Clinical trial NCT02359734: A National Study of Intravenous Medication Errors
Official title: A National Study of Intravenous Medication Errors: Understanding How to Improve Intravenous Safety With Smart Pumps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Administered in Error
Keywords: Patient safety
Medication errors
Smart infusion pump
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Winchester Medical Center
name: Central DuPage Hospital
name: Vanderbilt University
name: Massachusetts General Hospital
name: University of California, San Diego
name: Valleywise Health
name: Danbury Hospital
name: Association for the Advancement of Medical Instrumentation
name: CareFusion foundation
name: Candler Hospital
First posted: 2015-02-10
Enrollment: 900
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incident rates of wrong dose
timeFrame: Two years
measure: Incident rates of wrong rate
timeFrame: Two years
measure: Incident rates of wrong concentration
timeFrame: Two years
measure: Incident rates of wrong IV fluids/medications
timeFrame: Two years
measure: Incident rates of delay of medication administration
timeFrame: Two years
measure: Incident rates of omission of IV fluids/medications
timeFrame: Two years
measure: Incident rates of unauthorized medication
timeFrame: Two years
measure: Incident rates of patient identification (ID) error (wrong patient)
timeFrame: Two years
measure: Incident rates of smart pump or drug library not used
timeFrame: Two years
measure: Incident rates of oversight allergy
timeFrame: Two years
measure: Incident rates of pump setting error
timeFrame: Two years
measure: Compliance rate of label not complete according to policy
timeFrame: Two years
measure: Compliance rate of IV tubing not tagged according to policy
timeFrame: Two years
measure: Incident rates of expired drug
timeFrame: Two years
measure: Overall medication errors
timeFrame: Two years
measure: Higher-severity medication errors
timeFrame: Two years
Secondary outcomes:
measure: Compliance rate of using smart pump use
timeFrame: Two years
measure: Compliance rate of using drug library use
timeFrame: Two years
measure: Potential adverse drug events
timeFrame: Two years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: David W Bates, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.