Improving Drug Safety in Emergency Patients -a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 806
- 试验地点
- 1
- 主要终点
- Proportion of patients readmitted
研究概览
简要总结
Aim/Objective: Investigate the effect of implementing a working model for performing medication reconciliation (MR) and medication review (MRe) in the emergency department (ED), on readmissions, patient safety and efficiency of the stay in the ED and the hospital. Research design: randomized, controlled, non-blinded trial. Control group; standard care. Intervention group; MR and MRe performed at admission to the ED by a clinical pharmacist in the interdisciplinary team. The intervention is based on a working model for MR, developed in our initiation project, and it will be adapted to also include MRe. Key challenges in this research field: Currently no implemented systematic model ensuring that the patient's correct medication list is obtained and assessed at the point of admission. There is lack of studies investigating the clinically outcome of performing MR and MRe in the ED. Lack of knowledge on the extent of drug related hospital admissions in Norway. These challenges are also recognized and prioritized by the Norwegian authorities. Impact and utility: The results from this study will give important answers to the challenges listed above. The results could imply a huge impact on how to organize ED in Norway regarding drug safety. If the hypothesis of this study is confirmed, implementing the intervention described will increase patient safety, both the hospital and society can reduce health care expenses from readmissions, and also the readmission-burden can be reduced for the patients.
详细描述
Inclusion and randomization procedures
Staff at the emergency department, including physicians and nurses will be informed about the project. At admission, the project pharmacist will describe the project to each potential participant and/or their next of kin, then provide written information about the project and answer potential questions. If patients temporary are unable to consent when asked to participate (e.g. delirium) their next of kin will be asked to supply a preliminary consent in the patients place. If the patient later refuses to participate he/she will be excluded from the trial, and any registered data for this patient will be deleted. Patients will periodically be included at day shift and evening shift and by different clinical pharmacists to reduce potential bias. We will randomize the patients into two study groups. The randomization process will be conducted by Department of Biostatistics and Epidemiology at Oslo University Hospital. This department will deliver randomization lists, and the project pharmacist will follow randomization procedure.
Data registration
Patient data will be registered on paper forms, which will be de-identified after the patient data is transferred de-identified to the password protected project database on the hospital research server. Only a code list will connect the patient to his or her data. Paper forms will at all times be kept accessible only to authorized project personnel, and eventually the forms will be maculated. De-identified patient information will not be brought out of the hospital. The code list connecting the patients to their data will at the latest be deleted 3 years after start of data collection. When results are published it will not be possible to identify individual patients.
Customized Standard Operating Procedures addressing inclusion and randomization operations, registry operations and how to perform the intervention is developed.
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
盲法说明
Not possible to mask the intervention
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 ≥ 18 years admitted to the emergency department
- •Able and willing to provide written consent (see Inclusion and randomization procedures and 6.Ethics)
排除标准
- •Patient have previously been included
- •Terminal ill patients with short life expectancy
- •Control group patients where physician at the emergency department request an assessment from a clinical pharmacist
- •Control group patients where the project pharmacist reveal drug-related problems of major clinical relevance and has to intervene
研究组 & 干预措施
Intervention group
Pharmacist conducts medication reconciliation and medication review while the patient is admitted to the emergency Department. The pharmacist present results from medication reconciliation to physicians at the emergency Department before the Medical history is obtained. Further the pharmacist will discuss drug related problems obtained during the medication review with the physicians to customize and optimize the medication treatment for each patient.
干预措施: Medication reconciliation and medication review (Other)
Control group
Standard treatment without pharmacist intervention in the emergency department
结局指标
主要结局
Proportion of patients readmitted
时间窗: 12 months from inclusion
Difference between intervention- and control group in proportion of patients readmitted
次要结局
- High risk patients(Retrospective, 18 months after inclusion start (24. April 2017))
- Retrospectively testing the two prioritizing models(Retrospective, 2 years after inclusion start (24. April 2017))
- Proportion of patients readmitted(6 months from inclusion)
- Average number of admissions(12 months from inclusion)
- Proportion of patients not hospitalized following admission to the emergency department (patients which condition is resolved in the emergency department)(During the relevant hospital admission (at inclusion))
- Investigate the efficiency of the new working model (for conducting medication reconciliation and medication review)(During inclusion period)
- Time to next contact with a hospital(Time to next readmission, maximum 12 months from inclusion)
- Length of stay at the emergency department(During the relevant hospital admission (at inclusion))
- Overall length of hospital stay(During the relevant hospital admission (at inclusion))
- Identify risk factors correlated to medication related admissions and drug related problems(Retrospective, 18 months after inclusion start (24. April 2017))
- Drug related admission(By pharmacist during the relevant hospital admission (at inclusion), by physicians and multidisciplinary team; retrospective, 18 months after inclusion start (24. April 2017))
- Patients point of view(2 years after inclusion start (24. April 2017))
研究者
Lisbeth Damlien Nymoen
Ph.d. candidate and project pharmacist
Diakonhjemmet Hospital