Acid Suppressive Therapy - Review of Appropriateness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of long term ambulatory treatment with AST.
研究概览
简要总结
Acid suppressive therapy (AST) is used in a variety of indications in prevention and treatment of gastric acid related disorders. In recent years, an increase in the use of acid suppressive therapy has been documented. It has generally been accepted that these agents are effective and safe. However, very recently, reports describing hypomagnesaemia, hypocalcemia, vitamin B12 deficiency and enteric infections, were published.
The goal of this study is to evaluate 1) how many cases of long-term ambulatory treatment with AST are initiated during hospital stay (= ASTRA-1), and 2) assess the appropriateness of initiation of AST and the appropriateness of continuation of AST at discharge in a subset of the hospitalized patient population (= ASTRA-2). Finally, the pharmacoeconomic impact of inappropriate AST during hospitalisation will be calculated from these data.
The primary endpoint is defined as the number of patients on long-term ambulatory AST after initiation in the hospital. Secondary endpoints are the appropriateness check of AST both at the level of initiation during hospitalization and at discharge (appropriate continuation); also the impact on the hospital budget (lump sum budget) will be calculated, and potential cost avoidance for long-term ambulatory inappropriate AST will be estimated from a healthcare payer perspective for a period of 1, 3, 6 and 12 months.
详细描述
ASTRA 1
A retrospective, multi-centric, observational study will be carried out in 9 Belgian hospitals. Patients will be recruited hospital wide in all participating hospitals.
All hospitalized adult patients (defined as 18 years or older at the moment of discharge) discharged from participating hospitals from in 01-07-2012 until 01-07-2013 will be included, if they were treated at any moment during hospitalization with AST (both H2A, defined as all drugs belonging to ATC A02BA, and PPI, defined as all drugs belonging to ATC A02BC). Younger patients are excluded as they are often treated with compounded suspensions and these preparations are impossible to match with the dispensed medication. Fulfillment of these criteria will be based on queries retrieving data from the hospital information system. The query will generate, for each participating hospital, a list of unique hospitalizations. In order to guaranty the patients privacy, datasets will be made anonymous by a trusted third party (see further in protocol). Reporting will be anonymous, never on an individual patient, physician or hospital.
For this list, all potentially interesting covariates will be documented by adding coded patient-related data, in order to allow determination of associated risk factors by uni- and multivariate analysis. The following patient-related information will be requested from the HIS: number of participating hospital, date of admission and discharge, age, weight, sex, region of living, length of stay, diagnosis on admission, hospital outcome in terms of mortality, comorbidity details (based on ICD-9 coding), presence of gastro(duodenal) investigations during hospital stay (eg. gastroscopy), discipline of treating clinician and/or hospital ward.
Patients with multiple hospitalizations during the inclusion period will be included. Each separate hospitalization will be counted as a separate line in the database. Bias is expected to be minimal as long-term use of AST will exclude the subsequent hospitalization periods because the patient would not be naive to AST on admission.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Discharged from participating hospitals from July 2012 till July
- •Specific for part 2: startup of AST in hospital and AST on time of discharge
排除标准
- •Deceased at discharge
- •Critically ill patients
- •Younger then 18 years old at time of discharge
- •Requested by treating physician (negative consent)
结局指标
主要结局
Incidence of long term ambulatory treatment with AST.
时间窗: 1 year after discharge
The goal of this study is to evaluate how many cases of long-term ambulatory treatment with AST are initiated during hospital stay (= ASTRA-1). Period from 1 year before till 1 year after hospitalisation is assessed.
次要结局
- Appropriateness of startup of AST.(Period of hospitalisation (average of 9 days))
- Pharmacoeconomic impact from healthcarepayer perspective(One year after hospitalisation)