NCT03319368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
367

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 18, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2018

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

March 21, 2024

Completed
Last Updated

March 21, 2024

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

October 18, 2017

Results QC Date

October 25, 2022

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

  • 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

    5 months

Study Arms (1)

Intervention: Targeted gown and glove use

EXPERIMENTAL

Additional gowns and gloves used for high risk care activities

Other: Targeted gown and glove use

Interventions

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

Intervention: Targeted gown and glove use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lorien Riverside

Belcamp, Maryland, 21017, United States

Location

Lorien Mays Chapel

Lutherville-Timonium, Maryland, 21093, United States

Location

Related Publications (1)

  • Lydecker AD, Osei PA, Pineles L, Johnson JK, Meisel J, Stine OC, Magder L, Gurses AP, Hebden J, Oruc C, Mody L, Jacobs Slifka K, Stone ND, Roghmann MC. Targeted gown and glove use to prevent Staphylococcus aureus acquisition in community-based nursing homes: A pilot study. Infect Control Hosp Epidemiol. 2021 Apr;42(4):448-454. doi: 10.1017/ice.2020.1219. Epub 2020 Oct 20.

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Alison Lydecker, MPH
Organization
University of Maryland School of Medicine

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 24, 2017

Study Start

December 18, 2017

Primary Completion

July 26, 2018

Study Completion

July 26, 2018

Last Updated

March 21, 2024

Results First Posted

March 21, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations