mHealth Medication Safety Intervention

Study Overview
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Brief Summary
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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.

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

Conditions
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Medication Compliance

Intervention / Treatment
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* Other: Pharmacist-led medication therapy using mHealth application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth Group<br>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<br>* 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).<br>|
| No Intervention: Usual Care Group<br>Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication Safety, Mobile Health Technology