Staphylococcus AureusTAGGNCT04200508
Targeted Gown and Glove Intervention in Nursing Homes
A study testing Targeted gown and gloves use in people with Staphylococcus Aureus and Carbapenem Resistant Gram Negative Bacteria, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus, Carbapenem Resistant Gram Negative Bacteria
- What is being tested?
- Targeted gown and gloves use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Reside in a participating nursing home
Who cannot join
- Identified by nursing home staff as combative or with other behavioral problems which could lead to agitation if approached by project staff
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 (e.g., 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.
- Being tested
- Targeted gown and gloves use
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted gown and gloves useOther
Gown and glove use for high risk care activities in high risk residents
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Targeted gown and glove use for high risk care activities in high risk residents Receives: Other: Targeted gown and gloves use |
| Baseline | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Staphylococcus aureus acquisition as determined by surveillance cultures in short stay residents
Rate of Staphylococcus aureus acquisition by short stay residents comparing the baseline and intervention periods
Measured: 1 year
Carbapenem-resistant gram-negative bacteria acquisition as determined by surveillance cultures in short stay residents
Rate of carbapenem-resistant gram-negative bacteria acquisition by short stay residents comparing the baseline and intervention periods
Measured: 1 year
Percentage of high risk patients correctly identified and placed on contact precautions
Percentage of high risk patients with wound and medical devices correctly identified and placed on contact precautions
Measured: 1 year
Percentage of healthcare workers using personal protective equipment during high risk care
Percentage of healthcare workers using personal protective equipment when performing high risk care on high-risk residents
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Mar 2020
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Nursing home units with a mix of long- and short-stay residents will be the unit of analysis. All nursing homes participating will go through a 8-12 week baseline. Two nursing homes will be randomized to perform the intervention, while the other two continue with an extended baseline. After 8-12 weeks, there will be a washout period of 4 weeks and then the nursing homes will crossover; nursing homes that were in the intervention arm will go back to baseline and those in the extended baseline will perform the intervention. Throughout each study period, we will be assessing Staphylococcus aureus and carbapenem resistant gram-negative bacteria acquisition among residents on each of the nursing homes units being studied
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary-Claire Roghmann, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200508
- Sponsor's protocol ID
- HP-00088648
- Acronym
- TAGG
- Status last verified
- Nov 2022
- First submitted
- 6 Dec 2019
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04200508
- Acronym / sponsor ID
- TAGG / HP-00088648
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (e.g., 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Nursing home units with a mix of long- and short-stay residents will be the unit of analysis. All nursing homes participating will go through a 8-12 week baseline. Two nursing homes will be randomized to perform the intervention, while the other two continue with an extended baseline. After 8-12 weeks, there will be a washout period of 4 weeks and then the nursing homes will crossover; nursing homes that were in the intervention arm will go back to baseline and those in the extended baseline will perform the intervention. Throughout each study period, we will be assessing Staphylococcus aureus and carbapenem resistant gram-negative bacteria acquisition among residents on each of the nursing homes units being studied
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Targeted gown and gloves useTargeted gown and glove use for high risk care activities in high risk residents |
| Baseline | No intervention | –Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- Reside in a participating nursing home
Key exclusion criteria (1 listed)
- Identified by nursing home staff as combative or with other behavioral problems which could lead to agitation if approached by project staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted gown and gloves useGown and glove use for high risk care activities in high risk residents | Other | Intervention |
Primary outcome
Staphylococcus aureus acquisition as determined by surveillance cultures in short stay residents
Time frame: 1 year
Rate of Staphylococcus aureus acquisition by short stay residents comparing the baseline and intervention periods
Carbapenem-resistant gram-negative bacteria acquisition as determined by surveillance cultures in short stay residents
Time frame: 1 year
Rate of carbapenem-resistant gram-negative bacteria acquisition by short stay residents comparing the baseline and intervention periods
Percentage of high risk patients correctly identified and placed on contact precautions
Time frame: 1 year
Percentage of high risk patients with wound and medical devices correctly identified and placed on contact precautions
Percentage of healthcare workers using personal protective equipment during high risk care
Time frame: 1 year
Percentage of healthcare workers using personal protective equipment when performing high risk care on high-risk residents
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted gown and gloves use in people with Staphylococcus Aureus and Carbapenem Resistant Gram Negative Bacteria, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staphylococcus aureus acquisition as determined by surveillance cultures in short stay residents (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.