Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-25 @ 7:27 PM
Study NCT ID:
NCT02359734
Status:
COMPLETED
Last Update Posted:
2016-08-24
First Post:
2015-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A National Study of Intravenous Medication Errors
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
A National Study of Intravenous Medication Errors: Understanding How to Improve Intravenous Safety With Smart Pumps
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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?
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: