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A National Study of Intravenous Medication Errors

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Mass General Brigham

Status

Completed

Conditions

Medication Administered in Error

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT02359734
2012P000709

Details and patient eligibility

About

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?

Full 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.

Enrollment

900 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

900 participants in 10 patient groups

Brigham and Women's Hospital.
Description:
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.
Treatment:
Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
Johns Hopkins University Hospital
Description:
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.
Treatment:
Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
Winchester Medical Center
Description:
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.
Treatment:
Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
Central DuPage Hospital
Description:
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.
Treatment:
Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
Vanderbilt University
Description:
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.
Treatment:
Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
Massachusetts General Hospital
Description:
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.
Treatment:
Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
University of California, San Diego
Description:
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.
Treatment:
Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
Maricopa Integrated Health System
Description:
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.
Treatment:
Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
Danbury Hospital
Description:
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.
Treatment:
Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
Candler Hospital
Description:
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.
Treatment:
Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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