Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry
Phase: NA
Conditions: Smoking Cessation
Sponsor: NYU Langone Health

 
 
Official Title: 
Clinical Reminder Changes to Increase Smoking Cessation Treatment 
in Outpatient Psychiatry   
NCT Number: 
NCT04071795 
Study Number: 
19-00813 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
July 11, 2019 
 

 
 
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in writing by the study sponsor 
Behavioral Intervention Template Version: 11 January 2019 
 
 
 
 
Title: Clinical reminder changes to increase smoking cessation treatment in outpatient psychiatry  
 
 
 
Principal Investigator: 
 
Erin Rogers, DrPH, MPH 
NYU School of Medicine 
Department of Population Health 
180 Madison Avenue, New York, NY 10016 
Erin.Rogers@nyulangone.org 
646-501-3556 
Additional Investigator: 
 
Scott Sherman, MD, MPH 
NYU School of Medicine 
Department of Population Health 
180 Madison Avenue, New York, NY 10016 
Scott.Sherman@nyulangone.org 
646-501-2636 
NYULH Study Number: 
S19-00813 
Funding Sponsor: 
National Institute on Drug Abuse (NIDA) 
 
ClinicalTrials.gov 
Number                 
 
 
Initial version: 6/21/2019 
 

Study number: s19-00813 
 
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Statement of Compliance 
 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), any other applicable US government research regulations, and 
institutional research policies and procedures. The Principal Investigator will assure that no deviation from, 
or changes to the protocol will take place without prior agreement from the sponsor and documented 
approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate 
hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
 
 

Study number: s19-00813 
 
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Table of Contents 
 
PROTOCOL SUMMARY .............................................................................................................................. 1 
SCHEMATIC OF STUDY DESIGN ............................................................................................................... 4 
1 
KEY ROLES ......................................................................................................................................... 5 
PRINCIPAL INVESTIGATOR: ...................................................................................................................... 5 
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ....................... 5 
2.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE ................................................................ 5 
2.2 
RATIONALE .................................................................................................................................... 6 
2.3 
POTENTIAL RISKS & BENEFITS ........................................................................................................ 7 
2.3.1 
Known Potential Risks ............................................................................................................. 7 
2.3.2 
Known Potential Benefits ........................................................................................................ 7 
3 
OBJECTIVES AND PURPOSE ........................................................................................................... 7 
3.1 
PRIMARY OBJECTIVES .................................................................................................................... 7 
3.2 
SECONDARY OBJECTIVES (IF APPLICABLE) ...................................................................................... 8 
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................... 8 
4.1 
DESCRIPTION OF STUDY DESIGN .................................................................................................... 8 
4.2 
STUDY ENDPOINTS......................................................................................................................... 9 
4.2.1 
Primary Study Endpoints ......................................................................................................... 9 
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................................... 9 
5.1 
INCLUSION CRITERIA ...................................................................................................................... 9 
5.2 
EXCLUSION CRITERIA ..................................................................................................................... 9 
5.3 
VULNERABLE SUBJECTS ............................................................................................................... 10 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION .......................................................................... 10 
5.5 
DURATION OF STUDY PARTICIPATION ............................................................................................ 13 
5.6 
TOTAL NUMBER OF PARTICIPANTS AND SITES ................................................................................ 13 
5.6.1 
Reasons for Withdrawal or Termination ................................................................................ 13 
5.6.2 
Handling of Participant Withdrawals or Termination ............................................................. 14 
6 
BEHAVIORAL/SOCIAL INTERVENTION ......................................................................................... 14 
6.1 
ALL PARTICIPANTS ....................................................................................................................... 14 
6.1.1 
Control Arm ........................................................................................................................... 14 
6.1.2 
Intervention Arm .................................................................................................................... 15 
7 
STUDY PROCEDURES AND SCHEDULE ....................................................................................... 16 
7.1.1 
Study Specific Procedures .................................................................................................... 16 
7.1.2 
Standard of Care Study Procedures ..................................................................................... 17 
8 
ASSESSMENT OF SAFETY ............................................................................................................. 17 
8.1.1 
Definition of Adverse Events (AE) ......................................................................................... 17 
8.1.2 
Definition of Serious Adverse Events (SAE) ......................................................................... 17 
8.1.3 
Definition of Unanticipated Problems (UP) ............................................................................ 18 
8.2 
CLASSIFICATION OF AN ADVERSE EVENT ....................................................................................... 18 
8.2.1 
Severity of Event ................................................................................................................... 18 
8.2.2 
Relationship to Study Intervention......................................................................................... 19 
8.2.3 
Expectedness ........................................................................................................................ 19 
8.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT .............................................................. 19 
8.4 
REPORTING PROCEDURES – NOTIFYING THE IRB .......................................................................... 19 
9 
STATISTICAL CONSIDERATIONS .................................................................................................. 19 

Study number: s19-00813 
 
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9.1 
STATISTICAL HYPOTHESES ........................................................................................................... 19 
9.2 
DESCRIPTION OF STATISTICAL METHODS ...................................................................................... 20 
9.2.1 
General Approach ................................................................................................................. 20 
9.2.2 
Analysis of the Primary Efficacy Endpoint(s) ........................................................................ 20 
9.3 
SAMPLE SIZE ............................................................................................................................... 21 
10 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 21 
10.1 
ETHICAL STANDARD ..................................................................................................................... 21 
10.2 
INSTITUTIONAL REVIEW BOARD ..................................................................................................... 21 
10.3 
INFORMED CONSENT PROCESS .................................................................................................... 21 
10.3.1 
Consent/Assent and Other Informational Documents Provided to Participants ............... 21 
10.3.2 
Consent Procedures and Documentation ......................................................................... 22 
10.4 
PARTICIPANT AND DATA CONFIDENTIALITY .................................................................................... 22 
10.4.1 
Research Use of Stored Human Samples, Specimens, or Data ...................................... 22 
11 
DATA HANDLING AND RECORD KEEPING ................................................................................... 23 
11.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES .............................................................. 23 
11.2 
STUDY RECORDS RETENTION ....................................................................................................... 23 
11.3 
PUBLICATION AND DATA SHARING POLICY ..................................................................................... 23 
12 
STUDY FINANCES ............................................................................................................................ 23 
12.1 
FUNDING SOURCE ........................................................................................................................ 23 
12.2 
COSTS TO THE PARTICIPANT ......................................................................................................... 23 
12.3 
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................ 23 
13 
REFERENCES ................................................................................................................................... 24 
14 
APPENDICES .................................................................................................................................... 25 
 
 

Study number: s19-00813 
 
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Protocol Summary 
Title 
Clinical reminder changes to increase smoking cessation treatment 
in outpatient psychiatry  
Short Title 
Clinical reminder changes to increase smoking cessation treatment 
in outpatient psychiatry  
Brief Summary 
This study will use a scientifically robust, mixed-methods, two-arm 
cluster-randomized study design. We will implement a tobacco use 
clinical reminder for outpatient psychiatrists practicing at the VA New 
York Harbor Healthcare System (N = 20). Half of the psychiatrists will 
receive a reminder that encourages the psychiatrist to offer cessation 
medications and referral to cessation counseling to patients interested 
in quitting (Opt-In Reminder). The other half will receive a clinical 
reminder that includes a standing NRT order and a referral to 
cessation counseling that will automatically generate unless the 
provider 
actively 
opts-out 
(Opt-Out 
Reminder). 
Prior 
to 
implementation of the reminders, psychiatrists in both arms will 
receive a one-hour training on tobacco treatment and individual 
education outreach to demonstrate the clinical reminder and answer 
questions (academic detailing). 
Phase 
N/A 
Objectives 
1: Estimate the effects of an Opt-Out versus Opt-In Tobacco 
Treatment System on the proportion of mental health patients who are 
screened and treated for tobacco use by their psychiatrist.  
2: Assess intervention fidelity, provider perceptions, and barriers and 
facilitators to implementation. 
3: Estimate the effect of the Opt-Out Reminder versus the Opt-In 
Reminder on the use of cessation treatment and self-reported 
abstinence among mental health patients who smoke. 
Methodology 
Two-arm cluster-randomized study design. 
Endpoint 
The primary endpoint is provider rates of screening and treating their 
patients for tobacco use in the first 6 months of implementation.  
Study Duration 
3 years 
Participant Duration 
6 months 
Duration of behavioral 
intervention 
6 months 
Population 
VA Psychiatrists and psychiatric patients who smoke 
Study Site 
VA NY Harbor Healthcare System 
(No recruitment or consenting will take place at NYULH.)  
Number of participants 20 psychiatrists and 400 patients. Subjects are not NYULH 
employees or patients. 

Study number: s19-00813 
 
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Description of Study 
Intervention/Procedure 
Half of the psychiatrists will receive a reminder that encourages the 
psychiatrist to offer cessation medications and referral to cessation 
counseling to patients interested in quitting (Opt-In Reminder). The 
other half will receive a clinical reminder that includes a standing 
NRT order and a referral to cessation counseling that will 
automatically generate unless the provider actively opts-out (Opt-
Out Reminder). Prior to implementation of the reminders, 
psychiatrists in both arms will receive a one-hour training on tobacco 
treatment and individual education outreach to demonstrate the 
clinical reminder and answer questions (academic detailing). 
Reference Therapy 
The newly tailored opt-out reminder will be compared with the 
current “opt-in” National reminder. 
Key Procedures 
1. Psychiatrist training and academic detailing 
2. Provider survey at baseline and 6 months post implementation 
3. Patient survey post-visit and 6 months after post-visit 
4. Semi-structured interview with a subsample (n=12-14) of 
psychiatrists (6-7 per arm) at 1 year 

Study number: s19-00813 
 
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Statistical Analysis 
 
Objective 1: Based on administrative data, we will categorize the 
proportion of patients seen by a participating psychiatrist in each 
group who were: (1) screened for tobacco use by the psychiatrist, 
(2) among smokers, received a cessation medication prescription 
from the psychiatrist, and (3) among smokers, referred to cessation 
counseling by the psychiatrist. We will use generalized linear mixed 
effect models (GLMMs) to compare these screening and treatment 
rates between groups 
 
Objective 2: For intervention fidelity, we will use descriptive statistics 
to summarize the patient post-visit survey data to calculate the 
proportion of patients seen by a participating psychiatrist in each 
study arm who were asked about smoking, offered medications, 
offered counseling referral, and (among those offered) the proportion 
of patients who accepted medications and referral. We will also 
summarize training fidelity logs (the proportion of psychiatrists who 
attended the trainings and received an academic detailing session). 
To assess provider perceptions quantitatively, we will summarize 
provider survey data using descriptive statistics (means, standard 
deviations) to understand providers’ attitudes and beliefs regarding 
treating their patients for tobacco. 
 
Objective 3: We will use a similar analytic approach as in Aim 1. We 
will first categorize each patient as: (1) having achieved or not 
achieved 7-day abstinence 6 months after their psychiatry visit and 
(2) having used or not use any type of cessation treatment in the 6 
months after their visit. This will estimate use of treatment and 
abstinence rates for each study arm. We will use GLMMs to 
compare these two outcomes between groups. 
  
Qualitative Interviews: We will use ATLAS.ti to organize and analyze 
qualitative data. We will develop, test and refine a coding scheme 
based on the TDF that allows for systematic identification and 
conceptual definition of the main themes and sub-themes in the 
transcripts, as well as the relationships among the themes following 
Strauss’s process of content analysis 
 
 
 
 

Study number: s19-00813 
 
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Schematic of Study Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Opt-Out 
clinical 
reminder
Opt-In 
clinical 
reminder
Randomize 
providers
6-months: 
• Patient survey
• Provider survey 
and interview
• Administrative 
data extraction
Baseline: 
• Provider survey
• Administrative 
data extraction
Figure 1. Study Design
Opt-Out training 
and academic 
detailing
Opt-In training 
and academic 
detailing
Monthly
Patient post-
visit  survey
Training logs, 
reflections and 
observations
Ongoing
Implementation 
observations 

Study number: s19-00813 
 
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1 Key Roles 
Principal Investigator: 
Erin Rogers, DrPH (Assistant Professor) 
NYU School of Medicine 
180 Madison Avenue, Room 17-53 
New York, NY 10016 
646-501-2544 
Erin.rogers@nyulangone.org 
 
Sub-Investigator and site PI for the VA site: 
Scott Sherman, MD, MPH (Professor) 
NYU School of Medicine 
180 Madison Avenue, Room 17-55 
New York, NY 10016 
646-501-2636 
Scott.Sherman@nyulangone.org 
 
2 Introduction, Background Information and Scientific Rationale 
2.1 Background Information and Relevant Literature 
Smoking is a Significant Problem for Mental Health Patients 
Smoking is the leading preventable cause of death in the U.S., responsible for over 440,000 
deaths per year.[1] Mental health patients have rates of smoking that at are 2-4 times higher than 
those found in the general population,[2] and they smoke more heavily in terms of number of 
cigarettes smoked per day and a longer draw per cigarette.[3] This causes considerable health 
consequences for this already vulnerable population. Mortality from smoking-related 
cardiovascular disease is 2–6 times higher in persons with a mental health condition than the 
general, age-matched population.[4] Persons with serious mental illnesses die on average 25 
years earlier than the general population, and 60% of this excess mortality risk is due to smoking-
related illnesses.[5]   
 
Effective Tobacco Treatments Exist for Mental Health Patients 
Several effective tobacco treatments are available for smokers with and without a history of 
mental illness. The U.S. Public Health Service (PHS) and the American Psychiatric Association 
(APA) practice guidelines for the treatment of tobacco use include five nicotine replacement 
medications (NRT) and two non-nicotine medications (bupropion and varenicline).[6, 7] The PHS 
guidelines further recommend the combination of medications with behavioral therapy to produce 
the highest abstinence rates. Several studies, including two large randomized trials conducted by 
our team, support the effectiveness of telephone-based cessation counseling combined with NRT 
for smokers with mental health diagnoses.[8-10] Busy physicians who are unable to provide 
cessation counseling themselves can follow a brief 3A’s approach to providing tobacco treatment 
to mental health patients by – asking patients about tobacco use, advising them to quit and 
assisting them with quitting by prescribing cessation medications and referring them to a 
counseling program. 
 
Tobacco Use is Under-Screened and Under-Treated in Outpatient Psychiatry  

Study number: s19-00813 
 
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In 1996, the APA released guidelines for the treatment of nicotine dependence that recommended 
routine tobacco screening and treatment of psychiatric patients. Despite these recommendations, 
as well as the availability and need for effective cessation treatment among mental health 
patients, psychiatrists do not routinely screen or treat their patients for smoking.[11, 12] In a recent 
study, we used data from the National Ambulatory Medical Care Survey to analyze a national 
sample of outpatient psychiatry visits in the U.S. from 2006–2010. Results showed that only 60% 
of outpatient psychiatry visits included screening for tobacco use.[11] Moreover, psychiatrists 
provided cessation counseling or referral to only 23% of mental health patients known to be 
smokers. Of particular concern is that psychiatrists prescribed cessation medications to less than 
1% of these patients. 
 
Multiple Barriers Exist to Increasing Tobacco Treatment in Psychiatry that have not been 
Adequately Addressed in Prior Research 
The literature and our work have identified several barriers toward screening and treating mental 
health patients for smoking. Mental health providers often view tobacco cessation as a low priority 
for their patients,[13, 14] and many psychiatrists receive no training in tobacco cessation 
treatment in medical school or residency.[14] In a prior study, we implemented a telephone care 
program for smokers in Veterans Health Administration (VA) mental health clinics[15] and 
conducted semi-structured interviews with mental health providers to understand barriers toward 
referring patients to the program. These discussions revealed treatment barriers at multiple levels, 
including low organizational prioritization of tobacco control in psychiatry, lack of clarification for 
psychiatrists about their role in treating tobacco, lack of training and comfort among psychiatrists 
in treating tobacco, provider attitudes that smoking may benefit their patients or cessation may be 
harmful, and lack of treatment engagement by patients. Although some work has been done to 
improve tobacco training for psychiatrists,[16] there is a paucity of research on how to best 
implement tobacco treatment in mental health care. Our research aims to fill this role. 
 
Current Tobacco Treatment Systems Can Perpetuate Barriers to Tobacco Treatment for 
Vulnerable Populations  
Health care systems currently use a ‘no treatment’ default for tobacco, such that providers must 
actively choose (opt-in) to treat their patients who express interest in quitting and patients must 
actively opt to receive treatment. A failure to act by either provider or patient results in a failure to 
treat. Default bias theory and experimental evidence within the field of behavioral economics 
posits that humans have a bias to accept customary (status quo) or default options even in the 
presence of superior alternatives.[17, 18] Thus, in settings and populations for which tobacco 
treatment is uncommon or discouraged (such as psychiatry visits), an opt-in treatment approach 
may actually reinforce the status quo to not treat.  
 
2.2 Rationale 
Changing to an Opt-Out Tobacco Treatment System Should Increase Treatment Rates  
In recognizing that opt-in treatment approaches can introduce or reinforce systematic barriers to 
treatment, there has been a call in the literature to change tobacco treatment within health care 
settings to an opt-out system, where tobacco treatment is defaulted (i.e., automatically initiated) 
unless the provider or patient actively declines.[19] Research has shown that restructuring default 
options can significantly affect health-related choices and behavior.[20] Opt-out systems have 
been successful at modifying employee retirement plan contributions[21] and at dramatically 
improving rates of organ donation and HIV screening,[22] and preliminary evidence from an 
observational study suggests opt-out systems may increase the rate of cessation treatment 
referrals in maternity clinics.[23] Thus far, this approach has not been tested as a means to 

Study number: s19-00813 
 
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improve the treatment of tobacco use in a psychiatric setting, and questions remain as to the 
acceptability and effectiveness of the approach. Our proposed study aims to fill these clinical and 
scientific knowledge gaps. 
 
2.3 Potential Risks & Benefits 
2.3.1 Known Potential Risks 
 
Risk 
There is minimal risk associated with being involved with this study. One risk all participants may 
face is a breach in confidentiality; however, multiple safeguards are in place to ensure information 
security. In the event of a breach, project staff immediately report the incident to the PI, who would 
report the incident to the ISO and Privacy Officer as appropriate. The PI would also review and 
update the study’s standard operating procedures if needed and re-train staff to avoid incident 
recurrence.  
 
There will be no penalty or change in treatment if a psychiatrist declines to participate in the study. 
All psychiatrists are free to choose to participate or not. Any staff that does not participate will 
continue to treat patients exactly as they normally would, and their employment or advancement 
will be in no way negatively affected. 
 
Protection Against Risks 
Subjects will be protected against risks through all the information security safeguards put in place 
by VANYHHS. Patient information will be kept confidential and well protected.  
2.3.2 Known Potential Benefits 
 
Potential Benefits to Subjects 
The findings from this study will help inform future research and healthcare delivery at the VHA, 
and could lead to better implementation and treatment for tobacco dependence, with the potential 
to reduce smoking and its associated harms.  
 
3 Objectives and Purpose 
3.1 Primary Objectives 
 
1. To estimate the effects of an Opt-Out versus Opt-In Tobacco Treatment System on the 
proportion of mental health patients who are screened and treated for tobacco use by 
their psychiatrist.  
a. Hypothesis: An opt-out approach will be more effective at increasing tobacco 
screenings, NRT prescriptions and referrals to cessation counseling.  
 
2. To assess intervention fidelity, provider perceptions of the Opt-Out System, and barriers 
and facilitators to implementation of the Opt-Out System. 
 
3. To estimate the effects of an Opt-Out versus Opt-In Tobacco Treatment System on use 
of cessation treatment and abstinence among mental health patients who smoke. 

Study number: s19-00813 
 
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a. Hypothesis: An opt-out approach will be more effective at increasing use of 
cessation treatment and abstinence.  
 
3.2 Secondary Objectives (if applicable) 
Secondary outcomes will include patient use of cessation treatment and self-reported 7-day 
abstinence at 6 months. We will also measure intervention fidelity and provider perceptions of 
the intervention components. 
4 Study Design and Endpoints 
4.1 Description of Study Design 
 
This study will use a scientifically robust, mixed-methods, two-arm cluster-randomized study 
design. Study subjects are not NYULH employees or patients. We will implement a tobacco use 
clinical reminder for outpatient psychiatrists practicing at the VA New York Harbor Healthcare 
System (N = 20). Half of the psychiatrists will receive a reminder that encourages the psychiatrist 
to offer cessation medications and referral to cessation counseling to patients interested in quitting 
(Opt-In Reminder). The other half will receive a clinical reminder that includes a standing NRT 
order and a referral to cessation counseling that will automatically generate unless the provider 
actively opts-out (Opt-Out Reminder). Prior to implementation of the reminders, psychiatrists in 
both arms will receive a one-hour training on tobacco treatment and individual education outreach 
to demonstrate the clinical reminder and answer questions (academic detailing). 
 
We will use VA administrative data extracted on all patient visits with a participating psychiatrist 
6 months before and after implementation to calculate the study’s primary outcomes: 1) the 
percent of patients screened for smoking, 2) the percent of smokers prescribed a cessation 
medication and 2) the percent of smokers referred to counseling. To assess intervention fidelity, 
we will use training logs to track psychiatrist attendance at group and academic detailing trainings. 
Over the intervention period, we will also conduct post-visit surveys with a cluster sample of 400 
patients (20 per psychiatrist) to assess psychiatrist fidelity to the 3 A’s approach. At the end of the 
intervention period, we will conduct semi-structured interviews with 12-14 psychiatrists (6-7/arm) 
asking about their perceptions of the intervention components. We will also analyze 
implementation observations (e.g., training observations, reflection memos) and documents (e.g., 
meeting minutes) for implementation barriers and facilitators. At six months, we will survey the 
clustered 400-patient sample again to evaluate the study’s secondary outcomes: 1) patient use 
of cessation treatment in the prior 6 months and 2) self-reported 7-day abstinence at 6 months. 
 
One month before implementation of the provider training and reminders, all psychiatrists in the 
facility will be notified of the study at a required staff meeting. Psychiatrists will have the option at 
the meeting to ask questions and have the opportunity to opt-out of study participation. 
Psychiatrists will also have the opportunity to ask questions one-on-one with Drs. Rogers and 
Sherman before deciding whether to participate. Psychiatrist turn-over is low at the facility; 
however, during recruitment we will ask psychiatrists if they plan to leave in the next 6 months 
and only enroll those who have no plans to leave. When Dr. Sherman used this approach to 
provider participation in a study implementing a new tobacco treatment model in VA NYHHS 
primary care clinics, 50 of 51 primary care providers participated.[24] In the ongoing CHORD 
study, led by Dr. Schwartz, no primary care providers opted out of participation. We conservatively 
anticipate that 20 of 24 psychiatrists at the VA NYHHS will participate.   
 

Study number: s19-00813 
 
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Psychiatrists who do not opt-out of participation will be randomized to one of the two study arms, 
stratified by their patient panel size and by the number of patients who smoke (captured as a 
health factor in the EHR) in their prior-year panel. Randomization will be supervised by the study’s 
statistician. Psychiatrists who opt-out of study participation will receive the opt-in clinical reminder 
as a part of their routine care, but their performance will not be included in study analyses. 
 
 
Figure 1. Overview of study design 
 
 
 
4.2 Study Endpoints 
4.2.1 Primary Study Endpoints 
The study’s primary outcomes will measure provider rates of screening and treating their patients 
for tobacco use in the first 6 months of implementation: 1) the percent of patients screened for 
tobacco, 2) the percent of smokers prescribed a cessation medication, and 3) the percent of 
smokers referred to cessation counseling.  
5 Study Enrollment and Withdrawal 
 
5.1 Inclusion Criteria 
Study subjects are not NYULH employees or patients. In order to be eligible to participate in this 
study, an individual must meet all of the following criteria: 
A. Psychiatrists 
1. Works in outpatient psychiatry at the VA New York Harbor Healthcare System and 
has no plans to leave in the next 6 months 
B. VA patient Post-Visit Survey Population (NOT NYULH Patients) 
1. Had a visit with a psychiatrist included in the study 
2. Current smoker 
 
5.2 Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
 
A. Outpatient Psychiatrists 
1. None 
B. Patient Post-Visit Survey Population 
1. Non-English speaking 
Opt-Out 
clinical 
reminder
Opt-In 
clinical 
reminder
Randomize 
providers
6-months: 
• Patient survey
• Provider survey 
and interview
• Administrative 
data extraction
Baseline: 
• Provider survey
• Administrative 
data extraction
Figure 1. Study Design
Opt-Out training 
and academic 
detailing
Opt-In training 
and academic 
detailing
Monthly
Patient post-
visit  survey
Training logs, 
reflections and 
observations
Ongoing
Implementation 
observations 

Study number: s19-00813 
 
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5.3 Vulnerable Subjects 
Outpatient Psychiatrists (VA staff) will be included in this study.  
 
5.4 Strategies for Recruitment and Retention 
Data Sources 
 
Method of Subject Identification and Recruitment 
A. Psychiatrists (n=20) 
a. All outpatient psychiatrists at the VA NYHHS (based on administrative 
records) will be identified and notified of the study via a regular department 
meeting. Psychiatrists will have the opportunity to ask questions one-on-one 
with Drs. Rogers and Sherman before deciding whether to participate. 
Psychiatrist turn-over is low at the facility; however, during recruitment we will 
ask psychiatrists if they plan to leave in the next 6 months and only enroll 
those who have no plans to leave. 
b. Semi-Structured Interview Recruitment: We will use two methods to recruit 
psychiatrists for interviews. First, we will have a sign-up sheet during the 
training sessions and academic detailing sessions requesting volunteers. If 
we do not obtain our desired sample size using this method, we will employ 
the second approach of sending an email (with up to two follow-up emails 
and/or calls) notifying psychiatrists of the interview portion of the study with 
instructions on how to contact study staff if interested. A trained interviewer 
will follow an interview guide with a set of pre-specified questions and follow-
up probes. All interviews will be audio-taped.  
B. Patient Post-Visit Survey Population (n=400) 
c. To identify and recruit patients for the surveys, we will use the EHR to identify 
a list of patients seen by a participating psychiatrist on the day we run the 
EHR query. We will take a random selection of 5-10 male patients 
(depending on response rate) and all female patients (to increase 
representativeness of women) per psychiatrist at each monthly assessment 
point to reach out to for a survey. We aim to complete post-visit surveys with 
20 patients per psychiatrist over the intervention period (N=200/arm). 
 
 
AIM 1 Measures: Tobacco Screening, Prescriptions and Treatment Referrals  
Table 2 on page 9 of the protocol outlines our measures, data sources and data collection 
schedule for the study. Our assessment plan for Aim 1 is to use VA administrative data to 
estimate and compare the effect of the Opt-Out versus Opt-In treatment systems on the percent 
of all patients screened and treated for tobacco use by their psychiatrist during the study’s 
intervention period. The VA uses a fully electronic health record system that documents 
diagnostic and procedural data from all outpatient and inpatient encounters. The VA’s 
Informatics and Computing Infrastructure (VINCI) allows VA-affiliated researchers to query 
encounter data and has data analysts available to assist investigators with data selection. We 
will work with VINCI programmers to identify all patients seen by a participating psychiatrist in 
the six months before and after implementation of the clinical reminder. We will then ask VINCI 
programmers to calculate the percent of these patients who were screened for tobacco use by 
the psychiatrist, and then among smoking patients, the percent prescribed at least one 
cessation medication and the percent who were referred to the local cessation program. 
  

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AIM 2 Measures: Fidelity, Provider Perceptions, and Implementation Barriers and 
Facilitators  
 
Intervention Fidelity: We will use training logs and post-visit patient surveys to assess fidelity 
to the interventions:  
1. Training Logs: We will log all training activities to capture the proportion of participating 
psychiatrists who attended the training sessions and received an academic detailing 
visit, and the content and length of the academic detailing visits.  
2. Post-Visit Patient Surveys: Once a month during the 6-month intervention period we will 
survey a random sample of patients seen by a participating psychiatrist within 24 hours 
of their visit. The survey will ask patients whether their psychiatrist asked them about 
their smoking, and offered NRT and counseling, as well as the patient’s 
sociodemographics, smoking behavior, cessation treatment use, and motivation to quit.  
 
Provider Perceptions and Barriers/Facilitators to Implementation: We will use 
observations, provider surveys, and semi-structured interviews with psychiatrists to obtain rich 
data on psychiatrists’ perceptions of the different intervention components (training, 3A’s 
approach, opt-out and opt-in reminder) and implementation barriers/facilitators:  
1. Observations: We will use an approach used by Dr. Rogers on a study evaluating the 
implementation of a novel intervention for diabetes patients to collect observations 
during the study related to provider perceptions of the intervention and implementation 
barriers/facilitators. During the group training sessions, the study coordinator will take 
notes and the trainers will complete reflection memos after each session that capture the 
psychiatrists’ reactions to the training content, questions asked and any group 
discussion. The coordinator will also observe each academic detailing session and 
document psychiatrist reactions, comments and questions. The study investigators and 
coordinator will also use standardized reflection memos throughout the study to 
document issues that occur during and after implementation of the intervention 
components. All study meeting minutes (excluding confidential information) will be 
analyzed qualitatively for themes related to provider perceptions and barriers/facilitators. 
2. Provider Survey: We will use a repeated measures design to conduct an email or paper 
survey with participating psychiatrists at baseline and 6 months assessing their attitudes, 
beliefs, motivations and intentions to treat tobacco. The survey will assess the following 
domains:  
a. Attitudes toward the opt-in or opt-out reminder – We will adapt the Evidence-
Based Practice Attitude Scale (EBPAS),44,45 which was designed to measure 
mental health provider attitudes toward a new evidence based practice (EBP) 
along four dimensions: (1) the Appeal of the EBP, (2) perceived Requirements to 
use the EBP, (3) Openness to use EBP and (4) perceived Divergence between 
the EBP and their regular practice. The scale’s internal consistency reliability has 
been shown to be high-to-moderate. We will adapt the language of the scale to 
ask specifically about the study’s interventions.  
b. Psychiatrists’ perceived level of control in helping their patients quit smoking – 
Using questions adapted from the Determinants of Implementation Behavior 
Questionnaire,46 we will ask psychiatrists to indicate their level of confidence in 
helping their patients quit tobacco on 7-point scales ranging from “Not at all 
confident” to “Extremely confident.”  
c. Psychiatrists’ subjective disciplinary norms in treating tobacco – We will use 
questions from the Determinants of Implementation Behavior Questionnaire46 to 
ask psychiatrists to indicate their level of agreement on 7-point scales with the 

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statements: “Most of the psychiatrists in my department prescribe cessation 
medications for to their patients who smoke” and “Most psychiatrists in my 
department refer their patients who smoke to a smoking cessation program.”  
d. Psychiatrists’ intrinsic and extrinsic motivations to treat – We will adapt two items 
from the Treatment Self-regulation Questionnaire47 for smoking. Psychiatrists will 
be asked to rate on 7-point scales the level of truth to two statements related to 
the reasons they offer tobacco treatment to their patients. One statement will 
refer to a reason deriving from their personal beliefs about the importance of 
offering treatment. The second statement will refer to a reason deriving from the 
benefits the psychiatrist receives from the organization if he/she offers treatment.  
e. Psychiatrists’ intentions to help their patients quit smoking – We will use a 
question adapted from the Determinants of Implementation Behavior 
Questionnaire.46 Psychiatrists will respond to the statement “I intend to provide 
tobacco treatment to all my patients who smoke” on a 7-point scale ranging from 
“Agree completely” to “Disagree completely.” 
3. Semi-structured Provider Interviews: Guided by the Proctor and CFIR models, we will 
conduct semi-structured interviews with 12-14 psychiatrists (6-7 per arm) assessing their 
views on the appropriateness, acceptability and sustainability of the intervention 
components, as well as how the clinic’s inner setting (e.g., culture, norms, workflow 
compatibility with the intervention), outer setting (e.g., VA policies, psychiatric 
professional associations), psychiatrist characteristics (e.g., beliefs about the 
intervention), and the implementation process (e.g., how providers were informed, who 
championed the intervention) may impact their views on appropriateness, acceptability 
and sustainability. We will also ask psychiatrists for their insights into challenges and 
successes encountered during their participation in the intervention components.  
 
AIM 3 Measures: Patient Use of Cessation Treatment and Self-Reported Abstinence  
We will also assess patient use of cessation treatment and tobacco abstinence 6 months after 
seeing a participating psychiatrist in the two arms. For this aim, we will conduct a follow-up 
telephone survey with the 400 cluster-sampled patients who completed a post-visit survey 
during the intervention period. The follow-up survey will ask patients to indicate whether they 
used a list of tobacco treatments in the prior 6 months, including all FDA-approved cessation 
medications, in-person cessation counseling, telephone cessation counseling, and a mobile 
texting cessation service. Consistent with guidelines for measuring abstinence in pragmatic 
trials, the survey will also assess 7-day point prevalence abstinence.48 Using methods that we 
have successfully used on prior research, we will make up to 10 attempts at different times of 
the day and month to reach patients by phone for a follow-up survey. Telephone non-
respondents will be sent a survey in the mail with a pre-paid return envelope.  
 
Other Measures: Patient Characteristics 
Our patient surveys will collect additional information, including sociodemographics (age, 
gender, marital status, race/ethnicity, income), attitudes toward tobacco treatment using the 
Attitudes Toward Nicotine Replacement Therapy Scale49 adapted to ask about NRT and 
counseling, quitting self-efficacy using the Smoking Self-Efficacy Questionnaire,50 motivations 
to quit using a 0-10 scale, and smoking status and history using questions from the California 
Tobacco Survey. 51  
 
Table 2: Measures, Data Source and Collection Tool 
Measures  
Data Source  
Timing  
Aim  
PRIMARY OUTCOMES  

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Proportion of patients screened for 
smoking  
EHR  
6 months pre and post 
implementation  
1  
Proportion of smokers prescribed 
cessation medication  
EHR  
6 months pre and post 
implementation  
1  
Proportion of smokers referred for 
counseling  
EHR  
6 months pre and post 
implementation  
1  
SECONDARY OUTCOMES  
Patient use of cessation treatment  
Patient post-visit survey and 
telephone follow-up survey  
6 months before and after 
post-visit survey  
3  
Patient self-reported 7-day 
abstinence  
Patient follow-up survey  
6 months after post-visit 
survey  
3  
PROVIDER PERCEPTIONS  
Provider perceptions of the 
intervention  
Provider interviews  
Training observations  
6 months post-
implementation  
Training period  
2  
Provider attitudes toward 
treatment, self-efficacy toward 
treatment,46 treatment norms46, 
motivation7 and intention to treat46  
Provider Survey  
Baseline and 6 months post-
implementation  
2  
IMPLEMENTATION BARRIERS AND FACILITATORS  
Barriers/facilitators toward 
implementation of the intervention 
components  
Provider interviews  
Study observation logs  
6 months post- 
implementation  
Intervention period  
2 
 
5.5 Duration of Study Participation 
Both psychiatrists and patients will be participants for 6 months duration. 
5.6 Total Number of Participants and Sites 
Study subjects are not NYULH employees or patients.In total, this study plans to include 420 
participants: 
 
A. Psychiatrists (n=20) 
B. Patient Cohort (n=400 smokers) 
 
Participants will be recruited from the VA NY Harbor Healthcare System, at the Manhattan and 
Brooklyn campuses.  
 
Recruitment will end when approximately 20 psychiatrists and 400 smokers are enrolled. 
 
No recruitment or consenting will take place at NYULH. 
5.6.1 Reasons for Withdrawal or Termination 
Participants are free to withdraw from participation in the study at any time upon request. An 
investigator may terminate participation in the study if: 
• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or 
situation occurs such that continued participation in the study would not be in the best 
interest of the participant 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
 

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5.6.2 Handling of Participant Withdrawals or Termination 
After a participant withdraws, the study will not conduct any additional follow-up with the 
participant. Participants who withdraw will not be replaced.  
 
6 Behavioral/Social Intervention 
6.1 All Participants 
Both Arms: Psychiatrist Training and Academic Detailing 
Since psychiatrists cite lack of training as barrier to providing smoking cessation treatment, both 
arms will receive a 1-hour training in helping their patients quit smoking. One hour was chosen 
based on the provider trainings held by Dr. Sherman (MPI), and to maximize feasibility and fidelity 
(e.g., psychiatrist attendance) of the training. We will provide this education to both study arms, 
because education alone is necessary but not sufficient to change provider behavior.[25] 
 
The training will be a mix 
of content education and 
process 
education 
(Table 1). Our approach 
will be adapted from the 
one Dr. Sherman used to 
train primary care and 
mental health providers 
about 
depression[26] 
and the Psychiatry Rx for 
Change training program 
for psychiatry residents.[27] The lecture will include a 15-minute demonstration of motivational 
interviewing[28] (MI) in order to help psychiatrists provide brief motivational enhancement for 
patients resistant to treatment[29] (identified as a barrier in our prior psychiatrist interviews).  
To reinforce provider self-efficacy in treating mental health patients for smoking, we will also 
implement academic detailing (educational outreach) for providers in both arms. Academic 
detailing has consistently shown improvements in provider behavior.[30] Two study investigators 
will make a brief outreach visit to each psychiatrist, at least one of whom will be a physician to 
answer any questions about cessation medications. The investigators will follow a script, using 
the seven steps recommended by the National Resource Center for Academic Detailing:[31] 1) 
The Introduction; 2) Needs Assessment; 3) Key Messages/Features/Benefits; 4) Understanding 
Barriers and Enablers; 5) Identifying and Handling Objections; 6) Summary; and 7) Close. The 
key message (Step 3) will include demonstration of the clinical reminder, review of the evidence 
for smoking cessation medications and how to prescribe them, and review of the role of the facility 
Health Promotion staff and how to contact them. Note that detailing will occur after randomization, 
so each psychiatrist will receive a detailing visit on the specific intervention to which he or she will 
be exposed. 
 
6.1.1 Control Arm 
Arm 1: OPT-IN Clinical Reminder 
To increase actual and perceived behavior control and to increase perceived prioritization 
(disciplinary norms) of the treatment of psychiatric patients who smoke, we will implement a 
Content Education
• 
Epidemiology of tobacco use in psychiatric patients
• 
Tobacco treatment guidelines 
• 
Linking cessation to mental health treatment norms and outcomes
• 
Common myths about smoking in mental health patients
• 
3A’s model – ask, advise, assist
• 
Pharmacological Aids (focus on PHS guidelines)
• 
Counseling Strategies
• 
Overview of local cessation program
• 
Medication Interactions with smoking
• 
Patient resistance (motivational interviewing demonstration)
Process Education
• 
How to use clinical reminder, order NRT and refer
Table 1: Psychiatrist training 

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tobacco clinical reminder embedded within the EHR. Tobacco use clinical reminders are a best 
practice recommended by the PHS tobacco treatment guidelines and are routinely tested and 
used to address tobacco in primary care settings.[6] All VA facilities currently use clinical 
reminders, which are adapted locally and can be adapted for specific individuals or groups of 
providers. We will adapt the clinical reminder currently in use in Primary Care Clinics at VA New 
York Harbor Healthcare System, to make it suitable for the treatment of psychiatric patients who 
smoke. As we have done previously, the reminder will be self-explanatory, and will walk providers 
through each step of the 3A’s approach. The reminder will include the following domains: 
1. Ask and Advise – Providers will be prompted to ask their patients if they currently use 
tobacco and advise the patient to quit and to use treatment if interested in quitting.  
2. Assist: Medications – Providers will be able to order cessation medications by clicking a 
box associated with an order template embedded in the reminder. The VA already has pre-
set ordering templates for NRT (patch, gum, and lozenge), bupropion, and varenicline. For 
the proposed study, we will set combination NRT (patch plus gum or lozenge) as the preferred 
medication.  
3. Assist: Referral to Counseling – Providers will be able to refer patients to the local 
cessation counseling program by clicking a consult box embedded in the reminder. The 
consult will be sent to the facility’s Health Behavior Coordinator who runs the local cessation 
program. Program staff will proactively contact the patient to offer group behavioral counseling 
or warm-transfer to the VA Quitline via 3-way call for telephone counseling.  
4. Assist: Handout – The provider will be able to print out a handout for patients with: a) The 
local phone number for the VA NY Harbor Healthcare System Health Behavior Coordinator, 
b) Instructions for smoking cessation medications, and c) Information about the VA Quitline 
and text messaging service. 
Completing the reminder will turn it off for nine months. The reminder will be specific for 
psychiatrists – i.e., it will only be turned off if completed by a psychiatrist. The Tobacco Use 
Cessation clinical reminder that primary care providers complete will still be in effect and will be 
completely separate from this psychiatry reminder. 
 
 
6.1.2 Intervention Arm 
Arm 2: OPT-OUT Clinical Reminder 
Arm 2 will implement a clinical reminder that automatically initiates a standing order for NRT and 
referral to the cessation program at the time a smoker is identified. The psychiatrist will need to 
actively cancel the NRT and counseling orders in order to opt the patient out of treatment. The 
reminder will include the following domains: 
1. Ask and Advise – Providers will be prompted to ask their patients if they currently use 
tobacco. Psychiatrists will be prompted to advise patients that the VA’s goal is to help all 
patients quit by prescribing NRT and referring them to telephone tobacco cessation coaching.  
2. Assist: Automatic Medications – As discussed above, the VA has pre-set ordering 
templates for NRT, bupropion and varenicline. For smoking patients, the psychiatrist will 
receive an alert that an order for combination NRT (patch plus gum) will be placed unless the 
provider cancels the order by clicking a box within the reminder.  
3. Assist: Automatic Referral to Counseling – For smoking patients, the reminder will also 
automatically generate an electronic consult to the local smoking cessation program 

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(described above). The reminder will include a box to check if the psychiatrist does not want 
the Coordinator to follow up with the patient. 
4. Assist: Handout – The reminder will initiate the printing of a patient handout with: The local 
contact number for the VA NY Harbor Healthcare System Health Behavior Coordinator, 
Instructions for smoking cessation medications, and Information about the VA Quitline and 
text messaging service. The psychiatrist can cancel the print-out by clicking a box within the 
reminder. 
At each opt-out point (medications, counseling, handout), the psychiatrist will be asked to select 
the reason for cancellation: 1) the psychiatrist does not want to treat at this time, or 2) the patient 
refuses treatment. Completing the reminder will turn it off for 9 months, since the VA’s national 
goal is to ensure that all smokers are offered medications, counseling and referral annually. The 
reminder will be specific for psychiatrists – i.e., it will only be turned off if completed by a 
psychiatrist. The Tobacco Use Cessation clinical reminder that primary care providers complete 
will remain in effect and will be separate from this psychiatry reminder. 
 
7 Study Procedures and Schedule 
7.1.1 Study Specific Procedures 
7.1.1.1 Psychiatrist training  
One month before implementation of the provider training and reminders, all psychiatrists in the 
facility will be notified of the study at a required staff meeting.. Dr. Sherman will deliver a 
psychiatrist training adapted from Dr. Judith Prochaska, tailored for training psychiatrists on 
tobacco use cessation for mental health patients.    
7.1.1.2 Provider Randomization and Baseline Survey. 
Psychiatrists will be approached and given the opportunity to choose to participate in the study or 
opt out of participating. At this time, psychiatrists will also have the option to ask questions. 
Completion of the baseline survey during this point will serve as study assent and psychiatrist will 
then be randomized into the control group or the intervention group. 
 
7.1.1.3 Intervention (Clinical Reminders) 
Participants will be given the intervention components outlined in section 6.1 above.  
 
Psychiatrists who do not opt-out of participation will be randomized to one of the two study arms, 
stratified by their patient panel size and by the number of patients who smoke (captured as a 
health factor in the EHR) in their prior-year panel. Psychiatrists in the control arm will receive a 
clinical reminder similar to the one they currently receive as mandated by national standard. 
Psychiatrists in the intervention arm will receive a modified clinical reminder that is tailored for an 
opt-out smoking cessation approach. 
7.1.1.4 Post-Visit Patient Survey 
Patient PHI, including names, phone numbers, mental and physical health information, and 
tobacco-related measures will be obtained through CPRS and patients who see a participating 
psychiatrist. Once a month during the 6-month intervention period we will survey a random 
sample of patients seen by a participating psychiatrist within 24 hours of their visit. The survey 

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will ask patients whether their psychiatrist asked them about their smoking, and offered NRT 
and counseling, as well as the patient’s sociodemographics, smoking behavior, cessation 
treatment use, and motivation to quit.  
 
7.1.1.5 Six Month Follow-up Psychiatrist Survey and Patient Survey 
We will use a repeated measures design to conduct an email or paper survey with participating 
psychiatrists at baseline and 6 months assessing their attitudes, beliefs, motivations and 
intentions to treat tobacco. We will also assess patient use of cessation treatment and tobacco 
abstinence 6 months after seeing a participating psychiatrist in the two arms. For this aim, we will 
conduct a follow-up telephone survey with the 400 cluster-sampled patients who completed a 
post-visit survey during the intervention period 
 
7.1.1.6 Follow-up Qualitative Interview with Psychiatrists 
Guided by the Proctor and CFIR models, we will conduct semi-structured interviews with 12-14 
psychiatrists (6-7 per arm) assessing their views on the appropriateness, acceptability and 
sustainability of the intervention components, as well as how the clinic’s inner setting (e.g., culture, 
norms, workflow compatibility with the intervention), outer setting (e.g., VA policies, psychiatric 
professional associations), psychiatrist characteristics (e.g., beliefs about the intervention), and 
the implementation process (e.g., how providers were informed, who championed the 
intervention) may impact their views on appropriateness, acceptability and sustainability. We will 
also ask psychiatrists for their insights into challenges and successes encountered during their 
participation in the intervention components. 
 
7.1.2 Standard of Care Study Procedures 
Participants will receive their regular psychiatric care and tobacco treatment during the study.  
Study staff will not be involved in standard of care procedures. 
 
8 Assessment of Safety 
8.1.1 Definition of Adverse Events (AE) 
 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in 
severity during the course of the study.  Intercurrent illnesses or injuries should be regarded as 
adverse events.  Abnormal results of diagnostic procedures are considered to be adverse 
events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse event 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 
 
8.1.2 Definition of Serious Adverse Events (SAE) 
 
Serious Adverse Event 

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Adverse events are classified as serious or non-serious.  A serious adverse event is any AE 
that is:  
• fatal 
• life-threatening 
• requires or prolongs hospital stay 
• results in persistent or significant disability or incapacity 
• a congenital anomaly or birth defect 
• an important medical event 
 
Important medical events are those that may not be immediately life threatening, but are clearly 
of major clinical significance. They may jeopardize the subject, and may require intervention to 
prevent one of the other serious outcomes noted above.  For example, drug overdose or abuse, 
a seizure that did not result in in-patient hospitalization, or intensive treatment of bronchospasm 
in an emergency department would typically be considered serious.  
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-
serious adverse events.  
 
8.1.3 Definition of Unanticipated Problems (UP) 
 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
• Unexpected in nature, severity, or frequency (i.e. not described in study-related 
documents such as the IRB-approved protocol or consent form, the investigators 
brochure, etc) 
• Related or possibly related to participation in the research (i.e. possibly related means 
there is a reasonable possibility that the incident experience, or outcome may have been 
caused by the procedures involved in the research) 
• Suggests that the research places subjects or others at greater risk of harm (including 
physical, psychological, economic, or social harm). 
 
8.2 Classification of an Adverse Event 
8.2.1 Severity of Event 
 
For AEs not included in the protocol defined grading system, the following guidelines will be 
used to describe severity. 
 
• Mild – Events require minimal or no treatment and do not interfere with the participant’s 
daily activities. 
• Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic 
drug therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating. 
 

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8.2.2 Relationship to Study Intervention 
 
The clinician’s assessment of an AE's relationship to study intervention is part of the 
documentation process, but it is not a factor in determining what is or is not reported in the 
study. If there is any doubt as to whether a clinical observation is an AE, the event should be 
reported. All AEs must have their relationship to study intervention assessed. In a clinical trial, 
the study intervention must always be suspect. To help assess, the following guidelines are 
used. 
 
• Related – The AE is known to occur with the study intervention, there is a reasonable 
possibility that the study intervention caused the AE, or there is a temporal relationship 
between the study intervention and event. Reasonable possibility means that there is 
evidence to suggest a causal relationship between the study intervention and the AE. 
• Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study 
intervention and event onset, or an alternate etiology has been established. 
 
8.2.3 Expectedness 
The PI will be responsible for determining whether an AE is expected or unexpected. An AE will 
be considered unexpected if the nature, severity, or frequency of the event is not consistent with 
the risk information previously described for the study intervention. 
 
8.3 Time Period and Frequency for Event Assessment  
AEs and SAEs can be identified during any study procedure. When a study staff member learns 
of an AE or SAE, he or she will report it to the PI with 24 hours. All AEs, SAEs and Ups will be 
documented using standardized forms created for the study. 
 
8.4 Reporting Procedures – Notifying the IRB  
AEs, SAEs, and UPs will be reported to the IRB based on NYU SoM IRB reporting guidelines. 
The report will include: 
• Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• A detailed description of the event, incident, experience, or outcome; 
• An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an AE, SAE or UP; 
• A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the AE, SAE or UP. 
 
The PI will complete and sign all reports.  
 
9 Statistical Considerations 
9.1 Statistical Hypotheses 
We hypothesize that an opt-out approach will be more effective at increasing tobacco 
screenings, NRT prescriptions and referrals to cessation counseling. 
 

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9.2 Description of Statistical Methods 
 
9.2.1 General Approach 
We will first summarize survey and administrative data using descriptive statistics (means, 
medians, standard deviations, frequency distributions, and graphical displays) to characterize 
providers and patients treated by the providers in the two intervention arms.  
 
9.2.2 Analysis of the Primary Efficacy Endpoint(s) 
AIM 1: Estimate the effects of an Opt-Out versus Opt-In Tobacco Treatment System on the 
proportion of mental health patients who are screened and treated for tobacco use by their 
psychiatrist.  
Based on administrative data, we will categorize the proportion of patients seen by a participating 
psychiatrist in each group who were: (1) screened for tobacco use by the psychiatrist, (2) among 
smokers, received a cessation medication prescription from the psychiatrist, and (3) among 
smokers, referred to cessation counseling by the psychiatrist. We will use generalized linear 
mixed effect models (GLMMs) to compare these screening and treatment rates between groups. 
For all analyses, sensitivity analyses will be used to evaluate the impact on results from missing 
data and subject dropout. Specifically, missingness will be handled by creating a separate 
category, or removed by multiple imputation (MI). An intent-to-treat (ITT) approach will be 
compared with a complete-case only method.  
 
AIM 2: Assess intervention fidelity, provider perceptions, and barriers and facilitators to 
implementation: For intervention fidelity, we will use descriptive statistics to summarize the patient 
post-visit survey data to calculate the proportion of patients seen by a participating psychiatrist in 
each study arm who were asked about smoking, offered medications, offered counseling referral, 
and (among those offered) the proportion of patients who accepted medications and referral. We 
will also summarize training fidelity logs (the proportion of psychiatrists who attended the trainings 
and received an academic detailing session). To assess provider perceptions quantitatively, we 
will summarize provider survey data using descriptive statistics (means, standard deviations) to 
understand providers’ attitudes and beliefs regarding treating their patients for tobacco. For our 
qualitative data analysis (interviews, observations, reflection memos, meeting minutes), we will 
use a three-step coding process for each data source. First, two investigators will individually read 
a sub-sample of data (e.g., 3 interviews) to identify preliminary inductive codes, then meet to 
achieve consensus on coding the sub-sample and create the first draft of a code book. Second, 
the investigators will individually apply the codebook to a second sub-sample of data, and meet 
to achieve coding consensus on the second sub-sample to create final codebook for the data 
source. Third, once all data are coded, the investigators will meet to complete more focused 
coding to identify code clusters, relationships among codes, and common themes. Once all data 
sources are coded, we will also use group consensus meetings to look for themes across the four 
main data sources.  
 
AIM 3: Estimate the effect of the Opt-Out Reminder versus the Opt-In Reminder on the use of 
cessation treatment and self-reported abstinence among mental health patients who smoke: We 
will use a similar analytic approach as in Aim 1. We will first categorize each patient as: (1) having 
achieved or not achieved 7-day abstinence 6 months after their psychiatry visit and (2) having 
used or not use any type of cessation treatment in the 6 months after their visit. This will estimate 
use of treatment and abstinence rates for each study arm. We will use GLMMs to compare these 
two outcomes between groups. Sensitivity analyses will be used to evaluate the impact on results 

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from missing data and subject dropout. An IIT approach will be compared with the complete-case 
only method, but our primary analysis will be the complete case analysis, as The North American 
Quitline Consortium has found this approach to be more accurate in representing true quit rates 
and recommends use of this calculation,52 as do other reviews.53  
 
9.3 Sample Size 
We aim to enroll all practicing psychiatrists at the VA New York Harbor Healthcare System, but 
have conservatively estimated that 20 will enroll. This sample will allow us to study provider 
behavior during approximately 4,000 unique patient visits over 6 months. We calculated the level 
of power this will provide us to find a significant group effect on the proportion of patients 
prescribed a cessation medication by their psychiatrist (primary outcome 2). Our power 
calculation varied the intraclass correlation (ICC) of 0.05-0.15 based on a cluster-randomized trial 
of preventive care in primary care practices.54 We estimate that 10% of patients in Arm 1 will 
receive a prescription.15 With the smallest ICC of 0.05, a type I error of 5%, and 80% power, 
4,000 visits will provide us with enough power to detect a 21% or greater prescription rate in Arm 
2. With the largest ICC of 0.15, a type I error of 5%, and 80% power, 4,000 visits will provide us 
with enough power to detect a 29% or greater prescription rate in Arm 2.  
10 Ethics/Protection of Human Subjects 
 
10.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with Regulations for 
the Protection of Human Subjects of Research codified in 45 CFR Part 46. 
 
10.2 Institutional Review Board 
The protocol, waiver applications, recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form must be obtained before any participant is enrolled. Any amendment to the protocol will 
require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form will be IRB approved; a determination will be made regarding 
whether previously consented participants need to be re-consented. 
 
10.3 Informed Consent Process 
 
10.3.1 Consent/Assent and Other Informational Documents Provided to Participants 
Consent forms describing in detail the study intervention, study procedures, and risks are given 
to the participant and written documentation of informed consent is required prior to starting 
intervention. The following consent materials are submitted with this protocol: 
• 
Informed Consent (for psychiatrists) for qualitative interview 
• 
Audio Recording Consent (for psychiatrists) 
• 
Waiver of Documentation of Consent (Psychiatrist Study Population) 
• 
Waiver of Documentation of Consent (Patient Post-Visit Survey Population) 
 

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A waiver of authorization and a waiver of consent and documentation of consent have been 
submitted for IRB approval.  
 
10.3.2 Consent Procedures and Documentation 
Psychiatrists will have the option to  decline study participation at any point in the study. 
Psychiatrists who opt-out of study participation will receive the opt-in clinical reminder as part of 
their routine care, but their performance will not be included in study analyses. We will include a 
cover letter on the survey including all elements of informed consent. Completing the survey will 
serve as documentation of consent from psychiatrists for the baseline/6-month surveys. 
Psychiatrists face minimal risk by participating in this study and are able to withdraw at any time. 
During the consent process, subjects are able to express any questions or concerns with the 
research team. Research staff will request separate participant consent for participation in the 
qualitative interviews and for audio recording. 
 
Patient Post-Visit Survey Population (n=400). We will obtain a waiver of HIPAA authorization to 
identify smokers through CPRS. We will obtain verbal consent from participants for completing 
the short post-visit survey, and thus will obtain a waiver of documentation of consent. The 
consent will cover the post-visit survey and consent to participate in a short survey 6 months 
later to assess their use of cessation treatment and abstinence outcomes. As the survey will be 
conducted over the phone, it will not be possible to have documented informed consent.  
 
10.4 Participant and Data Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those 
regulations require a signed subject authorization informing the subject of the following:  
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information  
• The rights of a research subject to revoke their authorization for use of their PHI.  
 
The above information will be waived through a waiver of authorization for obtaining PHI, as well 
as a waiver of consent and documentation of consent for psychiatrists in the study.  
 
10.4.1 Research Use of Stored Human Samples, Specimens, or Data 
All 
electronic 
data 
will 
be 
stored 
on 
a 
secure 
VA 
research 
server 
(\\R04NYNNA/RNS21\NYN_Groups\Research). Only approved members of the research team 
will have access to the data and files in the research folder, which is housed In the VA NY Harbor 
Research drive. Additionally, all documents will be password protected. Data for this study will 
never be kept on a local hard drive. All hardcopy study materials, including consent forms, will be 
kept in a locked cabinet at the research coordinator's work space. All audio-recorded and 
transcribed data will be de-identified. The audio-recorders have been issued by the VA and have 
the necessary identification. Surveys filled out by participants will not contain any names or links 
to other identifiable information. Surveys will be anonymously entered into REDCap, a VA 
approved web application for storage and analysis.  
 

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Publications and presentations of the data will not allow identification of participants.  All physical 
documents will be safely secured in a locked cabinet monitored by members of the research team 
in Room 15028DN at the Manhattan campus of VANYHHS. 
11 Data Handling and Record Keeping 
 
11.1 Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of 
the site PI. The investigator is responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. All electronic data will be stored on a secure VA research 
server (\\R04NYNNA/RNS21\NYN_Groups\Research). The audio-recorders have been issued 
by the VA and have the necessary identification. Surveys filled out by participants will not 
contain any names or links to other identifiable information. Surveys will be anonymously 
entered into REDCap, a VA approved web application for storage and analysis. 
 
11.2 Study Records Retention 
Study documents will be retained for the longer of 3 years after close out or 5 years after final 
reporting/publication. 
 
11.3 Publication and Data Sharing Policy 
At the end of the study, the PI will make results of the research available to the research 
community and public at large by submitting at least one manuscript to a peer-reviewed journal 
reporting main findings and submitting at least one abstract for presentation at a national research 
conference. The PI (Dr. Rogers) will be responsible for resolving authorship issues. We plan to 
publish study results in respected peer-reviewed journals and present at national conferences. 
 
12 Study Finances 
12.1 Funding Source 
This study is funded by the National Institute on Drug Addiction (NIDA). 
 
12.2 Costs to the Participant 
There are no costs associated with participating in this study. 
 
12.3 Participant Reimbursements or Payments 
Participants will be reimbursed for their time depending on their amount of participation: 
 
A. Psychiatrists 
a. Psychiatrists will not be reimbursed for their l participation in using the studies 
modified clinical reminder or current clinical reminder (opt-in-versus-opt-out 
reminders) in the study, as their role will be to implement standard treatment of 
care. 

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b. Psychiatrists will be compensated $10 for each survey they complete, for up to 
$20. 
c. Psychiatrists who participate in the semi-structured interviews will be paid $20 for 
their time. 
B. Patient Post-Visit Survey Population 
a. Participants will be compensated $10 each for completing the post-visit survey 
and 6 month follow-up survey, for up to $20. 
 
The study will adhere to NYULH human subject payment policy and allowable payment methods. 
13 References 
 
1. 
Centers for Disease, C. and Prevention, Annual smoking-attributable mortality, years of potential 
life lost, and economic costs--United States, 1995-1999. MMWR Morb Mortal Wkly Rep, 2002. 
51(14): p. 300-3. 
2. 
Grant, B.F., et al., Nicotine dependence and psychiatric disorders in the United States: results from 
the national epidemiologic survey on alcohol and related conditions. Arch Gen Psychiatry, 2004. 
61(11): p. 1107-15. 
3. 
Williams, J.M. and D. Ziedonis, Addressing tobacco among individuals with a mental illness or an 
addiction. Addict Behav, 2004. 29(6): p. 1067-83. 
4. 
Goff, D.C., et al., Medical morbidity and mortality in schizophrenia: guidelines for psychiatrists. J 
Clin Psychiatry, 2005. 66(2): p. 183-94; quiz 147, 273-4. 
5. 
Colton, C.W. and R.W. Manderscheid, Congruencies in increased mortality rates, years of potential 
life lost, and causes of death among public mental health clients in eight states. Prev Chronic Dis, 
2006. 3(2): p. A42. 
6. 
A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public 
Health Service report. Am J Prev Med, 2008. 35(2): p. 158-76. 
7. 
Practice guideline for the treatment of patients with nicotine dependence. American Psychiatric 
Association. Am J Psychiatry, 1996. 153(10 Suppl): p. 1-31. 
8. 
Rogers, E.S., et al., Telephone Smoking-Cessation Counseling for Smokers in Mental Health 
Clinics: A Patient-Randomized Controlled Trial. Am J Prev Med, 2015. 
9. 
Grossman, E., et al., Effectiveness of smoking-cessation interventions for urban hospital patients: 
study protocol for a randomized controlled trial. Trials, 2012. 13: p. 126. 
10. 
Lukowski, A.V., et al., Quitline Outcomes for Smokers in 6 States: Rates of Successful Quitting 
Vary by Mental Health Status. Nicotine Tob Res, 2015. 17(8): p. 924-30. 
11. 
Rogers, E. and S. Sherman, Tobacco use screening and treatment by outpatient psychiatrists 
before and after release of the American Psychiatric Association treatment guidelines for nicotine 
dependence. Am J Public Health, 2014. 104(1): p. 90-5. 
12. 
Montoya, I.D., et al., Identification and treatment of patients with nicotine problems in routine clinical 
psychiatry practice. Am J Addict, 2005. 14(5): p. 441-54. 
13. 
Schroeder, S.A. and C.D. Morris, Confronting a neglected epidemic: tobacco cessation for persons 
with mental illnesses and substance abuse problems. Annu Rev Public Health, 2010. 31: p. 297-
314 1p following 314. 
14. 
Prochaska, J.J., et al., Training in tobacco treatments in psychiatry: a national survey of psychiatry 
residency training directors. Acad Psychiatry, 2006. 30(5): p. 372-8. 
15. 
Rogers, E., et al., Telephone care coordination for smokers in VA mental health clinics: protocol for 
a hybrid type-2 effectiveness-implementation trial. Addict Sci Clin Pract, 2013. 8: p. 7. 
16. 
Prochaska, J.J., et al., Evaluation of an evidence-based tobacco treatment curriculum for psychiatry 
residency training programs. Acad Psychiatry, 2008. 32(6): p. 484-92. 
17. 
Camerer, C.F., Behavioral economics. Curr Biol, 2014. 24(18): p. R867-71. 
18. 
Camerer, C., Behavioral economics: reunifying psychology and economics. Proc Natl Acad Sci U 
S A, 1999. 96(19): p. 10575-7. 
19. 
Richter, K.P. and E.F. Ellerbeck, It's time to change the default for tobacco treatment. Addiction, 
2015. 110(3): p. 381-6. 

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This material is the property of the NYU School of Medicine and NYU Langone Health.  Do not disclose or use except as authorized 
in writing by the study sponsor 
Behavioral Intervention Template Version: 11 January 2019 
20. 
Loewenstein, G., T. Brennan, and K.G. Volpp, Asymmetric paternalism to improve health 
behaviors. JAMA, 2007. 298(20): p. 2415-7. 
21. 
B.C., M. and D. F.S., The Power Of Suggestion: Inertia In 401(k) Participation And Savings 
Behavior. Quarterly Journal of Economics, 2001. v116(4,Nov): p. 1149-1187. 
22. 
Walmsley, S., Opt in or opt out: what is optimal for prenatal screening for HIV infection? Cmaj, 
2003. 168(6): p. 707-8. 
23. 
Bauld, L., et al., Implementation of routine biochemical validation and an 'opt out' referral pathway 
for smoking cessation in pregnancy. Addiction, 2012. 107 Suppl 2: p. 53-60. 
24. 
Schwartz, M.D., et al., Panel Management to Improve Smoking and Hypertension Outcomes by 
VA Primary Care Teams: A Cluster-Randomized Controlled Trial. J Gen Intern Med, 2015. 
25. 
Forsetlund, L., et al., Continuing education meetings and workshops: effects on professional 
practice and health care outcomes. Cochrane Database Syst Rev, 2009(2): p. CD003030. 
26. 
Sherman, S.E., et al., Teaching systems-based practice to primary care physicians to foster routine 
implementation of evidence-based depression care. Acad Med, 2007. 82(2): p. 168-75. 
27. 
Prochaska, J.J., et al., Designing for dissemination: development of an evidence-based tobacco 
treatment curriculum for psychiatry training programs. J Am Psychiatr Nurses Assoc, 2009. 15(1): 
p. 24-31. 
28. 
Steinberg, M.L., et al., Motivational interviewing with personalized feedback: a brief intervention for 
motivating smokers with schizophrenia to seek treatment for tobacco dependence. J Consult Clin 
Psychol, 2004. 72(4): p. 723-8. 
29. 
Steinberg, M.L., et al., An Adaptation of Motivational Interviewing Increases Quit Attempts in 
Smokers With Serious Mental Illness. Nicotine Tob Res, 2016. 18(3): p. 243-50. 
30. 
O'Brien, M.A., et al., Educational outreach visits: effects on professional practice and health care 
outcomes. Cochrane Database Syst Rev, 2007(4): p. CD000409. 
31. 
Farrell, S., et al., Introductory Guide to Academic Detailing. 2013, National Resource Center for 
Academic Detailing. 
 
14 Appendices 
 
A. Intervention Form  
a. Form A: Referral Form 
b. Form B: Opt-out Form 
B. Smoking Cessation Handout 
C. Patient Post-Visit Survey Verbal Consent Script 
D. Brief Qualitative Interview Guide 
E. Patient Post-Visit Survey 
 
 
 
 
 
 
 
 
 
 
 
 

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