Trial Outcomes & Findings for Preventing the Spread of Infection in Nursing Homes (NCT NCT03319368)
NCT ID: NCT03319368
Last Updated: 2024-03-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
367 participants
Primary outcome timeframe
5 months: 2 months in the baseline period, one month to prep the intervention, then 2 months in the intervention period
Results posted on
2024-03-21
Participant Flow
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.
Participant milestones
| Measure |
Baseline Period
Normal, day-to-day usage of gowns and gloves by health care workers in nursing homes.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
167
|
|
Overall Study
COMPLETED
|
101
|
121
|
|
Overall Study
NOT COMPLETED
|
57
|
46
|
Reasons for withdrawal
| Measure |
Baseline Period
Normal, day-to-day usage of gowns and gloves by health care workers in nursing homes.
|
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.
|
|---|---|---|
|
Overall Study
Discharge swabs not collected from resident
|
57
|
46
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Baseline Period
n=101 Participants
Normal, day-to-day usage of gowns and gloves by health care workers in nursing homes.
|
Intervention Period
n=121 Participants
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.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
0 Participants
n=101 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=222 Participants
|
|
Sex/Gender, Customized
|
0 Participants
n=101 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=222 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Co-colonized with MRSA and MSSA on admission swabs
|
0 Participants
n=101 Participants
|
1 Participants
n=121 Participants
|
1 Participants
n=222 Participants
|
PRIMARY outcome
Timeframe: 5 months: 2 months in the baseline period, one month to prep the intervention, then 2 months in the intervention periodPopulation: All short stay participants who had admission and discharge swabs collected and who were not co-colonized with MRSA and MSSA on admission swabs.
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.
Outcome measures
| Measure |
Baseline Period
n=101 Participants
Normal, day-to-day usage of gowns and gloves by health care workers in nursing homes.
|
Intervention Period
n=120 Participants
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.
|
|---|---|---|
|
Rates of Staphylococcus Aureus Acquisition: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) During the Study Period
|
17 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: All short stay participants who had admission and discharge swabs collected and who were not co-colonized with MRSA and MSSA on admission swabs.
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.
Outcome measures
| Measure |
Baseline Period
n=101 Participants
Normal, day-to-day usage of gowns and gloves by health care workers in nursing homes.
|
Intervention Period
n=120 Participants
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.
|
|---|---|---|
|
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
|
6 Participants
|
1 Participants
|
Adverse Events
Baseline Period
Serious events: 28 serious events
Other events: 0 other events
Deaths: 3 deaths
Intervention Period
Serious events: 28 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Baseline Period
n=158 participants at risk
Normal, day-to-day usage of gowns and gloves by health care workers in nursing homes.
|
Intervention Period
n=167 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
0.63%
1/158 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
1.8%
3/167 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
|
Gastrointestinal disorders
Hospitalization
|
0.63%
1/158 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
1.8%
3/167 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
|
General disorders
Hospitalization
|
6.3%
10/158 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
4.8%
8/167 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
|
General disorders
Death
|
1.9%
3/158 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
0.00%
0/167 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
|
Infections and infestations
Hospitalization
|
1.9%
3/158 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
1.8%
3/167 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
|
Nervous system disorders
Hospitalization
|
0.00%
0/158 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
0.60%
1/167 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
|
Psychiatric disorders
Hospitalization
|
1.3%
2/158 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
0.00%
0/167 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
4.4%
7/158 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
3.6%
6/167 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
|
Surgical and medical procedures
Hospitalization
|
0.63%
1/158 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
0.60%
1/167 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
|
Vascular disorders
Hospitalization
|
0.00%
0/158 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
1.8%
3/167 • During the baseline period (2 months) and the intervention period (2 months)
The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
|
Other adverse events
Adverse event data not reported
Additional Information
Alison Lydecker, MPH
University of Maryland School of Medicine
Phone: 410-706-0065
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place