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. 2018 Mar 2;7(3):e59.
doi: 10.2196/resprot.9078.

Improving Transplant Medication Safety Through a Pharmacist-Empowered, Patient-Centered, mHealth-Based Intervention: TRANSAFE Rx Study Protocol

James N Fleming #  1 , Frank Treiber  2 , John McGillicuddy  3 , Mulugeta Gebregziabher  4 , David J Taber  3   5
Affiliations

Improving Transplant Medication Safety Through a Pharmacist-Empowered, Patient-Centered, mHealth-Based Intervention: TRANSAFE Rx Study Protocol

James N Fleming et al. JMIR Res Protoc. .

Abstract

Background: Medication errors, adverse drug events, and nonadherence are the predominant causes of graft loss in kidney transplant recipients and lead to increased healthcare utilization. Research has demonstrated that clinical pharmacists have the unique education and training to identify these events early and develop strategies to mitigate or prevent downstream sequelae. In addition, studies utilizing mHealth interventions have demonstrated success in improving the control of chronic conditions that lead to kidney transplant deterioration.

Objective: The goal of the prospective, randomized TRANSAFE Rx study is to measure the clinical and economic effectiveness of a pharmacist-led, mHealth-based intervention, as compared to usual care, in kidney transplant recipients.

Methods: TRANSAFE Rx is a 12-month, parallel, two-arm, 1:1 randomized controlled clinical trial involving 136 participants (68 in each arm) and measuring the clinical and economic effectiveness of a pharmacist-led intervention which utilizes an innovative mobile health application to improve medication safety and health outcomes, as compared to usual posttransplant care.

Results: The primary outcome measure of this study will be the incidence and severity of MEs and ADRs, which will be identified, categorized, and compared between the intervention and control cohorts. The exploratory outcome measures of this study are to compare the incidence and severity of acute rejections, infections, graft function, graft loss, and death between research cohorts and measure the association between medication safety issues and these events. Additional data that will be gathered includes sociodemographics, health literacy, depression, and support.

Conclusions: With this report we describe the study design, methods, and outcome measures that will be utilized in the ongoing TRANSAFE Rx clinical trial.

Trial registration: ClinicalTrials.gov NCT03247322: https://clinicaltrials.gov/ct2/show/NCT03247322 (Archived by WebCite at http://www.webcitation.org/6xcSUnuzW).

Keywords: adherence; clinical trial; errors; mhealth; telemedicine; transplant.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

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Pharmacist process to resolve medication safety issues.
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Predominant medication safety issues with mitigating interventions.
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Conceptual diagram of mobile health (mHealth) system.
See this image and copyright information in PMC

References

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    1. Matas AJ, Smith JM, Skeans MA, Lamb KE, Gustafson SK, Samana CJ, Stewart DE, Snyder JJ, Israni AK, Kasiske BL. OPTN/SRTR 2011 Annual Data Report: kidney. Am J Transplant. 2013;13 Suppl 1:11–46. doi: 10.1111/ajt.12019. doi: 10.1111/ajt.12019. - DOI - DOI - PubMed
    1. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR) OPTN / SRTR 2010 annual data report. Rockville, MD. Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation. 2011 https://srtr.transplant.hrsa.gov/annual_reports/2010/pdf/01_kidney_11.pdf
    1. Scientific Registry of Transplant Recipients. [2018-02-07]. Scientific Registry of Transplant Recipients https://www.srtr.org/ 6x3dmOtbE
    1. Meier-Kriesche H, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378–383. http://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pub... - PubMed

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