Targeted Gown and Glove Intervention in Nursing Homes

NCT ID: NCT04200508

Last Updated: 2022-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-03-10

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 (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.

Conditions

Staphylococcus Aureus; Carbapenem Resistant Gram Negative Bacteria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Targeted gown and glove use for high risk care activities in high risk residents

Group Type: EXPERIMENTAL

Targeted gown and gloves use

Intervention Type: OTHER

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

Baseline

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Targeted gown and gloves use

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Mary-Claire Roghmann

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Maryland

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00088648

Identifier Type: -

Identifier Source: org_study_id