Ignite Creation Date:
2024-05-06 @ 2:04 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04200508
Status:
TERMINATED
Last Update Posted:
2022-11-18
First Post:
2019-12-06
Brief Title:
Targeted Gown and Glove Intervention in Nursing Homes
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Cluster Randomized Trial With Cross-over of Targeted Gown and Glove Intervention to Prevent Staphylococcus Aureus and Carbapenem-resistant Gram-negative Bacteria Acquisition in Community-based Nursing Homes
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped due to COVID-19 in March 2022 It will not resume because the intervention enhanced barrier precautions has been recommended by the CDC and Prevention for nursing homes and is currently being implemented
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAGG
Brief Summary:
This project will assess the feasibility of a cluster-randomized trial with crossover of our intervention targeted gown and glove use among high-risk residents of community nursing homes to prevent Staphylococcus aureus and carbapenem gram negative bacteria acquisition and infection
Detailed Description:
Nursing homes are settings with a high rate of Staphylococcus aureus SA and carbapenem -resistant Gram-negative bacteria C-GNB acquisition which can lead to infection particularly for short stay residents who are recovering from an acute illness The current standard of care for preventing antibiotic-resistant bacteria acquisition in nursing homes is Standard Precautions gowns and gloves for anticipated contact with blood body fluids skin breakdown or mucous membranes for all residents
The intervention is gown and glove use for high-risk care of high-risk residents based on prior research showing the increased risk of transmission from residents to healthcare workers hands and clothing associated with certain care activities Rather than wearing gowns and gloves for all care activities to prevent transmission as would be indicated for Contact Precautions gown and glove use is targeted to specific resident care activities eg bathing dressing and toileting with prolonged resident-staff contact
The intervention will occur on units with a mix of long stay and short stay residents within the nursing home with the NH as the unit of analysis The primary outcome will be SA both methicillin-resistant Staphylococcus aureus MRSA and methicillin susceptible Staphylococcus aureus MSSA and C-GNB acquisition as determined by surveillance cultures in short stay residents which is a more frequent outcome than infection During an 8-12 week baseline period SA and C-GNB acquisition will be assessed via culture and use of gown and gloves for high-risk care of high-risk residents shall be assessed at all nursing homes A 4-week training period shall occur for each of the nursing homes prior to the start of the intervention period where the NH staff shall be trained on the targeted gown and glove approach The training period shall be followed by an 8-12 week intervention period during which SA and C-GNB acquisition shall be assessed via culture and use of own and gloves for high risk care of high-risk residents shall again be assessed and compared to the baseline period Each nursing home shall act as their own control via direct comparison of each nursing home during the intervention to itself during the baseline period reducing variability The two nursing homes in group 1 shall be trained on and then implement the intervention during study period 1 while the two nursing homes in group 2 continue the baseline period The two nursing homes in group 2 shall then undergo training and implementation the intervention in study period 2 while the group 1 nursing homes have a washout period then the cross-over baseline observations and cultures The baseline period intervention period and the cross-over baseline period shall each continue for 8-12 weeks aiming for at least 100 resident admissions during each of the study periods baseline period intervention period and cross-over baseline period Some facilities may not reach 100 but the average across must exceed 100 each
The intervention is gown and glove use for high-risk care of high-risk residents based on prior research showing the increased risk of transmission from residents to healthcare workers hands and clothing associated with certain care activities Rather than wearing gowns and gloves for all care activities to prevent transmission as would be indicated for Contact Precautions gown and glove use is targeted to specific resident care activities eg bathing dressing and toileting with prolonged resident-staff contact
The intervention will occur on units with a mix of long stay and short stay residents within the nursing home with the NH as the unit of analysis The primary outcome will be SA both methicillin-resistant Staphylococcus aureus MRSA and methicillin susceptible Staphylococcus aureus MSSA and C-GNB acquisition as determined by surveillance cultures in short stay residents which is a more frequent outcome than infection During an 8-12 week baseline period SA and C-GNB acquisition will be assessed via culture and use of gown and gloves for high-risk care of high-risk residents shall be assessed at all nursing homes A 4-week training period shall occur for each of the nursing homes prior to the start of the intervention period where the NH staff shall be trained on the targeted gown and glove approach The training period shall be followed by an 8-12 week intervention period during which SA and C-GNB acquisition shall be assessed via culture and use of own and gloves for high risk care of high-risk residents shall again be assessed and compared to the baseline period Each nursing home shall act as their own control via direct comparison of each nursing home during the intervention to itself during the baseline period reducing variability The two nursing homes in group 1 shall be trained on and then implement the intervention during study period 1 while the two nursing homes in group 2 continue the baseline period The two nursing homes in group 2 shall then undergo training and implementation the intervention in study period 2 while the group 1 nursing homes have a washout period then the cross-over baseline observations and cultures The baseline period intervention period and the cross-over baseline period shall each continue for 8-12 weeks aiming for at least 100 resident admissions during each of the study periods baseline period intervention period and cross-over baseline period Some facilities may not reach 100 but the average across must exceed 100 each
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