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临床试验/NCT02435290
NCT02435290已完成不适用

Cross-sectional Study to Enhance the Prediction of Prescribing Errors for Oncology Patients

hadeer ehab0 个研究点目标入组 500 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
主要终点
prescribing errors average

研究概览

简要总结

It is a cross-sectional study examining a random sample of in- and out-patients, with proven malignant disease receiving chemotherapy, over a period of 6 months from the start of the study who visit the Oncology department, Ain Shams University Teaching Hospitals. The effect of some risk factors on the prescribing error will be studied; these risk factors include the following: Tumor type ,Cancer stage ,type of comorbid illness ,type of medication , type of anti-cancer treatment , number of abnormal lab data ,type of abnormal lab data , the number of drugs in the treatment regimen , the number of side effects after chemotherapy administration, the age of patient ,the dosing frequency of anticancer ,the route of administration .

Summary statistics are performed to describe patient characteristics , frequency, types and classification of medication error; and frequency with which Medication errors occur.

Logistic regression will be applied to the collected data to perform a predictive relation between the risk factors which may be (categorical, continuous, or discrete) and the prescribing errors which are (categorical).

详细描述

This study will be performed according to the hospital's ethics board. Data on age, cancer diagnosis, cancer stage, comorbid illness, details of the anticancer treatment, and drugs for comorbid illness as well as any laboratory abnormalities will be collected.The data will be collected from medical records review.Progress notes and changes made to patients' medication orders since admission are reviewed.

Drugs are classified as either "active agents" (defined as medications to treat cancer- and/or therapy-related symptoms) or "medications to treat comorbid conditions." A comorbid illness is defined as a non-cancer clinical condition that required pharmacologic treatment .

Prescribing errors will be classified as:

  • Incorrect Medication: Medication ordered was not appropriate for patient based on indication, patient-specific variables, or clinical status.
  • Medication Omission Error: patient having an indication for which no treatment or inadequate treatment was prescribed.
  • Dose error: Under or over dosage of more than 5% of antineoplastic drugs .
  • Dose omission: unspecified dosage for the medications.
  • Incorrect Treatment Duration: Medication prescribed without an appropriate stop time.
  • Potential drug-drug interactions: a modification of the effect of a drug when administered with another drug.
  • Duplicate prescribing: two or more drugs from the same class are prescribed to treat the same condition, or different conditions.
  • Omitted or improper route of administration: unspecified route, wrong route, or improper route to the patient clinical status.
  • Improper medication infusion rate: wrong infusion rate for medications administrated via intravenous route.

The prescribing errors will be identified utilizing:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • in- and out-patients, with proven malignant disease receiving chemotherapy

排除标准

  • Patients receiving experimental agents and
  • patients who are too ill or unwilling to participate will be excluded.

结局指标

主要结局

prescribing errors average

时间窗: 6 months

to determine the average number of prescribing errors per patient

次要结局

  • cancer staging(6 months)

研究者

发起方
hadeer ehab
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

hadeer ehab

clinical pharmacist

Ain Shams University

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