JMIR Publications

ABSTRACT

Background:

Medication errors, adverse drug events, and nonadherence lead to increased healthcare utilization and increased risk of adverse clinical outcomes, including graft loss, in solid organ transplant recipients. Veterans living with organ transplants represent a population that is at substantial risk for medication safety events and fragmented care coordination issues. To improve medication safety and long-term clinical outcomes in Veteran transplant patients, interventions should address inter-organizational system failures, as well as provider and patient-level factors.

Objective:

The goal of this study is to measure the clinical and economic effectiveness of a pharmacist-led, technology-enabled intervention, as compared to usual care, in Veteran organ transplant recipients.

Methods:

This is a 24-month prospective, parallel arm, cluster-randomized, controlled multicenter study. The pharmacist-led intervention utilizes an innovative dashboard system to improve medication safety and health outcomes, as compared to usual post-transplant care. Pharmacists at 10 study sites will be consented into this study prior to undergoing randomization, 5 sites will then be randomized to each study arm. Approximately 1600 Veteran transplant patients will be included in the assessment of the primary outcome across the 10 sites.

Results:

This study is ongoing. IRB approval was received on October 11, 2018 and the study opened on March 18, 2019.

Conclusions:

With this report we describe the study design, methods, and outcome measures that will be utilized in this ongoing clinical trial. Successful completion of the ISTEP study will provide empirical evidence of the effectiveness of a feasible and scalable technology-enabled intervention on improving medication safety and costs. Clinical Trial: Improving Transplant Medication Safety Through a TEchnology and Pharmacist (ISTEP) Intervention in Veterans ClinicalTrials.gov Identifier: NCT03860818 https://clinicaltrials.gov/ct2/show/NCT03860818