mHealth Medication Safety Intervention

Improving Transplant Medication Safety Through A Pharmacist-Empowered, Patient-Centered, Mhealth-Based Intervention (TRANSAFE Rx Study)

TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial, involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve medication safety and health outcomes, as compared to usual post-transplant care. The primary goal of the TRANSAFE Rx study is to demonstrate significant reductions in med safety issues leading to reduced healthcare resource utilization in kidney transplantation through a pharmacist-led, mHealth-enabled, intervention. This study will provide detailed and novel information on the incidence, etiologies and outcomes of med errors and adverse drug events in this high-risk population; while also demonstrating the effectiveness of this intervention on reducing the incidence and impact of med safety issues in kidney transplantation.

Study Overview

• Status: Completed
• Conditions: Medication Compliance
• Intervention / Treatment: Other: Pharmacist-led medication therapy using mHealth application

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Kidney transplant recipient between 6 and 36 months post-transplant
• At least 18 years of age
• Transplant MD agrees that patient is eligible to participate

Exclusion Criteria:

• Multi-organ recipient
• Patient is incapable of:
• Measuring their own blood pressure and glucose (if applicable)
• Self-administering medications
• Speaking, hearing and reading English
• Utilizing the mHealth application, after training

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mHealth Group; Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).	Other: Pharmacist-led medication therapy using mHealth application; This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
No Intervention: Usual Care Group; Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Medication Errors	Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended	1 year
Incidence and Severity of Adverse Drug Events	Adverse Events will be defined according to the AHRQ Patient Safety Network as an injury resulting from medical care. Rates of Events Per Patient Year by AE Grade	1 year
Severity of Medication Errors	Severity of Medication Errors were measured using the Overhage criteria	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization Rate	Number of hospitalizations per patient-year	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection Rate	Number of infections per patient-year	1 year
Opportunistic Infection Rate	Opportunistic infections per patient-year	1 year

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: David Taber, PharmD,MS, Medical University of South Carolina

Publications and helpful links

General Publications

• Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
• Gonzales HM, Fleming JN, Gebregziabher M, Posadas Salas MA, McGillicuddy JW, Taber DJ. A Critical Analysis of the Specific Pharmacist Interventions and Risk Assessments During the 12-Month TRANSAFE Rx Randomized Controlled Trial. Ann Pharmacother. 2022 Jun;56(6):685-690. doi: 10.1177/10600280211044792. Epub 2021 Sep 8.
• Taber DJ, Fleming JN, Su Z, Mauldin P, McGillicuddy JW, Posadas A, Gebregziabher M. Significant hospitalization cost savings to the payer with a pharmacist-led mobile health intervention to improve medication safety in kidney transplant recipients. Am J Transplant. 2021 Oct;21(10):3428-3435. doi: 10.1111/ajt.16737. Epub 2021 Jul 14.
• Fleming JN, Treiber F, McGillicuddy J, Gebregziabher M, Taber DJ. Improving Transplant Medication Safety Through a Pharmacist-Empowered, Patient-Centered, mHealth-Based Intervention: TRANSAFE Rx Study Protocol. JMIR Res Protoc. 2018 Mar 2;7(3):e59. doi: 10.2196/resprot.9078.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): February 3, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Mobile Health Technology; Medication Safety
• Other Study ID Numbers: Pro00068746

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No