Proactive Outreach for Smokers in VA Mental Health
Phase: NA
Conditions: Smoking
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
PROACTIVE OUTREACH FOR SMOKERS IN VA MENTAL HEALTH  
Protocol Number: IIR 11-291-3 
Funding Agency: VA HSR&D 
Principal Investigator/Study Chairs:  
Scott Sherman, MD, MPH and Steven Fu, MD, MSCE 
  
10/08/2015 
 
 

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ABSTRACT 
 
Background:  
Tobacco use is the leading preventable cause of death in the United States and contributes up 
to 24% of all VA healthcare costs. Veterans enrolled in the VA healthcare system smoke 
substantially more than the general population, which is particularly true among Veterans 
diagnosed with mental illness. Patients with bipolar disorder or schizophrenia have the highest 
smoking rates (69% and 58-90%, respectively) followed by those with PTSD (45-63%) and 
depression (31-51%). Numerous barriers exist for tobacco cessation among mental health 
patients, including high nicotine dependency, low rates of follow through for referrals, and 
limited availability of tobacco treatment tailored to their needs.  
Rationale:  
Most medical care providers assess tobacco use and advise smokers to quit, but they have 
insufficient time to follow up with treatment, leading to low long-term quit rates. Mental health 
providers who often meet regularly with patients report that they find tobacco cessation outside 
the scope of their practice and neither assess tobacco use nor refer smokers for treatment. 
These practice patterns have been very difficult to change even with intensive methods and 
across various settings and provider types. Therefore, we propose to use the electronic medical 
record system to identify smokers receiving mental health care and proactively reach out to 
engage them in treatment in line with the following aims:  
Specific Aims: 
1. Compare the reach and efficacy of a proactive outreach telephone-based tobacco cessation 
(PRO) program for patients seen in mental health to usual care (UC) advice and referral to 
local VA and community tobacco cessation resources.  
2. Model longitudinal associations between baseline sociodemographic, medical and mental 
health characteristics and abstinence at 6 and 12 months in the PRO and UC conditions. 
Methods:  
We will use the electronic medical record to identify N=20,000patients across 4 VA healthcare 
facilities who have a clinical reminder code indicating current tobacco use in the past year and 
who have had a mental health visit in the past 6 months. We will send each patient an 
introductory letter and baseline survey. Respondents will be randomized in a 1:1 fashion to 
intervention or control. Control participants will receive VA usual care. Intervention participants 
will receive proactive telephone counseling and cessation medications. We will survey 
participants at 2 weeks, 6 months and 12 months from enrollment. The primary outcome is 
cotinine-validated abstinence at the 12-month follow-up. 
 
 

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LIST OF ABBREVIATIONS 
 
ACOS 
Associate Chief of Staff. 
COPD 
Chronic obstructive pulmonary disease 
CPRS 
Computerized Patient Record System. The VA’s electronic medical record 
system. 
EMR 
Electronic medical record. 
FAQ 
Frequently asked questions. 
FDA 
U.S. Federal Drug Administration. 
HCS 
Healthcare system 
ICD-9 
International classification of diseases – version 9 
MH 
Mental health 
MHC 
Mental health clinic 
MIRECC 
Mental illness research, education, and clinical center. 
NRT 
Nicotine replacement therapy. 
PACT 
Patient-aligned care teams. The VA’s model for managing panels of patients, 
rather than individual patients. 
PCMH 
Patient-centered medical home. 
PHS 
U.S. Public Health Service. 
PRO 
Proactive outreach telephone-based tobacco cessation program. This is the 
name of the study arm that receives our proactive outreach intervention. 
PTSD 
Post traumatic stress disorder 
QUERI 
The VA’s Quality Enhancement Research Initiative program. 
TeleQuitMH Telephone Quality Improvement Trial for Mental Health. This is the name of our 
previous research study that evaluated a telephone smoking cessation program 
for smokers using VA mental heath clinics.  
UC 
Usual care. This is the name of the study arm that receives usual care at each 
site.  
 

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Contents 
 
Protocol Title  ............................................................................................................................. 5 
1.0 Study Personnel ................................................................................................................... 5 
2.0 Introduction .......................................................................................................................... 6 
3.0 Objectives ............................................................................................................................ 7 
4.0 Resources and Personnel .................................................................................................... 7 
5.0 Study Procedures................................................................................................................. 9 
5.1 Overview .................................................................................................................. 9 
5.2 Settings ...................................................................................................................11 
5.3 Identifying Potential Participants ..............................................................................11 
5.4 Participant Recruitment ...........................................................................................12 
5.5 Randomization and Blinding ....................................................................................12 
5.6 Study Groups ..........................................................................................................12 
5.7 Data Collection ........................................................................................................14 
5.8 Outcomes ................................................................................................................16 
5.9 Informed Consent ....................................................................................................16 
6.0 Statistics and Analysis ........................................................................................................17 
7.0 Withdrawal of Subjects ........................................................................................................20 
8.0 Safety Monitoring and Reporting .........................................................................................21 
9.0 Privacy and Confidentiality ..................................................................................................21 
10.0 Communication Plan .........................................................................................................22 
11.0 References ........................................................................................................................22 
 
  

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Protocol Title:  Proactive Outreach for Smokers in VA Mental Health 
1.0 
STUDY PERSONNEL 
Principal Investigator: 
Scott Sherman, MD, MPH 
Staff Physician, VA New York Harbor Healthcare System 
Associate Professor of Medicine and Psychiatry, New York University School of 
Medicine 
423 East 23rd Street,  
New York, NY 10010 
Phone: 212-686-7500 x7386  
Fax: 212-951-3269 
Email: scott.sherman@va.gov 
Co-Principal Investigator: 
Steven Fu, MD, MSCE 
Director, Center for Chronic Disease Outcomes Research 
Associate Professor of Medicine, University of Minnesota Medical School 
Minneapolis VA Health Care System 
One Veterans Drive (152/2E) 
Minneapolis, MN 55417 
Phone: 612.467.2582   
Fax: 612.467.5699 
Email: Steven.Fu@va.gov 
 
Co-Investigators: 
Paul Krebs, PhD 
Clinical Psychologist, VA New York Harbor Healthcare System 
Assistant Professor, Division of General Internal Medicine, NYU School of Medicine  
423 23rd St. 15th Floor  
New York, NY 10010 
Phone: 212-686-7500 x5045 
Fax: 212-263-4240 
Email: Paul.Krebs@va.gov 
 
Erin Rogers, MPH 
Health Science Specialist, VA New York Harbor Healthcare System 
423 East 23rd Street – 15167AN 
New York, NY 10010 
Phone: 212-686-7500 x7358 
Fax: 212-263-4240 
Email: erin.rogers2@va.gov 
 
Radha Rao, MD 
Staff Physician, Houston VAMC 
2002 Holcombe Blvd 
Houston, TX 77030 
Phone: 713-791-1414 
Email: RadhaM.Rao@va.gov 
 

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Carolyn Schlede, MD 
Staff Physician, James A. Haley Veterans Hospital 
13000 Bruce B. Downs Blvd. 
Tampa, Florida 33612 
Phone: 813-972-7627 
Email: Carolyn.Schlede@va.gov 
2.0 
INTRODUCTION 
Tobacco use is the leading preventable cause of death in the United States, responsible for 
443,000 deaths per year and 8-24% of all VA healthcare costs.1,2 Persons with a mental health 
diagnosis (DSM-IV, Axis I or II), which represent about 25% of VA patients, have particularly 
high rates of tobacco use and consume over 46% of cigarettes sold in the U.S.3,4 Patients with 
bipolar disorder or schizophrenia have the highest smoking rates (69% and 58-90%, 
respectively) followed by those with PTSD (45-63%) and depression (31-51%).4-6 Numerous 
barriers exist for tobacco cessation among mental health patients, including high nicotine 
dependency, limited support from mental health providers, low follow through by patients with 
referrals, and limited availability of tobacco treatment targeted to their needs. These barriers 
suggest a more specialized approach to tobacco cessation with mental health populations is 
warranted to maximize quit rates in this at-risk population.    
The overall objective of the proposed research is to address tobacco use as a chronic health 
condition and improve tobacco cessation services for Veterans with mental health diagnoses, 
which is one of the top priorities of the VA Public Health National Prevention Program. While VA 
primary care providers now consistently assess tobacco use and advise smokers to quit, most 
have insufficient time to follow up with treatment, leading to low long-term quit rates.7  Mental 
health providers often meet regularly with patients, yet report that they find tobacco cessation 
outside the scope of their practice and neither assess tobacco use nor refer smokers for 
treatment, often due to a misperception that tobacco cessation treatment would exacerbate 
patients’ conditions.8 These mental health practice patterns have been very difficult to change. 
In our team’s recently-completed research study, we have been providing telephone-based 
counseling customized to the needs of mental health patients referred by their mental health 
provider. While patient participation rates are high (65%) and the long-term abstinence rate is 
comparable to primary care populations (20%), referrals from mental health providers have 
remained significantly lower than expected. Despite consistent provider support efforts, our 
referrals represent only 1.5 - 9% of mental health patients who smoke.  
Our central hypothesis is that we can increase the number of Veterans with mental health 
diagnoses who receive evidence-based tobacco cessation services by proactively enrolling 
them in treatment. We therefore propose a randomized, controlled trial that will use the 
electronic medical record system at four VA facilities to identify N=6,400 smokers receiving 
mental health care and contacting them via letters and telephone to offer cessation treatment. 
As suggested by our previous experience with this population, the treatment protocol will be 
targeted to the needs of mental health patients by integrating relapse-sensitive scheduling, 
stress reduction and problem-solving techniques, educational information, and coordination with 
patients’ mental health providers. 

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3.0 
OBJECTIVES 
The Specific Aims of the study are to:  
2. Compare the reach and efficacy of a proactive outreach telephone-based tobacco 
cessation (PRO) program for patients seen in mental health to usual care (UC) advice 
and referral to local VA and community tobacco cessation resources.  
H1: We hypothesize that compared to the control group, the proactive intervention 
will increase the smoking abstinence rate at 12 month follow up. 
3. Model longitudinal associations between baseline sociodemographic, medical and 
mental health characteristics and abstinence at 6 and 12 months in the PRO and UC 
conditions. 
H2: We hypothesize that mental health distress and active substance abuse will be 
related to treatment uptake and long-term abstinence.4,9 
4.0 
RESOURCES AND PERSONNEL 
Resources 
The majority of the work for this study will be conducted centrally at our NY Harbor site. Tasks 
that will be performed at our NY Harbor site include: overall study management and IRB 
coordination, mailing outreach letters and baseline surveys to potential participants, providing 
telephone counseling to participants in the Intervention arm, coordinating the mailing of 
medications to participants in the Intervention arm, completing telephone follow-up surveys, 
mailing biochemical validation (saliva) kits to participants, and performing all data entry and data 
quality assurance. 
VA programmers and statisticians at our Minneapolis site will be responsible for using VINCI to 
create our list of potential participants, periodically verifying the list, taking a random sample of 
the list that will become our pool of patients to whom we will send outreach letters, and 
conducting all statistical analyses for study reports and publications. 
Personnel: Investigators 
Scott Sherman, MD, MPH (Principal Investigator) – Dr. Sherman is a Physician at the VA 
NYHHS and Associate Professor of Medicine and Psychiatry at New York University School of 
Medicine (NYUSOM). He has 20 years experience in health services research, with particular 
emphasis on implementation research in smoking cessation and organizational changes to 
improve tobacco control. He has been Principal Investigator on 10 studies for smoking 
cessation in the past 10 years, including a six-site VA QUERI implementation study evaluating a 
telephone program for smokers referred by their mental health provider. Dr. Sherman will work 
with Dr. Fu to oversee the entire study and serve as site Principal Investigator for the NYHHS 
site. 
Steven Fu, MD, MSCE (Principal Investigator) – Dr. Fu is Co-Associate Director and a Core 
Investigator of the Center for Chronic Disease Outcomes Research at the Minneapolis VAMC, a 
Core Investigator at the University of Minnesota Transdisciplinary Tobacco Use Research 
Center, and an Associate Professor of Medicine at the University of Minnesota. He is nationally 
recognized as a leader in the treatment of tobacco use among diverse racial/ethnic minority 

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groups. He has been PI on six tobacco cessation studies in the past seven years. His research 
is focused on identifying best practices for improving the delivery and utilization of tobacco 
dependence treatments among diverse populations. Dr. Fu will work with Dr. Sherman to 
oversee the entire study and serve as site Principal Investigator for the Minneapolis HCS site. 
Paul Krebs, PhD (Co-Investigator) – Dr. Krebs is a Clinical Psychologist at the VA NYHHS and 
an Assistant Professor of Medicine at NYUSoM. Dr. Krebs’ research focuses behavioral 
interventions for cancer risk behaviors and tobacco cessation. He is currently PI on an NIH pilot 
grant testing an e-health intervention to promote healthy lifestyle behaviors among cancer 
survivors and a co-investigator on a NIDA-funded study developing and testing a structured 
gaming environment to promote cessation and prevent relapse in hospitalized smokers. Given 
Dr. Krebs’ background in clinical care for tobacco cessation, he will serve as clinical supervisor 
to the telephone counselors working on the Intervention arm, which will involve weekly live 
supervision and fidelity coding of counseling calls. 
Radha Rao, MD (Co-Investigator) – Dr. Rao is a staff physician at the Michael E. DeBakey 
VAMC in Houston, TX. She has facilitated multiple research projects at this site over the past 
several years. She is currently working on a VA Public Health Strategic Healthcare Group-
funded project evaluating inpatient-outpatient transitions in tobacco cessation for surgical 
patients. On that project she works as the Primary Care Liaison between surgical and primary 
care staff to ensure appropriate delivery of smoking cessation treatment to recently-discharged 
surgical patients. She is also currently Principal Investigator on a local project retrospectively 
examining the side effects of Varenicline in a VA sample. Dr. Rao will serve as site Principal 
Investigator for the Houston site. 
Carolyn Schlede, MD (Co-Investigator) – Dr. Schlede is a staff Physician and the Founder of 
the Smoking Cessation Clinic at the James A. Haley Veterans' Hospital in Tampa, Florida and 
has served as Director of the Clinic since 1984. Since 1997 she has also served as Chief of 
Clinical Champions for Smoking Cessation Clinical Practice Guidelines in VISN 8. Dr. Schlede 
is currently a Co-Investigator and site Principal Investigator on Dr. Fu’s Proactive Outreach to 
Smokers in Primary Care study. Dr. Schlede will serve as site Principal Investigator for the 
Tampa VAMC site. 
Erin Rogers, MPH (Co-Investigator and Project Director) – Ms. Rogers has an MPH in 
health services management and is currently enrolled in a Doctorate of Public Health 
program. She is a Health Science Specialist at the VA NYHHS and Project Director of 
several tobacco cessation studies. Ms. Rogers will coordinate all aspects of the study, 
including writing the study’s IRB applications, coordinating with each site to obtain a list 
of smokers with a mental health diagnosis, developing the study’s data entry program 
and database, and supervising the study’s research assistants and counselors. 
Personnel: Study Staff 
Telephone Counselors – NY Harbor site 
We will have two telephone counselors working at our NY Harbor site who will responsible for 
calling patients who enroll in the study and providing them with tailored, multi-session telephone 
counseling session. The counselors will use the study’s structured counseling protocol and 
relapse-sensitive scheduling. Based on previous studies, we expect that each counselor will 
serve an annual caseload of 250-300 patients. The counselors will have access to PHI stored in 
password-protected study databases on a VA network server folder designated for this study. 

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Research Assistants – NY Harbor site 
We will have two full-time research assistants and multiple part-time interns who will be 
responsible for mailing outreach letters and cotinine validation kits to participants, conducting 
verbal informed consent with participants in the Intervention arm, entering survey data into study 
databases, conducting telephone follow up calls for 6 and 12 month assessments, and other 
tasks as needed. The research assistants and interns will have access to PHI stored in 
password-protected study databases on a VA network server folder designated for this study. 
 
Programmers – Minneapolis site 
We will have 1-2 programmers at the Minneapolis site responsible for using VINCI to create our 
list of potential participants, periodically verifying the smoking status of patients on the list, and 
selecting a random sample of patients on the list to whom we will send outreach letters each 
month. The programmers will have access to PHI via VINCI and stored in password-protected 
study databases on a VA network server folder designated for this study..   
 
Statisticians – Minneapolis site 
We will have 1-2 statisticians at the Minneapolis site responsible for designing and conducting 
all statistical analyses and randomization procedures, and overseeing randomization during the 
participant enrollment period. The statisticians will have access to PHI stored in password-
protected study databases on a VA network server folder designated for this study. 
Contracts 
We will be contracting with the company Salimetrics. Salimetrics will be analyzing our saliva 
samples for cotinine (validation of our primary outcome). The study research assistants will 
send the saliva samples by FedEx to Salimetrics for analysis using FedEx and U.S. government 
guidelines for shipping biological samples. We will label the samples with a unique barcode only 
that contains no information that can identify participants as individuals. The VA will maintain 
ownership over the samples after they are sent to Salimetrics. Salimetrics will send the results 
of their analyses to the study’s PI in an excel report sent via email to the PI’s VA email address. 
A sample report is included in Appendix F. This file will contain no patient identifiers. Results will 
be labeled with the number on each sample’s barcode.  
 
5.0 
STUDY PROCEDURES 
5.1 
OVERVIEW 
Figure 1 provides an overview of our study design. We will use the EMR to identify 20,000 
patients across four VA health care facilities who have a clinical reminder code indicating 
tobacco use in the past six months and who have had a mental health visit in the past 12 
months. We will send each patient an introductory letter and baseline survey. Respondents will 
be randomized in a 1:1 fashion to intervention or control. Control participants will receive VA 
usual care. Intervention participants will receive proactive telephone counseling. For each 
Intervention participant, study staff will send a medication request via CPRS to the smoking 
cessation program at their site and primary care provider or psychiatrist as backup. Intervention 
participants’ regular VA mental health providers will be updated on their patients’ progress in 
treatment via CPRS progress notes and be provided with information about the program and 
with suggestions for how to support their patients. Control participants will receive a mailed list 
of local VA smoking cessation treatment options that they can access on their own or to which 

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they can be referred by their regular VA providers (i.e., usual care). We will survey participants 
at 2 weeks, 6 months and 12 months from enrollment. The primary outcome is cotinine-
validated abstinence at the 12-month follow-up.  
Figure 1. Overview of Study Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Use EMR to 
identify
Packet sent 
to patient: 
1)
C
Advance 
Comp
leted 
Patient not in
Randomize
Control 
Group 
Mailed
Intervention 
Group 
VA
6m follow up survey and
12m follow up survey and
2 week survey

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5.2 
SETTINGS 
 
This study will take place at 4 sites: the VA New York Harbor Healthcare System, VA 
Minneapolis Healthcare System, Houston VAMC and Tampa VAMC.  
5.3 
IDENTIFYING POTENTIAL PARTICIPANTS  
Using a three-step process, we will work with VA programmers at our Minneapolis site to 
identify potential participants using specific combinations of administrative data contained in the 
EMR system.  
Selecting current smokers: Current smokers will be identified using the EMR tobacco use 
clinical reminder codes, where information is stored as a health factor. Patients will be included 
if they have screened positive for current tobacco use in the previous six months. We selected 
six months to reduce the false-positive rate of this sampling method (i.e., reduce the number of 
patients we contact who are no longer smoking). Patients will be excluded if they have an ICD 9 
diagnosis of dementia (i.e., 290.XX or 331.XX).  
Identifying Mental Health patients: Within the list of all eligible smokers, VA programmers will 
identify patients treated in the previous 12 months in a VA Mental Health Clinic, using VA clinic 
stop codes: 502-581.  
Selecting the initial sample: After receiving a list for each site of current smokers with a recent 
Mental Health visit, we will select all women and a random sample of men to total 5,000 
potential participants from each site (N=20,000) as our initial recruitment pool. We are selecting 
all women as an initial recruitment pool to increase the representation of women in our final 
sample. 
Verifying  the sample: We will verify our list of eligible patients each month, since we will be 
sending out letters and surveys to patients each month throughout the enrollment phase. If we 
relied solely on data collected at the beginning, smoking status could be over a year old on 
some subjects by the time they received their letter. Each patient who is no longer listed as a 
current smoker will be replaced by another patient from the site prior to mailing out any 
materials (and thus prior to enrollment and randomization). 
Inclusion/exclusion criteria: Using administrative data and data from the baseline survey, we will 
verify the study’s inclusion and exclusion criteria with each potential participant. Anyone who is 
found to be ineligible will be excluded prior to randomization and replaced with a randomly 
selected person from the list of current smokers for that particular site. We will thus send 
recruitment letters to 20,000 patients over five quarters (approximately 1400 patients per 
month). To maximize reach and impact we have chosen broad inclusion criteria; patients do not 
have to report being ready to quit within a specific time frame to enroll. 
Inclusion criteria: 
 Current smoker (i.e., any tobacco use in past 30 days) 
 Mental Health clinic visit in past 12 months (and primary mental health diagnosis at 
checkout) 
Exclusion criteria: 
 ICD 9 diagnosis of dementia (excluded during data abstraction process) 
 Does not speak English  
 Does not have telephone and mailing address (necessary to mail out informed consent 
materials and to deliver the telephone-based intervention) 

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5.4 
PARTICIPANT RECRUITMENT 
Returning a mailed baseline survey will enroll a potential participant in the study. We will use a 
modified Dillman protocol to maximize recruitment response rates and data quality.10 First, we 
will send each patient a letter from the Chief of Staff and facility Behavioral Health Coordinator 
(or other comparable leader from the facility) stating they will soon be contacted about a 
smoking cessation research study with the goal of helping Veterans who use VA mental health 
clinics stop smoking (Appendix A). The letter will also include information on how to contact the 
project director to opt out of receiving further study materials (flyer and baseline survey 
described below) or if they feel they have been contacted in error (e.g., not a current smoker). 
One week later, we will send out a packet of information, including a cover letter (Appendix B), a 
sheet of Frequently Asked Questions (FAQ; Appendix C), and the self-administered baseline 
survey. The cover letter and FAQ sheet accompanying the mailed baseline survey will contain 
all the elements of informed consent and explain the purpose of the study. Patients will have 
information that will explain the study’s risk and benefits, that names are not attached to study 
documents and that choosing to participate or not to participate in the study will have no effect 
on their medical care. They will also be informed that they will receive a $10 payment for 
returning the survey. These documents will contain telephone numbers if participants have 
further questions about the study. Potential participants can also contact us if they wished to be 
no longer contacted by the study.  
5.5 
RANDOMIZATION AND BLINDING 
After returning the baseline survey, we will randomize respondents in a 1:1 fashion to 
intervention or control, stratified by site. To randomize a patient, the Project Director will log onto 
the study’s database system (which will be adapted from the one used in Dr. Sherman’s 
previous studies), enter the subject’s unique study ID, confirm eligibility, and confirm that the 
survey has been received. The database system verifies that all randomization criteria have 
been satisfied, then assigns a study ID and a group to the subject. The database system will 
automatically input the date of randomization and the participant’s assignment into their study 
record. The study’s Project Director and counselors will have access to treatment assignments. 
The study’s research assistants and our biochemical validation company (Salimetrics, described 
in section 4.0) will be kept blind to treatment assignments. Intervention participants will be 
aware of the arm to which they are assigned when they receive the first phone call from a study 
counselor. 
5.6 
STUDY GROUPS 
INTERVENTION  
Telephone Counseling  
Within one week of receiving a completed baseline survey, a counselor will phone intervention 
participants. Up to 6 contact attempts will be made at different times (i.e., morning, afternoon, 
evening) during the week. The purpose of the outreach call is to: 1) deliver motivational 
enhancement to quit smoking, 2) promote self-efficacy, and 3) encourage participants to 
participate in smoking cessation treatment. The full telephone counseling protocol is 
characterized by: 
 Motivational enhancement – We will include motivational enhancement in each of the first 
several telephone calls and as-needed during later calls to increase patient motivation to 
quit and reduce relapse.  

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 Multiple sessions – Participating smokers will receive 8 calls over two months and then, for 
those who quit in this timeframe, monthly maintenance calls for six months. The initial call 
will be 30-45 minutes and subsequent calls will be 10-20 minutes.   
 Relapse-sensitive scheduling – Participants will receive 4 calls to plan a quit date, three 
calls in the first two weeks after their Quit Date, when the relapse risk is highest, followed by 
another call in another two weeks. Patients who are quit at the 8 week call will receive 
monthly maintenance calls to work through any slips or barriers to continued abstinence.11,12  
 Problem-solving therapy – This approach, based on helping the smoker identify and solve 
expected and actual challenge, is endorsed by the national smoking cessation guidelines.13  
 Stress Reduction – Our previous work providing tobacco cessation counseling to VA mental 
health patients identified stress and anxiety as a major barrier toward quitting and long-term 
abstinence among this population. Our counseling protocol includes stress reduction 
techniques, such as relaxation and mindfulness exercises,11,12 and the incorporation of 
smoking schedules to remove the link between smoking and stress responses.14 We will 
also send stress reduction self-help materials to intervention participants that the counselors 
will discuss during the counseling. 
Medication Requests 
All smokers in the intervention arm will be asked about their NRT preference during their first 
counseling call. Their counselor will place a View Alert in CPRS for their facility’s smoking 
cessation program or regular primary care provider indicating that the participant expressed 
interest in receiving NRT and their preference. The View Alert will also contain relevant 
information from the US Public Health Services guidelines for the treatment of tobacco. The 
counselors will monitor the participants’ EMR for whether a prescription is written. If no 
prescription is written within 1 week after sending the View Alert, the counselor will place a 
follow-up View Alert reiterating the participant’s expressed interest in NRT. The regular smoking 
cessation providers will not be required to prescribe or be required to prescribe the patient’s 
preferred NRT. Rather, study staff will simply notify the providers that the patient expressed 
interest in receiving NRT. The Intervention counselors will also encourage participants to 
discuss NRT use with their regular providers.  
Engaging MH Providers in the Treatment Process 
In recognizing that a patient’s regular Mental Health providers are an important source of 
support and treatment encouragement for our patient population, we will engage all intervention 
patients’ primary mental health providers into the treatment process by alerting the providers of 
their patients’ progress via CPRS progress notes and providing them information via email 
about the program and how they can support their patients. As we have done with Dr. 
Sherman’s prior studies, the study’s counselors will place a progress note into CPRS for each 
patient documenting the first counseling call and the quit plan developed during that call. 
Additional progress notes will be entered into the medical record when the patient quits 
smoking, when there is a significant change in the quit plan, and when the patient is discharged 
from the program. On each note, the patient’s primary Mental Health provider (identified on the 
baseline survey and confirmed with EMR review) and psychiatrist (if different from the primary 
provider) will be added as an additional signer to the note. This process will also ensure the 
safety of participants using antipsychotic medications by notifying their psychiatrist of their 
quitting process. 

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CONTROL GROUP (USUAL VA CARE) 
We will send smokers randomized to the control group a mailed list of local VA and non-VA 
smoking cessation services that they can access on their own. In addition, patients randomized 
to the control group may receive treatment or referrals to treatment from their regular VA 
providers as part of usual care. Pharmacotherapy is available at all sites in the form of nicotine 
replacement (patches, gum and lozenges) and bupropion.  
5.7 
DATA COLLECTION 
All participants will be surveyed by mail at baseline, by mail 2 weeks after enrollment, and by 
telephone (or mail for non-respondents) at 6 and 12 months from enrollment. Research 
assistants will make up to 10 attempts at different days and times to reach participants by phone 
for the 6 and 12 month surveys. If we cannot reach a participant after 10 attempts, we will mail a 
paper version of the survey with a cover letter (Appendix K) to participants. Patients will receive 
a $10 payment as reimbursement for completing each survey. 
5.7.1 Baseline Survey 
Smoking questions 
 Smoking habits and history. We will use measures adapted from the California Tobacco 
Survey15 that we have used in several previous studies to assess the number of cigarettes 
smoked per day, number of days smoking per week, and nicotine dependence..16  
 Motivation. We will assess readiness for change using the Stage of Change scale.17  
 Tobacco treatment used in prior 12 months. We will ask participants to indicate whether a 
VA provider talked to them about smoking in the prior 12 months and which tobacco 
treatments they used in the prior 12 months. 
 Health. We will ask a single item asking participants to rate their general level of health on a 
5-point Likert type scale. 
5.7.2 2-Week Survey 
Sociodemographics 
 Demographics.  Age, sex, marital/partnership status, race/ethnicity, education, and 
occupation will be assessed, as well as text messaging interest and capabilities. 
 Environment. Using questions from the California Tobacco Survey15 we will assess 
household tobacco use and restrictions on smoking at home. 
Smoking questions 
 Smoking habits and history. We will use measures adapted from the California Tobacco 
Survey15 that we have used in several previous studies. 
 Self-Efficacy. Self-efficacy for smoking cessation will be measured with the 14-item 
Confidence Questionnaire Form18 which assesses smoking cessation self-efficacy across 14 
different situations or mood states. 
 Pros and Cons. We will use the 6-item decisional balance scale which measures positive 
and negative attitudes toward quitting.19  
 Perceptions regarding tobacco use. We will also assess perceived control over withdrawal 
symptoms74 and perceived antismoking norms,20-24 measures that predict tobacco use.  

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Health questions 
 Health habits. We will use the AUDIT-C24,25 to assess alcohol use and a single item measure 
developed to assess drug use in primary care.26 We will measure frequency, type and 
quantity of exercise using questions from the National Health Interview Survey. 
 Comorbidities. We will assess baseline comorbid conditions using the survey version of the 
Charlson index.27  
 Mental Health. We will use the Kessler-6 psychological distress scale, as used by the 
National Survey on Drug Use and Health to measure general psychological distress.28 The 
scale validity discriminates between cases and non-cases of mental illness. In addition we 
will use 14-item Hospital Anxiety and Depression Scale29 to assess specific mood 
symptoms. 
 Mental Health provider. In order to coordinate care and encourage involvement of the 
mental health clinicians, we will ask each patient for the name of the person he/she 
identifies as his/her primary mental health provider. This would be the provider he/she sees 
the most or feels is the most involved in his/her mental health care.  
5.7.3 6- and 12-Month Surveys  
All measures assessed at baseline and 2 weeks (except the sociodemographic measures) will 
be assessed again at 6 and 12 months. In addition, we will assess: 
 Cessation outcomes at 6 and 12 months: We will follow recommended guidelines for 
measuring and validating tobacco abstinence in clinical trials.30,31 Smoking cessation (7-day 
point prevalence), quit attempts, reduction in smoking, use of cessation pharmacotherapy, 
and counseling received outside of this study will be collected.  
5.7.4 Saliva Sample - Validation of self-reported abstinence 
Self-reported smoking abstinence can be verified by assays of cotinine, the principal metabolite 
of nicotine. Patients with cotinine levels > 15ng/ml will be classified as current smokers.32 
Sample collection will be conducted by mail. Patients will be eligible for verification if they report 
7-day abstinence from cigarettes, other tobacco products, e-cigarettes and nicotine replacement 
therapy (NRT). A research assistant will send a saliva collection kit, collection instructions 
(Appendix D), a collection date sheet (Appendix E), and a postage-paid return envelope on the 
day of telephone survey with a postage paid return envelope.  Subjects will receive a reminder 
call 5 and 8 days later. If they do not respond, another kit will be sent at 2 weeks, followed by 
two more reminder calls. We will mail a $25 payment to participants who return a saliva sample.  
5.7.5 Administrative Data – Mental Health Diagnoses and Utilization 
Programmers at our Minneapolis site will use the EMR to obtain the number of mental health 
clinic visits in the 12 months following study enrollment by each participant and to obtain a list of 
mental health diagnoses in each participant’s EMR in the 12 months prior to study enrollment. 
The programmers will use this list to assign to each patient a primary mental health diagnosis 
using methods recommended by the MH QUERI. Primary mental health diagnosis will be 
defined as the most frequently occurring diagnosis at MH encounters during the 12 months prior 
to enrolling in the trial. For example, if a patient had three schizophrenia diagnoses and two 
schizoaffective diagnoses, s/he would be assigned the diagnosis of schizophrenia. We will then 
assign one of six main diagnostic categories to each participant based on their primary 
diagnosis: affective disorders, substance abuse disorders, non-PTSD anxiety disorders, PTSD, 
schizophrenia disorders, or other diagnoses.  
 

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5.8 
OUTCOMES 
The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up. 
Secondary outcomes include the following: 
1. Self-reported 7-day abstinence (to estimate rates of misreporting) at 6 and 12 month follow-
up. 
2. Other cessation related outcomes at 6 and 12 months – e.g., quit attempts, cigarettes per 
day, cessation medication use, motivation, and self-efficacy. 
3. Self-reported mental health distress and active substance abuse. 
5.9 
INFORMED CONSENT PROCEDURES 
There are several levels of patient information and consent for this study, which are summarized 
in the table and discussed below. 
Category 
Type of data 
Approx. 
n 
Authorization 
Comments 
1. Health 
system users 
Administrative data 
 Smoking status 
 Mental Health clinic 
use 
 Phone number 
 Mailing address 
40,000 
HIPAA waiver  
We will randomly select 
20,000 from the EMR 
to contact via mail for 
possible enrollment 
2. All study 
participants 
Survey data 
 Baseline survey 
 Follow-up surveys 
 
Saliva sample 
Administrative data 
 Utilization 
 Mental health 
diagnoses 
 
3,840 
Waiver of 
documentation 
of consent 
Completing the 
baseline survey will 
serve as implied 
consent to the 
telephone follow-up 
surveys and saliva 
collection, to be 
contacted for 
counseling if in the 
Intervention arm, and 
to collect follow-up 
administrative data 
from the EMR. 
3. Intervention 
treatment 
participants 
 
Intervention data 
 Counseling 
information 
 Nicotine replacement 
preference 
 
384 
Verbal 
consent with a 
waiver of 
documentation 
of consent 
Participants will provide 
verbal informed 
consent prior to 
enrolling in counseling  
 
Category 1: Health System Users. The proposed study will include men and women over the 
age of 18 years old who smoke and have had a Mental Health visit in the past 6 months. We will 

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request a HIPAA waiver to obtain a limited data set from the EMR to identify eligible subjects, 
which is necessary to carry out the study.  
Category 2: All Study Participants. Patients who complete and return the baseline survey will be 
participants in the study. As indicated in the cover letter and FAQ sheet, their returning the 
survey implies they consent to participate and no written documentation of consent will be 
required. After receiving the baseline survey and verifying that the respondent is still smoking, 
we will randomize each person to either the intervention or control group.  
Category 3: Intervention Arm Participants. Intervention participants will be offered telephone 
counseling. Prior to starting treatment, the counselors will discuss what each treatment involves 
and obtain verbal consent to proceed.  
6.0 
STATISTICS AND DATA ANALYSIS 
Analysis 
In the data analysis, we will focus on the analysis for inference in the subpopulation of smokers 
who respond to the baseline survey. The underlying assumption is that respondents to the 
baseline survey are comparable to non-respondents. With our proposed sample size, random 
assignment among subjects who returned baseline surveys stratified by hospital site can be 
expected to create two groups that are balanced with respect to observed and unobserved 
baseline characteristics. Balance of the two groups will be tested using Mantel-Haenszel 2 
tests for categorical variables and appropriate parametric tests (e.g., Blocked Anova F-tests) or 
nonparametric tests (e.g., Wilcoxon rank-sum test). In addition, the data will be summarized 
numerically using descriptive statistics (means, medians, standard deviations, frequency 
distributions, and graphical displays including box plots) to characterize study participants in the 
two groups.  
 
Missing Data  
We anticipate low, but potentially important rates of survey non-response to all or part of the 6- 
and 12-month surveys. We will use the evidence-based recruitment strategies described above 
(incentives, reminders, mixed mode survey administration) to minimize non-response. A 
common practice in smoking cessation research is to treat non-respondents at follow-up as 
continuing smokers (i.e., intent to treat). This practice is perceived to be a conservative 
approach but does not, in fact, produce valid estimates of quit rates.33 We will use multiple 
imputations to fully use available baseline information and partial later surveys. We will use a 
propensity-based multiple imputation method similar to that discussed by Little34 using separate 
imputation procedures within each study group and design stratum combination. Within a given 
combination, we will estimate the propensity for responding to cotinine validated abstinence for 
each individual from a logistic regression model for survey response using the characteristics 
measured at baseline as explanatory measures. Within a combination of intervention and 
design strata, we will further stratify the sample according to the values for these estimated 
propensities. Within a propensity substratum, we will impute a value for the outcome measure 
for each non-respondent by randomly sampling an outcome value from the respondent values in 
the substratum. Multiple completed datasets will be created and the point estimates and the 
estimated standard error from each dataset will be combined to arrive at a single point estimate 
(using the specific method discussed below), its estimated standard error, and the associated 
confidence interval or significance test. This approach assumes that missing outcome data due 
to non-response is missing at random.  
 

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To assess the impact of non-ignorable survey non-response, or missing not at random non-
response, we will implement pattern-mixture analyses. Using content expertise and the 
observed missing data patterns, we will develop these pattern-mixture models. The nature of 
these models is difficult to specify in advance of observing the different patterns but we will posit 
distributions for the missing data. For each set of posited distributions and the observed data, 
we will calculate revised estimates for the relevant intervention effects. One potential model 
would be to use the propensity stratum derived in the analysis described above and, within each 
stratum build a distribution for the outcome of interest by shifting the observed distribution 
among the responders. Content expertise and empirical results will be used to determine the 
form and magnitude of shift. These distributions would then be used to impute values for the 
non-responders to cotinine validation in the imputation process described immediately above. 
Variations of this approach and other approaches will be used to assess the sensitivity of the 
analyses above to non-ignorable non-response.  
 
We will be enrolling patients after they complete the baseline survey, which maximizes our 
internal validity; thus we will have baseline data on all participants. The methods above for 
imputing missing data address the issue of non-response to all or part of either the 6-month or 
12-month survey and cotinine validation. We will have limited data available on those who do 
not respond to the baseline survey, but we will use what data we have to compare initial 
responders to non-responders, in order to address external validity.  
 
Specific aim analysis  
The data will first be summarized numerically using descriptive statistics and frequency 
distributions examined for validity. Comparison of the baseline demographic and tobacco use 
characteristics between the two treatment groups will be performed using chi-square tests for 
categorical data and t-tests or nonparametric tests for ordinal or continuous data. 
Aim 1: Compare the reach and efficacy of a proactive outreach telephone-based tobacco 
cessation (PRO) program for patients seen in mental health to usual care (UC) advice and 
referral to local VA and community tobacco cessation resources.  
H1: Compared to the control group, the proactive intervention will increase the smoking 
abstinence rate at 12 month follow up. 
Method: The study design is a randomized block design with the blocks comprising 
combinations of the four hospital sites.  
We will address the question of Reach via two indices: 
 
Proportion of patients who respond to the outreach letters and enroll in the study (i.e., 
completed the baseline survey). This analysis will help us understand the proportion of 
smokers in Mental Health who will respond to proactive outreach. Given the innovative 
nature of the proactive outreach approach, we will examine the acceptability of the 
intervention to determine which patients are more likely to accept treatment in the PRO 
and UC conditions. Specifically, we will use multivariable logistic regression to determine 
which baseline characteristics (e.g., age, race/ethnicity, income, mental health 
diagnosis, symptom severity) are associated with receipt of cessation counseling (state 
quitline or VA) or use of cessation medications. 
 
Proportion of patients who engage in at least one treatment session compared to control 
patients. Specifically, we will determine how many patients in the intervention arm used 
treatment (counseling and/or medications) and compare this to the number of patients 

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enrolled in the control arm who report using existing VA tobacco cessation services on 
the follow-up surveys, which will provide data regarding acceptability of treatment.  
The primary smoking outcome variable that is expected to be affected by treatment is 
dichotomous cotinine-validated abstinence at 12 months post-enrollment. The comparisons of 
the abstinence rates across the two groups will be made using exact logistic regression 
methods, accounting for stratification by site, to model the log odds of use of smoking cessation 
treatment and log odds of 12-month abstinence. Exact logistic regression employs the non-
parametric Chi-square test or Fisher’s exact test.35 These tests are widely applicable in 
complete randomized experimental designs that yield contingency tables. Fisher’s exact test is 
particularly suitable for contingency tables with small and unbalanced frequency counts, which 
are to be expected for the population-based outcome we have chosen where our population quit 
rate in the control condition is expected to be 4%.  
Aim 2: Model longitudinal associations between baseline sociodemographic, medical and 
mental health characteristics and validated abstinence at 6 and 12 months in the PRO and UC 
conditions.  
H2: We hypothesize that mental distress and active substance abuse are the strongest baseline 
predictors of treatment uptake and long-term abstinence in a mental health population. 
Method: We will use a generalized linear mixed model approach36 to determine smoking 
outcomes at 6 and 12 months. Following the recommended best practices in longitudinal data 
analysis,37 we will use a two-level hierarchical linear model to fit the data. The outcome variable 
of interest will be the dichotomous cotinine-validated smoking abstinence data. Therefore, a 
logit model is appropriate at Level 1, where individual outcomes will be fitted for each subject 
using time as the primary covariate. The parameter estimates from these individual functions 
will then be entered as dependent variables in Level 2 in which treatment group (PRO vs. UC) is 
the covariate. This longitudinal analytic approach will help understand to what extent treatment 
effects differ between 6 and 12 months and whether they show a delayed effect (either 
increasing or decreasing over time). This will allow us to determine a treatment main effect as 
well as a treatment by time interaction. Baseline covariates will be included at the patient level 
(age, sex, race/ethnicity, nicotine dependence, motivation, self-efficacy, mental distress, and 
current substance use). Inclusion of covariates typically reduces residual errors and thus boosts 
statistical power as well as allows us to determine factors that affect abstinence to better target 
intervention design and content. 
Power calculations  
The power analysis is based on the primary outcome – cotinine-validated abstinence at 12-
month follow-up. Our data is stratified on four hospital sites. Considering that a stratified random 
sample is usually more efficient than a simple random sample, to be conservative, we assume 
the two groups are two independent simple random samples in the following power analysis. 
Based on response rates during the first quarter of recruitment, we expect to receive completed 
surveys from 20-25% of the 20,000 patients receiving the initial mailing and 85% of respondents 
will be eligible (i.e., report smoking cigarettes in the prior 30 days). We will send initial mailings 
until we receive completed surveys from 3,840 eligible patients who will be randomly assigned 
to intervention and control and comprise the study population. We estimate the quit rate in the 
control group will be 4%. In the intervention group, about 20% of the people will accept our offer 
of telephone treatment, based on Dr. Fu's data. We anticipate that the quit rate among Veterans 

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enrolled in counseling will be 16%. We are using a more conservative estimate from what we 
found in our recently-completed reactive recruitment study (20%) because participants will not 
have been directly referred from a healthcare provider. When the treatment cessation rate is 
combined with that from patients who do not accept treatment (assuming also a 4% quit rate), 
there will be a population-level quit rate of 6.4% in the intervention group, which gives us a 90% 
chance to detect a difference between the two groups.  
 
The table below shows the detectable increases in anticipated long-term abstinence rate for the 
intervention group for power = 0.75, 0.80, 0.85, 0.90, based on two sided two independent 
proportions test with type I error of alpha=0.05, We varied the anticipated long-term abstinence 
rate in the control group from 3% to 4%. (We used Pass 2008 NCSS software for the 
calculation.) As an example, the proposed sample size provides 80% power to detect any 
increase greater than 2.0% in population-level abstinence rate for the intervention group when 
the abstinence rate in the control group is 4%, a small but clinically-meaningful quit rate that 
results in overall cost-savings.38  Reversing the calculation and solving for the quit rate for 
people who accept counseling, if the underlying quit rate is 4% and we get 20% of intervention 
patients to enroll in counseling (N=384), we will have 80% power to detect a difference if the 
success rate at counseling is as low as 14%.  
 
Note that a lower response rate on the baseline survey does not affect our power. Since we 
randomize after response, we can mail additional surveys until we have 3,840 respondents. A 
recruitment cohort of 20,000 patients and enrolled sample of 3,840 participants therefore gives 
us some safety margin, to allow for variability in:  
 The treatment engagement rate  
 The rate of success at counseling (i.e., if less than 16%)  
 If the success rate among intervention patients who do not enroll in counseling is <4% 
(which is conceivable, since these are the people who declined to enroll in telephone 
counseling).  
 
Table 1: Statistical Power Analysis (1920 baseline survey respondents per group) for 
Abstinence Rates  
 
Control 
group P1 
Power 
Intervention 
group P2 
Difference P2-P1 
Odds 
Ratio 
0.03 
0.95 
0.053 
0.023 
1.82 
0.03 
0.90 
0.051 
0.021 
1.72 
0.03 
0.85 
0.049 
0.019 
1.66 
0.03 
0.80 
0.047 
0.017 
1.61 
0.03 
0.75 
0.046 
0.016 
1.57 
0.04 
0.95 
0.066 
0.026 
1.70 
0.04 
0.90 
0.063 
0.023 
1.62 
0.04 
0.85 
0.061 
0.021 
1.56 
0.04 
0.80 
0.060 
0.020 
1.52 
0.04 
0.75 
0.058 
0.018 
1.49 
7.0 
WITHDRAWAL OF SUBJECTS 
Participants can withdraw from the study at any time verbally or in writing by contacting one of 
the Principal Investigators. Any data collected prior to the participant’s withdrawal will still be 

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used, but no further data collection or contact with the participant will occur after the date of their 
withdrawal.   
8.0 
SAFETY MONITORING AND REPORTING 
Potential Risks 
The intervention treatment being delivered in this study (counseling) is already shown to be 
effective and approved by the VA for use without informed consent. The main risk in this study 
is a breach of confidentiality similar to the risk incurred during a normal visit for care. 
 
Surveillance and Reporting Procedures 
In order to ensure patient safety, we will use the same approach we are using for our ongoing 
VA studies. We will monitor the following events: 
 
Adverse events (AEs): 
 
Violations of confidentiality 
 
ER visits without hospitalization 
 
Suicidal ideation not requiring intervention 
Serious adverse events (SAEs): 
 
Death 
 
Life-threatening event 
 
Hospitalization 
 
Suicidal ideation requiring intervention 
 
Any AE that the research staff thinks may be related to study participation will be reported to a 
PI within 24 hours. If the PI is unavailable, the research staff will report it to the Project Director. 
The PI or Project Director will determine whether the event is a) serious or non-serious and b) 
anticipated or unanticipated. The PI or Project Director will ensure that any necessary actions 
are taken immediately to address the current patient situation, and then will decide if the team 
needs to make any changes in the protocol and/or consent forms to prevent future occurrences 
or better inform future participants. We will report the event to the IRB and DSMB as per VHA 
Handbook 1058.01 requirements.  
 
In the case of suicidal or homicidal ideation, we will follow a protocol used on previous studies. 
We will train each person who contacts participants (tobacco cessation counselors and research 
assistants) in appropriate methods for assessing risk, conversing with participants, and 
completing a ‘warm-transfer’ to the VA National Suicide Prevention Hotline if a patient reports 
suicidal or homicidal ideation, plan or intent during counseling or a telephone survey. Clinicians 
(either Dr Sherman, a VA primary care physician, or the counseling supervisor, Dr. Krebs, a VA 
clinical psychologist) will also be informed to evaluate cases and provide any further advisement 
or follow-up with patients’ primary mental health providers. 
9.0 
PRIVACY AND CONFIDENTIALITY 
We will obtain a HIPAA waiver for the entire study. This waiver will allow us to access patient 
PHI using the EMR in order to identify our random sample of potential participants and collect 
administrative follow-up data on participants enrolled in the study. All study staff who have 
access to PHI will complete all required VA patient privacy trainings and the Project Director will 
be responsible for ensuring that each staff member’s training is up to date.  

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Participants’ identifiers will be kept in a separate password-protected database from their PHI 
abstracted from the EMR and other study data. All databases will be stored on VA network 
servers behind the VA firewall. Only study staff will have access to the password. Paper data 
will be stored in locked filing cabinets in locked offices at the Manhattan or Brooklyn campuses 
of the VA NY Harbor Healthcare System. 
Electronic and paper data collected by study staff will not be transmitted or shipped outside the 
VA’s protected environment. This study will be collecting saliva samples for cotinine analysis. 
These samples will be sent by FedEx to Salimetrics for analysis using FedEx and U.S. 
government guidelines for shipping biological samples. The samples will be labeled with a 
unique barcode only that contains no information that can identify participants as individuals. 
Salimetrics will send the results of their analyses to the study’s PI in an excel report sent via 
email to the PI’s VA email address. A sample report is included in Appendix F. This file will 
contain no patient identifiers. Results will be labeled with the number on each sample’s barcode.  
10.0 
COMMUNICATION PLAN 
The Project Director will work with the local site coordinators to develop their local IRB 
applications and ensure that they receive appropriate approvals before beginning research at 
any site.  
Hard copies of all current study materials (e.g., outreach letters, surveys) will be stored on a VA 
network server to which all study staff will have access to ensure that only the most recent, IRB-
approved documents are used. The verbal informed consent process for enrollment in 
telephone counseling and all telephone surveys will be completed using computer-assisted 
script and interview programs to ensure that staff are delivering informed consent information 
and obtaining survey answers in a standardized, IRB-approved methods. 
We will have bi-weekly study meetings at our primary site (NY Harbor) and monthly conference 
calls with all sites to discuss overall study progress, protocols, and updates. When protocol 
changes, unanticipated problems, and SAEs occur, the Project Director will immediately notify 
the LSIs and their appropriate staff via phone and schedule a conference call as soon as 
possible to discuss the events or changes with all sites. Minutes from each meeting and 
conference call will be emailed to all study staff and stored on a VA server to which all study 
staff will have access. 
11.0 
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