Clinical trial NCT01209234
Conditions: Methicillin-resistant Staphylococcus Aureus
Keywords: Methicillin-resistant Staphylococcus aureus MRSA
Sponsor: University of California, Irvine
Start date: 2011-01-01; Completion date: 2019-01-01
Enrollment: 2140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized controlled trial will compare strategies to reduce the risk of methicillin-resistant Staphylococcus aureus (MRSA) infection and re-hospitalization in MRSA carriers. This trial will provide critical answers about the role of decolonization versus standard-of-care education in preventing MRSA infections in the large group of high risk MRSA-positive patients being discharged from hospitals. Findings could potentially impact best practice for the 1.8 million MRSA carriers who are discharged from US hospitals each year.

Detailed description:
This randomized controlled trial will compare strategies to reduce the risk of methicillin-resistant Staphylococcus aureus (MRSA) infection and re-hospitalization in MRSA carriers. This trial will provide critical answers about the role of decolonization versus standard-of-care education in preventing MRSA infections in the large group of high risk MRSA+ patients being discharged from hospitals. Findings could potentially impact best practice for the 1.8 million MRSA carriers who are discharged from US hospitals each year.

Specific Aims:

Methicillin-resistant Staphylococcus aureus (MRSA) is arguably the most important single pathogen in healthcare-associated infection when accounting for virulence, prevalence, diversity of disease spectrum, and propensity for widespread transmission. MRSA infection causes or complicates 300,000 hospitalizations each year \[Klein, Smith, Laxminarayan\], a number which has doubled in the past five years. An additional 1.5 million hospitalized patients either acquire or already harbor the pathogen without current infection. Altogether, these 1.8 million MRSA inpatient carriers experience a high amount of MRSA invasive disease in the year following discharge. Due to increased delivery of complex medical care at home or other post-hospital settings, more and more patients experience serious healthcare-associated morbidity after hospital discharge.\[Huang, Platt; Huang, Hinrichsen, Stulgis et al.\] In fact, over 80% of patients admitted for MRSA infection have had prior healthcare exposures and are at high risk for repeated MRSA infection.\[Huang, Platt; Huang, Hinrichsen, Stulgis et al.; Klevens, Morrison, Nadle, et al.\]

Project CLEAR compares two strategies to reduce infection and re-hospitalization due to MRSA among patients being discharged from hospitals. Our trial will compare a long-term regimen aimed at eradicating MRSA body reservoirs with patient education on general hygiene and self care, which is the current standard of care. Our specific aims are:

* To conduct a randomized controlled trial of serial decolonization versus standard-of-care patient education among MRSA carriers upon hospital discharge to reduce post-discharge MRSA infection and re-hospitalization for one year
* To identify predictors of a) infection or re-hospitalization due to MRSA, and b) successful MRSA decolonization, including patient demographics, comorbidities, medical devices, risk behaviors, socioeconomic status, and colonizing MRSA genotype
* To estimate medical and non-medical costs of MRSA infection among MRSA carriers and evaluate the potential for cost savings associated with decolonization

Arms: arm 1: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. arm 2: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.
Interventions: intervention 1: Standard-of-Care Education intervention 2: MRSA Decolonization
Intervention descriptions: intervention 1: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. intervention 2: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.

Protocol documents:
Prot_000.pdf: 
 
 
Manual of 
Operations and Procedures  
 
 
Project CLEAR 
Changing Lives by Eradicating Antibiotic Resistance  
 
 
 
Funded by:  
Agency for Healthcare Research and Quality 
 
 
 
 
 
 
 
Principal Investigator: Susan S. Huang, MD, MPH 
 
 


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Table of Contents 
 
Introduction .............................................................................................................................................. 4 
1. 
List of Abbreviations and Definition of Terms............................................................................... 5 
2. 
Forms and Binders .......................................................................................................................... 7 
2.1 Forms ................................................................................................................................................ 7 
2.2 Binders and Files............................................................................................................................... 8 
2.3 Logs................................................................................................................................................... 8 
3. 
Key Personnel ................................................................................................................................. 8 
4. 
Participating Centers ..................................................................................................................... 10 
5. 
Identification Numbers ................................................................................................................. 11 
6. 
Assessing Eligibility for Recruitment ........................................................................................... 11 
7. 
Inclusion/Exclusion Criteria ......................................................................................................... 14 
8. 
Informed Consent Process ............................................................................................................ 15 
9. 
Recruitment/Enrollment Study Visit............................................................................................. 15 
9.1 Stratification .................................................................................................................................... 15 
9.2 Randomization ................................................................................................................................ 15 
9.3 Participant Education ...................................................................................................................... 16 
9.4 Surveys ............................................................................................................................................ 16 
9.5 Body Site Swabbing ........................................................................................................................ 16 
9.5.1 Swabbing Technique: Nasal .................................................................................................... 16 
9.5.2 Swabbing Technique: Throat ................................................................................................... 17 
9.5.3 Swabbing Technique: Inguinal Region and Axilla .................................................................. 18 
9.5.4 Swabbing Technique: Open Wounds....................................................................................... 19 
9.6 Study Intervention ........................................................................................................................... 20 
9.7 Scheduling Next Visit ..................................................................................................................... 21 
9.8 Scheduling Bi-Monthly Phone Calls .............................................................................................. 22 
9.9 Physician Letters ............................................................................................................................. 22 
9.10 Product Start Date/Study Start Date ............................................................................................. 22 
10. Central Office Reference Guide .................................................................................................... 22 
10.1 Daily Tasks ................................................................................................................................... 22 
10.2 Day-Specific Tasks ....................................................................................................................... 23 
10.3 Recurring Tasks ............................................................................................................................ 23 
10.4 Morning Routine ........................................................................................................................... 23 
10.5 Randomization .............................................................................................................................. 23 
10.6 Patient Tracking Log..................................................................................................................... 25 
10.7 Scheduling Appointments ............................................................................................................. 25 
10.8 Assigning Appointments ............................................................................................................... 28 
10.9 Rescheduling and Cancelling Appointments ................................................................................ 28 
10.10 Disenrolling Patients ................................................................................................................... 29 
10.11 Adverse Events ........................................................................................................................... 31 
10.12 Medical Visit Reporting .............................................................................................................. 31 
10.13 Scanned Consents/Releases ........................................................................................................ 32 
10.14 Creating Consent/Recruitment and Follow-Up Visit Packets .................................................... 33 
10.15 PCP Letters ................................................................................................................................. 34 


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10.16 Exit Survey.................................................................................................................................. 34 
10.17 Reports……………………………………………………………………………….................34 
10.18 Shipping ...................................................................................................................................... 35 
10.19 End of Day Laboratory Email ..................................................................................................... 35 
10.20 Study Products ............................................................................................................................ 35 
11.
 Follow-Up Participant Tracking and Scheduling .......................................................................... 36 
11.1 Patient Contact .............................................................................................................................. 36 
11.2 Calendars....................................................................................................................................... 37 
11.3 Call Lists ....................................................................................................................................... 37 
11.4 Patient Phone Calls ....................................................................................................................... 37 
11.4.1 Initial Post-Discharge Phone Call .......................................................................................... 37 
11.4.2  Reminder Calls...................................................................................................................... 37 
11.4.3 Product Review/Orientation Calls ......................................................................................... 38 
11.5 Study Helpline .............................................................................................................................. 39 
12.   Bi-Monthly Phone Calls ................................................................................................................ 39 
13.    Follow-up Study Visits .................................................................................................................. 41 
13.1 Participant Education .................................................................................................................... 41 
13.2 Interviews ...................................................................................................................................... 41 
13.3 Adverse Events ............................................................................................................................. 42 
13.4 Medical Events.............................................................................................................................. 42 
13.5 Body Site Swabbing ...................................................................................................................... 42 
13.6 Scheduling Next Visit ................................................................................................................... 42 
13.7 Update Contact Information ......................................................................................................... 42 
13.8 Participant Payments ..................................................................................................................... 43 
13.9 Off Site Follow-Up Visits ............................................................................................................. 44 
13.9.1 Home Visit Procedures .......................................................................................................... 44 
14.    Adverse Event Reporting............................................................................................................... 46 
15.    Obtaining Medical Records ........................................................................................................... 46 
16.    Data Entry ...................................................................................................................................... 46 
17.    Ordering Supplies .......................................................................................................................... 47 
18.  Enrollment Reports ........................................................................................................................ 47 
19.  Specimen Delivery and Order Entry .............................................................................................. 48 


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Introduction 
 
This Manual of Operations and Procedures (MOP) will be used to standardize study procedures 
for the clinical trial, “Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance”. 
Study personnel are to refer to this document when conducting all study procedures. If there are 
further questions or clarification is needed please call/email the Senior Project Coordinator 
Supervisor  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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1. List of Abbreviations and Definition of Terms  
 
Abbreviation     
 
Arm of the study: 
E: Education Group 
D: Decolonization and Education Group 
 
CHG: Chlorhexidine gluconate. The active antiseptic ingredient in the Hibiclens body wash and 
Perioguard mouthwash.   
 
ICF: Informed Consent Form. A form that must be signed by subjects documenting their willing 
participation in the study. The ICF explains the objectives, design, risks, and benefits of the 
study including compensation for participating.  
 
ID: Identification. As in identification number for a person or center. 
Study ID numbers associated with ethnicity/location: 
1,000’s and 6,000’s NN: Non-Hispanic/Not long term care facility 
2,000’s HN: Hispanic/Not long term care facility 
3,000’s NL: Non-Hispanic/Long term care facility 
4,000’s HL: Hispanic/Long term care facility 
 
IRB: Institutional Review Board.  A faculty committee charged with reviewing and approving 
the use of human subjects in all research projects to ensure that the safety and welfare of subjects 
are protected.  
 
LTC: Long-term care facility. A facility such as a nursing home, skilled nursing facility, or 
rehabilitation center that subjects may be discharged to, rather than 
house/apartment/condo/townhouse. 
 
MRSA: Methicillin Resistant Staphylococcus aureus. 
 
MSSA: Methicillin Sensitive Staphylococcus aureus. 
 
PHI: Protected Health Information. 
 
S. aureus: Staphylococcus aureus. 
 
Specimen Sources: 
NA 
Nares 
TH 
Throat 
SK 
Skin (axilla/groin) 
WD 
Wound (if applicable for not all patients will have wounds) 
 


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UCI: University of California, Irvine. The primary investigative team site. 
 
UCI-CO: UCI Central Office. The call center to be contacted when randomizing a patient. 
 
VTOC: Vision Tree Optimal Care.  Web-based database application used for tracking and 
maintaining study data for Project CLEAR. 
 
Visit Numbers: 
R0 
Recruitment/Enrollment visit 
V1 
Month 1 visit 
V2 
Month 3 visit 
V3 
Month 6 visit 
V4 
Month 9 visit 
 
PT: Participant 
 
 
 
 


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2. Forms and Binders 
2.1 Forms 
 
All forms for subjects will be available in English and Spanish. 
 
            ICF: 
 
1. Adult Informed Consent Form + PHI Authorization 
             
            Questionnaires: 
             
1. Participant Screening Form 
2. Participant Identifier – Enrollment Contact Information 
3. Participant Enrollment Survey 
4. Participant Identifier – Follow up Contact Information 
5. Participant Follow up Survey (Education) 
6. Participant Follow up Survey (Decolonization) 
7. Adverse Event Reporting Form 
8. Medical Visit Reporting Form 
9. Trial Exit Survey 
             
            Other: 
             
1. Field Checklist 
2. Initial Hospital Visit  
3. Consented Patient (Identifier)        
            4. Facilities                                        
            5. Travel                                                 
6. Staff Directory                                     
7. IRB                                               
8. Q & A                                       
9. Study Procedures Checklist 
10. Directions for forms and surveys 
            11. Shipping Specimen Tracking Form 
13. Educational Handouts 
14. Specimen Labels 
15. Calendar 
16. Missed Appointments Letter 
17. Study Product 
 
 


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2.2 Binders and Files 
 
Recruitment Log File Folder (Contains: Recruitment, Consent, and Count Logs for each 
recruitment center) 
 
Subject File (Contains: ICF, medical information release form, contact sheet, all questionnaires, 
adverse event forms and medical event forms. Each subject will have one binder) 
 
Subject Study Binder (Contains: study and visit information, MRSA Education and 
Decolonization 
 
Lab Results Binder (Contains: Colonization lab results)  
 
2.3 Logs 
 
Central Office Enrollment Log (List of all randomized and enrolled participants from the various 
participating centers, including the participant’s name, study ID, recruiter, hospital, discharge 
date, and first follow-up visit) 
 
Central Office Lab Count Log (List of the number of specimen swabs with corresponding Study 
ID numbers collected daily from each recruiter and hospital and sent to the UCI Microbiology 
Lab for processing) 
 
Recruitment Log (List of eligible MRSA positive patients from each participating center—see 
Figure 6.1) 
 
Consent Log (List of enrolled patients from each individual participating center to be kept at the 
facility—See Figure 6.2) 
 
Count Log (Count of potential participants who enrolled, declined, or were missed at each 
participating center) 
 
3. Key Personnel  
 
Faculty - UCI: 
Susan Huang – Principal Investigator 
Steven Park – Co-investigator 
Dan Gillen - Statistician 
 
Study Staff - UCI: 
Raveena Singh – Sr. Clinical Research Coordinator, Supervisor 
Adrijana Gombosev – Senior Clinical Research Coordinator 
Victor Quan – Senior Clinical Research Coordinator 


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Suzie Hong – Clinical Research Coordinator 
Eric Cui – Assistant Clinical Research Coordinator 
Diane Kim – Assistant Clinical Research Coordinator 
Cameron Lee – Assistant Clinical Research Coordinator 
Syma Rashid – Assistant Clinical Research Coordinator 
Courtney Reynolds – MD, PhD candidate 
Chenghua (Mick) Cao – Programmer Analyst  
Jiayi He – Programmer Analyst 
Thomas Tjoa – Programmer Analyst 
Qixin (Bay) Wang – Programmer Analyst 
 
Recruiters – UCI (Assistant Clinical Research Coordinator): 
Stephanie Arredondo-Glacet 
Elizabeth Arreola 
Donald Bayley 
Claudia Cervantes 
Heather Clayton 
Nhi Dam 
Tabitha Dutciuc 
Lauren Heim 
Brian Lewis 
Andrea Marcantonio 
Lisa “Angie” McErlain 
Belinda Prado 
Ivonne Turner 
Emily Wawro 
 
Central Office - UCI (Assistant Clinical Research Coordinator): 
Nelly Beltran 
Sandra Ibarra 
Maureen Schroeder 
 
 
Central Office Coordinators (Medical Records Request and Redaction): 
Jennifer Do – Assistant Clinical Research Coordinator 
Phillip Duffy – Assistant Clinical Research Coordinator 
Marlene Estevez – Assistant Clinical Research Coordinator 
Usme Kushbu – Assistant Clinical Research Coordinator 
Jennifer Lequieu – Assistant Clinical Research Coordinator 
Nicole Mohajer – Assistant Clinical Research Coordinator 
Jennifer Nam – Assistant Clinical Research Coordinator 
Hanna Owens – Assistant Clinical Research Coordinator 
Lauren Akahoshi – Junior Specialist 
Deborah Prunean – Junior Specialist 
Justin Chang – Research Assistant 


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Institute for Clinical and Translational Science (ICTS): 
Angela Mendoza – Front Office 
Barbara Bodenhoefer – ICTS Nurse 
Diane Capobianco – ICTS Nurse 
Melanie Meton – ICTS Nurse 
UC Irvine Microbiology Lab 
Kaye Evans – Microbiology CLS Supervisor 
Maria Mejia – Microbiology Clinical Laboratory Scientist  
Cynthia Toyoshima – Microbiology Clinical Laboratory Scientist 
Harbor-UCLA:  
Loren Miller – Co-Investigator 
James McKinnell – Co-Investigator 
Michael Bolaris – Co-Investigator 
Samantha Eells – Program Coordinator 
Jenna Alcaron – Study Coordinator 
Isabel Alegria – Study Coordinator  
Ramiro Correa – Study Coordinator 
Nathalia Cressey – Study Coordinator 
Margarita Flores – Study Coordinator 
Ann Nguyen – Study Coordinator 
Katy Precaido – Study Coordinator 
Sean Prendergast – Study Coordinator 
Diana Romero – Study Coordinator  
Aubrianne Rose – Study Coordinator 
Grace Tagudar – Study Coordinator 
Raul Macias-Gil – Lab/Medical Records Review 
Jun Zozobrado – Medical Records Requests 
Ventura County Medical Center:  
Gail Simpson – Co-Investigator 
Stefan Boghossian – Student Intern/Recruiter 
4. Participating Centers
Hospitals: 
Downey Regional Medical Center 
Fountain Valley Regional Hospital 
Harbor-UCLA Medical Center 
Hoag Memorial Hospital Presbyterian  
Little Company of Mary, San Pedro 
Little Company of Mary, Torrance 
Long Beach Memorial Medical Center 


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Mission Hospital – Laguna Beach 
Mission Hospital – Mission Viejo 
Orange Coast Memorial Medical Center 
Saddleback Memorial Medical Center – Laguna Hills 
Saddleback Memorial Medical Center – San Clemente 
St. Jude Medical Center 
St. Mary Medical Center 
Torrance Memorial Medical Center 
UC Irvine Medical Center 
Ventura County Medical Center 
 
Nursing Homes:  
Chapman Care Center 
Country Villa Plaza Convalescent Center 
Covington Care Center 
Pacific Haven Healthcare 
Regents Point - Windcrest 
Royale Healthcare Center 
Villa Elena Healthcare 
 
5. Identification Numbers 
 
Subjects ID numbers are: D or E followed by a four-digit number – NN, HN, HL, NL 
D represents patients randomized to the decolonization arm 
E represents patients randomized to the education arm 
NN represents patients enrolled in the non-Hispanic, non-long-term care facility stratum (see 
stratification section 9.1) 
HN represents patients enrolled in the Hispanic, non-long-term care facility stratum 
HL represents patients enrolled in the Hispanic, long-term care facility stratum 
NL represents patients enrolled in the non-Hispanic, long-term care facility stratum 
 
Subject ID numbers and Arms (D or E) will be assigned using the next sequential assignment 
within the appropriate strata (NH, HN, HL, NL) per statistician-created randomization file as 
pulled from the randomization block by the UCI Central Office (UCI-CO) 
 
6. Assessing Eligibility for Recruitment 
 
Each medical center may have a slightly different preferred method of identifying MRSA 
positive cultures and eligible individual screening. The information below applies in general to 
our participating centers. 
 
 
 


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Positive MRSA cultures: 
 
Infection prevention and control personnel at each site will notify study personnel about the 
eligible inpatients who have a positive MRSA culture (either clinical culture or nasal swab) by 
providing a line list of positive cultures from the hospital microbiology lab. 
 
Contacting Potential Patients: 
 
All patients with a MRSA positive culture will be recorded in the Recruitment Log (Figure 6.1). 
For all patients with a positive culture that are not enrolled, the reason why the patient is not 
approached or enrolled will be recorded according to the following matrix: 
 
CODE 
STATUS 
MISS 
Missed opportunity for recruitment, patient not approached for 
recruitment 
D1 
Declined, minimal to no pitch  
D2 
Declined, moderate pitch 
 
D3 
Declined, full pitch 
CONSENT 
Patient consented 
 
 
 
Figure 6.1. Recruitment Log 
 
 
 


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If an eligible patient is still hospitalized, the study coordinator will approach the patient in the 
hospital. Recruiters will leave either a note or the consent form in the medical record. Prior to 
approaching the patient, the recruiter will speak with the patient’s nurse (as the patient may not 
have been told they have MRSA yet). Once the patient’s nurse approves, the recruiter will then 
speak with the patient in their room to determine whether they wish to participate in the study. 
Subjects that agree to participate will be consented at this time. Patients who are unsure or 
unavailable will be recorded in the recruitment log by the coordinator so that the patient can be 
approached again at a later time. For patients who need additional time to think about the trial, a 
brochure will be left with them with information about the trial. Trial declinations will also be 
recorded in the Recruitment Log. 
 
When approaching a patient in person, the coordinator should have all current versions of the 
consent form and PHI form with them. Study binders and/or study product will be provided to 
the patient by the coordinator following consent and randomization and will be kept in a 
temporary storage location at the facility until the patient is ready to be discharged. 
 
Eligible patients that agree to participate will be consented and recorded in the Consent Log 
(Figure 6.2). 
 
Eligible patients who were hospitalized, but have now been discharged: If the patient’s treating 
MD during the hospitalization gives permission to contact them, the study coordinator will call 
the patient at the phone number listed on the hospital chart to approach the patient and use the 
treating MD’s name to explain how we are reaching out to them. If the eligible patient does not 
answer, the study coordinators will leave a message stating that the patient is eligible for a 
research study. In the message, study coordinators will not mention that the eligible patient had 
an MRSA infection or colonization. If the patient verbally agrees to participate, the patient must 
be consented and complete their baseline visit at the clinic within 30 days of hospital discharge. 
If the potential patient is unable to come into the clinic, study coordinators may schedule a home 
visit or nursing home visit with the patient.  
 
Eligible patients who are being discharged to a LTC facility: The study coordinators will call all 
facilities to make them aware that a patient has enrolled in the study. For LTC facilities not 
already engaged in study participation, study coordinators will call the facility that the eligible 
patient will be discharged to and assess the willingness of the center to participate. Study 
coordinators will also be available to visit the facility per patient needs, introduce Project 
CLEAR, and provide instructions on study protocol, e.g., bathing instructions.  
 
Eligible patients who call central office due to the media campaign: Patients who call the 800 
number because they have seen or heard one of the study advertisements will speak to study 
coordinators over the phone to determine eligibility. Patients deemed to be meet inclusion 
criteria will have a visit scheduled for enrollment. Patients must provide documentation of a 
hospitalization and a MRSA positive culture within 30 days of hospitalization in order to be 
enrolled. 
 
 


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Figure 6.2.  Consent Log 
 
7. Inclusion/Exclusion Criteria 
 
The Inclusion and Exclusion Criteria Checklist should be reviewed with the patient to determine 
the patient’s eligibility for the study.  
 
Inclusion Criteria: 
 
1) 18 years of age or older 
2) Have a recent hospitalization (within the past 30 days) 
3) Have an MRSA positive culture identified by microbiology laboratory  
4) Able to provide their consent to participate or have a surrogate provide consent 
5) Must be able to bathe, shower, or have this task performed daily by a caregiver (if 
applicable) 
 
Exclusion Criteria: 
 
1) The subject is allergic to mupirocin 
2) The subject is allergic to chlorhexidine 
3) Subject is receiving end-of-life hospice measures 


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8. Informed Consent Process 
 
The UCI and LA BioMed institutional Standard Operating Procedures will be utilized as a guide 
for consenting patients. Inpatients will be consented in a private or semi-private setting (usually 
their hospital room). Eligible patients who are contacted over the phone will be consented at the 
research clinic, home, or long-term care facility. 
 
If the patient is more comfortable speaking in Spanish, a Spanish-speaking study coordinator 
should be contacted to approach the patient.  
9. Recruitment/Enrollment Study Visit 
 
The baseline enrollment visit must occur either in the hospital before discharge or within 30 days 
of hospital discharge. Items required for the baseline visit include: enrollment survey, contact 
survey, required swabs, study product, and review of the arm-specific toolkit binder. 
9.1 Stratification 
 
Once a patient has been consented, each subject will be classified into one of four groups: 
  
1) Non-Hispanic ethnicity and long-term care facility (NL) 
2) Hispanic ethnicity and long-term care facility (HL) 
3) Non-Hispanic ethnicity and non-long-term care facility (NN) 
4) Hispanic ethnicity and non-long-term care facility (HN) 
 
Hispanic ethnicity is based upon self-report (or surrogate report) and long-term care facility 
refers to the subject being discharged to a nursing home. Assisted living does not qualify for long 
term care stratification. The ethnicity and facility information will be required by the UCI-CO at 
randomization. Study coordinators should collect this information prior to enrollment. 
9.2 Randomization 
 
Subjects will be randomized by calling the UCI Central Office (CO) at 949-824-0057. This line 
will be answered between the hours of 8:00 and 17:30. Study coordinators must call CO as soon 
as the subject completes all enrollment and informed consent processes. Study coordinators must 
have the subject’s name, gender, ethnicity, and LTC status. The project coordinator at UCI-CO 
will utilize the stratified randomization charts developed by statistician and provide the next 
available assignment number and arm in chronological order. The study coordinator will inform 
the patient of their randomization assignment and proceed to the next steps. For after-hours 
enrollment, please call the Project Coordinator Supervisor. 
 
 
 


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9.3 Participant Education 
 
Each participant will be provided with an educational binder in his or her preferred language 
(English or Spanish). Subjects randomized to the Education Arm will receive an education only 
binder. Subjects randomized to the Decolonization Arm will receive the same education material 
as part of the decolonization binder. The study coordinator will review the binder with the 
participant. It is important to note that study coordinators cannot provide information other than 
what is specified in the binder. Study coordinators cannot extend specific medical advice to 
anyone. If participants have further questions they should be instructed to contact their physician.  
9.4 Surveys 
 
Surveys will be administered in-person by study coordinators. If the participant does not know or 
remember the answer, remind the participant to answer as best they can and move on the next 
question. Patients are encouraged to answer all questions and skip questions only when 
necessary. The survey interview should take no more than 20 minutes.  
9.5 Body Site Swabbing 
 
All participants will be swabbed using a BBLTM CultureSwabTM for S. aureus colonization at 
four body sites: the bilateral nares, throat, groin and axilla as a combined swab, as well as any 
wounds that the patient might have. The body swabs should be sent to the central lab within 24 
hours for processing. 
9.5.1 Swabbing Technique: Nasal  
 
The study coordinator will place a sterile culture swab into the anterior nares of the participant as 
shown in Figure 9.5.1. 
 
 
Figure 9.5.1: Depicts nasal chambers, nares (pear-shaped apertures) and vestibule. The culture 
swab is shown inserted through the anterior nares (nostril vestibule) to make contact with nasal 
membrane. 


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A. Label sample by placing the pre-printed label on the outside of the sleeved device.
B. Use “nares swab” label sticker.
C. Write subject ID number, date/time collected on the label with a permanent marker
(Sharpie or similar).
D. Remove the protective sleeve of the culture swab exposing the shaft and rayon fiber
bud. Only touch the outer hub of the swab without contacting the swab or shaft.
E. Insert swab into sterile transport tube to moisten the swab. If the swab accidentally
touches anything that is non-sterile (e.g. outside of transport tube), discard and begin
again.
F. Tell patient the swab is being moistened with sterile fluid. Tell them you will only go
as far “as someone would put their finger in.”
G. Insert tip of swab 1-2 cm into nares. Insert the sterile culture swab into right anterior
nares into the nostril vestibule toward the apex of the nose to make contact with the
nasal mucous membrane (see Figure 1)
H. Gently rotate the culture swab for two full turns while in contact with the nasal
membrane.
I.
Gently withdraw the culture swab from right nares.
J.
With the same culture swab, gently repeat insertion and rotation on the left side
K. Carefully re-sleeve the culture swab.
L. Bury tip of culture swab in gel at bottom of tube.
9.5.2 Swabbing Technique: Throat 
The study coordinator will place a sterile culture swab into throat (tonsil area) of the participant 
as shown in Figure 9.5.2. 
Figure 9.5.2: Depicts the throat and tonsillar area. The culture swab is shown touching 
(swabbing) the tonsil.   


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A. Explain to patient what you are about to do.
B. Label sample by placing the pre-printed label on the outside of the sleeved device.
C. Use “throat swab” label sticker.
D. Write subject ID, date/time collected on the label with a permanent marker.
E. Remove the protective sleeve of culture swab exposing the shaft and rayon fiber bud.
F. Only touch the outer hub of the swab without contacting the swab or shaft.
G. Insert swab into transport tube to moisten the swab. If the swab accidentally touches
anything that is non-sterile (e.g. outside of transport tube), discard and begin again.
H. Tell patient the swab is being moistened with sterile fluid.
I.
Have patient tilt head back, breathe deeply open mouth wide and have them say
“Ah”. This serves to lift the uvula and aids in reducing the gag reflex.
J.
Use tongue depressor to gently depress the tongue, if necessary (consider moistening
the tongue depressor with tap water if the participant gags).
K. Every effort should be made to avoid touching the swabs to the tongue, teeth, roof of
the mouth or the inside of the cheeks.
L. Carefully but firmly rub the swabs over:
a. Both of the tonsils (or tonsilar crypts if tonsils have been removed).
b. Posterior pharynx (back of throat).
M. Remove swabs carefully from the mouth, again avoid touching the swabs to the
tongue, teeth, roof of the mouth or the inside of the cheeks.
N. Carefully re-sleeve the culture swab.
O. Bury tip of culture swab in gel at bottom of tube.
9.5.3 Swabbing Technique: Inguinal Region and Axilla 
A. Explain to patient what you are about to do.
B. Label sample by placing the pre-printed label on the outside of the sleeved device.
C. Use “inguinal/axilla swab” label sticker.
D. Write subject ID, date/time collected on the label with a permanent marker.
E. Remove the protective sleeve of culture swab exposing the shaft and rayon fiber bud.
F. Only touch the outer hub of the swab without contacting the swab or shaft.
G. Insert swab into transport tube to moisten the swab. If the swab accidentally touches
anything that is non-sterile (e.g. outside of transport tube), discard and begin again.
H. Tell patient the swab is being moistened with sterile fluid.
I.
Put sterile culture swab at bottom Right armpit (See Figure 9.3).
J.
Swab with upwards motion from bottom to top of R armpit fold.
K. While moving culture swab, upwards, simultaneously rotate swab at least two
complete turns.
L. With same culture swab, repeat technique on the Left armpit fold.
M. With same culture swab, use a similar technique to swab the R groin.
N. With same culture swab, use a similar technique to swab the L groin.
O. Carefully re-sleeve the culture swab.
P. Bury tip of culture swab in gel at bottom of tube.


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Figure 9.5.3: Depicts the left and right inguinal folds that should be swabbed 
9.5.4 Swabbing Technique: Open Wounds 
Only ZRXQGVWKDWDUHDFFHVVLEOHshould be swabbed. Do not disturb wounds that are 
inaccessible (occlusive dressing) or have a wound vac on. 
A. Explain to patient what you are about to do.
B. Label sample by placing the pre-printed label on the outside of the sleeved device.
C. Use “wound swab” label sticker.
D. Write subject ID, date/time collected on the label with a permanent marker.
E. Remove the protective sleeve of the culture swab exposing the shaft and rayon fiber
bud.
F. Only touch the outer hub of the swab without contacting the swab or shaft.
G. Insert swab into transport tube to moisten the swab. If the swab accidentally touches
anything that is non-sterile (e.g. outside of transport tube), discard and begin again.
H. Tell patient the swab is being moistened with sterile fluid.
I.
Roll the swab over the wound, attempt to sample any drainage
J.
Carefully re-sleeve the culture swab.
K. Bury tip of culture swab in gel at bottom of tube.


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9.6 Study Intervention 
Subjects may be given their arm-specific toolkit binder and/or study materials (decolonization 
products) under four different scenarios: 
 On the day of enrollment – The study coordinator may provide the toolkit binder to the study
participant at the time of enrollment once randomized to the respective Education or
Decolonization arm.
 At hospital discharge – In an effort to not lose study materials during a prolonged hospital
stay, study coordinators may return on the day of discharge to provide the subject with their
toolkit binder and study materials.  Some medical centers may deliver the study materials
(toolkit binder or decolonization products) at discharge via the pharmacy.
 After discharge – If a subject is discharged without receiving their toolkit binder or
decolonization products or if they misplace their study products during their hospital stay the
study material will be mailed or delivered to their home.
 In clinic/home visit/nursing facility – If a subject is recruited and enrolled outside of a
hospital setting (at home, at the study clinic, or at a nursing home), the study coordinators
will provide the toolkit binder and study materials at the time and place of enrollment. The
toolkits will be reviewed in full with each participant at the time of receipt. 
The study toolkit will contain: 
Decolonization Group: 
1) Study product (nasal mupirocin, CHG body wash (Hibiclens) and mouth wash)
2) Calendar cling
3) Copy of the consent form
4) Adverse Event form
5) Medical Visit Reporting form
6) Arm-specific educational binder
7) Appointment reminder card
Education Group: 
1) Copy of the consent form
2) Adverse Event form
3) Medical Visit Reporting form
4) Arm-specific educational binder
5) Appointment reminder card
The recruiter is responsible for assigning the decolonization patients to the Plan A or Plan B 
schedule based upon week of start. The assignment to Plan A or Plan B is based on the first day 
of the initial five day decolonization cycle post discharge. 
Once the patient is informed of the schedule that he or she follow, the study coordinator will 
remind the participant to start bathing for five consecutive days after being discharged from the 
hospital.  The study coordinator will explain to the patient that after five day post discharge 
bathing regimen, they will follow the assigned calendar Plan A or Plan B calendar schedule. The 


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study coordinator will also remind the participant that UCI CO will call to remind them of the 
decolonization bathing schedule prior to the five-day CHG bathing cycle.  The study coordinator 
will also instruct the participant to add an additional day to the end of their bathing regimen if a 
day is skipped during their assigned bathing cycle.  In the event that the participant misses two or 
more days of the decolonization bathing cycle, they will have to restart the regimen.     
The patient will be told that all of the products that they receive are used to reduce bacteria.  The 
study coordinator will then instruct the study participant on how to use each study product and 
remind that the decolonization products must all be used together: 
Hibiclens: “This chlorhexidine soap is a body wash/shampoo that needs to be used anytime you 
shower when you are scheduled to be on your five-day regimen. It is intended to substitute your 
body wash, shampoo and facial cleanser. Do not get product into eyes or ear canal. Also, it is 
very important to keep the product on your skin for two minutes while out of the water stream or 
reapply on the skin twice while out of the water stream for a total of two minutes Also, it is very 
important to keep the product on your skin for two minutes while out of the water stream before 
rinsing. The two minutes is approximately the time to soap up twice out of the water stream 
before rinsing.”  The study coordinator will also provide and demonstrate how to use the two-
minute waterproof sand timer. Bactroban Nasal: “This mupirocin ointment is a prescription nasal 
ointment that needs to be used twice a day, in the morning and in the evening, when you are 
scheduled to be on your five-day regimen cycle.  You will use half a tube for each nostril and 
dispose the empty tube into the container that is provided.” 
PerioGard: “This bottle is a chlorhexidine oral rinse that needs to be used twice a day, morning 
and evening, when you are scheduled to be on your five-day regimen cycle.  You need to make 
sure you brush your teeth prior to swishing the oral rinse in your mouth for 30 seconds.  Do not 
rinse your mouth with water after using this product. Also, make sure not to eat for at least a half 
an hour after using the oral rinse.”    
The study coordinator will remind the patient that if they have any study-related questions, they 
may call the toll-free study telephone number where the UCI Central Office will answer any 
questions regarding the study or study products. 
9.7 Scheduling Next Visit 
The study recruiter will make every effort to schedule the one month follow-up visit while 
conducting the enrollment visit if possible. If the participants cannot schedule the follow up visit 
at the time of enrollment, they will be provided with an appointment reminder card with a date 
that the visit should occur (approximately 30 days after discharge). The central office will call 
the participant two weeks prior to the time when the one-month follow-up should occur in order 
to schedule a fixed follow up appointment day, time, and location. See protocol for visit 
schedule. 


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9.8 Scheduling Bi-Monthly Phone Calls 
 
Bi-monthly reminder phone calls should be scheduled the Friday before the start date of the 
intervention week. Central Office staff will reference the Study Contact Sheet to verify the best 
times to call based on indicated availability  
 
9.9 Physician Letters 
 
Participants are informed that, shortly after study enrollment, a notification letter will be sent to 
the participant’s primary physician as well as be placed in their chart during hospitalization for 
the inpatient attending physician to see.  The letter informs the physician of their patient’s 
participation Project CLEAR and informs the physician of the study group that their patient has 
been randomized to (i.e. Education or Decolonization). The UCI Central Office will be 
responsible for sending letters to all study participant’s physicians on their behalf.  
9.10 Product Start Date/Study Start Date 
 
The product start date vs. trial start date, they are the same date, labeled differently in Vision 
Tree and databases. Study start date (aka. “Trial entry date” in our analytics dataset for Dan 
Gillen) is termed “product start date” in Vision Tree surveys and was used to capture study start 
date for both Decolonization and Education subjects.  
 
Admit Date (Hosp) – Admit date of the recruitment hospitalization 
Trial Start Date – Generally the date of discharge or the date of enrollment if enrollment was 
performed post-discharge.  
 
10. Central Office Reference Guide 
 
Below is a reference guide describing the daily and weekly tasks of central office coordinators 
for Project CLEAR. 
10.1 Daily Tasks 
x Randomize patients and update tracking log, Recruitment Progress Report will be sent 
out daily to study investigators and senior project coordinator supervisor 
x Create and send out swab collection email 
x Call patients for next day’s appointments 
 
 


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10.2 Day-Specific Tasks 
 
x Monday: Bathing Regimen Cycle Reminder Calls 
x Tuesday: Assign follow-up visits two weeks out (for example, on week one, schedule 
visits for week three). Scheduling should occur at least two weeks prior to the visit. 
x Wednesday: Prepare UCI Missed Visit Names report, call patients who have missed 
visits (in person or for Trial Exit Report) and send out Missed Appointment Letter 
Thursday: Based on Trial Exit Report, schedule courtesy visits for potential Loss to 
Follow Up patients for coming week 
x Friday: Prepare and send out Trial Exit Report, Prepare Monday Bathing Regimen 
Reminder Call List 
10.3 Recurring Tasks 
 
Note: These do not have to be done on any particular day of the week, but must be done 
regularly each week, so as to remain current.  
 
x Create participant consent and follow up visit folders. 
x Scan patient consents and medical release forms. Call patients needing exit surveys from 
the UCI List.  
x Create swab bags containing. 
o Specimen Sheets Biohazard Bags and Lab Requisition forms (carbon copy 
duplicates)   
o Swabs  
x Create and send out Primary Care Physician letters.  
x Maintain supply of compensation forms for recruiters.  
10.4 Morning Routine 
 
1. Obtain “enrollment log” & “specimen log” from locked cabinet.  
2. Check voice mailbox to listen to voice messages left from after-hours calls  
3. Locate “Patient Tracking Log” and update with current date  
 
10.5 Randomization 
 
1. Log in VTOC with username & password. Click on “New Patient” 


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2. In VTOC enter the below information. Indicate if PT is Hispanic and if PT is going to a 
nursing home (Check Yes or No for both) 
 
3. Provide recruiter with new Study ID #  
4. Schedule V1 with recruiter or provide available days/times for patient’s location  
a. For more information, see Scheduling Appointments (page 6) 
5. Ask the recruiter for the swab count and fill out Lab Count Log (note recruiter may need 
to give swab count to you later in the day)  
6. On paper Enrollment Log, write in recruitment date, recruiter initials, hospital name, 
patient first and last name, and note swab count in margin. 
7. Edit the Contact Sheet in VTOC and select the appropriate recruiter’s name in the 
Recruiter Name pull down. Enter Visit One Date.  
8. Under “initial recruitment” click new record to create a new “Participant Screening 
Form” – ADD today’s date and verify inclusion criteria 


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9. Click new record to create “participant enrollment survey”- ADD today’s date ONLY.  
Note that Today’s Date indicates the Consent Date, not the date data entry was done.  
a. If patient was consented POST DISCHARGE, add name of original hospital in 
hospital field. Ex: Hospital: UCI PD (LBM) 
10. Input new participant information into Patient Tracking Log 
11. Text Senior Project Coordinator Supervisor information: 1-(recruiter(initials)\(hospital 
initials) 
x Example: 1-IT\UCI 
10.6 Patient Tracking Log 
 
Study patient information is entered into the “tracking log” and applicable information will be 
transferred over to VTOC. 
 
The following information can be found on the “tracking log” 
1. Patient ID & initials- An asterisk (*) will be placed after the ID # for Spanish 
speakers. 
1. Decolonization Plan (differentiated by color: (A-Green or B-Orange) 
2. Discharge date 
3. Recruiter Initials 
4. Notes: used for comments regarding any communication with the patient 
(optional) 
IMPORTANT NOTES are in RED (Ex: Do NOT call, email pref., Spanish speaking etc).  
5. Initial bathing dates (1st & 5th day) 
6. Date that the primary care provider was mailed notification 
7. Consent scanned (Y for Yes) 
8. Clinic visit dates, time & location 
9. Date exit survey completed 
10. Bathing cycle dates (1stday) 
 
10.7 Scheduling Appointments 
ALL appointments should be entered in the following locations:  
 
1. VTOC:  
a. Contact Sheet’s Visit Field: Visit One, Visit Two, Visit Three, Visit Four 
b. Communication Log: “HOME VISIT (V#) - Date @ Time; Assigned to [Staff 
Name].” 
 
2. Patient Tracking Log: 
Date, time, location and geographic area (ie: 8/30/13 @12PM Home4) 
 
 


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3. ENDMRSA calendar – Sample set up: 
 
a. Categorize (Colors listed below) and Invite Attendees 
 
4. Enrollment Log (V1 only) 
 
 ENDMRSA Calendar Color Codes: 
1. Blue= Home, NH, hospital 
2. Red= ALL cancellations /no shows 
3. Green= Melanie (Wednesdays) appointments 
4. Light green=Product review/product drop-off/courtesy visit 
5. Light blue= Recruitment visits (post-discharge) 
6. Yellow = Institute for Clinical and Translational Science (ICTS) Irvine/Orange 
Visit Scheduling by Area 
1. Institute for Clinical and Translational Science (ICTS) Nurse Visits 
a. Monday, Friday – ICTS Orange 
b. Tuesday, Thursday – ICTS Irvine 
c. Wednesday – ICTS nurse visits Area 3, 4 and 5 (double check address, must be 
within 15 miles of ICTS Irvine) 
2. Home Visits  
a. As possible, the coordinators are to group Area Visits together and in descending 
order of distance 
i. Geographically distant visits should be scheduled earlier in the morning if 
possible, so that recruiters can go farthest distance in the morning, and 
work their way back in the afternoon 
3. Home Visits (Spanish) 
a. Schedule when PT is available, but try to group area appointments together (i.e. if 
staff is in Area 4 on Thursday, try to schedule Area 4 visits around that 
appointment) 


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ICTS Appointments 
1. Create New Appointment on End MRSA Calendar  
2. Subject: PT ID number (with asterisk if patient is Spanish speaking) 
3. Location: ICTS (Orange or Irvine); Visit Number (V1, V2, V3, V4) 
4. Select Time 
5. Message: Patient name and marital status 
6. Invite Attendees: End MRSA, ICTS Scheduling Coordinator and ICTS Nurse.  
7. Categorize as Yellow 
8. Note Appointment in Patient Tracking Log 
 
 
Home/NH Appointments 
1. Create New Appointment on End MRSA Calendar  
2. Subject: PT ID number (with asterisk if patient is Spanish speaking) 
3. Location: Home(Area Number) / NH(Area Number); Visit Number (V1, V2, V3, V4) 
4. Select Time 
5. Message: Patient name  
6. Invite Attendees: End MRSA 
a. If scheduling home visit for Melanie on Wednesday, also invite: ICTS Scheduling 
Coordinator and ICTS Nurse 
7. Categorize as Blue 
8. Note Appointment in Patient Tracking Log 
 
Remote Visits – Rare. Should only occur when patient has moved out of the area (e.g. another 
state), but is still participating. Relates to collecting swabs from patients out of the 
coverage area 
1. Call patient before their next visit due date and set up delivery and return of swabs for 
FedEx labels. 
2. Create Visit Packet to overnight to participant 
a. Study Visit Packet Contents: 
Decolonization participants receive products for V1 and V2 (V3 and V4 do 
not receive study product) in addition to items listed below 
i. Visit Survey Questionnaire with a “CONFIDENTIAL” envelope (this will 
need to be picked up from UCIMC Micro Lab) 
ii. Swab bag (label the stickers and study paperwork with Visit #, Study ID, 
swab collection site (Na, Thr, Sk, Wd) and date that the patient is to 
complete swabbing 
b. Compensation 
i. Subject Compensation Form 


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x Fill out the following: Date Paid, Cash (with corresponding visit 
amount), Amount Paid, Home Visit CASH Sign Out (your 
signature) and PT signs “Paid To” column – Overnight to PT 
 
ii. Compensation (wait until signed compensation is received) 
x $ in small envelope labeled and sealed  
“VISIT [#] COMPENSATION  
FOR: __________________ 
 
iii. FedEx Package 
 
10.8 Assigning Appointments 
 
x There will be one primary study coordinator for home visits 
o Try to make sure that there is as little duplication of area assignments as possible 
(if one study coordinator is conducting an appointment in Area 4, ensure that a 
second study coordinator does not have to drive there as well). 
 Note: study coordinators will be assigned to area visits that are closest to 
their geographical location (home) 
x All Spanish appointments will be assigned to a Spanish speaking study coordinator. 
Senior Project Coordinator Supervisor will also receive an invitation as an FYI) 
x Post-discharge R0 Enrollment Visit appointments should be scheduled according to the 
regular home visit schedule and study coordinators assigned to the closest geographical 
area  
Note: R0 Enrollment Visit appointments will typically require a full hour and should be 
scheduled accordingly and take driving time into consideration as well 
10.9 Rescheduling and Cancelling Appointments  
 
1. If an appointment is CANCELLED- change category to RED, indicate CANCELLED 
next to Study ID, add today’s date w/ notes in comments section.  
2. If an appointment is RESCHEDULED-keep same color category (unless it needs to be 
changed), update date and time, add current date and notes in comments section, and 
resend a new appointment invitation. 
i. Note: Keep original appointment on the calendar & create a new calendar 
appointment if study coordinator drove to destination but the appointment 
had to be rescheduled for any reasons.  
3. Inform ICTS Scheduling Coordinator of any ICTS cancellations or reschedules by editing 
existing calendar invite.  


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a. If it is a last minute cancellation or reschedule, make sure to also call the ICTS 
Appointment Center. 
4. Save new date & time to: tracking log, contact sheet & communication log (VTOC).  
10.10 Disenrolling Patients 
 
Patients are considered to be an “early” exit/disenrollment if they exit the study due to death, 
active disenrollment, or confirmed lost to follow up.   
 
Active Disenrollment:  
1. If a patient expresses that they cannot participate in the study, the study coordinators will 
document reasons for withdrawing participation, attempt to address concerns and 
encourage continued participation, if possible.  During the disenrollment interview, the 
coordinator is to attempt to gather outcomes data from the patient (they will ask if the 
participant has been re-hospitalized or has visited a clinic for a possible infection).  
2. Fill out a Medical Visit Reporting Form if applicable  
3. If they are adamant about dropping, notify the Senior Project Coordinator Supervisor via 
email and cc: the patient’s recruiter and End MRSA email account.  
a. In the email, the participant’s ID # will be included in the subject line and a brief 
summary of the situation will be described in the body of the email. 
4. A summary of the disenrollment event will also be recorded in the VTOC 
Communication Log.  
5. After the Senior Project Coordinator Supervisor has followed up with patient, the patient 
will be added to the Trial Exit Report. 
6. The patient will also be added to the “Physician Follow Up” Spreadsheet (Non-
Participant List tab) for follow-up discussions and documented decisions regarding trial 
exit. 
7. The VTOC Enrollment survey will also be updated  
a. Complete Change of Enrollment Status section  
i. Click YES 
ii. Enter Date Disenrolled 
iii. Set Reason Disenrolled to DECLINE  
iv. Select the appropriate value for Reason Declined and give description 
under Notes.  
1. IMPORTANT: If no known outcome data is obtained during this 
time, use last date patient provided outcome data (Ex: RO, V1).  


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8. Update Patient Tracking Log 
a. Highlight patient entry in red 
b. Note “Active disenrollment” and “Supervisor notified” in comments section 
Death:   
1. If study staff is informed that a patient has expired, request information on the exact date 
of death, cause of death and if the patient expired at home/hospital.   
a. Study staff will attempt to gather outcome information by inquiring whether the 
patient was re-hospitalized or had a medical visit for an infection prior to death.  
b. A Medical Visit Reporting Form will also be completed.  
2. Update the Physician Follow Up spreadsheet.   
3. Patient will be added to the Trial Exit Report  
4.  The VTOC Enrollment survey will be updated.  
a. Fill out Change of Enrollment Status section.   
b. Enter Date of Death 
c. Set Reason Disenrolled to “Death”  
d. Add description under Notes for disenrolling. 
5. Patient Tracking Log will be updated. 
a. Highlight patient entry in red 
b. Note “Patient deceased” and date of death in comments section 
Confirmed Lost to Follow Up:   
1. A patient will be considered confirmed lost to follow up when study staff are unable to 
contact patient for three or more months.  
a. Contact attempts should include phone calls (to patient, alternate and emergency 
contacts), courtesy visit attempts, and engaging the original patient recruiter for 
new phone number/checking for readmission. 
Central Office will:  
2. Update the Physician Follow Up spreadsheet.   
3. Add patient to the Trial Exit Report  


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4. Update VTOC Enrollment Survey 
a. Fill out Change of Enrollment Status section.   
b. Set Reason Disenrolled to “Lost to Follow Up”.   
c. Date Disenrolled is set to date of last known outcomes.  
d. Add description under Notes for disenrolling.  
5. Update Patient Tracking Log 
a. Highlight patient entry in red 
b. Note “Active disenrollment” and “Supervisor notified” in comments section 
10.11 Adverse Events  
 
After receiving notification from a recruiter or patient via telephone/email that a study 
participant has experienced an adverse event, central office will:  
1. Page study physicians using a secured intranet portal  
2. A study physician will speak to patients who are reporting a study related AE.  
3. Fill out Adverse Event Form on VTOC  
a. Beneath “Unscheduled Events”, click “New Record” next to “Adverse Event 
Reporting Form”.  
b. Fill out all information as possible according to the form. 
4. Wait for the study physician’s follow-up email & transcribe the assessments into the 
Physician Follow-Up spreadsheet: 
a. Fill in information under tab marked “Adverse Events” 
b. Save with current date.  
5. The patient will be contacted by a study member daily until resolved (this will include 
any deemed non study related events) and updates will be entered into VTOC and 
Physician Follow-Up spreadsheet.  
10.12 Medical Visit Reporting 
 
If a patient indicates they have been to a hospital/NH/rehab center for any reason OR have 
visited the ER or outpatient clinic due to an infection, a Medical Visit Reporting Form must be 
completed and entered into VTOC. 
1. To fill out Medical Visit Reporting Form on VTOC  
a. Under “Unscheduled Events”, click “New Record” next to “Medical Visit 
Reporting Form” 


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b. 
Fill out all information as possible according to the 
form
 
 
10.13 Scanned Consents/Releases 
 
All consent forms and HIPPA Authorization forms are to be filed electronically as well as within 
paper files as well. In order to ensure all consent forms are properly scanned, central office will: 
1. Review Patient Tracking Log to see what consents need to be scanned.  
a. “Y” for Yes will be placed in the corresponding cell to indicate that the consent 
signature page/surrogate signature form has been scanned. 
2. Locate files in Central Office Cabinets  
3. Create new folder w/ Study ID in the scanned consents folder 
4. Go to “Xerox Scans” to find the newly scanned consents and rename each signature 
document.  
a. Ex: D-2222-NL Consent or D-2222-NL Surrogate or D-2222-NL Release  
 
5. Ensure consent is appropriately completed. If not, the study recruiter must be contacted 
immediately 
6. Move renamed documents into appropriate folders 
7. Open corresponding Consent without Signature Page  
8. Append signature page 
a. Go to Document Æ Insert Pages Æ From File 
b. Select Patient’s Consent Page (i.e. D-2222-NL) and insert at appropriate place 
i. Double check after insertion that page numbers and consent versions 
match up  
c. Save Document as Consent in the Scanned Consents folder (i.e. as D-2222-NL) 


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i. You will be asked if you are sure you want to replace the current 
document  
ii. Click Yes 
10.14 Creating Consent/Recruitment and Follow-Up Visit Packets 
 
Consent/Recruitment Packets: 
*Consent Packets should all have the following: 
1. Screening Form 
2. Consent Packet (Corresponding to hospital) 
a. Consent Packets (UCI) – to be used for UCI, Hoag or any post discharge 
recruitment.  
b. Consent Packets (UCI) Spanish 
c. Consent Packets (Mission) 
d. Consent Packets (Memorial) 
e. Consent Packets (Fountain Valley) 
3. Extra signature page (exempt Mission & Memorial) – Spanish Signature Page 
4. HIPPA (UCI) – Spanish HIPAA UCI 
5. HIPAA (Project CLEAR)- Spanish HIPAA Project Clear  
6. HIPAA (Memorial) – only for Memorial Consents 
7. Contact Sheet – Spanish Contact Sheet 
8. Enrollment Survey – Spanish Enrollment Survey  
9. Medical Release Forms (2) – Spanish Medical Release Forms (2) 
10. Consent Checklist – Spanish Consent Checklist  
11. Dear Dr. Letter – to be placed in the patient chart for the attending physicians  
 
Follow Up Visit Packets: 
1. Decolonization FU (English & Spanish) 
a. Envelope for Cash 
b. Cash Payment Form  
c. Decolonization Follow-Up Survey (Spanish) 
d. 2 Medical Visit Reporting Forms (Spanish) 
e. 2 Adverse Event Forms (Spanish) 
f. 2 Medical Visit Worksheets (Spanish) 
2. Education FU (English & Spanish) 
a. Envelope for Cash 
b. Cash Payment Form  
c. 2 Education Follow-Up Surveys (Spanish) 
d. 2 Medical Visit Report Forms (Spanish) 
e. 2 Medical Visit Worksheets (Spanish) 


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10.15 PCP Letters  
Primary Care Physician letters are generated for all patients. 
10.16 Exit Survey 
 
The Trial Exit Survey should be conducted approximately one year after enrolled (i.e. 365 days 
after discharge or consent date, whichever is greater).  
In order to complete the trial exit survey, central office will: 
1. Check the Patient Tracking Log for Patients who are to complete their exit survey based on 
the above criteria. 
2. Call patient and ask if he or she has a few minutes to complete a quick exit survey over the 
phone. 
3. If so, Click on “New Record” underneath Exit Survey on VTOC. 
 
4. Complete the questions listed within the trial exit survey 
a. Fill out Medical Visit Form on VTOC if necessary (VTOC will prompt). 
5. Thank the patient for participating in the trial. 
6. Inquire if patient would be interested in future studies. Note their response in Communication 
Log, along with completion status of survey. 
7. If a patient requests their lab results, inform the participant that the Senior Project 
Coordinator Supervisor will follow up within a week. 
a. Each week, send Senior Project Coordinator Supervisor a list of patients who have 
requested their lab results. 
10.17 Reports 
 
Central Office will distribute a study progress report to Senior Project Coordinator Supervisor 
and principal investigator daily. This progress report with include updates to the recruitment 


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numbers, dis-enrolled participants, follow up visits and status, as well as any other pertinent 
information involving the progress of the trial. 
 
Additionally, quarterly reports will be sent to each participating facility’s study champion 
and infection prevention team to inform them of the recruitment progress in the trial and 
at their site. 
10.18 Shipping 
 
There will be situations where central office will assist with specimens that are shipped to UCI 
Medical Center for processing (from out of area visits or enrollment), as well as with the 
shipment of deidentified MRSA isolates that are sent to Rush University for resistance testing. 
10.19 End of Day Laboratory Email 
 
A summary email will be sent to the UCI microbiology lab daily to confirm the number of 
cultures that are to be received.  A sample email is included below: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.20 Study Products 


Project CLEAR MOP Version 1.3 
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36 
 
 
 
 
Recruitment visit bags include: 
 
 
Visit Type 
Hibiclens 
Bactroban 
Periogard 
Sponges 
Container/Timer 
Lotion 
Pump 
Recruitment 
1 
3 
1 
3 
1 
1 
1 
V1 
1 
4 
1 
4 
n/a 
n/a 
n/a 
V2 
2 
6 
2 
6 
n/a 
n/a 
1 
V3 
n/a 
n/a 
n/a 
n/a 
n/a 
n/a 
n/a 
V4 
n/a 
n/a 
n/a 
n/a 
n/a 
n/a 
n/a 
 
11. Follow-Up Participant Tracking and Scheduling 
 
Study personnel are responsible for keeping track of scheduled visits and updating contact 
information to ensure that subjects remain in the study. It is of the utmost importance that 
participant data are documented and kept well organized so as to avoid loss of information.  
 
Harbor UCLA recruiters are responsible for following up with appointments for participants 
recruited from their facilities.  UCI Central Office is responsible for following up on 
appointments for all other participants.   
 
UCI-based Enrollees  
Visit 1 appointments are scheduled by recruiters during the initial enrollment visit. Subsequent 
study visits (V2 – V4) are scheduled with the patient by the ICTS clinic nurse or 
coordinator/recruiter completing the follow up visits. UCI recruiters schedule appointments by 
calling the ICTS appointment line (714) 456-2307 and then notifying UCI Central Office.  ICTS 
nurses will record subsequent appointments into VTOC and email UCI Central Office on 
scheduled clinic visit dates, times and locations. UCI Central Office records all scheduled 
appointment into the Patient Tracking Log, ICTS appointment log or Recruiter appointment log, 
calendar, and ensures that the VTOC database is updated accordingly. Each Friday, UCI Central 
Office sends the ICTS nursing staff the appointment log to ensure that there are no discrepancies 
between the ICTS calendar and UCI Central Office records. 
11.1 Patient Contact 
 
Contact information sheets for subjects will be kept in a locked cabinet when not in use. Contact 
information should be entered into VTOC within 24 hours of recruitment.  All communication 
with a patient should be logged in the VTOC Communication Log. The date, time, mode, staff, 
urgency, category, and status in the Communication Log should be filled out along with the 
description of the communication with the patient.  
 
UCI Central Office is responsible for tracking all important study events for UCI-based enrollees 
in the Patient Tracking Log excel spreadsheet and VTOC Communication Log.  The log includes 
the patient Study ID, patient initials, recruiter initials, discharge date, decolonization plan (A/B), 


Project CLEAR MOP Version 1.3 
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clinic visit dates, decolonization regimen cycle start and end dates, and reminder phone call 
dates.   
11.2 Calendars 
 
Subject scheduling will be managed through the study website calendar. Once a patient is 
enrolled, study coordinators are responsible for updating the calendar within 72 hours. 
11.3 Call Lists 
 
UCI uses the Patient Tracking Log to track which patients must be called for initial bathing, 
regular start bathing cycles, and appointment reminder calls.  UCLA uses a similar tracking log 
to determine phone calls that must be made to patients.  It is anticipated that VTOC will soon 
have a function to facilitate listing events such as bathing, appointments, and follow up that must 
be made on a given date or time period across all subjects in the VTOC database.  Based on the 
event type and/or date enter as parameters, VTOC will list all patients requiring phone calls or 
additional follow back. 
11.4 Patient Phone Calls 
 
Patient phone calls are made by the UCI Central Office to the Decolonization patients up to five 
times per month. Patients assigned to the Decolonization group will be called after hospital 
discharge or on the date the patient indicated they would be able to start using the study products, 
the first and last day of their initial bathing cycle, the first day of their subsequent bathing cycles 
and the day prior to their scheduled clinic/home visits.  
Patient phone calls are made by the UCI Central Office to the Education patients up to two times 
per month. Patients assigned to the Education group may be called after hospital discharge, on 
any day of the month to follow-up on any questions they may have regarding the educational 
materials and/or the study in general. Education patients will also be called the day prior to their 
scheduled clinic/home visits. 
11.4.1 Initial Post-Discharge Phone Call 
 
The UCI Central Office is responsible for calling each patient the next business day after hospital 
discharge.  Patients assigned to the decolonization arm should be instructed to immediately begin 
their five day decolonization regimen. UCI Central Office will also answer any questions the 
patients might have about using the decolonization products or any general study questions. The 
toolkit binder should have been reviewed in full with each participant at the time of enrollment, 
so focused questions should be answered or a courtesy visit can be scheduled for additional 
support as requested by the participant. 
 
Patients assigned to the Education Arm may also be called post-discharge, at the discretion of the 
recruiter, to answer any further questions about the study educational materials or any general 
study questions. The toolkit binder should have been reviewed in full with each participant at the 


Project CLEAR MOP Version 1.3 
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time of enrollment, so focused questions should be answered or a courtesy visit can be scheduled 
for additional support as requested by the participant. 
 
11.4.2 Reminder Calls 
 
Reminder phone calls for all study visits should be made 48 to 24 hours before the visit will 
occur. The outcome of reminder calls must be documented in the patient contact database. A 
message will be left if the subject does not answer. If a message cannot be left, coordinators will 
call the subject three times throughout the day. All phone call attempts will be documented in the 
patient contact database. Subjects will be called on 3 different days to attempt to reschedule the 
visit. 
 
Bathing: Initial bathing (start & stop calls) - After PT has been discharged, each person 
(decolonization & education) is called to follow-up on the products given (binder/soaps 
& medicines), reinforce product start date adherence, answer general study questions and 
remind/ schedule V1.  
Monday calls- All decolonization PTs are called on Mondays depending on Plan (A or B), see 
laminated calendar for assignment.  
 
Decolonization patients have five day bathing cycles (Monday – Friday) twice a month.  The 
dates of those cycles are determined on whether the patient is assigned to Plan A or Plan B.   
11.4.3 Product Review/Orientation Calls 
 
All patients that require product review/orientation are listed on the Product Review Spreadsheet 
from which central office study staff can reference for follow-up calls or visits. 
. 
General script for contacting study participants: 
 
Phone Call: 
Hello, this is ___________ from Project CLEAR, may I speak with ________________? 
Great! I was just calling to see if you had any questions about the trial, the educational 
materials, or the decolonization products. I also wanted to offer to have someone drop by 
to go over the products and educational materials if you needed a refresher.  
Yes: Ok, no problem at all. We are in your area… 
No: Ok that’s great! If you have any questions, please feel free to call us and otherwise, 
we will see you on __date/time @ location__ for your first follow up visit! (Confirm 
address if home visit) 
 
 
Voicemail: 
Hello, this message is for ____________. My name is _________ and I am calling from 
Project CLEAR. I was calling to see if you had any questions about the educational 
materials or the products, and if you needed a refresher on how to use the products, I will 


Project CLEAR MOP Version 1.3 
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be in the area this Friday afternoon from 12-4. Please feel free to give us a call at 855-
END-MRSA or 855-363-6772.  
 
1. If the patients are education patients, the script will be modified to not reference the 
decolonization products.  
2. If the patients are nursing home patients, the nursing home will be contacted by senior 
study staff for collaboration.  
11.5 Study Helpline 
 
A 1-800 helpline desk number plus an emergency pager number (the Senior Project Coordinator 
Supervisor) will be provided to the subjects. This 24-hour helpline is intended for Adverse Event 
reporting, urgent Medical Visit Reporting or any other urgent questions or concerns from study 
participants.  
 
  
12. Bi-Monthly Phone Calls 
 
Bi-monthly courtesy phone calls, intended to remind subjects of the upcoming study 
intervention, will occur the Friday prior to the 1st and 3rd or 2nd and 4th Monday of each month, 
depending on Plan A or Plan B. An additional call will be made on the Monday of a 
decolonization week to initiate the regimen and the Friday of a decolonization week to stop the 
intervention. A voicemail will be left if the subject does not answer. If voicemail is not available, 
coordinators will make three additional call attempts that day. All phone call attempts will be 
documented in the patient contact database. 
 
Coordinators will call subjects who have been randomized to the intervention arm (serial 
decolonization) to: 
x Remind them to begin the study intervention 
x Inquire about adverse events 
x Inquire about medical issues 
x Re-educate patients on how to use the study products 
x Answer any questions the subject may have 
 
 
Start Regimen Script:   
“Hello, may I please speak to Mr. /Ms. <patient’s last name>?  My name is <caller’s name> 
and I am calling from the Project CLEAR MRSA study to remind you to begin your five day 
Hibiclens bathing, nose ointment, and mouthwash regimen today.  Will you be able to start 
today?”   
 
(Patient says yes): “Great, the products work best against MRSA when you use all 3 
together for all five days and don’t miss any doses”. 


Project CLEAR MOP Version 1.3 
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(Patient says no) – Find out why and if they can start the next day.  If there is a delay in 
starting the regimen, be sure to have them start up as soon as possible and continue for 
five consecutive days.  
 
“One last question for the study, we always ask that you let us know if you have been 
hospitalized for any reason or have had a clinic visit for a possible infection.  Do you have 
either of those to report?  Any other questions I can answer?  Call us anytime toll free at 
855-END-MRSA.” 
 
If the patient does not answer the call, it is acceptable to leave a message if the patient has 
indicated that messages may be left.  Check the patient’s contact sheet to see if they answered 
yes or no to “Is it okay to leave messages on this number?”  Use the script below when leaving a 
message. 
 
Start Regimen Message Script:  
“Hello Mr./Ms. <patient’s last name>, I am calling from the Project CLEAR MRSA study to 
remind you to begin your five day Hibiclens bathing, nose ointment, and mouthwash regimen 
today.  We also wanted to remind you to please let us know if you have been hospitalized for 
any reason or have had a clinic visit for a possible infection.  We can be reached anytime toll 
free at 855-END_MRSA.” 
 
Fill out a Medical Visit Reporting Form if a patient reports any hospitalizations for any reason or 
visits a clinic or doctor for a possible infection.  Fill out an Adverse Event Reporting Form if the 
patient reports any adverse effects.  See Section 14 for more information on reporting adverse 
events 
 
Add-on Lines to calls, rotating:  
Scripted add-on to use when making calls/leaving messages (pick one or more & rotate): 
1. Bactroban – Since MRSA’s main home is in the nose, be sure to use the nose ointment in 
the morning and at night during your 5-day bathing cycles to stop it from living in your 
nose.  
2. Hibiclens – Each time you bathe during your 5-day cycle, it is important to lather with 
the water off and leave the Hibiclens on your skin for 2 full minutes before rinsing off.  It 
is also very important that you not use any other soaps, shampoos or lotions during your 
5-day bathing cycles since some of them make Hibiclens stop working. 
3. Periogard – Sometimes MRSA will also live in the throat. Be sure to use the special 
mouthwash (Periogard) in the morning and at night during your 5-day cycles. Swish for 
30 seconds and don’t rinse with water immediately after using. 
4. Your best chance of getting rid of MRSA is when you use all three products together. Let 
us know if you need more before your next visit with us.   
 
The above statements can be followed with “Do you have any questions?” 
 
 


Project CLEAR MOP Version 1.3 
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Additional Info: 
x ONLY stop bathing calls (prior to V3) when a patient requests not to be called.  
- 
Send email if possible to these patients. 
x Any changes to PT’s regimen Plan or to call list should be noted in Communication Log 
on VTOC and Patient Tracking Log.  
 
13. Follow-up Study Visits 
 
The UCI ICTS clinic hours for Project CLEAR are Mondays and Wednesday 8am-5pm at the 
UCI Medical Center in Orange, and Tuesdays and Thursdays 8am-5pm at the ICTS Clinic on the 
UC Irvine campus in Irvine. Weekends are available upon request.  
 
The Harbor-UCLA CTRC Outpatient Clinic is open 7:30am to 4pm Monday through Friday. 
Subjects can be seen outside of these hours at the Inpatient CTRC Monday through Friday. 
Saturday follow-up visits can be arranged with prior notice. 
 
Home and/or nursing home visits will occur when a subject is unable to come into the clinic for a 
study visit. Subjects who move or do not wish to have in-person visits may have their visit 
conducted over the telephone.  
 
The follow-up visits occur at 1, 3, 6, and 9 months after the baseline visit. 
 
Subjects will undergo the same body swabs as occur at the baseline visit and they will be 
administered a follow-up survey. Subjects will be compensated as outlined in Section 13.8. 
13.1 Participant Education 
 
If the participants request an additional patient education binder, it will be provided in their 
preferred language (English or Spanish).  
 
Subjects will be provided reminder educational handouts specific to each follow-up visit. Study 
coordinators will review these handouts and any other information the subject would like to go 
over. 
13.2 Interviews 
 
The surveys will be completed in-person by study personnel. If the participant does not know or 
remember the answer, remind the participant to answer as best they can and move on the next 
question. The interview should take no more than 20 minutes. 


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13.3 Adverse Events 
 
Adverse events will be recorded at the time the study coordinator becomes aware of the event. 
Study coordinators can be made aware of an adverse event in four ways: 
1. The subject reports an event over the phone on a Bi-Monthly Call 
2. The subject reports an event over the phone on a Reminder Call 
3. The subject calls the 1-800 helpline number or pages the Senior Project Coordinator 
Supervisor 
4. The subject reports an event at a follow-up visit 
 
All adverse events will be followed until resolved, unless the subject exits the study and requests 
no contact. 
 
Serious Adverse Events will be handled as described in the protocol Section 14. 
13.4 Medical Events 
 
If a patient affirms that they have been hospitalized or had an outpatient visit associated with a 
suspected MRSA infection on a phone call or follow-up visit, study coordinators will fill out a 
Medical Event Form and an Adverse Event Form with the subject. Patient will be asked to obtain 
records of their visit if easy to do so. Study coordinators will also contact the medical center the 
patient was seen at to request the medical records.  
13.5 Body Site Swabbing 
 
The same four body sites (nares, throat, groin/axilla, and wounds) will be swabbed at the follow-
up visits. Refer to Section 9.5 for more information on how to swab body sites.  
13.6 Scheduling Next Visit 
 
Attempt to schedule the 1 month follow-up visit during the baseline visit whenever possible. If 
the participants cannot schedule the next visit, give them an appointment reminder card with the 
date on which the visit should occur. Two weeks before the 1 month follow-up visit, call the 
subject to schedule the appointment. The next study visit should always be scheduled at the 
current study visit; for example, the 6-month visit should be scheduled at the 3-month visit. 
13.7 Update Contact Information 
 
Study coordinators must ask the subject to update their contact information prior to the end of all 
study visits. This includes: 
 
x Phone number 


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x Address 
x Emergency contact  
13.8 Participant Payments 
 
The participants will be compensated with cash at the completion of each follow-up visit.  
x $25 for the 1 month follow-up visit 
x $30 for the 3 month follow-up visit 
x $35 for the 6 month follow-up visit 
x $50 for the 9 month follow-up visit 
x $140 for the whole study 
 
Fill out the Certification of Payment (see Figure 13.8) with the lead study coordinator’s name, 
date, study IRB number, and the participant’s name. Have the participant sign the receipt. At this 
time they will be given the cash.  
 
Figure 13.8: Certification of Payment to Anonymous Persons – ICTS Irvine 
 


Project CLEAR MOP Version 1.3 
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13.9 Off Site Follow-Up Visits 
 
If the subject is unable to come in for the follow-up visit due to hospitalization or residence in a 
nursing home, study coordinators will complete the study visit at the medical center, nursing 
home, or patient’s home, wherever the subject is currently residing. 
 
13.9.1 Home Visit Procedures 
 
The following items are needed prior to the home visit: 
• 
Project Clear Lab Coat (See VTOC for notes on patient preference for or against a lab 
coat) 
• 
UCI Badge 
• 
Gloves (Wear while swabbing patient) 
• 
Anti-Bacterial gel/wipes 
• 
Prepared Swabs (4 sterile swabs per bag with labels, carbon copy white/yellow form, and 
1 white form) 
• 
Pen 
• 
Visit Compensation Amount (V1-$25, V2-$30, V3-$35, V4-$50) with small manila 
envelope 
• 
“Certification of Payment to Anonymous Person – ICTS Irvine” form (see Figure 13.8). 
• 
Patients Name, ID Number, and Contact Details (address & directions) 
• 
New Binder Sections: 
 V1: N/A 
 V2: “MRSA & Pets”  
 V2: General binder reminder 
 V3: V3 General binder reminder (Decol ONLY) 
 V4; N/A 
• 
Calendar and area chart to book next visit (Month 1, 3, 6, 9) 
• 
Staffed ICTS and Orange Clinic Visit Dates (Mon & Fri –  Orange; Tues & Thurs – ICTS 
Irvine)   
• 
Business card to write down next visit date and time for patient 
• 
Pocket calendar note book or scrap paper to write next visit date to bring back to Central 
Office 
• 
Trash Bag (for gloves, swab packaging, and to place empty Bactroban containers in after 
counting if Decolonization patient) 
 
 
If Patient is in Education Group: 
1. “Participant Follow-up Survey Education”  
2. “Medical Visit Reporting Form” x 2 (Same form used for Decolonization patient) 


Project CLEAR MOP Version 1.3 
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45 
 
 
 
3. “Medical Visit Worksheet” x2 
 
If Patient is in Decolonization Group:  
1. “Participant Follow-up Survey Decolonization”  
2. “Adverse Event Reporting Form” x 2 
3. “Medical Visit Reporting Form” x 2 (Same form used for Education patient) 
4. “Medical Visit Worksheet” x2 
5. Prepackaged CHG Compliance Test Swabs (2 swabs per package with form) 
6. Replenishment Products 
 
 
V1 Bags (1 month after enrollment) 
  
• 1 Project Clear Canvas Bag (Containing below items) 
• 4 Sponges 
• 1 Hibiclens (1 bottle should last 2 months, ask how much used prior to visit) 
• 4 Bactroban 
• 1 Periogard 
• 1 Pump (If needed) 
 
V2 Bags (3 months after enrollment) 
• 2 x Project Clear Paper Bags  
• 6 Sponges 
• 2 Hibiclens (1 bottle should last 2 months, ask how much used prior to visit) 
• 6 Bactroban 
• 2 Periogard 
• 1 Pump (If needed) 
 
Check Vision Tree (VTOC) for: 
• 
Specific patient notes i.e. needs translator for patient or caregiver, non-communicative 
patients so look for the main contact, ability to be swabbed, unusual home conditions  
• 
Notes on previous medical visits already recorded in VTOC so not duplicated 
 
Post Visit 
• 
In VTOC, briefly report on visit in “Communication Log” (Ex: Home Visit (V1), 
completed.)  
• 
Book Visit Date with Central Office. Enter next visit date on tracking log, VTOC, 
ENDMRSA calendar.  
• 
Enter new survey data into VTOC.  File hard copy into subject folder in locked 
cabinet.  Ask Central Office for file cabinet key.  
• 
Swabs to be transported to microbiology laboratory for processing 
• 
If CHG compliance swabs were performed, bring back to office for logging and 
shipment preparation 
• 
If adverse event form is completed email information as soon as possible to Central 
Office. 
• 
Provide signed “Certification of Payment to Anonymous Person – ICTS Irvine” to 
Central Office or sign back in money if visit was not completed with Fiscal Officer. 


Project CLEAR MOP Version 1.3 
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14.  Adverse Event Reporting 
 
Adverse events will be collected at the follow-up visits or when reported by the patient at any 
time. All adverse events should be inputted into the study database and the UCI CO should be 
notified immediately.  The UCI CO will summarize the adverse event on the Adverse Event 
tracking log and will immediately notify the principal investigator of the adverse event.  Adverse 
events reported for patients recruited from Harbor UCLA facilities should reported the Harbor-
UCLA physician co-investigators. Adverse events reported for all other patients should be 
reported to the assigned study physician.  The staff member completing adverse event should let 
the patient know that a study doctor will be following up with them. 
 
Anticipated mild adverse events will be reported to the IRB on continuing review. All adverse 
events (mild and serious) will be summarized in the quarterly DSMB report. Serious Adverse 
Events (SAEs) requiring prompt reporting will be reported within the required timelines to the 
IRB and Data Safety and Monitoring Board. Any SAEs that result in a death must be reported to 
the UCI IRB and DSMB promptly, within 5 days.  
15. Obtaining Medical Records 
 
Complete medical records associated with the following will be requested from the appropriate 
medical center: 
x The enrollment hospitalization 
x Any subsequent hospitalization 
x Any outpatient visit associated with any suspected infection, even if infection was not the 
purpose of the outpatient visit 
 
All subjects will sign a page waiver allowing study personnel to request their medical records 
from any appropriate medical center. Study coordinators will fax, mail, or go in person to the 
request medical records as soon as the subject notifies them of the hospitalization or outpatient 
visit. If study coordinators do not receive the medical records within two weeks, they will send a 
repeat request up to 5 times. If incomplete records are received, another five attempts will be 
made to secure complete data. 
16.  Data Entry 
 
Data entry will be performed by personnel at UCI and LA BioMed on a secure online database 
developed by Vision Tree Optimal Care (VTOC). 
 
 
 
 
 


Project CLEAR MOP Version 1.3 
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47 
 
 
 
Figure 16.1: Vision Tree Optimal Care webpage. 
 
 
All forms must be checked for completeness and accuracy before being entered by the data 
management team. Incomplete or inaccurate forms will be flagged and the responsible personnel 
will be contacted to verify answers on the form.  
 
Inaccuracies will be recorded as a means of monitoring the quality of the data reported. Data 
quality reports will be issued monthly by the data management team.  
17. Ordering Supplies 
 
Each site will be responsible for ordering their own office and laboratory supplies. 
 
The UCI group will be responsible for providing intervention toolkits and lab coats.  UCI will 
also be responsible for emailing the latest versions of interviews, questionnaires, and other forms 
to the Project CLEAR Team.  
 
The UCI group maintains a detailed inventory tracking log for all study supplies.  Each item has 
an individual tracking sheet.  Anytime a supply or product is taken from the central supply area, 
study personnel are responsible for recording the date, initials and number taken on the 
appropriate inventory sheet. UCI CO is responsible for monitoring inventory and requesting 
supplies before stock is depleted.  When new stock is received, UCI CO updates the tracking log 
to reflect the number added. 
 
Decolonization supplies will be kept in a temperature controlled area. 
18.  Enrollment Reports 
 
Enrollment reports that show the progress of recruitment are to be created daily and sent to the 
Principle Investigator and Senior Project Coordinator Supervisor each Friday. The report will be 
discussed each Monday at the investigative team call at 11:00 AM (PST). The enrollment report 
contains information about number of subjects enrolled per week and per month, progress by 


Project CLEAR MOP Version 1.3 
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recruiter and recruiting site, number exiting trial and distribution of participants by 
randomization scheme and study arm.  
19. Specimen Delivery and Order Entry
Swab specimens collected from enrolled patients must be delivered to the appropriate 
microbiology laboratory within 24 hours of collection. Specimens collected from UCI associated 
facilities must be delivered to UCI Medical Center Microbiology laboratory at the end of each 
day.  Specimens may also be dropped off at the Gottschalk Medical Plaza lab, before 5:00 pm, so 
that the courier service will transport the specimens to the UCI Medical Center Microbiology 
laboratory that same day. 
The ICTS nurse or study coordinator/recruiter will fill out the Laboratory Requisition slip for the 
CLEAR Study Specimens for each patient.  For the Laboratory Requisition slip the ICTS nurse 
or study coordinator/recruiter will be responsible for filling out the Subject ID, Collection Date, 
Specimen Collection Origin, Specimen Source and Visit. The ICTS nurse or study 
coordinator/recruiter will also be responsible for filling out his/her name, Date of Collection, 
Number Swabs Taken and Stamp the Study ID number in the four boxes to the left.    
6WXG\VWDII must notify UCI Central Office of all specimens they have collected for the day.  UCI 
Central Office will record recruiter initials under Visited By, and log the Study ID, Visit 
Location, number of swabs, and Visit Type in the Central Office Lab Count Log.  UCI Central 
Office will send the UCI Medical Center Microbiology laboratory an email (with cc: to UCI lead 
investigator and project supervisor) at the end of the day summarizing the specimens they should 
expect to receive for the day as shown in the table below.   
Visited By   
(Initials) 
Study ID 
Visit Location 
#  Swabs 
Visit Type 
Recruiter 
Visit number naming convention is R0 (initial recruitment), V1 (study visit 1), V2 (study visit 2), 
V3 (study visit 3), and V4 (study visit 4).  The UCI Medical Center Microbiology laboratory 
sends a reply email verifying that all specimens are accounted for with the correct Study ID and 
paper work. 
Should a problem arise the following is the contact information: 
During regular hours – any issues, call Central Office 855-363-6772 or call after hours 
numbers if need assistance right away. 
After hours, report of missing swabs etc..  
The project assistant will bring the swabs to the lab. The bag with the specimens will be placed 
by the CLEAR assistant into the bin in the refrigerator in Central Processing.  The bin will be 
marked CLEAR.  
The swabs will be in a plastic bag clearly labeled PROJECT CLEAR containing a lab requisition 
form and CLEAR Specimen Sheet for each patient.  The lab will place the specimen labels that 


Project CLEAR MOP Version 1.3 
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go with the corresponding patient on the CLEAR Specimen Sheet received. The Specimen Sheet 
will be kept in the lab and the lab requisition will be taken to Referral Services for billing. 
 
The study location code CLR- will be documented in the medical record field. 
 
Each swab will be labeled with the arm of the study (E or D), a study number (unique for each 
patient), and an alphabetical designation for randomization strata.  The study-sample identifier 
will be entered into the patient name field during the specimen computer order-entry.  In this 
way the specimen ID will appear on all labels.  For example:    
              E1001, NN 
 
This refers to E (education only group), 1001 is the patient identifier, NN means Non-
Hispanic/Non-long term care facility. 
 

SAP_001.pdf: 
09-18-2012 
Project CLEAR – Statistical Analysis Plan 
Lead Statistician: Daniel Gillen, PhD 
 
1.0 Statistical Analyses 
 
1.1 Data Processing and Statistical Analysis  
 
 
All final statistical analyses will be completed in using R statistical software and results 
will be validated using SAS version 9.2 (Cary, NC).  
 
1.2 General Analytic Considerations  
 
The study population description will include demographic and socioeconomic 
characteristics, comorbidities, MRSA risk behaviors, recent surgical procedures, wounds 
or medical devices, personal hygiene activities, and household and employment 
characteristics at the time of study entry (hospital discharge). All descriptions will be 
stratified by study arm. Further exploratory descriptive statistics will also be presented by 
randomization (nursing home status and Hispanic race/ethnicity). Participant 
characteristics will be described by mean and standard deviation, by median and 
interquartile range, or by frequency and percentage for normally distributed variables, 
non-normally distributed variables, and categorical variables, respectively. We will use t 
tests, Mann-Whitney U tests, or 
2 tests to compare these characteristics between the 
two study arms.  
 
1.3 Analysis Populations 
 
Safety analyses will be performed on the ITT Population, defined as all subjects who 
were randomized into the study.  Efficacy analyses will be conducted on the Intention-
To-Treat (ITT) Analysis Population, defined as all subjects who were deemed eligible 
and randomized in the study. Data summaries will be based on the intervention that was 
randomly assigned. 
1.4 Handling of Missing Data 
In primary analyses, missing values will not be imputed. All censored values will be 
considered in the primary analysis regardless of the reason for censoring.  
1.5 Subgroup Analyses 
Descriptive analyses of safety and efficacy data will be presented by Hispanic 
race/ethnicity and nursing home status. The primary efficacy endpoint, as well as all 
secondary efficacy endpoints and safety outcomes will be presented overall and by 
subgroup. 
1.6 Accounting for Multiple Comparisons 
 
The primary analysis comparing the relative risk of MRSA infection between the SOCE 
and SOCE+D arms will be conducted to maintain an overall 0.05 (two-sided) significance 
level.  The primary analysis will be conducted in the full ITT Analysis Population.  
Subgroup analyses in Hispanic patients and nursing home residents are considered 
secondary and hence no adjustment for multiple comparisons will be accounted for in 


09-18-2012 
the primary analysis. 
 
1.7 Data Transformations 
 
No transformations of data are planned. 
 
1.8 Efficacy Data 
 
1.8.1 Analysis Population 
 
Efficacy analyses will be conducted on the Intention-To-Treat (ITT) Analysis Population, 
defined as all subjects who were deemed eligible and randomized in the study. 
 
1.8.2 Analysis of the Primary Outcome  
 
 
For the primary analyses, we will evaluate time from discharge to first MRSA 
infection. The primary endpoint will be summarized using Kaplan-Meier estimates of 
survival distributions and the 3 month, 6 month, and one year incidence of MRSA 
infection.  Inference for the primary endpoint will be assessed using a Cox proportional 
hazard model.  The proportional hazard assumption will be assessed graphically by 
plotting log(-log(estimated survival distribution function)) against log(survival time).  The 
resulting graphs should have approximate parallel lines when the assumption holds.  In 
addition, we will also assess potential treatment by time interactions.  If the proportional 
hazards assumption is reasonably met, then the hazard ratio estimated via the Cox 
model will be used as summary of treatment effect.  If the proportional hazards 
assumption is violated, then the inference remains statistically valid for testing equality in 
survival distributions, but treatment effect will be summarized by the proportion of 
observed infections at relevant time points.  
 
1.8.3 Analysis of Secondary Outcomes  
 
 
Additional secondary analyses will involve the assessment of MRSA infection and 
hospitalization rates. Given that time to hospitalization associated with MRSA 
infection reflects a very important high cost and high severity metric this outcome will 
also be assessed using the above Cox analysis.  In addition, we will consider the impact 
of intervention on multiple re-infections/re-admissions.  In these analyses, participants 
will be allowed to contribute multiple discrete MRSA infections. As above, we will provide 
descriptive data including the median time to infection, types of infection, and whether 
infections resulted in hospitalization, stratified by study arm. A multivariate Cox 
proportional hazards model will be used to estimate the relative hazard for re-infection 
and/or hospital readmission [LIN, 2000].  Separate baseline hazard functions will be 
estimated conditional upon the number of previous infections/admissions and 
multiplicative interactions will be used to test whether the effect of treatment differs by 
the previous number of infections/hospitalizations.  Robust standard errors will be used 
for all inference in order to account for correlation within individuals with multiple 
infections/readmissions [LIN, 1989]. Secondary analyses will compare the rates of 
MRSA infection for a) both inpatient and outpatient infection combined, and b) only 
inpatients visits due to or complicated by MRSA infection 
 
In addition, we will evaluate whether either arm differentially engendered antibiotic 
resistance. This will be done by comparing the proportion of patients in each arm with 
MRSA isolates obtained after at least six months of follow-up who has strains that were 


09-18-2012 
non-susceptible to a) mupirocin, or b) chlorhexidine. Comparisons will be done using chi-
square tests. Total deaths and deaths due to MRSA will also be described between the 
two study arms and compared using chi square tests.  
 
All analyses will be repeated using as treated data where participants in the serial 
decolonization arm will be considered adherent to the study arm if the 5-day 
decolonization regimen is completed at least 50% of the time during the follow up period 
without more than two consecutive missed decolonization regimens. Participants in the 
education arm who receive any decolonization regimen will be excluded from this 
analysis.  
 
Finally, we will construct data-driven classification models to identify groups at 
increased risk for short-term infection (within three months of discharge) and long-term 
infection (within one year of discharge) infection, as well as. Outcomes will be the MRSA 
the occurrence of infection within first 3 months following discharge and within the first 
12 months following discharge.  Two methods will be used to build classification model 
and assess covariate importance in predicting short and long term risk of MRSA 
infection.  The models will then be compared based upon their out of sample 
misclassification rates.  First, we will you logistic regression to model the log-odds of 
short- and long-term infection. To avoid model over-fitting and reduce out-of-sample 
classification error, parsimonious models will be chosen using 10-fold cross-validation, in 
which a proposed model will be fit using 9/10 of the available data and used to predict 
the remaining 1/10 of the sample. The resulting logistic regression will be summarized in 
terms of the risk score associated with coefficient values derived from the estimated 
model parameters. In addition, classification and regression trees (CART) will also be 
used to build a flexible predictive model, accounting for potential effect modification 
across covariates. Again, 10-fold cross-validation will be used for pruning CART trees to 
avoid overfitting.  Using the final CART model as a guide for covariate selection, logistic 
regression will be used to model the odds of 3-year cognitive impairment and risk scores 
for covariate values will be derived from the fitted regression coefficients.  Both the 
logistic regression and CART prediction will summarized via receiving operating 
characteristic curves and individual covariate contributions to the models will be 
reported. 
 
1.9 Sample Size Justification 
 
Initial power analyses considered exponential survival with a baseline one year infection 
rate of 24%.  A blinded reassessment of power (pooling data over both treatment arms) 
was performed one year into the trial to more accurately assess the precision of the 
study based upon the overall event rates occurring in the trial.  In the reassessment, 
power for the study was based upon the following design assumptions:  
1. 
Level 0.05 (two-sided) for the primary outcome of MRSA re-infection 
2. 
24% baseline MRSA infection rate at 1 year 
3. 
75% of events infections will occur within 6 months of discharge 
4. 
5% of treated population will have high level resistance 
 
Further we considered the lost-to-follow-up rate of 30% distributed uniformly from 0 to 2 
months (was assumed to be 10% uniformly distributed over 12 months) and that there 
existed a decrease in initial treatment effect that attenuates to the null over the final 6 
months of follow-up.  Based upon these assumption, simulated power as a function of 
the hypothesized treatment effect (HR) for MRSA-specific infection (24% baseline event 
rate at 1 year) over the first 6 months of follow-up and an assumed relative reduction in 
the initial effect for the final 6 months of follow-up are provided in Table 2. A similar table 


09-18-2012 
considering all infections (assuming a baseline infection rate of 35%) is provided in 
Table 3. 
Table 2.  Simulated power as a function of the hypothesized treatment effect (HR) for 
MRSA-specific infection (24% baseline event rate at 1 year) over the first 6 months of 
follow-up and an assumed relative reduction in the initial effect for the final 6 months of 
follow-up. 
Percent Decrease in Effect for 
6-12 Months 
True Hazard Ratio For First 6 Months 
0.60 
0.65 
0.70 
0.75 
N=1800 
 
 
 
 
50% 
0.880 
0.779 
0.619 
0.432 
60% 
0.849 
0.750 
0.596 
0.408 
70% 
0.831 
0.718 
0.576 
0.388 
80% 
0.808 
0.688 
0.545 
0.371 
90% 
0.769 
0.657 
0.521 
0.349 
100% 
0.733 
0.628 
0.497 
0.317 
 
 
 
 
 
N=1900 
 
 
 
 
50% 
0.891 
0.788 
0.650 
0.491 
60% 
0.861 
0.760 
0.625 
0.465 
70% 
0.838 
0.733 
0.595 
0.435 
80% 
0.814 
0.703 
0.562 
0.419 
90% 
0.796 
0.677 
0.524 
0.391 
100% 
0.777 
0.647 
0.493 
0.368 
 
 
 
 
 
N=2000 
 
 
 
 
50% 
0.913 
0.813 
0.659 
0.477 
60% 
0.885 
0.788 
0.633 
0.456 
70% 
0.860 
0.762 
0.603 
0.433 
80% 
0.834 
0.732 
0.585 
0.411 
90% 
0.804 
0.701 
0.558 
0.386 
100% 
0.778 
0.666 
0.533 
0.360 
 
 
 
 
 
N=2100 
 
 
 
 
50% 
0.923 
0.848 
0.703 
0.512 
60% 
0.899 
0.819 
0.674 
0.493 
70% 
0.879 
0.787 
0.654 
0.471 
80% 
0.867 
0.758 
0.614 
0.449 
90% 
0.839 
0.727 
0.571 
0.422 
100% 
0.811 
0.685 
0.546 
0.389 
 
 
 
 
 
N=2200 
 
 
 
 
50% 
0.929 
0.859 
0.702 
0.493 
60% 
0.914 
0.833 
0.688 
0.468 
70% 
0.899 
0.803 
0.662 
0.442 
80% 
0.875 
0.780 
0.634 
0.415 
90% 
0.846 
0.751 
0.608 
0.389 
100% 
0.828 
0.712 
0.576 
0.371 
 
 
 
 
 
N=2300 
 
 
 
 
50% 
0.946 
0.861 
0.718 
0.557 
60% 
0.933 
0.840 
0.686 
0.532 
70% 
0.922 
0.819 
0.661 
0.515 
80% 
0.899 
0.786 
0.625 
0.491 
90% 
0.880 
0.755 
0.591 
0.461 
100% 
0.862 
0.726 
0.565 
0.434 


09-18-2012 
 
Table 3.  Simulated power as a function of the hypothesized treatment effect (HR) for any 
infection (35% baseline event rate at 1 year) over the first 6 months of follow-up and an 
assumed relative reduction in the initial effect for the final 6 months of follow-up. 
 
 
Percent Decrease in Effect for 
6-12 Months 
True Hazard Ratio For First 6 Months 
0.60 
0.65 
0.70 
0.75 
N=1800 
 
 
 
 
50% 
0.979 
0.920 
0.795 
0.594 
60% 
0.973 
0.903 
0.777 
0.574 
70% 
0.965 
0.889 
0.749 
0.545 
80% 
0.953 
0.868 
0.715 
0.516 
90% 
0.938 
0.841 
0.690 
0.474 
100% 
0.913 
0.815 
0.653 
0.443 
 
 
 
 
 
N=1900 
 
 
 
 
50% 
0.976 
0.932 
0.804 
0.635 
60% 
0.963 
0.914 
0.773 
0.608 
70% 
0.958 
0.888 
0.740 
0.575 
80% 
0.944 
0.870 
0.710 
0.546 
90% 
0.936 
0.850 
0.675 
0.527 
100% 
0.927 
0.821 
0.648 
0.500 
 
 
 
 
 
N=2000 
 
 
 
 
50% 
0.984 
0.946 
0.828 
0.653 
60% 
0.980 
0.934 
0.796 
0.629 
70% 
0.974 
0.913 
0.767 
0.605 
80% 
0.961 
0.893 
0.749 
0.581 
90% 
0.946 
0.869 
0.711 
0.553 
100% 
0.924 
0.836 
0.681 
0.524 
 
 
 
 
 
N=2100 
 
 
 
 
50% 
0.990 
0.938 
0.838 
0.662 
60% 
0.987 
0.925 
0.814 
0.638 
70% 
0.982 
0.905 
0.788 
0.621 
80% 
0.976 
0.883 
0.768 
0.597 
90% 
0.966 
0.865 
0.752 
0.565 
100% 
0.953 
0.826 
0.720 
0.533 
 
 
 
 
 
N=2200 
 
 
 
 
50% 
0.986 
0.971 
0.831 
0.689 
60% 
0.978 
0.962 
0.817 
0.672 
70% 
0.973 
0.948 
0.793 
0.647 
80% 
0.963 
0.936 
0.768 
0.624 
90% 
0.948 
0.917 
0.745 
0.586 
100% 
0.937 
0.900 
0.714 
0.557 
 
 
 
 
 
N=2300 
 
 
 
 
50% 
0.990 
0.964 
0.892 
0.716 
60% 
0.986 
0.954 
0.872 
0.690 
70% 
0.984 
0.940 
0.838 
0.658 
80% 
0.978 
0.924 
0.814 
0.630 
90% 
0.970 
0.901 
0.781 
0.602 
100% 
0.962 
0.884 
0.748 
0.574 


09-18-2012 
References 
Lin D, Wei L, Yang I, Ying Z. Semiparametric regression for the mean and rate functions 
of recurrent events. Journal of Royal Statistics. 2000. 62(4):711-30. 
 
Lin D and Wei L. Robust inference for the Cox proportional hazards model. Journal of 
the American Statistical Association. 1989. 84:1074-8.