 28,31 The findings from one study 28 highlight the importance of assessing health literacy because of the positive correlation between health literacy and warfarin knowledge. This relationship between health literacy and knowledge was also highlighted in one study of patients with hypertension.…”

“…Duplicates were removed, and the articles based on titles and abstracts were screened. For all articles, (including published conference abstracts), 31,38 the full-text version was retrieved and assessed according to the objectives of this review. The reference lists of the retrieved articles and review articles were examined manually to identify further relevant studies not identified using the search strategy.…”

“…The articles identified in this review used different tools to measure the level of health literacy. 28–31 These included The Rapid Estimate of Adult Literacy in Medicine (REALM) tool 32 and the shortened version of the Test of Functional Health Literacy in Adults (S-TOFHLA). 33 Newer tools such as the Health Literacy Questionnaire 34 are available to access health literacy, however, were not identified in this review.…”

“…Proper transition to daily administration on day 22 did not differ between the groups, and adherence did not differ between the R-PAK patients and those patients taking rivaroxaban with no discharge kit. 31 However, in that study, health literacy was assessed based on a single-item health literacy screening tool. Most patients stated they rarely or never required help to read instructions, pamphlets, or other written materials from their doctor or pharmacy, meaning that their rate of health literacy was high.…”

“…Most patients stated they rarely or never required help to read instructions, pamphlets, or other written materials from their doctor or pharmacy, meaning that their rate of health literacy was high. 31…”