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Completed

NCT Number: NCT03247322

mHealth Medication Safety Intervention

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.

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Key information

Conditions

Medication Compliance Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacist-led medication therapy using mHealth application

Other

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).

Primary outcomes

  1. Number of Medication Errors

    Time frame: 1 year

    Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended

  2. Incidence and Severity of Adverse Drug Events

    Time frame: 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

  3. Severity of Medication Errors

    Time frame: 1 year

    Severity of Medication Errors were measured using the Overhage criteria

Secondary outcomes

  1. Hospitalization Rate

    Time frame: 1 year

    Number of hospitalizations per patient-year

Other outcomes

  1. Infection Rate

    Time frame: 1 year

    Number of infections per patient-year

  2. Opportunistic Infection Rate

    Time frame: 1 year

    Opportunistic infections per patient-year

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2017
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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