## Protocol Section
### Identification Module
**NCT ID:** NCT01350479

**Brief Title:** Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers

**Official Title:** Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers

#### Organization Study ID Info
**ID:** IIR 10-154
#### Organization
**Class:** FED
**Full Name:** VA Office of Research and Development
### Status Module
#### Completion Date
**Date:** 2016-11-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-10-05

**Type:** ACTUAL

**Last Update Submit Date:** 2017-09-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-01-15

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-03-15

**Type:** ACTUAL

**Results First Submit Date:** 2016-11-16

**Results First Submit QC Date:** 2017-01-24

#### Start Date
**Date:** 2012-10-01

**Type:** ACTUAL

**Status Verified Date:** 2017-09

#### Study First Post Date
**Date:** 2011-05-09
**Type:** ESTIMATED
**Study First Submit Date:** 2011-05-06
**Study First Submit QC Date:** 2011-05-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** FED

**Name:** VA Office of Research and Development

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Methicillin-resistant S. aureus (MRSA) infections are a common cause of morbidity and mortality in nursing home residents. MRSA is predominantly spread from patient-to-patient by health care workers. The use of gowns, gloves and hand washing prevents this spread; however, their use detracts from a patient-centered, home-like environment which is an important priority for nursing homes. The goal of this project is to determine when it is most important for health care workers to wear gowns and to wash their hands when caring for MRSA colonized Veterans in community living centers.

**Detailed Description:** Methicillin-resistant S. aureus (MRSA) infections are a common cause of morbidity and mortality in nursing home residents. MRSA is predominantly spread from patient-to-patient by health care workers. The use of gowns, gloves and hand washing prevents this spread; however, their use detracts from a patient-centered, home-like environment which is an important priority for nursing homes. The goal of this project is to determine when it is most important for health care workers to wear gowns and to wash their hands when caring for MRSA colonized Veterans in community living centers. To meet this goal, the investigators will enroll \~400 MRSA-colonized residents and health care workers from VA community living centers in four states and the District of Columbia. Additionally, the investigators will enroll some non-MRSA colonized residents as control subjects. Each enrolled resident will be followed for 6-25 episodes of care observations over 30 days. During each observation, the investigators will have health care workers wear disposable gowns and gloves during each care activity (e.g. wound dressing) that occurs during the study visit. At the end of each care activity, the investigators will swab the gown and gloves prior to disposing of them. Each swab will be tested for MRSA to determine if MRSA from the resident was transferred to the healthcare worker's gown or gloves during that episode of care. The results of the investigators' analysis will be used to develop new infection control guidelines which balance patient safety and a home-like, patient-centered environment.

### Conditions Module

**Conditions:**

- Methicillin-Resistant Staphylococcus Aureus

**Keywords:**

- Cross infection

- Long term care

### Design Module

#### Bio Spec

**Description:** Swabs of the gowns and gloves of health care workers that interact with the participants will be tested for MRSA and other types of bacteria. Swabs from body sites (e.g. nose) of participants will be tested for MRSA and other types of bacteria.

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 203

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Residents with history of MRSA in the past year

**Label:** MRSA colonized

#### Arm Group 2

**Description:** Residents without history of MRSA in the past year

**Label:** Not MRSA colonized

### Outcomes Module

#### Primary Outcomes

**Description:** Presence of MRSA on gown or gloves worn by enrolled health care worker for research purposes while providing a specific type of care for enrolled resident

**Measure:** MRSA Transmission

**Time Frame:** Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Resident:

* Age 18 years
* Reside in a participating LTCF for rehabilitation, skilled nursing or maintenance care
* Expected length of stay of \>4 weeks from enrollment
* Written informed consent from participant, or written informed consent from legally authorized representative (LAR) with assent from participant

Health Care Worker:

* Has direct interaction with participating residents at participating VA Long Term Care Facility (LTCF)
* Verbal informed consent

Exclusion Criteria:

Residents:

* None

Health Care Worker:

* Unable or unwilling to wear protective gown or gloves during healthcare workers (HCW)-resident interaction

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Veterans residing in a participating VA Long Term Care Facility

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Washington, D.C.

**Country:** United States

**Facility:** Washington DC VA Medical Center, Washington, DC

**State:** District of Columbia

**Zip:** 20422

**Location 2:**

**City:** Baltimore

**Country:** United States

**Facility:** Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

**State:** Maryland

**Zip:** 21201

**Location 3:**

**City:** Baltimore

**Country:** United States

**Facility:** Rehabilitation R&D Service, Baltimore, MD

**State:** Maryland

**Zip:** 21202

**Location 4:**

**City:** Perry Point

**Country:** United States

**Facility:** Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD

**State:** Maryland

**Zip:** 21902

**Location 5:**

**City:** Boston

**Country:** United States

**Facility:** VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

**State:** Massachusetts

**Zip:** 02130

**Location 6:**

**City:** Buffalo

**Country:** United States

**Facility:** VA Western New York Healthcare System, Buffalo, NY

**State:** New York

**Zip:** 14215

**Location 7:**

**City:** San Antonio

**Country:** United States

**Facility:** South Texas Health Care System, San Antonio, TX

**State:** Texas

**Zip:** 78229

#### Overall Officials

**Official 1:**

**Affiliation:** Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

**Name:** Mary-Claire Roghmann, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Pineles L, Morgan DJ, Lydecker A, Johnson JK, Sorkin JD, Langenberg P, Blanco N, Lesse A, Sellick J, Gupta K, Leykum L, Cadena J, Lepcha N, Roghmann MC. Transmission of methicillin-resistant Staphylococcus aureus to health care worker gowns and gloves during care of residents in Veterans Affairs nursing homes. Am J Infect Control. 2017 Sep 1;45(9):947-953. doi: 10.1016/j.ajic.2017.03.004. Epub 2017 Apr 18.

**PMID:** 28431853

**Citation:** Jackson SS, Lydecker AD, Magder LS, Roghmann MC. Development and Validation of a Clinical Prediction Rule to Predict Transmission of Methicillin-Resistant Staphylococcus aureus in Nursing Homes. Am J Epidemiol. 2019 Jan 1;188(1):214-221. doi: 10.1093/aje/kwy220.

**PMID:** 30351349

**Citation:** Roghmann MC, Andronescu LR, Stucke EM, Johnson JK. Clostridium difficile Colonization of Nursing Home Residents. Infect Control Hosp Epidemiol. 2017 Oct;38(10):1267-1268. doi: 10.1017/ice.2017.172. Epub 2017 Aug 22. No abstract available.

**PMID:** 28826425

**Citation:** Blanco N, Pineles L, Lydecker AD, Johnson JK, Sorkin JD, Morgan DJ; VA Gown and Glove Investigators; Roghmann MC. Transmission of Resistant Gram-Negative Bacteria to Health Care Worker Gowns and Gloves during Care of Nursing Home Residents in Veterans Affairs Community Living Centers. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00790-17. doi: 10.1128/AAC.00790-17. Print 2017 Oct.

**PMID:** 28717036

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6642

- Name: Cross Infection

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Only serious adverse events were collected.

#### Event Groups

**Group ID:** EG000

**Title:** MRSA Colonized

**Description:** Residents colonized with MRSA by culture at study admission

**ID:** EG000

**Serious Number Affected:** 9

**Serious Number At Risk:** 94

**Title:** MRSA Colonized

**Group ID:** EG001

**Title:** Not MRSA Colonized

**Description:** Residents not colonized with MRSA by culture at study admission

**ID:** EG001

**Serious Number Affected:** 8

**Serious Number At Risk:** 106

**Title:** Not MRSA Colonized

**Frequency Threshold:** 0

#### Serious Events

**Term:** Hospitalization

**Notes:** Residents transferred from nursing home to acute care hospital, unrelated to study

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 94

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 106

**Term:** Death

**Notes:** Death of resident unrelated to study

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 94

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 106

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 94

**Group ID:** BG001

**Value:** 106

**Group ID:** BG002

**Value:** 200

**Units:** Participants

### Group

**ID:** BG000

**Title:** MRSA Colonized

**Description:** Residents colonized with MRSA by culture at study admission

### Group

**ID:** BG001

**Title:** Not MRSA Colonized

**Description:** Residents not colonized with MRSA by culture at study admission

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13

**Value:** 73

#### Measurement

**Group ID:** BG001

**Spread:** 13

**Value:** 70

#### Measurement

**Group ID:** BG002

**Spread:** 13

**Value:** 71

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 8

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 92

#### Measurement

**Group ID:** BG001

**Value:** 100

#### Measurement

**Group ID:** BG002

**Value:** 192

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 94

#### Measurement

**Group ID:** BG001

**Value:** 106

#### Measurement

**Group ID:** BG002

**Value:** 200

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** mroghman@epi.umaryland.edu
**Organization:** VA Maryland Healthcare System
**Phone:** 410-706-0062
**Title:** Mary-Claire Roghmann
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.02
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.01
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Presence of MRSA on gown or gloves worn by enrolled health care worker for research purposes while providing a specific type of care for enrolled resident
**Parameter Type:** NUMBER
**Population Description:** We analyzed the number of gown and glove swabs from HCW interacting with MRSA and non-MRSA colonized residents.
**Reporting Status:** POSTED
**Time Frame:** Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment
**Title:** MRSA Transmission
**Type:** PRIMARY
**Type Units Analyzed:** swabs
**Unit of Measure:** Proportion of swabs positive for MRSA
##### Group
**Description:** Swabs collected from healthcare workers interacting with residents colonized with MRSA by culture on enrollment
**ID:** OG000
**Title:** Swabs From Interactions With MRSA Colonized Residents
##### Group
**Description:** Swabs collected from healthcare workers interacting with residents not colonized with MRSA by culture on enrollment
**ID:** OG001
**Title:** Swabs From Interactions With Not MRSA Colonized Residents
### Participant Flow Module
#### Group
**Description:** Residents colonized with MRSA by culture at study admission
**ID:** FG000
**Title:** MRSA Colonized
#### Group
**Description:** Residents not colonized with MRSA by culture at study admission
**ID:** FG001
**Title:** Not MRSA Colonized
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 94
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 106
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 94
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 106
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Pre-Assignment Details:** Three participants withdrew from the study prior to cultures being obtained and were not assigned to a study group.
**Has Results:** True