Correlates of Economic Outcomes of Enteral and Parenteral PPI Use in the ICU and After Discharge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- Determine qualifying criteria of enteral versus parenteral PPIs
研究概览
简要总结
This study will be a retrospective electronic medical chart review of all patients admitted to adult intensive care medicine units (ICU) at The Nebraska Medical Center over a three-year period from January 2006 through December 2008. The study will have three primary aims:
- Aim 1: Determine correlates (qualifying criteria) of patients initiated on enteral versus parenteral PPIs as first choice in ICU and after discharge from ICU,
- Aim 2: Based on correlates determine number of patients receiving parenteral PPIs that could receive enteral therapy as first choice in ICU and after discharge from ICU,
- Aim 3: Estimate the potential savings in drug costs associated with conversion of eligible patients from parenteral to enteral PPI therapy with emphasis on lansoprazole solutab in the ICU and conversion of eligible patients requiring continued AST from parenteral to enteral PPI therapy after discharge from ICU.
详细描述
BACKGROUND AND SIGNIFICANCE:
Detail: Proton pump inhibitors (PPIs) are commonly used in intensive care unit (ICU) patients for various clinical conditions, including acute stress related gastrointestinal bleeding (ASRGIB) and clinically significant upper gastrointestinal bleeding (UGIB). Although randomized prospective clinical trials are limited with PPIs and other agents that suppress gastric acid, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires patients receive acid-suppressive therapy on admission to any ICU. Physicians and pharmacists tend to choose the parenteral route for PPI administration rather than the enteral route despite several potential advantages for administration into the gastrointestinal tract. Factors supporting enteral PPI administration include: the ease with which PPIs can be formulated as a liquid suspension, their high bioavailability in healthy patients, an efficacy that has been shown to be greater than intravenous histamine-2 receptor antagonists (H2RA) therapy, and a low acquisition cost. In fact, studies completed in healthy patients demonstrate that enterally administered PPIs may lead to greater acid suppression than parenterally administered PPIs on a mg-for-mg basis. A potential limitation associated with the use of the gut to administer medication to the critically ill patient relates to whether the drug will be adequately absorbed. We have repeatedly showed at our institution (650 bed teaching hospital with 54 ICU beds) that seriously ill patients, adequately absorbed enterally administered PPIs and provide equal or superior acid suppression profiles when compared to equivalent doses of PPIs administered parenterally. Limited information is available on the utilization trends and associated potential cost savings with the use of enteral therapy compared with parenteral PPI administration in the ICU setting. Lansoprazole oral solutab use in the ICU and hospital setting may lead to further cost savings by reducing the lengthy preparation ease in administration compared with enterally administered PPIs like omeprazole, pantoprazole and esomeprazole. Therefore, to inform formulary decisions and cost-effective quality of care, we propose a real-world retrospective study of the correlates of and economic outcomes in terms of potential savings in drug costs with use of enteral PPI including lansoprazole solutab compared with parenteral PPI use in and out of the ICU.
RESEARCH DESIGN AND METHODS:
Overview: Study Design: This study will be a retrospective electronic medical chart review of all patients admitted to adult intensive care medicine units (ICU) at The Nebraska Medical Center over a three-year period from January 2006 through December 2008.
Following investigational review board (IRB) approval, a computerized list of all patients admitted to the ICU over the designated period will be generated. Using laboratory personal, all patients will be reviewed and data recorded into an access data base. Data will be collected in our outcomes laboratory which is a 400 square feet room housing 5 computers equipped with related software and connected to PHAMIS, the hospital electronic medical record of our institution.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients greater than 18 years admitted to the ICU during 2006-2008 (January 2006 through December 2008; 3-year period)
排除标准
- •Patients ineligible to receive a PPI (e.g. hypersensitivity to any PPI)
结局指标
主要结局
Determine qualifying criteria of enteral versus parenteral PPIs
时间窗: 2006-2008
Determine correlates (qualifying criteria) of patients initiated on enteral versus parenteral PPIs as first choice in ICU and after discharge from ICU
次要结局
- Potential savings in drug costs from parenteral to enteral PPI therapy(2006-2008)
