A National Study of Intravenous Medication Errors

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

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?

Study Overview

• Status: Completed
• Conditions: Medication Administered in Error
• Intervention / Treatment: Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump

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.

• Study Type: Observational
• Enrollment (Actual): 900

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- Any patients who are hospitalized in Medical ICU, surgical ICU, medicine unit and surgical unit on the day of data collection

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brigham and Women's Hospital.; 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; 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
Johns Hopkins University Hospital; 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; 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
Winchester Medical Center; 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; 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
Central DuPage Hospital; 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; 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
Vanderbilt University; 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; 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
Massachusetts General Hospital; 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; 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
University of California, San Diego; 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; 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
Maricopa Integrated Health System; 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; 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
Danbury Hospital; 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; 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
Candler Hospital; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Johns Hopkins University; Massachusetts General Hospital; University of California, San Diego; Vanderbilt University; Valleywise Health; Central DuPage Hospital; Danbury Hospital; Winchester Medical Center; Association for the Advancement of Medical Instrumentation; CareFusion foundation; Candler Hospital

Publications and helpful links

General Publications

• Schnock KO, Dykes PC, Albert J, Ariosto D, Call R, Cameron C, Carroll DL, Drucker AG, Fang L, Garcia-Palm CA, Husch MM, Maddox RR, McDonald N, McGuire J, Rafie S, Robertson E, Saine D, Sawyer MD, Smith LP, Stinger KD, Vanderveen TW, Wade E, Yoon CS, Lipsitz S, Bates DW. The frequency of intravenous medication administration errors related to smart infusion pumps: a multihospital observational study. BMJ Qual Saf. 2017 Feb;26(2):131-140. doi: 10.1136/bmjqs-2015-004465. Epub 2016 Feb 23.
• Schnock KO, Dykes PC, Albert J, Ariosto D, Cameron C, Carroll DL, Donahue M, Drucker AG, Duncan R, Fang L, Husch M, McDonald N, Maddox RR, McGuire J, Rafie S, Robertson E, Sawyer M, Wade E, Yoon CS, Lipsitz S, Bates DW. A Multi-hospital Before-After Observational Study Using a Point-Prevalence Approach with an Infusion Safety Intervention Bundle to Reduce Intravenous Medication Administration Errors. Drug Saf. 2018 Jun;41(6):591-602. doi: 10.1007/s40264-018-0637-3.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 5, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Estimate): August 24, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Patient safety; Medication errors; Smart infusion pump
• Other Study ID Numbers: 2012P000709