Comparison of Cost-effectiveness Between Electronic Notes Versus Telephone Calls to Alert the Prescriber of a Possible IV to Oral Switch.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,000
- 试验地点
- 2
- 主要终点
- Effectiveness of the type of alert
研究概览
简要总结
The goal of this study compare the effectiveness of an electronic note versus a telephone call to alert the prescriber of a possible IV to oral switch. Secondary endpoints are the time-to-switch and the economic impact of earlier IV to oral switch.
详细描述
Methods
o Study design
A prospective, mono-centric, interrupted time series interventional study will be carried out starting in August 2015. Patients will be recruited hospital wide, except for patients admitted at the ICU or pediatric wards. The study protocol will be send for approval to the Clinical Trial Centre and Ethics Committee. Based on the NIH, Code of Federal Regulations Chapter 45-46, an exemption on informed consent is requested at Ethics Committee in order to prevent bias by informing physicians and/or patients; as there's only a suggestion to alter therapy to the treating physician and no clinical intervention is planned and data are processed anonymously and retrospectively, patient safety and patient rights are guaranteed. The study protocol will be registered in the public registry ClinicalTrials.gov.
o Inclusion and exclusion criteria and general assessment process
All prescriptions for levofloxacin (J01MA12), moxifloxacin (J01MA14), clarithromycin (J01FA09), fluconazole (J02AC01), clindamycin (J01FF01), acetaminophen (N02BE01), rifampicin (J04AB02), ornidazole (J01XD03) and metronidazole (J01XD01) in the hospitals CPOE from 01-08-2015 until 30-11-2015 for all hospitalized patients will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Therapy with prescriptions for levofloxacin (J01MA12), moxifloxacin (J01MA14), clarithromycin (J01FA09), fluconazole (J02AC01), clindamycin (J01FF01), acetaminophen (N02BE01), rifampicin (J04AB02), ornidazole (J01XD03) and metronidazole (J01XD01) in the hospitals CPOE from 01-08-2015 until 30-11-2015 for hospitalized patients.
排除标准
- •Therapy prescribed in PDMS (in casu: ICU)
结局指标
主要结局
Effectiveness of the type of alert
时间窗: 4 months - August till November 2015 - calculated after each from 4 periods (=months)
Difference in number of switches and time to swich between electronic note and telephone alert of the prescriber.
次要结局
- The number of possible IV/PO switches, per discipline and per type of product(4 months - August till November 2015 - calculated after each from 4 periods (=months))
- Pharmacoeconomic impact of the intervention on time to switch(4 months - August till November 2015 - calculated after each from 4 periods (=months))
- Evidence and motivation for overruling the switch(4 months - August till November 2015 - calculated after each from 4 periods (=months))
- Learning curve over time and this for both methods of alerting on possible IV/PO switches(4 months - August till November 2015 - calculated after each from 4 periods (=months))
研究者
Thomas De Rijdt
Assistant-head of Pharmacy
Universitaire Ziekenhuizen KU Leuven