mHealth Medication Safety Intervention

Not Applicable

Completed

• Conditions: Medication Compliance
• Interventions: Other: Pharmacist-led medication therapy using mHealth application

• Registration Number: NCT03247322
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-11
• Study Start: 2017-10-11
• Primary Completion: 2020-02-03
• Study Completion: 2020-05-30
• Status Verified: 2021-02
• Results First Submitted: 2021-02-01
• Results First Submitted QC: 2021-02-24
• Last Update Submitted: 2021-02-24
• Results First Posted: 2021-02-25
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mHealth Group	Pharmacist-led medication therapy using mHealth application	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).

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Adverse Drug Events	1 year	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
Number of Medication Errors	1 year	Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended
Severity of Medication Errors	1 year	Severity of Medication Errors were measured using the Overhage criteria

Secondary Outcome Measures

Name	Time	Method
Hospitalization Rate	1 year	Number of hospitalizations per patient-year

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States