Improving Transplant Medication Safety Through A Pharmacist-Empowered, Patient-Centered, Mhealth-Based Intervention (TRANSAFE Rx Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Incidence and Severity of Adverse Drug Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
In order to minimize bias, data for outcomes will be collected by a blinded study coordinator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence and Severity of Adverse Drug Events
时间窗: 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
时间窗: 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
时间窗: 1 year
Severity of Medication Errors were measured using the Overhage criteria
次要结局
- Hospitalization Rate(1 year)