A National Study of Intravenous Medication Errors
- Conditions
- Medication Administered in Error
- Interventions
- Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
- Registration Number
- NCT02359734
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
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:
1. What are the frequency and types of intravenous medication errors?
2. How much variability is there by frequency and type among settings?
3. After review of the initial data, what strategies appear to have the greatest potential for reducing intravenous medication error frequency?
4. How effective is an intervention including a bundle of these strategies at multiple sites?
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
- Patients if they receive any IV fluid or medication on the day of observation in the study units.
- patients who are under 21 years old.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Johns Hopkins University Hospital Smart pump safety Intervention bundle for improving IV medication administration process with smart pump Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Johns Hopkins University Hospital. In these unit, the intervention bundle was implemented. Vanderbilt University Smart pump safety Intervention bundle for improving IV medication administration process with smart pump Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Vanderbilt University Medical Center. In these unit, the intervention bundle was implemented. University of California, San Diego Smart pump safety Intervention bundle for improving IV medication administration process with smart pump Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at University of California, San Diego. In these unit, the intervention bundle was implemented. Maricopa Integrated Health System Smart pump safety Intervention bundle for improving IV medication administration process with smart pump Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Maricopa Integrated Health System. In these unit, the intervention bundle was implemented. Brigham and Women's Hospital. Smart pump safety Intervention bundle for improving IV medication administration process with smart pump Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Brigham and Women's Hospital. In these unit, the intervention bundle was implemented. Central DuPage Hospital Smart pump safety Intervention bundle for improving IV medication administration process with smart pump Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Central DuPage Hospital. In these unit, the intervention bundle was implemented. Candler Hospital Smart pump safety Intervention bundle for improving IV medication administration process with smart pump Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Candler Hospital. In these unit, the intervention bundle was implemented. Winchester Medical Center Smart pump safety Intervention bundle for improving IV medication administration process with smart pump Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Winchester Medical Center. In these unit, the intervention bundle was implemented. Massachusetts General Hospital Smart pump safety Intervention bundle for improving IV medication administration process with smart pump Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Massachusetts General Hospital. In these unit, the intervention bundle was implemented. Danbury Hospital Smart pump safety Intervention bundle for improving IV medication administration process with smart pump Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Danbury Hospital. In these unit, the intervention bundle was implemented.
- Primary Outcome Measures
Name Time Method Incident rates of unauthorized medication 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 wrong dose Two years The same medication but the dose is different from the prescribed order.
Incident rates of wrong rate 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 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 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 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 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 patient identification (ID) error (wrong patient) 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 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 Two years Medication is administered to a patient with a known allergy to the drug or class.
Incident rates of pump setting error Two years Setting programmed into the pump is different from the prescribed order.
Compliance rate of label not complete according to policy 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 Two years IV tubing change label is not tagged per institution policy.
Overall medication errors Two years Total number of all observed medication errors(including outcome 1-14)
Higher-severity medication errors 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 Two years The expiration date or time of the fluids/medications has passed.
- Secondary Outcome Measures
Name Time Method Compliance rate of using smart pump use Two years Compliance rate of using smart pump
Compliance rate of using drug library use Two years Compliance rate of using drug library
Potential adverse drug events Two years Medication errors with potential for harm categorized as D (errors that would have required increased monitoring to preclude harm) or higher by NCC MERP Index
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States