A National Study of Intravenous Medication Errors

Medication Administered in Error Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359734
• Other study ID #: 2012P000709
• Status: Completed
• Phase: N/A
• First received: January 5, 2015
• Last updated: August 23, 2016
• Start date: April 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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?

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 information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Medication Administered in Error

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (12)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Association for the Advancement of Medical Instrumentation, Candler Hospital, CareFusion foundation, Central DuPage Hospital, Danbury Hospital, Johns Hopkins University, Maricopa Integrated Health System, Massachusetts General Hospital, University of California, San Diego, Vanderbilt University, Winchester Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, Lipsi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident rates of wrong dose	The same medication but the dose is different from the prescribed order.	Two years	Yes
Primary	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	Yes
Primary	Incident rates of wrong concentration	An amount of a medication in a unit of solution that is different from the prescribed order.	Two years	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Incident rates of oversight allergy	Medication is administered to a patient with a known allergy to the drug or class.	Two years	Yes
Primary	Incident rates of pump setting error	Setting programmed into the pump is different from the prescribed order.	Two years	Yes
Primary	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	Yes
Primary	Compliance rate of IV tubing not tagged according to policy	IV tubing change label is not tagged per institution policy.	Two years	Yes
Primary	Incident rates of expired drug	The expiration date or time of the fluids/medications has passed.	Two years	Yes
Primary	Overall medication errors	Total number of all observed medication errors(including outcome 1-14)	Two years	Yes
Primary	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	Yes
Secondary	Compliance rate of using smart pump use	Compliance rate of using smart pump	Two years	Yes
Secondary	Compliance rate of using drug library use	Compliance rate of using drug library	Two years	Yes
Secondary	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	Yes