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Completed

NCT Number: NCT02359734

A National Study of Intravenous Medication Errors

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?

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Key information

Conditions

Medication Administered in Error

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Incident rates of wrong dose

    Time frame: Two years

    The same medication but the dose is different from the prescribed order.

  2. Incident rates of wrong rate

    Time frame: Two years

    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.

  3. Incident rates of wrong concentration

    Time frame: Two years

    An amount of a medication in a unit of solution that is different from the prescribed order.

  4. Incident rates of wrong IV fluids/medications

    Time frame: Two years

    A different fluid/medication as documented on the IV bag label is being infused compared with the order in the medical record.

  5. Incident rates of delay of medication administration

    Time frame: Two years

    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.

  6. Incident rates of omission of IV fluids/medications

    Time frame: Two years

    The medication ordered was not administered to a patient or administered anytime after 4 hours of the intended start time.

  7. Incident rates of unauthorized medication

    Time frame: Two years

    Fluids/medications are administered to the patient but no order is present in medical record. This includes failure to document a verbal order.

  8. Incident rates of patient identification (ID) error (wrong patient)

    Time frame: Two years

    Patient either has no ID band on or information on the ID band or label is incorrect.

  9. Incident rates of smart pump or drug library not used

    Time frame: Two years

    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)

  10. Incident rates of oversight allergy

    Time frame: Two years

    Medication is administered to a patient with a known allergy to the drug or class.

  11. Incident rates of pump setting error

    Time frame: Two years

    Setting programmed into the pump is different from the prescribed order.

  12. Compliance rate of label not complete according to policy

    Time frame: Two years

    Documented information on the medication label is different from required information per institution policy.

  13. Compliance rate of IV tubing not tagged according to policy

    Time frame: Two years

    IV tubing change label is not tagged per institution policy.

  14. Incident rates of expired drug

    Time frame: Two years

    The expiration date or time of the fluids/medications has passed.

  15. Overall medication errors

    Time frame: Two years

    Total number of all observed medication errors(including outcome 1-14)

  16. Higher-severity medication errors

    Time frame: Two years

    All medication errors with an NCC MERP severity rating of C or greater (excluding violation of hospital policy errors;outcome 12 and 13).

Secondary outcomes

  1. Compliance rate of using smart pump use

    Time frame: Two years

    Compliance rate of using smart pump

  2. Compliance rate of using drug library use

    Time frame: Two years

    Compliance rate of using drug library

  3. Potential adverse drug events

    Time frame: Two years

    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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Association for the Advancement of Medical Instrumentation
  • Candler Hospital
  • CareFusion foundation
  • Central DuPage Hospital
  • Danbury Hospital
  • Johns Hopkins University
  • Massachusetts General Hospital
  • University of California, San Diego
  • Valleywise Health
  • Vanderbilt University
  • Winchester Medical Center

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2015
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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