A National Study of Intravenous Medication Errors

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

Official Title
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A National Study of Intravenous Medication Errors: Understanding How to Improve Intravenous Safety With Smart Pumps

Conditions
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Medication Administered in Error

Intervention / Treatment
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* Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients if they receive any IV fluid or medication on the day of observation in the study units. Exclusion Criteria: patients who are under 21 years old.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brigham and Women's Hospital.<br>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. | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump<br>* Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies<br>|
| Johns Hopkins University Hospital<br>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. | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump<br>* Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies<br>|
| Winchester Medical Center<br>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. | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump<br>* Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies<br>|
| Central DuPage Hospital<br>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. | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump<br>* Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies<br>|
| Vanderbilt University<br>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. | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump<br>* Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies<br>|
| Massachusetts General Hospital<br>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. | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump<br>* Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies<br>|
| University of California, San Diego<br>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. | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump<br>* Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies<br>|
| Maricopa Integrated Health System<br>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. | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump<br>* Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies<br>|
| Danbury Hospital<br>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. | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump<br>* Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies<br>|
| Candler Hospital<br>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. | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump<br>* Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident rates of wrong dose | The same medication but the dose is different from the prescribed order. | Two years | 
| Incident rates of wrong rate | 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. | Two years | 
| Incident rates of wrong concentration | An amount of a medication in a unit of solution that is different from the prescribed order. | Two years | 
| Incident rates of wrong IV fluids/medications | A different fluid/medication as documented on the IV bag label is being infused compared with the order in the medical record. | Two years | 
| Incident rates of delay of medication administration | 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. | Two years | 
| Incident rates of omission of IV fluids/medications | The medication ordered was not administered to a patient or administered anytime after 4 hours of the intended start time. | Two years | 
| Incident rates of unauthorized medication | Fluids/medications are administered to the patient but no order is present in medical record. This includes failure to document a verbal order. | Two years | 
| Incident rates of patient identification (ID) error (wrong patient) | Patient either has no ID band on or information on the ID band or label is incorrect. | Two years | 
| Incident rates of smart pump or drug library not used | 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) | Two years | 
| Incident rates of oversight allergy | Medication is administered to a patient with a known allergy to the drug or class. | Two years | 
| Incident rates of pump setting error | Setting programmed into the pump is different from the prescribed order. | Two years | 
| Compliance rate of label not complete according to policy | Documented information on the medication label is different from required information per institution policy. | Two years | 
| Compliance rate of IV tubing not tagged according to policy | IV tubing change label is not tagged per institution policy. | Two years | 
| Incident rates of expired drug | The expiration date or time of the fluids/medications has passed. | Two years | 
| Overall medication errors | Total number of all observed medication errors(including outcome 1-14) | Two years | 
| Higher-severity medication errors | All medication errors with an NCC MERP severity rating of C or greater (excluding violation of hospital policy errors;outcome 12 and 13). | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance rate of using smart pump use | Compliance rate of using smart pump | Two years | 
| Compliance rate of using drug library use | Compliance rate of using drug library | Two years | 
| Potential adverse drug events | 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 | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient safety, Medication errors, Smart infusion pump