Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04815369
Status:
SUSPENDED
Last Update Posted:
2023-08-28
First Post:
2021-03-22
Brief Title:
Evaluating UTI Diagnosis in Nursing Homes
Sponsor:
Pathnostics
Organization:
Pathnostics
Study Overview
Official Title:
Evaluating UTI Diagnosis in Nursing Homes
Status:
SUSPENDED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective multicenter comparative cohort observational study is to determine whether the use of Guidance UTI Clinical Pathway a standardized infrastructure for specimen collection and result delivery compared with current traditional pathways for urine testing reduces the proportion of UTI patients with poor outcomes
Detailed Description:
The objective of this study is to determine if prospective data collected over 12 months from over 200 nursing homes will show that the use of Guidance UTI Clinical Pathway is more effective than the Traditional Clinical Pathways for urine testing in UTI diagnosis in Nursing Homes Guidance UTI Clinical Pathway provides standardized infrastructure for specimen collection and result dissemination via assigned report point person to verify receipt of actionable data The pathway also includes several in-services on molecular testing for UTI Pooled Antibiotic Susceptibility Testing and polymicrobial infections to help providers better understand test methodology Standardizing a Clinical Care Pathway for testing and reporting of clinical results approach may lead to a reduction in empiric broad spectrum antibiotic use and in turn better health-related outcomes for patients Such efficiency in clinical decision making at the time of initial presentation may lead to improved patient care by avoiding ineffective therapy due to mismanagement or incomplete lab diagnosis The study will be observing the implementation of the Guidance UTI Clinical Pathway and comparing it to traditional clinical care pathways from facility-level data entered into the National Healthcare Safety Network for its LTCF Long Term Care Facilities Component
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None