Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial
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ORIGINAL RESEARCH ARTICLE
Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial Amanda M. Kibbons1 · Megan Peter1 · Josh DeClercq2 · Leena Choi2 · Jacob Bell1 · Jacob Jolly1,3 · Elizabeth Cherry1 · Bassel Alhashemi1 · Nisha B. Shah1 · Autumn D. Zuckerman1 Published online: 21 September 2020 © The Author(s) 2020
Abstract Background The effectiveness of specialty medications in complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence. Objective This study aims to determine whether pharmacist interventions improve specialty medication adherence. Methods This is a single-center, pragmatic, randomized controlled trial ongoing since 10 May 2019 at an integrated health system specialty pharmacy. This study evaluates usual care compared with usual care plus patient-tailored adherence interventions. Study design and procedures were informed by focus groups with patients and specialty pharmacists. Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC) 30 days beyond their anticipated refill date were highly likely to have either discontinued treatment or have excess medication because of previous overlapping refills. Therefore, an additional requirement of > 30 gap days in the previous 4 months was included to reduce the risk of excluding patients with a medication surplus because of early refills.
The pilot also identified forgetfulness as a primary reason for nonadherence, often because of administration frequencies of two or four times per month. We explored several options for aiding memory and decided to use smartphone reminders. In the pilot experience, patients were willing to set up reminders on their phone. Therefore, we sent written instructions via post for how to set up reminders as a component of the intervention when memory was indicated as a reason for nonadherence and the patient reported using a smartphone.
Fig. 1 Visual summary of the adherence intervention study process. REDCap Research Electronic Data Capture, PDC number of covered days from supply diary/calculated number of days in time period of interest, VUMC Vanderbilt University Medical Center
2.2.4 Health System Determinants We noted several patients missed refills because of inaccurate data input in the pharmacy management system.
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Examples included refill tasks that did not fire appropriately, new prescriptions required but not sent, or prescriptions sent to the incorrect pharmacy. To minimize the impact of health system determinants, the investigator ensures all refill requirements are met for each patient in the intervention arm prior to the date they will run out of their previous fill if taking as prescribed. 2.2.5 Defining Nonadherence Adherence thresholds have been proposed by the Pharmacy Quality Alliance for noninfused biologic medications used to treat rheumatoid arthritis, noninfused disease-modifying therapy used to treat multiple sclerosis, and antiretrovir
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