Ignite Creation Date:
2024-05-06 @ 2:12 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01997099
Status:
COMPLETED
Last Update Posted:
2015-11-05
First Post:
2013-11-18
Brief Title:
A Workflow and Satisfaction Study Evaluating the Implementation of a New Smart Ambulatory Infusion System
Sponsor:
Smiths Medical ASD Inc
Organization:
Smiths Medical ASD Inc
Study Overview
Official Title:
A Workflow and Satisfaction Study Evaluating the Implementation of a New Smart Ambulatory Infusion System Work Smart Study
Status:
COMPLETED
Status Verified Date:
2015-11
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:
Work Smart
Brief Summary:
The purpose of this study is to describe the home healthcare organization ambulatory infusion pump programming workflow and the process that was followed to introduce the new CADD-Solis VIP System to each home healthcare organization or facility In addition this study will characterize the overall clinician Phase 1 and patient Phase 2 ease of use and satisfaction with the CADD-Solis VIP System
Detailed Description:
This is a prospective multi-center non-randomized post-market study conducted within the United States There will be two independent components Phases to this study Phase 1 will involve data collection to describe the home infusion pump programming workflow and the process that was used to introduce the new CADD-Solis VIP System to each home healthcare organization This phase is further broken down into data collection consisting of four parts drug protocol library creation and development within the CADD Solis Medication Safety Software Administrator pump programming home care implementation and overall workflow and new smart pump implementation Phase 2 will involve data collection from patients that receive a prescription requiring use of the CADD-Solis VIP pump
Study Oversight
Has Oversight DMC:
None
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?:
None