跳至主要内容
临床试验/NCT05210335
NCT05210335已完成不适用

RISK ANALYSIS AND MANAGEMENT FOR MEDICATION OPTIMIZATION IN THE PREOPERATIVE AND POSTOPERATIVE PERIOD OF CARDIAC SURGICAL PATIENTS

Hacettepe University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Obtaining drug related problems preoperative and postoperative periods

研究概览

简要总结

Optimal perioperative and long-term success in cardiac-surgery require precise management of drug treatment. This study was aimed to determine prevalence, types and associated factors of drug related problems (DRPs) at both preoperative and postoperative stages in patients at cardiac-surgery by using risk analysis method.

详细描述

Cardiac surgery becomes a life-saving option in patients once medical treatments become inadequate. In order to achieve optimal perioperative and long- term success in cardiac surgery, drug treatment should be managed precisely. Patients with cardiovascular diseases are at risk for developing drug related problems (DRPs) due to polypharmacy and having received high-alert medications, such as antiarrhythmics or antithrombotic agents. In addition, type of operation (multiple artery bypass or combined valve procedures), existence of chronic atherosclerotic diseases (such as diabetes mellitus, hypertension), length of stay (LOS) at hospital, frailty, changes in medications for unstable cardiac conditions, incomplete or inadequate history for medication at hospital admission, transition between wards by different healthcare teams and transfer of discrepancies throughout entire perioperative period contributes to increased risk of DRPs in patients at cardiac surgery. It has been shown that over one third of patients suffer from DRPs during hospitalization. Clinical pharmacists are in a position to identify and prevent DRPs, therefore can help to provide optimal pharmaceutical treatment by performing medication reconciliation, improving patient compliance, monitoring of laboratory values and conducting patient education for surgical patients.However, there is limited information about prevalence and risk factors of DRPs in patients at cardiac surgery, in particular with perioperative stages. Majority of studies regarding DRPs have been conducted in specific populations such as elderly, pediatrics or in general medicine. Therefore this study was aimed to determine prevalence, types and associated factors of drug related problems (DRPs) at both preoperative and postoperative stages in patients at cardiac-surgery by using risk analysis method.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
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

  • •Patients are aged 18 years or older
  • •admitted to the hospital for a planned elective cardiac surgery during the study period were considered eligible.

排除标准

  • •Patients who refused to participate,
  • •transferred from different wards
  • •have urgent surgery planned were excluded

研究组 & 干预措施

Observational part

No Intervention

This part covers the list for comprehensive medication use at admission, medication reconciliation and medication review at preoperative surgical ward, postoperative intensive care, postoperative surgical ward and discharge made by clinical pharmacist. The identification and classification of drug related problems was made at each ward according to PCNE classification system. The expert panel (2 surgeon, 2 nurse, 1 pharmacist) scored all the drug related problems as a part of the risk analysis model development. Patients quality of life, nutritional status, cognitive functions and frailty status also recorder at admission, discharge and 1 month after surgery.

Interventional part

Experimental

This part covers the list for comprehensive medication use at admission, medication reconciliation and medication review at preoperative surgical ward, postoperative intensive care, postoperative surgical ward and discharge made by clinical pharmacist. Clinical pharmacist made recommendation about drug related problems regarding solutions, record intervention type and problem status differently from observational part. As a component of the risk analysis model the affect of clinical pharmacist was shown clearly. Patients quality of life, nutritional status, cognitive functions and frailty status also recorder at admission, discharge and 1 month after surgery.

干预措施: Clinical pharmacist's recommendation to physicians about drug related problems (Other)

结局指标

主要结局

Obtaining drug related problems preoperative and postoperative periods

时间窗: 6 months (1 November 2019-30 March 2020)

Obtaining valid drug related problems and their characteristic is the primary outcome as a part of the risk analysis.

Building risk analysis model

时间窗: 3 months (30 March 2020-30 June 2020)

In line with the valid drug related problems expert panel build the model

Obtaining clinical pharmacist affect

时间窗: 6 months (1 August 2020- 30 January 2021)

Obtaining clinical pharmacist affect as a part of the risk analysis model

次要结局

  • Obtaining clinical pharmacist intervention on other factors(6 months (1 August 2020- 30 January 2021))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Burcu Kelleci Cakir

Lecturer

Hacettepe University

研究点 (1)

Loading locations...

相似试验