A National Study of Intravenous Medication Errors: Understanding How to Improve Intravenous Safety With Smart Pumps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Incident rates of wrong dose
研究概览
简要总结
To identify the key issues around use of computerized patient infusion devices (called "smart pumps").
To develop strategies that will improve the prevention of intravenous errors that will be broadly applicable.
The investigators will conduct a national study using the general methodology developed by Husch et al. to allow a rapid assessment of the frequency and types of medication errors at an institution.
The key questions the investigators will address are:
- What are the frequency and types of intravenous medication errors?
- How much variability is there by frequency and type among settings?
- After review of the initial data, what strategies appear to have the greatest potential for reducing intravenous medication error frequency?
- How effective is an intervention including a bundle of these strategies at multiple sites?
详细描述
Overall Study Design: This is a multi-hospital study to investigate medication errors using smart pumps. The proposed study will be conducted over three phases for a total of 36 months phases. In Year 1, an observational study will be conducted by investigators at ten multiple hospital sites. The investigators will prospectively compare the medication, dose, and infusion rate on the IV pump with the prescribed medication, doses, and rate in the medical record. Preventability with smart pump technology will be retrospectively determined based on a rigorous definition of currently available technology. The investigators will also make comparisons across sites by overall rate and degree of variability among sites.
Then, in Year 2, these results will be evaluated, and a consensus process including a face-to-face meeting will take place to evaluate the types of events and to develop an intervention which will be implemented at multiple sites. After a run-in period, the intervention will be tested in Year 3 at the sites, and the data will be analyzed, and the investigators will produce a report and a set of recommendations.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients if they receive any IV fluid or medication on the day of observation in the study units.
排除标准
- •patients who are under 21 years old.
结局指标
主要结局
Incident rates of wrong dose
时间窗: Two years
The same medication but the dose is different from the prescribed order.
Incident rates of wrong rate
时间窗: Two years
A different rate is displayed on the pump from that prescribed in the medical record. Also refers to weight based doses calculated incorrectly including using a wrong weight.
Incident rates of wrong concentration
时间窗: Two years
An amount of a medication in a unit of solution that is different from the prescribed order.
Incident rates of wrong IV fluids/medications
时间窗: Two years
A different fluid/medication as documented on the IV bag label is being infused compared with the order in the medical record.
Incident rates of delay of medication administration
时间窗: Two years
An order to start or change medication or rate not carried out within 4 hours of the written order or intended start time per institution policy.
Incident rates of omission of IV fluids/medications
时间窗: Two years
The medication ordered was not administered to a patient or administered anytime after 4 hours of the intended start time.
Incident rates of unauthorized medication
时间窗: Two years
Fluids/medications are administered to the patient but no order is present in medical record. This includes failure to document a verbal order.
Incident rates of patient identification (ID) error (wrong patient)
时间窗: Two years
Patient either has no ID band on or information on the ID band or label is incorrect.
Incident rates of smart pump or drug library not used
时间窗: Two years
Smart pump is not used (bypassing smart pump) or smart pump was used but the drug library was not selected, rather manual entry mode was used (bypassing drug library)
Incident rates of oversight allergy
时间窗: Two years
Medication is administered to a patient with a known allergy to the drug or class.
Incident rates of pump setting error
时间窗: Two years
Setting programmed into the pump is different from the prescribed order.
Compliance rate of label not complete according to policy
时间窗: Two years
Documented information on the medication label is different from required information per institution policy.
Compliance rate of IV tubing not tagged according to policy
时间窗: Two years
IV tubing change label is not tagged per institution policy.
Overall medication errors
时间窗: Two years
Total number of all observed medication errors(including outcome 1-14)
Higher-severity medication errors
时间窗: Two years
All medication errors with an NCC MERP severity rating of C or greater (excluding violation of hospital policy errors;outcome 12 and 13).
Incident rates of expired drug
时间窗: Two years
The expiration date or time of the fluids/medications has passed.
次要结局
- Compliance rate of using smart pump use(Two years)
- Compliance rate of using drug library use(Two years)
- Potential adverse drug events(Two years)
研究者
David W. Bates, MD, MSc
Chief, Division of General Medicine
Brigham and Women's Hospital