NCT02359734

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. 1.What are the frequency and types of intravenous medication errors?
  2. 2.How much variability is there by frequency and type among settings?
  3. 3.After review of the initial data, what strategies appear to have the greatest potential for reducing intravenous medication error frequency?
  4. 4.How effective is an intervention including a bundle of these strategies at multiple sites?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

January 5, 2015

Last Update Submit

August 23, 2016

Conditions

Medication Administered in Error

Keywords

Patient safetyMedication errorsSmart infusion pump

Outcome Measures

Primary Outcomes (16)

  • 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 Outcomes (3)

  • Compliance rate of using smart pump use

    Two years

  • Compliance rate of using drug library use

    Two years

  • Potential adverse drug events

    Two years

Study Arms (10)

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

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

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

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

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

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

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

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

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

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

Interventions

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

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

Brigham and Women's Hospital.Candler HospitalCentral DuPage HospitalDanbury HospitalJohns Hopkins University HospitalMaricopa Integrated Health SystemMassachusetts General HospitalUniversity of California, San DiegoVanderbilt UniversityWinchester Medical Center

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients if they receive any IV fluid or medication on the day of observation in the study units.

You may not qualify if:

  • patients who are under 21 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (2)

  • 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.

    PMID: 26908900RESULT

  • 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.

    PMID: 29411338DERIVED

Study Officials

  • David W Bates, MD, MSc

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of General Medicine

Study Record Dates

First Submitted

January 5, 2015

First Posted

February 10, 2015

Study Start

April 1, 2012

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

US(1)