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Preventing the Spread of Infection in Nursing Homes

Implementation of a Novel Strategy to Prevent Staphylococcus Aureus (SA) Acquisition in Community-Based Nursing Homes to Prevent Invasive SA Infection - Feasibility and Pilot to Guide a Multicenter Stepped Wedge Cluster Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03319368
Enrollment
367
Registered
2017-10-24
Start date
2017-12-18
Completion date
2018-07-26
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcus Aureus

Brief summary

This study evaluates the feasibility of targeting more frequent gown and glove use for specific high risk moments of care in specific nursing home residents in order to prevent Staphylococcus aureus (SA) acquisition and infection.

Detailed description

Nursing homes are settings with a high rate of Staphylococcus aureus (SA) acquisition, which leads to infection, particularly for short stay residents. The current standard of care for preventing SA acquisition and SA infection 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 investigators propose a feasibility study of a novel strategy, the addition of targeted gown and glove use, to prevent SA acquisition and SA infection in residents of nursing homes. Rather than wearing gowns and gloves for all care activities to prevent transmission, gown and glove use can be targeted to specific high risk moments of care for specific high risk residents. High risk moments for gown and glove use are care activities most likely to transmit SA based on prior research. Residents with chronic wounds and medical devices are: 1) most likely to be colonized with SA; 2) most likely to acquire SA; 3) most likely to transmit SA to healthcare worker clothing and hands; and 4) most likely to develop a SA infection based on prior research and thus would be considered high risk residents. The investigators will perform a quasi-experimental (before-after) study of this intervention, targeted gown and glove use, at two community-based nursing homes to demonstrate its feasibility and evaluate its effect on SA acquisition and SA infection rates.

Interventions

OTHERTargeted gown and glove use

Gown and glove use for high risk care activities in high risk residents

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years * Reside in a participating nursing home

Exclusion criteria

* Identified by nursing home staff as combative or with other behavioral problems which could lead to agitation if approached by project staff

Design outcomes

Primary

MeasureTime frameDescription
Rates of Staphylococcus Aureus Acquisition: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) During the Study Period5 months: 2 months in the baseline period, one month to prep the intervention, then 2 months in the intervention periodRates of Staphylococcus aureus acquisition in the baseline and intervention periods: Participants were swabbed in the anterior nares and inguinal fold at nursing home admission (or start of study period) and again at discharge (or end of study period). This is the percentage of participants who acquired MRSA or MSSA (or both) during the study period.

Secondary

MeasureTime frameDescription
Rates of Staphylococcus Aureus Transmission: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) From MRSA/MSSA Transmission From Another Study Participant During the Study Period5 monthsRates of Staphylococcus aureus transmission in the baseline and intervention periods: Participants were swabbed in the anterior nares and inguinal fold at nursing home admission (or start of study period) and again at discharge (or end of study period). The DNA sequences of each SA isolate from each acquisition were evaluated to see if there was a match to another epidemiologically linked (same floor, same study period) SA isolate. This is the percentage of participants who acquired MRSA or MSSA (or both) from MRSA/MSSA transmission from another study participant during the study period.

Countries

United States

Participant flow

Pre-assignment details

Long stay residents (n=42) were enrolled in the study specifically to examine if they transmitted S. aureus to short stay residents for the secondary outcome measure. They were excluded from all other study analyses.

Participants by arm

ArmCount
Baseline Period
Normal, day-to-day usage of gowns and gloves by health care workers in nursing homes.
101
Intervention Period
Targeted gown and glove use by health care workers in the nursing home. Gowns and gloves were worn when providing high risk care to high risk residents.
121
Total222

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDischarge swabs not collected from resident5746

Baseline characteristics

CharacteristicBaseline PeriodIntervention PeriodTotal
Age, Customized0 Participants0 Participants0 Participants
Co-colonized with MRSA and MSSA on admission swabs0 Participants1 Participants1 Participants
Race and Ethnicity Not Collected0 Participants
Sex/Gender, Customized0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 1580 / 167
other
Total, other adverse events
0 / 1580 / 167
serious
Total, serious adverse events
28 / 15828 / 167

Outcome results

Primary

Rates of Staphylococcus Aureus Acquisition: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) During the Study Period

Rates of Staphylococcus aureus acquisition in the baseline and intervention periods: Participants were swabbed in the anterior nares and inguinal fold at nursing home admission (or start of study period) and again at discharge (or end of study period). This is the percentage of participants who acquired MRSA or MSSA (or both) during the study period.

Time frame: 5 months: 2 months in the baseline period, one month to prep the intervention, then 2 months in the intervention period

Population: All short stay participants who had admission and discharge swabs collected and who were not co-colonized with MRSA and MSSA on admission swabs.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Baseline PeriodRates of Staphylococcus Aureus Acquisition: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) During the Study Period17 Participants
Intervention PeriodRates of Staphylococcus Aureus Acquisition: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) During the Study Period8 Participants
Secondary

Rates of Staphylococcus Aureus Transmission: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) From MRSA/MSSA Transmission From Another Study Participant During the Study Period

Rates of Staphylococcus aureus transmission in the baseline and intervention periods: Participants were swabbed in the anterior nares and inguinal fold at nursing home admission (or start of study period) and again at discharge (or end of study period). The DNA sequences of each SA isolate from each acquisition were evaluated to see if there was a match to another epidemiologically linked (same floor, same study period) SA isolate. This is the percentage of participants who acquired MRSA or MSSA (or both) from MRSA/MSSA transmission from another study participant during the study period.

Time frame: 5 months

Population: All short stay participants who had admission and discharge swabs collected and who were not co-colonized with MRSA and MSSA on admission swabs.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Baseline PeriodRates of Staphylococcus Aureus Transmission: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) From MRSA/MSSA Transmission From Another Study Participant During the Study Period6 Participants
Intervention PeriodRates of Staphylococcus Aureus Transmission: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) From MRSA/MSSA Transmission From Another Study Participant During the Study Period1 Participants

Source: ClinicalTrials.gov · Data processed: Jun 20, 2026