Improving Transplant Medication Safety Through a Technology and Pharmacist Intervention (ISTEP): Protocol for a Cluster Randomized Controlled Trial

Abstract

Background Medication errors, adverse drug events, and nonadherence lead to increased health care 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 interorganizational system failures and provider-level and patient-level factors. Objective This study aims to measure the clinical and economic effectiveness of a pharmacist-led, technology-enabled intervention, compared with 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 uses an innovative dashboard system to improve medication safety and health outcomes, compared with usual posttransplant care. Pharmacists at 10 study sites will be consented into this study before undergoing randomization, and 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. Institutional review board approval was received in October 2018 and the study opened in March 2019. To date there are no findings from this study, as the delivery of the intervention is scheduled to occur over a 24-month period. The first results are expected to be submitted for publication in August 2021. Conclusions With this report, we describe the study design, methods, and outcome measures that will be used in this ongoing clinical trial. Successful completion of the Improving Transplant Medication Safety through a Technology and Pharmacist Intervention study will provide empirical evidence of the effectiveness of a feasible and scalable technology-enabled intervention on improving medication safety and costs. Clinical Trial ClinicalTrials.gov NCT03860818; https://clinicaltrials.gov/ct2/show/NCT03860818 International Registered Report Identifier (IRRID) PRR1-10.2196/13821

Feasibility study and determination of prerequisites of telecare programme to enhance patient management in lung transplantation: a qualitative study from the perspective of Iranian healthcare providers

“…Thus, equipping telecare programmes with smart electronic prescription modules to prevent medication errors is required. Such tools could check medications for their safety, drug interaction and appropriateness of dosing in patients and lessen the complexity of long-term immunosuppressive therapy and other specific therapies 20 21…”

A Randomized Control Trial Testing a Medication Safety Dashboard in Veteran Transplant Recipients

“…The full methodology used in this study has been previously published elsewhere. 16 In brief, this was a 24-month, multicenter, prospective, cluster-randomized, parallel-arm, pragmatic clinical trial (NCT03860818) entitled, “Improving Transplant Medication Safety Through a Technology and Pharmacist Intervention (ISTEP).” The study was reviewed and approved by the VA central institutional review board (cIRB). Informed written consent was obtained from the participating pharmacists at each study site.…”

“…15 As part of a follow-up grant, this system's functionality was expanded and tested in a multicenter, randomized clinical trial. 16 This analysis sought to address if a multicenter bioinformatics dashboard was able to accurately identify potential medication safety issues in Veteran transplant recipients. This was assessed by measuring the number and type of medication-related alerts identified by pharmacists and assessed the use of the dashboard by measuring the percent of alerts addressed by pharmacists, the time to addressing the alert, and actions taken to address the alert.…”