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
Phase: NA
Conditions: Staphylococcus Aureus
Sponsor: University of Maryland, Baltimore

 
 
PROTOCOL NAME 
Preventing the Spread of Infection in Nursing Homes 
 
CDC Contract Title: 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 
 
 
UMB IRB protocol number: HP-00077879 
 
 
NCT Number: NCT03319368 
 
 
PROTOCOL VERSION NUMBER: 1.1 
PROTOCOL VERSION DATE: November 7, 2017   
 
 
 
 
 
 
 

Preventing the Spread of Infection in Nursing Homes 
2 
 
GENERAL INFORMATION 
 
 
Name and address of the study monitor and person authorized to sign the protocol and 
amendments:  
 
Mary-Claire Roghmann, MD, MS 
Professor of Epidemiology and Public Health and Medicine 
University of Maryland School of Medicine 
10 South Pine St., MSTF 3-36 
Baltimore, MD 21201 
Phone  
 
(410) 706-0062 
Fax  
 
 
(410) 706-0098 
Beeper  
 
(410) 447-4143 
E-mail   
 
mroghmann@som.umaryland.edu 
 
 
Name and addresses of the laboratories and local study sites involved in the study: 
 
Microbiology Research Lab 
Department of Pathology 
Allied Health Building, Room 450 
100 S. Penn St. 
Baltimore, MD 21201 
 
Study Sites: Lorien Healthcare Systems 
 
 
Commonly Used Abbreviations 
SA 
Staphylococcus aureus 
MRSA
Methicillin-resistant S. aureus
MSSA
Methicillin-susceptible S. aureus
HCW 
Health care worker 
NH 
Nursing home
LTCF 
Long term care facility 
CRISP
Chesapeake regional information system for our patients
ADL
Activities of daily living
 
 
 
 
 

Preventing the Spread of Infection in Nursing Homes 
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Table of Contents 
ABSTRACT................................................................................................................................................... 4 
 
BACKGROUND .................................................................................................................................. 6 
 RATIONALE ........................................................................................................................................ 6 
 POPULATION ...................................................................................................................................... 6 
 RISK/BENEFITS .................................................................................................................................. 6 
 STUDY CONDUCT ............................................................................................................................... 7 
 
STUDY OBJECTIVE ........................................................................................................................... 7 
 
STUDY DESIGN ................................................................................................................................. 7 
 PRIMARY STUDY ENDPOINTS/SECONDARY ENDPOINTS ........................................................................ 7 
 STUDY DESIGN/TYPE .......................................................................................................................... 8 
 DURATION .......................................................................................................................................... 9 
 
SELECTION AND WITHDRAWAL OF PARTICIPANTS ................................................................... 9 
 INCLUSION CRITERIA FOR RESIDENTS .................................................................................................. 9 
 EXCLUSION CRITERIA FOR RESIDENTS ................................................................................................ 9 
 INCLUSION CRITERIA FOR STAFF (SHADOWING, TEAM LIAISONS) ............................................................ 9 
 EXCLUSION CRITERIA FOR STAFF (SHADOWING, TEAM LIAISONS) .......................................................... 9 
 SUBJECT WITHDRAWAL ...................................................................................................................... 9 
 MEDICATION ..................................................................................................................................... 10 
 
FACILITY ENGAGEMENT ............................................................................................................... 10 
 
WAIVER OF INFORMED CONSENT FOR RESIDENTS ................................................................. 10 
 WAIVER OF INFORMED CONSENT ...................................................................................................... 10 
 ENROLLMENT PROCESS FOR RESIDENTS ........................................................................................... 10 
 WAIVER OF HIPAA AUTHORIZATION .................................................................................................. 10 
 
INFORMED CONSENT FOR HEALTH CARE WORKERS (HCWS) ............................................... 12 
 RECRUITMENT PROCESS .................................................................................................................. 12 
 INFORMED CONSENT PROCESS FOR HEALTH CARE WORKERS ........................................................... 12 
 
STUDY PROCEDURES .................................................................................................................... 12 
 STUDY SCHEDULE ............................................................................................................................ 12 
 STUDY PERIOD START OR RESIDENT ADMISSION ............................................................................... 13 
 STUDY PERIOD END OR RESIDENT DISCHARGE .................................................................................. 13 
 
ADVERSE EVENTS .......................................................................................................................... 13 
 ADVERSE EVENTS AND THEIR GRADING ............................................................................................. 13 
 ATTRIBUTION OF ADVERSE EVENTS ................................................................................................... 13 
 ADVERSE EVENT REPORTING............................................................................................................ 13 
 
STATISTICAL PLAN ........................................................................................................................ 13 
 
DATA ANALYSIS, SAMPLE SIZE, AND PRECISION ............................................................................ 13 
 
DATA COLLECTION, HANDLING AND STORAGE ....................................................................... 14 
 
STUDY MANAGEMENT PLAN ........................................................................................................ 15 
 
STUDY COORDINATION ................................................................................................................. 15 
 
PERFORMANCE MONITORING: ....................................................................................................... 15 
 
DATA AUDITS: .............................................................................................................................. 15 
 
DATA EDITS: ................................................................................................................................ 15 
APPENDIX: STUDY VARIABLES ............................................................................................................. 17 

Preventing the Spread of Infection in Nursing Homes 
 
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Abstract 
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.  
We 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 community-based nursing homes. Our novel strategy is 
based on prior research on the risk of transmission from residents to healthcare workers’ (HCWs) gowns and 
gloves, the first step in SA transmission. Rather than wearing gowns and gloves for all care activities to prevent 
transmission (as in Contact Precautions), 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 to HCW clothing and hands (in the absence of gown and glove use) based on prior 
research. (1, 2) 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 HCW clothing and hands; and 4) most likely to 
develop a SA infection based on prior research (1-3) and thus would be considered high risk residents. 
We 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. A quasi-experimental study design allows each nursing home to act as its 
own control, reducing variability. During a two month baseline period, we will measure SA acquisition and SA 
infection using surveillance cultures from residents and review of health care records. We will also assess 
gown and glove use for high risk care in high risk residents during the baseline period and begin to develop the 
intervention using a participatory human factor engineering informed approach. During a one month training 
period, we will begin phase implementation of the intervention in the nursing homes. During a two month 
intervention period, we will again measure SA acquisition and SA infection using surveillance cultures from 
residents and review of a state-wide electronic health information repository. We will also assess gown and 
glove use for high risk care in high risk residents during the intervention period and evaluate the intervention. 
SA acquisition is an excellent measure of resident-to-resident SA transmission, which our intervention is 
designed to decrease. It is also a more frequent outcome than SA infection, increasing the power of our study 
to detect a difference if one exists. We will assess adherence with all components of the intervention and the 
change in gown and glove use between baseline and intervention periods. 

Preventing the Spread of Infection in Nursing Homes 
 
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Figure 1. Overview of Project  
 
Perform sequentially in two community-based nursing homes
Collect study start (S), admission 
(A) and discharge (D), study end 
(E) surveillance swabs from 
anterior nares and inguinal skin
Weekly observations of gown and 
glove use for high risk care
Follow residents for 90 days after 
admission for SA Infection via 
health care records
Development of intervention
through QI meetings, direct 
observations and research team 
liaisons
Objective 2 
Objective 1 
Objective 3 
Collect study start (S), admission 
(A) and discharge (D), study end 
(E) surveillance swabs from 
anterior nares and inguinal skin
Weekly point prevalence studies 
for identification and flagging of 
high risk residents and 
observations of gown and glove 
use for high risk care
Feedback on intervention through 
QI meetings and research team 
liaisons
Follow residents for 90 days after 
admission for SA Infection via 
health care records
Regulatory 
approvals
Engage 
stakeholders 
at nursing 
homes
Baseline period: 
Measure S. aureus 
acquisition and 
infection in residents 
(N~100)
Training period: 
Phased 
implementation 
with feedback 
on intervention
Intervention period: 
Measure S. aureus 
acquisition and 
infection in residents 
(N~100)
Data 
analysis
Write protocol 
for larger trial

Preventing the Spread of Infection in Nursing Homes 
 
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Background 
 
Rationale 
Nursing homes are healthcare settings that house a high prevalence of people with both MRSA and 
MSSA colonization, creating a high risk for resident-to-resident transmission of Staphylococcus aureus (SA). 
There is a mingling of long term and short term stay residents in community-based nursing homes which mix a 
population recovering from acute illness with a chronically ill population which has high prevalence of SA 
colonization. For example, we found that short stay residents are at four-fold higher risk for MRSA acquisition 
than long stay residents. Once SA acquisition occurs, people are at higher risk for infection as colonization 
typically precedes infection. Up to 30% of MRSA colonized patients develop an infection contributing to 
community onset invasive SA infections. Nursing home stay was identified as a common risk factor for invasive 
MRSA infection after recent hospital discharge. 
Nursing home staff are the most frequent vector for SA transmission as their clothing and hands become 
contaminated with SA during the care of SA colonized residents. In contrast to hospitals, where the standard of 
care for patients with MRSA is Contact Precautions (gowns and gloves for all patient contact), community-
based nursing homes typically use Standard Precautions (gowns and gloves for anticipated contact with blood, 
body fluids, skin breakdown or mucous membranes) for residents with MRSA. Prior research demonstrating 
high rates of MRSA acquisition in nursing homes suggests that Standard Precautions do not adequately 
reduce the transmission of SA. 
Contact Precautions have not been widely adopted by nursing homes for several reasons. Nursing 
homes are resource-limited settings without the level of professional staff and laboratory infrastructure of 
hospitals. In addition, nursing home staff have deeply rooted beliefs that Contact Precautions stigmatize 
residents. There is a clear need for a solution - tailored to the nursing home setting - to reduce the risk of SA 
(and other antibiotic resistant bacteria) acquisition and infection. Our goal in this project is to demonstrate the 
feasibility of a novel intervention, targeted gown and glove use, to decrease SA acquisition and SA infection as 
a precursor for a future multisite stepped wedge cluster trial. 
 
Population 
Study participants will be nursing home (NH) residents and staff in participating community-based NH 
study sites. All study activities will occur in the participating community-based NH study sites. 
 
Risk/Benefits 
The risks related to this study are minimal – the same as that encountered in daily life or at a routine 
doctor's visit. There are two types of participants, NH residents and staff. The two types of participants have 
different risks which we have minimized. 
Potential risks to resident participants include those associated with non-invasive cultures (anterior nares 
and inguinal fold skin) and the loss of confidentiality of individual health information collected as part of the 
study.   
We will minimize these risks as follows. Resident participants will be educated on how the cultures are 
performed at the time of enrollment to reduce any psychological discomfort. Study coordinators will have 
competencies in doing these procedures and will use gentle pressure to reduce possible irritation or discomfort 
during from the culture procedures.  
Access to study records will be restricted to study staff, investigators and officials of the Office of Human 
Research Protections. Every effort will be made to keep the study records confidential through the use of 
locked briefcases for transport of paper records, assignments of unique participant identifiers, password 
protected databases and storage of paper records in locked filing cabinets in rooms that are locked when not in 
use (see 11. Data Handling and Record Keeping for additional details).  
There are few, if any potential risks to staff. Staff will be observed during routine care in order to estimate 
gown and glove use. A number of staff will be shadowed in order to determine how to best implement the 
intervention, targeted gown and glove use. A few staff will serve as liaisons to the project team. All staff will 
wear disposable gowns and non-latex gloves while providing specific care for specific residents during the 
intervention period. Wearing gowns and gloves are part of Standard (infection control) Precautions for certain 
care activities and pose no risk to the staff. We will not collect any identifiable data on any staff and thus there 
is no risk of loss of confidentiality. 

Preventing the Spread of Infection in Nursing Homes 
 
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There is no direct, individual benefit that can be guaranteed as a result of participation in this research 
study. There is societal benefit as this study will provide information about the transmission of S. aureus and 
other bacteria that could ultimately reduce the risk of infection for other nursing home residents. All residents 
and staff will be given the opportunity to have their questions answered by the study coordinators or 
investigators as needed. Given the minimal risks to the participants, the benefits outweigh the risks. 
 
Study Conduct 
This study will be conducted in compliance with the current protocol approved by the Institutional Review 
Board and according to Good Clinical Practice standards. All study documents will be posted on a secure 
document management site. No deviation from the protocol will be knowingly implemented without the prior 
review and approval of the IRB except where it may be necessary to eliminate an immediate hazard to a 
research subject. In such case, the deviation will be reported to the IRB as soon as possible. 
 
Study Objective 
Our goal in this project is to demonstrate the feasibility of a novel intervention, targeted gown and glove 
use, to decrease SA acquisition and SA infection as a precursor for a future multisite stepped wedge cluster 
trial. Our targeted intervention limits both cost and stigma while blocking the transmission and acquisition of 
multiple organisms. 
Objective 1: To implement a targeted gown and glove intervention in two community-based nursing 
homes.  
Expected Outcome 1: A targeted gown and glove intervention can be successfully implemented across 
two community-based nursing homes with >80% compliance with gown and glove use for high risk care 
in high risk residents. 
Objective 2: To evaluate the impact of a targeted gown and glove intervention on SA acquisition and SA 
infection rates.  
Expected Outcome 2a: The intervention will decrease SA acquisition and infection rates. 
Expected Outcome 2b: We will determine the effect size to guide the design (including the sample size) 
of a future trial. 
Objective 3: To develop an implementation “toolkit” that can be easily adapted and implemented at 
nursing homes in a future trial.  
Expected Outcome 3: Barriers to and strategies for implementation of the targeted gown and glove 
intervention will be identified leading to modification of the pilot intervention and development of an 
implementation “toolkit” for a future trial. 
 
Study Design 
 
Primary Study Endpoints/Secondary Endpoints 
Outcome 1: Compliance with each component of the intervention (identification and flagging of high risk 
residents, use of gowns and gloves for high risk care) based on 1) weekly point prevalence studies for high risk 
residents and 2) weekly observations of high risk care interactions with 5-10 residents over the 2-month 
intervention periods. There will also be weekly observations of high risk care interaction of 5-10 residents over 
the 2-month baseline period to assess the change in gown and glove use. 
 
Outcome 2a: The primary outcome will be a change in SA acquisition rates comparing baseline and 
intervention periods. Residents in the nursing home will be swabbed at the start of the study period, or when 
they are admitted. Then they will all be re-swabbed at discharge or when the study ends. Acquisition will be 
defined as a positive culture for a new SA in a resident who was negative for that SA at the start of the study 
period or admission. Cultures will be performed in the research lab using well established methods. Specimens 
will be saved for future evaluation of other bacteria. The secondary outcome will be invasive SA infections and 
other infections within 90 days of nursing home admission in residents as detected through surveillance from 
health care records including but not limited to CRISP, a state-wide central repository of health care records 
including hospital and nursing home discharge summaries.  
Outcome 2b: The observed SA acquisition rate reduction from this pilot study will be used to estimate the effect 
size that will inform the sample size for a larger trial. 

Preventing the Spread of Infection in Nursing Homes 
 
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Outcome 3: We will qualitatively examine the acceptability of, and any barriers to implementation using broad 
stakeholder feedback. Elements found to be infeasible or unacceptable will be modified at each stage and an 
implementation toolkit will be developed for the future trial.  
 
Study Design/Type 
Study Design 
 
We will use a quasi-experimental study of a targeted gown and glove intervention (described below) 
with each nursing home acting as its own control to reduce between nursing home variability. 
 
Intervention 
Our novel strategy is based on extensive prior research 
on the risk of S. aureus (SA) transmission from residents to 
staff gown and gloves during care interactions, the first step in 
transmission. Our prior work suggests a novel, evidence-based 
approach to preventing SA transmission and SA acquisition: 
targeted gown and glove use. Rather than wearing gowns and 
gloves for all care activities, gown and glove use could be 
targeted at a) specific high risk “moments” while caring for b) 
high risk residents. The staff interactions targeted for gown and 
glove use are those most likely to transmit SA to staff clothing 
and hands based on prior 
research. The targeted gown and glove use is in addition to Standard 
Precautions for all residents. The residents targeted are both long and short 
stay residents and are: 1) most likely to be colonized with SA; 2) most likely 
to acquire SA; 3) most likely to transmit SA to staff clothing and hands; and 
4) most likely to develop a SA infection based on prior research.  
 
Implementation Strategy 
We will use a participatory approach to develop, implement, and evaluate the intervention. In other 
words, we will actively involve multiple stakeholders, including front-line staff and nursing home leaders in all 
stages of the project, including design, implementation, and evaluation. 
 
For the intervention, gown and gloves will be used for high risk care in high risk residents. 
Implementation will require the following steps: identification and flagging of high risk residents, then making 
acceptable gowns and gloves available at point of care. We will engage stakeholders including nursing home 
administrative and clinical staff, residents and family in these steps. We will develop separate human-factors 
engineering informed educational materials for staff, residents and family members, incorporating the feedback 
from our prior focus groups (4) and considering the well-known usability engineering (usefulness + ease of 
use) principles to increase acceptability and use. Phased assessment of the implementation of this intervention 
will be performed with modification at each step.  
We will use the existing quality improvement infrastructure in each of the two nursing homes to actively 
involve and obtain input from multiple key stakeholders (nursing assistants, nurses, nurse manager, and other 
leaders) about the intervention and implementation toolkit. Each nursing home has regular quality improvement 
meetings attended by key stakeholders. The staff member responsible for infection control at the nursing home 
and a human factors expert from the research team will attend these meetings. In these meetings, we will first 
introduce the intervention idea and any evidence supporting the intervention and will seek input and active 
involvement of health care workers in detailing the intervention and implementation plan. We will use this same 
mechanism to conduct a qualitative evaluation of the intervention and implementation toolkit.  
We will conduct direct observations of nursing assistants’ and nurses’ use of gowns and gloves for 
residents with wounds and/or devices before (for informing the intervention design and implementation 
process) and after implementing the intervention (for conducting qualitative evaluation of the intervention and 
how to improve the intervention/implementation package). Before implementation, we will conduct direct 
observations in order to: (1) understand the baseline process and workflow; (2) identify necessary changes in 
work system design and workflow to make it easy for HCWs to comply with the new targeted gown and glove 
High risk “Moments” for Gown and 
Glove Use 
 dressing the resident 
 transferring the resident 
 providing hygiene 
 changing linens  
 changing the resident’s brief or diaper 
 device care or use 
 dressing wounds 
High Risk Residents 
 Chronic wounds 
 Invasive medical devices 
 Short stay 
 Totally dependent on HCW 

Preventing the Spread of Infection in Nursing Homes 
 
9
intervention; and (3) identify any potential barriers before implementation to take the necessary precautions. 
We will develop an observation instrument based existing literature, and input from multidisciplinary 
stakeholders. We will form two-person teams consisting of a team member with infection control certification 
and a human factors engineer who will shadow a HCW while taking care of high risk residents. Based on 
preliminary studies and our previous research experience using this type of methodology, we expect to reach 
theoretical saturation after observing five HCW, on different days and shifts, while they perform activities that 
require gowns and gloves (based on current standard of care), each for 2-4 times. After implementation, we 
will use a similar methodology to observe a comparable number of HCW to identify any barriers to compliance 
with the new targeted gown and glove intervention and any workarounds/strategies they developed to 
overcome the barriers. These findings and learnings will be key for improving our intervention and 
implementation toolkit for future large-scale implementation efforts.  
In this participatory approach, we will identify 2-3 HCWs (e.g. 2 nursing assistants, 1 nurse) from each 
nursing home to be liaisons to our research team. Our research team member with infection control 
certification and human factors experts will work closely with these HCWs, through regular meetings, in every 
phase of the study, including design, implementation and evaluation. For example, before implementation, 
these HCWs will be asked to describe the nursing assistant workflow and provide input on how to redesign the 
“nursing home work system” (e.g., best locations to store gowns and gloves, alternatives approaches to 
flagging eligible patients, and design characteristics of effective visual cues to flag high risk patients) to ensure 
successful implementation of the intervention.  
 
Duration 
Each of two nursing homes will participate for a period of approximately 6 months. After an initial month 
of engagement, the next 2 months will be a baseline data collection period; the next 1 month, an intervention 
training period and the final 2 months, an intervention data collection period. 
 
Selection and Withdrawal of Participants 
 
All residents present in the two nursing homes during the project will be potential participants. HCWs 
can participate in a number of ways. HCWs will be observed during routine care in order to estimate gown and 
glove use. A number of HCWs will be shadowed in order to determine how to best implement the intervention, 
targeted gown and glove use. Up to 6 HCWs will serve as liaisons to the project team. All HCW will wear 
disposable gowns and non-latex gloves while providing specific care for specific residents during the 
intervention period. 
 
Inclusion Criteria for Residents 
 Age ≥18 years 
 Reside in a participating NH 
 
Exclusion Criteria for Residents 
 Identified by NH staff as combative or with other behavioral problems which could lead to agitation if 
approached by project staff 
 
Inclusion Criteria for Staff (shadowing, team liaisons) 
 Staff at study site 
 Willing to work with project team on intervention implementation 
 
Exclusion Criteria for Staff (shadowing, team liaisons) 
 None 
 
Subject Withdrawal 
Study residents or staff will be withdrawn from the study if found to have been initially ineligible or if they 
refuse to participate. No follow-up with withdrawn participants is required. 

Preventing the Spread of Infection in Nursing Homes 
 
10
 
Medication 
All medications are permitted during the study.  
 
Facility Engagement 
Within a month of project start at the NH, a meeting will occur with facility/unit administrators at each NH. 
We will then meet with the unit nurse managers to discuss the study procedures and develop solutions to 
anticipated problems. 
 
Waiver of Informed Consent for Residents 
 
Waiver of Informed Consent 
We are requesting a waiver of informed consent for residents participating in this study. Under 45 CFR 
46.116(d), the IRB "may approve a consent procedure which does not include, or which alters, some or all of 
the elements of informed consent” or waive the requirement to obtain consent all together, provided that: 
1. The research involves no more than minimal risk to the participants; 
2. The waiver or alteration will not adversely affect the rights and welfare of the participants; 
3. The research could not practicably be carried out without the waiver or alteration; and 
4. Whenever appropriate, the participants will be provided with additional pertinent information after 
participation; and 
5. The research is not FDA-regulated. 
We are requesting a waiver of consent for this study population for the following reasons: 
1. The study will involve no more than minimal risk of harm to participants 
See 1.3 Risks/Benefits.  
2. The waiver will not adversely affect the rights and welfare of the subjects.   
Current nursing home accreditation standards mandate that equal, high quality care be provided to 
all patients, whether or not they are on contact precautions. All residents will receive the same high 
quality care during the study. 
3. The research could not practicably be carried out without the waiver.  
To adequately evaluate the study outcomes, it is important that all or nearly all residents are included 
in the study. Obtaining authorization from 100% of residents is not practical in a nursing home 
because many residents lack decision making capacity. Contacting 100% of legally authorized 
representatives to obtain proxy authorization would also not be possible within the time constraints of 
the study given residents should be cultured within 72 hours of admission or study start. Requiring 
authorization would bias the estimate of acquisition of SA since more ill patients will be less likely to 
provide authorization but may be more likely to acquire SA. 
4. Whenever appropriate, patients can be provided with additional pertinent information after 
participation 
In the event that individual residents, family members or staff members request additional information 
about the study, each site will have readily available copies of a study information sheet for residents 
and families which describes the purpose of the study, the procedures involved in the study, and who 
to contact for further information. 
 
Enrollment Process for Residents 
The study information sheet for residents and families will be provided in admission materials and made 
available to other residents. Similar to any routine clinical procedure, we will briefly explain the procedure of 
obtaining the surveillance swabs and ask whether we can perform the cultures now. The resident or their 
family member can refuse to have the surveillance cultures performed. If during the surveillance cultures, a 
resident exhibits a negative response to specimen collection, the procedure will be stopped. 
 
Waiver of HIPAA Authorization 
This study meets the criteria for a waiver or alteration of HIPAA under 45 CFR 164.512(i)(2)(ii) as 
described below. The waiver for recruitment is to allow research staff to discuss the resident with NH staff to 
determine eligibility criteria. Residents who are identified by NH staff as combative or with other behavioral 

Preventing the Spread of Infection in Nursing Homes 
 
11
problems which could lead to agitation if approached for the study will not be approached. Accessing this 
information from NH staff reduces the burden on the resident with regard to time and research procedures, 
increases the feasibility of the study, and does not confer any additional risk. 
In addition, we will capture information from the medical records of all residents at participating facilities. 
This information includes: demographics (ex. age, gender, ethnic and racial category), length of stay, level of 
care, recent hospitalizations, activities of daily living, case mix index, facility characteristics, skin breakdown, 
medical devices, recent antibiotic use and co-morbidities. Resident identifiers will be collected on case report 
forms to facilitate collection; however, no resident identifiers will be entered into the study database for non-
enrolled residents; instead, a unique identifier or code will be assigned to each resident. 
 
This study meets the requirements for waiver or alteration of HIPAA under 45 CFR 164.512(i)(2)(ii):  
A. Use or disclosure involves no more than minimal risk to the privacy of individuals because of the 
presence of at least the following elements: 
1. An adequate plan to protect health information identifiers from improper use or disclosure, 
2. An adequate plan to destroy identifiers at the earliest opportunity absent a health or research 
justification or legal requirement to retain them, and 
3. Adequate written assurances that the PHI will not be used or disclosed to a third party except 
as required by law, for authorized oversight of the research study, or for other research uses 
and disclosures permitted by the Privacy Rule 
Confidentiality will be maintained to the fullest extent permitted by law. All study data 
collected at the NHs will be recorded on case report forms. These case report forms will be 
entered into a password protected relational database which will be kept on a research server 
which has a level and scope of security that equals or exceeds that established by the HIPAA 
Security Rules. Clinical data on study participants will be obtained electronically from the 
participating NHs and uploaded into the study database. Data regarding S. aureus infections 
will be sourced from a state-wide electronic health information repository and entered into the 
study database. Paper records will be stored in locked filing cabinets in a protected space. 
Data will be maintained on a secure electronic central database on a research server. Data 
will be backed up according to the network backup schedule. 
A unique identifier or code will be assigned to each resident participant. Bacterial 
isolates and culture specimens and datasets used for analysis will be labeled with this code. 
Only the study personnel who directly interact with subject or manage the subject’s clinical 
protocol data will have access to participant identifying information. Culture data will be 
entered directly into the relational database; however, microbiology laboratory personnel will 
not have access to participant identifiers in the database. Study personnel who leave the 
research team will have their access to study data removed.  
As soon as permitted and when all data analyses are complete and have been 
published, source documents containing identifiable information will be shredded and 
identifying information will be removed from the database. During the entire study, all data will 
be managed centrally at the primary site. There will be a single data table which maintains the 
link between the unique code and patient identifiers. This table containing the link between 
code and identifying information will be destroyed on the server and in any backups when it is 
time to de-identify the database. If any paper copies of the link have been made, they will be 
shredded. PHI will not be shared or disclosed unless required by law. 
B. Research could not practicably be conducted without the waiver or alteration 
To adequately evaluation the study outcomes, it is critical that all or nearly all residents are included 
in the study. Obtaining authorization from 100% of residents is not practical in a nursing home due to 
many residents’ lack of decision making capacity. Requiring authorization would bias the estimate of 
acquisition of SA since more ill residents will be less likely to provide authorization but may be more 
likely to acquire SA. 
C. Research could not practicably be conducted without access to and use of PHI 
To adequately evaluate the study outcomes, it is critical that we include basic clinical information as 
described in 11 Data Collection, Handling and Storage. This includes important data such as 

Preventing the Spread of Infection in Nursing Homes 
 
12
whether residents are short stay or long stay which could affect the SA acquisition, an outcome 
variable and other data which will allow us to describe our population in aggregate. 
 
Informed Consent for Health Care Workers (HCWs) 
HCWs will participate in a number of ways. 1) Up to 10 HCWs will be shadowed in order to determine 
how to best implement the intervention, targeted gown and glove use. 2) Up to 6 staff will serve as liaisons to 
the project team. 3) HCWs will be observed during routine care in order to estimate gown and glove use. 4) All 
staff will wear disposable gowns and non-latex gloves while providing specific care for specific residents during 
the intervention period. 
We request a waiver of documentation of informed consent (verbal/oral consent) for healthcare workers 
who are involved as research team liaisons or in shadowing to help develop this infection control intervention. 
This is a minimal risk study in which staff are being asked to participate as stakeholders in the development of 
an infection control intervention. The information collected is anonymous. If we were to use a consent 
document, the signed document would be the only link between the healthcare worker and the information.  
We will not obtain informed consent for our observations of gown and glove use or the routine use of 
gown and gloves for providing specific care for specific residents during the intervention period because this 
will be standard practice in the nursing home as agreed upon by the participating NH (see below, 7.1 
Recruitment Process). 
 
Recruitment Process 
HCWs will be recruited through participating NHs. Prior to study commencement at a NH, a meeting will 
be scheduled with facility/unit administrators at each prospective NH. Upon confirming their agreement to 
participate, we will meet with unit nurse managers and medical providers, distribute a study information sheet 
for nursing home staff to all HCWs at that facility that interact with residents and provide a phone number for 
follow-up. We will also present at a staff meeting to explain study procedures, answer questions and address 
concerns.  
 
Informed Consent Process for Health Care Workers 
Prior to study start in the NH, research staff will describe the study at a staff meeting. Research staff will 
introduce themselves, briefly re-explain the study and ask the healthcare worker if he/she would like to 
participate in a research study being conducted by the PI by being shadowed or participating as a project team 
liaison. The staff member will make clear that participation is voluntary and there will be no repercussions for 
not participating. The staff member will explain the procedure of shadowing the HCW in order to determine the 
best way to implement this intervention or what will be involved in being a project team liaison. As part of being 
a project team liaison, meetings or discussion may be recorded. The staff member will also explain that we are 
not collecting any identifiable information and any results will not be linked to the individual staff member. The 
staff member will offer to answer any questions and will offer contact information for the investigator on 
request.  
 
Study Procedures 
 
Study Schedule 
 
Study Period Start or 
Resident Admission 
Study Period End or 
Resident Discharge 
 
Day 0 
Day 1-60 
Obtain medical history for eligibility from electronic medical 
record (HIPAA waiver for study) 
R 
 
Obtain permission from Resident 
(waiver of informed consent) 
R 
 
Confirm permission from Resident 
 
R 
Collect anterior nares and inguinal skin specimens 
R 
R 

Preventing the Spread of Infection in Nursing Homes 
 
13
 
Study Period Start or 
Resident Admission 
Study Period End or 
Resident Discharge 
 
Day 0 
Day 1-60 
Monitor for Adverse Events 
R 
R 
 
Study Period Start or Resident Admission  
Research staff will speak with NH staff to determine which residents are eligible. Eligible residents will be 
approached for permission to perform study procedures. At study period start or resident admission, subjects 
will have a specimen of the anterior nares and inguinal skin. 
 
Study Period End or Resident Discharge  
Research staff will confirm with NH staff to determine that the resident is eligible. Eligible residents will be 
approached for permission to perform study procedures. At study period end or resident discharge, subjects 
will have a specimen of the anterior nares and inguinal skin. 
 
Adverse Events 
 
Adverse Events and their Grading 
We will collect data on SERIOUS ADVERSE EVENTS as defined by HRPO policy that occur while the 
study participants are enrolled.  
 
Attribution of Adverse Events 
The Principal Investigator will determine attribution of serious adverse events. The following scale will 
assess the relationship of AEs to the study procedures: 
 
Not related: no temporal association, or the cause of the event has been identified, or the study 
procedures cannot be implicated 
 
Possibly related: temporal association, but other etiologies are likely to be the cause; however 
involvement of the study procedures cannot be excluded 
 
Probably related: temporal association, other etiologies are possible but unlikely 
 
Related: established temporal or other association for event not reasonably explained by the patient’s 
known clinical state or any other factor 
 
Adverse Event Reporting  
Serious Adverse Events that are more likely than not (probably or definitely) related to the research will 
be reported immediately of the site investigator becoming aware of the SAE to the local IRB according to 
established IRB policy. The principal investigator will evaluate the adverse event and determine whether the 
adverse event affects the Risk/Benefit ratio of the study and whether modification to the protocol is required.  
The principal investigator will conduct a review of all serious adverse events annually. The principal 
investigator will evaluate the frequency and severity of the serious adverse events and determine if 
modifications to the protocol is required. A summary of the serious adverse events will be reported to the UMB 
IRB annually, when renewal is sought.  
 Statistical Plan 
 Data Analysis, Sample Size, and Precision 
For objective 1, we will calculate point estimates and 95% confidence intervals for the rates of 
compliance with each component of the intervention (identification and flagging of high risk residents, use of 
gowns and gloves for high risk care) as well as the change in gown and glove use for high risk care during the 
baseline and intervention periods. We will observe 40-80 encounters per nursing home where gowns and 
glove should be used which will result an estimate of the rate of compliance that is accurate +/- 8-10 
percentage points. 

Preventing the Spread of Infection in Nursing Homes 
 
14
For objective 2, we will estimate and compare the rates of transmission in the baseline and intervention 
periods in each nursing home. To estimate the rates from binary data, we note that the risk that a person 
acquires the infection in the interval between swabs can be written as 1-exp(-λt) where “t” is the number of 
days between swabs and λ is interpretable as the daily rate of acquisition. We will estimate λ in the baseline 
and intervention periods using maximum likelihood estimation and compare the two rates. Likelihood methods 
will be used to calculate a confidence interval for the ratio of the rates. This will be done for each nursing home 
separately. We will test 100 residents per nursing home per period which will result an estimate of the rate of 
acquisition that is accurate +/- 4-6 percentage points. These estimates will give us insight into the effect size of 
the intervention and the variation between nursing homes for future planning. 
For objective 3, primary data will be notes and transcribed audio recordings from quality improvement 
meetings, regular meetings with the research team liaisons, and direct observation. No identifiable information 
or PHI will be collected. All qualitative data will be transferred to the qualitative software package, NVivo©. 
Data will be organized so that the setting and the method of collection can be traceable. We will use an 
iterative data analysis approach; after some data are collected, these will be analyzed to inform future 
qualitative data collection efforts 
 Data Collection, Handling and Storage 
 The Principal Investigator is responsible to ensure the accuracy, completeness, legibility, and 
timeliness of the data reported.  Data collection is the responsibility of the study staff. 
Paper records or case report forms will be filled out at the participating community-based NHs. Copies of 
the paper records or case report forms will serve as source documents and maintained for recording data for 
each subject enrolled in the study. All source documents will be completed in a legible manner to ensure 
accurate interpretation of data. Black ink is required to ensure clarity of reproduced copies.  When making 
changes or corrections, the original entry will be crossed out with a single line, and the change initialed and 
dated. Erasing, overwriting, or use of correction fluid or tape will not be done. 
All available source documents and laboratory reports will be reviewed by the clinical team and data 
entry staff, who will ensure that they are accurate and complete. AEs must be graded, assessed for severity 
and causality, and reviewed by the site PI or designee.  
Confidentiality will be maintained to the fullest extent permitted by law. All study data collected at the 
NHs will be recorded on case report forms. These case report forms will be entered into a password protected 
relational database which will be kept on a research server which has a level and scope of security that equals 
or exceeds that established by the HIPAA Security Rules. Clinical data on study participants will be obtained 
electronically from the participating NHs and uploaded into the study database.  Data regarding S. aureus 
infections will be sourced from a state-wide electronic health information repository and entered into the study 
database. Paper records will be stored in locked filing cabinets in a protected space. Data will be maintained 
on a secure electronic central database on a research server. Data will be backed up according to the network 
backup schedule.  
A unique identifier or code will be assigned to each resident participant. Bacterial isolates and culture 
specimens and datasets used for analysis will be labeled with this code. Only the study personnel who directly 
interact with subject or manage the subject’s clinical protocol data will have access to participant identifying 
information. Culture data will be entered directly into the relational database; however, microbiology laboratory 
personnel will not have access to participant identifiers in the database. Study personnel who leave the 
research team will have their access to study data removed.  
As soon as permitted and when all data analyses are complete and have been published, source 
documents containing identifiable information will be shredded and identifying information will be removed from 
the database. During the entire study, all data will be managed centrally at the primary site. There will be a 
single data table which maintains the link between the unique code and patient identifiers. This table containing 
the link between code and identifying information will be destroyed on the server and in any backups when it is 
time to de-identify the database. If any paper copies of the link have been made, they will be shredded. 
Selected discussions and meetings with research team liaisons will be audio-recorded on a case-by-case 
basis. To protect the privacy of participants, they will be referred to by a letter or number only. These 
anonymous identifiers will only be used to track the statements of each participant throughout the meetings. 
Audio recordings will be kept on a secure password-protected server with access only by research team 

Preventing the Spread of Infection in Nursing Homes 
 
15
members. The audio recordings of the meetings/discussions will be held until completion of analyses in case 
questions arise regarding the transcripts and then they will be destroyed. 
Shadowing observations of healthcare workers will be conducted using an observation form. The use of 
gowns and gloves will be recorded. No identifiable information will be recorded during the shadowing 
observations.  
 Study Management Plan 
 Study Coordination 
The University of Maryland, Baltimore will be the coordinating site for this study under the direction of the 
PI, Dr. Roghmann. It will also implement the protocol in community-based NHs in Maryland. It will coordinate 
study operations and be the central repository for data entry into a centralized database and perform all of the 
microbiology testing. 
It is also responsible for training study personnel and monitoring study progress and performance. The PI 
and project manager will visit the NHs for a one day study start up meeting in which we review the study 
protocol, informed consent procedures and study procedures. In addition, the project manager will visit the 
NHs for study monitoring as needed during the study. We will have weekly meetings with study staff during 
enrollment to review performance (see below), protocol deviations and adverse events.  
 Performance monitoring 
Study performance will be monitored via the centralized study database. The monitoring period will begin 
soon after enrollment begins and continue through data collection closeout. Monitoring will focus on timing, 
frequency and quality of study recruitment, follow-up, and data collection. Reports will be generated on a 
regular basis related to recruitment and data completeness. Components of the reports will include number of 
participants screened, number of participants enrolled, number of participants lost to follow-up, key 
demographics of enrolled participants, number of missing or deficient forms and summaries of data audits and 
edits.  
 Data audits  
A list of completed forms for specific participants will be randomly selected from the study database on a 
regular basis (approximately quarterly). Hard-copies of these forms will be compared with the study database. 
Forms will also be inspected for proper tracking of modifications and completion of fields not captured in the 
study database. Discrepancies between the study forms and database and any errors found on the forms will 
be reported to study staff and resolution required. 
 Data edits  
The data entry process will be guided by range and logic checks built into the study database. However, 
the entry of inappropriate data is still possible, so data edits will be run on the study database on a regular 
basis (approximately quarterly). Data edit reports will be generated for missing, out-of-range, unusual and 
inconsistent values. Study staff must respond to each data edit and make modifications to the study form and 
database as needed.  
References 
1. Roghmann MC, Johnson JK, Sorkin JD, Langenberg P, Lydecker A, Sorace B, Levy L, Mody L. 
Transmission of methicillin-resistant Staphylococcus aureus (MRSA) to healthcare worker gowns and gloves 
during care of nursing home residents. Infect Control Hosp Epidemiol. 2015 Sep; 36(9): 1050-1057. [PMID: 
26008727]. 
2. 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 

Preventing the Spread of Infection in Nursing Homes 
 
16
Staphylococcus aureus to health care worker gowns and gloves during care of residents in veterans affairs 
nursing homes. Am J Infect Control. 2017 Apr 18 [PMID: 28431853]. 
3. Emerson CB, Eyzaguirre LM, Albrecht JS, Comer AC, Harris AD, Furuno JP. Healthcare-associated 
infection and hospital readmission. Infect Control Hosp Epidemiol. 2012 Jun; 33(6): 539-544. [PMCID: 
PMC3677598] [PMID: 22561707]. 
4. Albrecht JS, Croft L, Morgan DJ, Roghmann MC. Perceptions of gown and glove use to prevent methicillin-
resistant staphylococcus aureus transmission in nursing homes. J Am Med Dir Assoc. 2017 Feb 1; 18(2): 158-
161. [PMCID: PMC5272866] [PMID: 27687079]. 
5. Katz S. Multidisciplinary studies of illness in aged persons II. A new classification of functional status in 
activities of daily living. J Chron Dis. 1959; 9(1): 55-62. 
  
 

Preventing the Spread of Infection in Nursing Homes 
 
17
APPENDIX: Study Variables  
Table: Study Variables 
Ascertained
 
 
Variables
When
How
Purpose
Format
RESIDENT  CHARACTERISTICS (measured once on each subject) 
Identifying information-  
Name as appears in existing 
medical record at  
LTCF
Enrollment 
Existing medical 
record at LTCF 
(MR) 
Looking up 
information in 
MR 
Nominal 
Medical record number 
Enrollment 
MR 
Looking up 
information in 
MR 
Ordinal 
SSN 
Enrollment 
MR 
Looking up 
information in 
MR 
Nominal 
Demographics
 
 
 
 
Level of Care 
Enrollment 
MR 
Study variable 
Nominal: 
Rehabilitation, 
Skilled Nursing, 
Maintenance 
Short Stay 
Enrollment 
MR 
Study variable 
Yes/no 
Unit in Facility
Enrollment 
MR 
Descriptive 
Nominal: from 
list of units in 
participating 
LTCFs 
Age
Enrollment 
MR 
Descriptive 
Interval 
Sex
Enrollment 
MR 
Descriptive 
Nominal 
Race
Enrollment 
MR 
Descriptive 
per OMB 
Directive 15 
definitions 
Ethnicity
Enrollment 
MR 
Descriptive 
per OMB 
Directive 15 
definitions 
Length of Stay in LTCF prior 
to Enrollment
Enrollment 
MR  
Descriptive 
Interval 
Charlson Co-morbidity Index
Enrollment 
MR 
Descriptive 
Ordinal: 0-37 
Dependence with ADLs
Enrollment 
MR 
Descriptive 
Ordinal:  
1 - minimal 
assistance,  
2 - moderate 
assistance,  
3 - requires 
assistance with 
most ADLs 
Katz ADL (5)
Enrollment 
MR/MDS 
Descriptive 
 
History of colonization or 
infection with
Multidrug Resistant 
Organism
Enrollment 
MR 
Descriptive 
Yes/no 
Types of Medical Devices:
 
 
 
 
Urinary catheter
Enrollment 
MR  
Study variable 
Yes/no 
Venous catheter for 
parenteral medications
Enrollment 
MR 
Study variable 
Yes/no 
Gastro or jejunostomy tube 
for enteral nutrition
Enrollment 
MR 
Study variable 
Yes/no 
Other
Enrollment 
MR 
Study variable 
Nominal 
Type of skin breakdown:
 
 
Study variable 
 

Preventing the Spread of Infection in Nursing Homes 
 
18
Ascertained
 
 
Variables
When
How
Purpose
Format
Pressure ulcer
Enrollment 
MR  
Study variable 
Yes/no 
Unhealed surgical incision
Enrollment 
MR  
Study variable 
Yes/no 
Percutaneous medical 
device
Enrollment 
MR 
Study variable 
Yes/no 
Tracheostomy
Enrollment 
MR  
Study variable 
Yes/no 
GI Ostomy
Enrollment 
MR 
Study variable 
Yes/no 
Other
Enrollment 
MR  
Study variable 
Nominal 
HEALTHCARE SETTING FACTORS (measured once per facility)
Facility (Study Site)
Facility Start-up 
 
Descriptive 
Nominal: from 
list of 
participating 
NHs 
Number of Licensed beds 
Facility Start-up 
Administrator 
Descriptive 
Interval 
Number of current beds
Facility Start-up 
Administrator 
Descriptive 
Interval 
Units
Facility Start-up 
Administrator 
Descriptive 
Nominal: from 
list of units 
Proportion of Beds- Rehab 
or Skilled nursing 
Facility Start-up 
Administrator 
Descriptive 
Ratio 
Proportion of Beds- Short 
stay
Facility Start-up 
Administrator 
Descriptive 
Ratio 
Resident to staff ratio by 
Type of HCW and Shift
Facility Start-up 
Administrator 
Descriptive 
Ratio  
Staff Infection Control 
Training
Facility Start-up 
Administrator 
Descriptive 
Yes/no; record 
policy 
Full time employees for 
Infection Prevention
in Facility
Facility Start-up 
Administrator 
Descriptive 
Interval 
OUTCOME VARIABLES
SA or other Infection
Within 90 days of at 
admission or study period 
start 
MR 
Outcome 
variable 
Yes/no 
SA colonization of Anterior 
nares
At admission or study period 
start/discharge or study 
period end 
Culture 
Outcome 
variable 
Yes/no 
SA colonization of Inguinal 
skin
At admission or study period 
start/discharge or study 
period end 
Culture 
Outcome 
variable 
Yes/no 
STAFF/HCW OBSERVATIONS (weekly for 5-10 high risk care activities in each nursing home during both the 
baseline period and the intervention period)
Gown use
Observation visits 
Observation 
Study variable 
Yes/no 
Glove use
Observation visits 
Observation 
Study variable 
Yes/no