Ignite Creation Date:
2024-05-06 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03244917
Status:
COMPLETED
Last Update Posted:
2021-08-10
First Post:
2017-08-07
Brief Title:
Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimers Disease and Other Dementias
Sponsor:
Hebrew SeniorLife
Organization:
Hebrew SeniorLife
Study Overview
Official Title:
Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimers Disease and Other Dementias TRAIN-AD
Status:
COMPLETED
Status Verified Date:
2021-07
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:
TRAIN-AD
Brief Summary:
This is a 52-month study 8 months preparation 36 months to conduct the trial 8 months data analyses and manuscript preparation of a cluster randomized controlled trial RCT of an intervention to improve infection management for suspected UTIs and LRIs among residents with advanced dementia N480 N240arm living in NHs N24 N12arm The NH is the unit of randomization as the intervention must be delivered at the facility level to avoid contamination and because this is how it would be employed in the real-world Analyses will be at the patient level
Detailed Description:
The final stage of dementia is characterized by recurrent suspected infections Research has shown these episodes are widely mismanaged leading to adverse patient and public health outcomes Antimicrobials are extensively prescribed in advanced dementia most often in the absence of clinical evidence to support a bacterial infection Antimicrobial exposure is the main risk factor for multidrug-resistant organisms MDROs Nursing home NH residents with advanced dementia are three times more likely to be colonized with MDROs compared to other residents Moreover as these patients are in the terminal phase of dementia evidence suggests they may not clinically benefit from antimicrobials Comfort is the stated goal of care for 90 of advanced dementia patients and the risks and burdens associated with work-up and treatment of suspected infections generally do not promote that goal particularly when hospitalization is involved Taken together there is a clear need to improve infection management in advanced dementia both to provide better end-of-life care to these patients and reduce the public health threat of MDROs
This is a 52-month study 8 months preparation 36 months to conduct the trial 8 months data analyses and manuscript preparation of a cluster randomized controlled trial RCT of an intervention to improve infection management for suspected UTIs and LRIs among residents with advanced dementia N410 N205arm living in NHs N28 N14arm The NH is the unit of randomization as the intervention must be delivered at the facility level to avoid contamination and because this is how it would be employed in the real-world Analyses will be at the patient level
This is a 52-month study 8 months preparation 36 months to conduct the trial 8 months data analyses and manuscript preparation of a cluster randomized controlled trial RCT of an intervention to improve infection management for suspected UTIs and LRIs among residents with advanced dementia N410 N205arm living in NHs N28 N14arm The NH is the unit of randomization as the intervention must be delivered at the facility level to avoid contamination and because this is how it would be employed in the real-world Analyses will be at the patient level
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