A National Study of Intravenous Medication Errors

NCT ID: NCT02359734

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Medication Administered in Error

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type 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

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.

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

Intervention Type 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

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.

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

Intervention Type 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

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.

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

Intervention Type 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

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.

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

Intervention Type 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

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.

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

Intervention Type 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

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.

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

Intervention Type 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

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.

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

Intervention Type 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

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.

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

Intervention Type 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

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.

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

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

Winchester Medical Center

OTHER

Sponsor Role collaborator

Central DuPage Hospital

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

Valleywise Health

OTHER

Sponsor Role collaborator

Danbury Hospital

OTHER

Sponsor Role collaborator

Association for the Advancement of Medical Instrumentation

OTHER

Sponsor Role collaborator

CareFusion foundation

UNKNOWN

Sponsor Role collaborator

Candler Hospital

UNKNOWN

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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David W. Bates, MD, MSc

Chief, Division of General Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David W Bates, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26908900 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29411338 (View on PubMed)

Other Identifiers

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2012P000709

Identifier Type: -

Identifier Source: org_study_id

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