Evaluation of the Effect of Management of Drug-Related Problems on Clinical Outcomes of Pulmonary Embolism Outpatients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Acceptance rate of suggested intervention (number)
研究概览
简要总结
Pulmonary embolism (PE) presents notable risks of morbidity and mortality, underscoring the need for customized anticoagulant treatment. There is a scarcity of research examining drug-related issues (DRPs) in PE. This research endeavor seeks to assess how addressing DRPs affects the clinical outcomes of PE patients receiving outpatient care, offering valuable insights to bolster patient safety measures.
This study will conduct a randomized controlled trial on PE patients in Istanbul, Turkey, from January 15, 2022, to January 15, 2023. The intervention group (IG) will receive clinical pharmacist (CP) recommendations for DRPs, while the control group (CG) will undergo observation only. Evaluations will occur at 90- and 180-days post-discharge, focusing on DRPs, CP interventions, and patient outcomes. Data will be systematically recorded and analyzed, adhering to ethical standards and employing the PCNE v9.1 classification system.
详细描述
Pulmonary embolism (PE) involves the blockage of the pulmonary artery or one of its branches by materials like thrombus from elsewhere in the body. This condition is linked to increased mortality and morbidity rates, and if left untreated, it can result in recurring episodes. Additionally, using anticoagulant therapy poses a significant risk of severe bleeding.
Recent guidelines recommend customizing the duration of PE treatment based on the type of underlying risk factor, distinguishing between transient and persistent factors. Prolonged treatment without a persistent risk factor may heighten the risk of bleeding. Hence, selecting appropriate treatment options tailored to individual patient needs is crucial.
The main goal of our study is to evaluate how managing drug-related problems (DRPs) in pulmonary embolism (PE) outpatients influences their clinical outcomes. This research aims to provide valuable insights into the effectiveness of interventions targeting DRPs within the framework of PE management .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •A confirmed diagnosis of pulmonary embolism (ICD-10 code: I26.0)
- •Patients visited the chest diseases outpatient clinic for post-discharge follow-up
- •Being 18 years or older.
- •Patients who could be evaluated by the clinical pharmacist for at least 24 hours within the intervention group.
排除标准
- •Being under 18 years old.
- •Lost follow up in 90th day after pulmonary embolism.
结局指标
主要结局
Acceptance rate of suggested intervention (number)
时间窗: From the date of randomization until there are 50 patient participants in each group. Average 1 year.
Acceptance rate of suggested intervention. Dru-related problems and recommendations are classified according to PCNE (Pharmaceutical Care Network Europe) version 9.1. It was recorded how many suggestions were made in the intervention group and how many of these suggestions were accepted.
Bleeding
时间窗: From the date of randomization until there are 50 patient participants in each group. Average 1 year.
Occasions of bleeding within the 180th day.
次要结局
- Increase in pulmonary embolism related quality of life(From the date of randomization until there are 50 patient participants in each group. Average 1 year.)
研究者
Muhammed Yunus BEKTAY
Dr.
Bezmialem Vakif University