Testing an Organizational Change Model to Address Smoking in Mental Healthcare
Phase: NA
Conditions: Nicotine Dependence
Sponsor: University of Pennsylvania

Organizational Change Model to Address Smoking 
 
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TESTING AN ORGANIZATIONAL CHANGE MODEL TO ADDRESS SMOKING 
IN MENTAL HEALTHCARE 
 
 
Principal Investigator  
Dr. Robert A. Schnoll 
Department of Psychiatry (4435) 
Center for Interdisciplinary Research on Nicotine Addiction 
3535 Market Street, Suite 4100, Philadelphia, PA 19104 
Phone: 215-746-7143 
Email: schnoll@mail.med.upenn.edu 
Regulatory Sponsor 
 
National Cancer Institute 
Funding Sponsor 
 
National Cancer Institute 
IRB Number 
823871 
NIH Grant Number 
 
1 R01 CA202699-01A1 
 
 
Initial version 
V1: 05-04-2016 
Amended 
V2: 07-24-2016   
 
V3: 08-29-2016 
 
V4: 09-26-2016 
 
V5: 11-14-2016 
 
V6: 04-10-2017 
 
V7: 05-01-2017 
  
V8: 06-13-2017 
 
V9: 07-24-2017 
 
V10: 07-24-2018 
 
V11: 07-24-2018 
 
V12: 03-27-2019 
 
V13: 05-06-2019 
 
V14: 05-28-2019 
 
V15: 07-05-2019 
 
V16: 09-23-2019 
 
V17: 02-21-2020 
 
V18:03-19-2020 
 
V19:05-29-2020 
 
V20:06-22-2020 
 
V21:08-11-2020 
 
V22:09-24-2020 
 
V23:11-16-2020 
 
V24:04-29-2021 
 
V25:09-01-2021 
 
V26: 10-07-2021 
 
V27:11-04-2021 
 
V28:01-19-2022 

Organizational Change Model to Address Smoking 
 
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TABLE OF CONTENTS 
1 
STUDY SUMMARY 
4 
2 
INTRODUCTION 
5 
2.1 
STUDY SIGNIFICANCE AND RATIONALE 
6 
2.2 
RELEVANT LITERATURE 
9 
3 
STUDY OBJECTIVES 
10 
3.1 
PRIMARY OBJECTIVES 
10 
3.2 
SECONDARY AND EXPLORATORY OBJECTIVES 
10 
4 
INVESTIGATIONAL PLAN 
10 
4.1 
GENERAL DESIGN 
10 
4.2 
RANDOMIZATION TO INTERVENTIONAL GROUP 
11 
4.3 
RATIONALE FOR STUDY DESIGN 
111 
4.4 
STUDY TIMELINE 
11 
4.5 
STUDY MEASURES 
12 
4.6 
STUDY ENDPOINTS 
14 
4.6.1 
Primary Study Endpoints 
14 
4.6.2 
Secondary Study Endpoints 
14 
5 
STUDY POPULATION AND DURATION OF PARTICIPATION 
14 
5.1 
DURATION OF STUDY PARTICIPATION 
15 
5.2 
TOTAL NUMBER OF SUBJECTS AND SITES 
15 
5.3 
INCLUSION CRITERIA 
15 
5.4 
EXCLUSION CRITERIA 
15 
5.5 
SUBJECT RECRUITMENT 
15 
5.6 
VULNERABLE POPULATIONS 
16 
6 
STUDY PROCEDURES 
16 
6.1 
PARTICIPANT SCREENING 
18 
6.1.1 
Baseline 
18 
6.1.2 
Pre-Week 1 Phone Call (ATTOC Clinics Only) 
18 
6.2 
STUDY INTERVENTION PHASE 
18 
6.2.1 
Overview of Interventions 
18 
6.2.2 
Week 1 
17 
6.2.3 
Weeks 4 and 8 
18 
6.2.4 
Week 12 
18 
6.2.5 
Weeks 16 through 52 
19 
6.3 
SESSION WINDOWS 
19 
6.4 
SUBJECT WITHDRAWAL 
19 
7 
STATISTICAL PLAN 
19 
7.1 
SAMPLE SIZE AND POWER DETERMINATION 
21 
7.2 
STATISTICAL METHODS 
22 
7.2.1 
Analysis of Outcomes of Interest 
22 
8 
SAFETY AND ADVERSE EVENTS 
23 
8.1 
DATA SAFETY MONITORING PLAN (DSMP) 
23 
8.2 
INTERNAL MONITORING AND AUDITING 
24 
8.3 
REPORTING OF ADVERSE EVENTS AND UNANTICIPATED PROBLEMS 
24 
9 
STUDY ADMINISTRATION, DATA HANDLING AND RECORD KEEPING 
24 
9.1 
CONFIDENTIALITY 
24 
9.2 
SOURCES OF RESEARCH MATERIAL 
25 
9.3 
COMPUTERS AND DATABASES 
25 
10 
ETHICAL CONSIDERATIONS 
25 
10.1 
RISKS 
25 
10.2 
RISK MINIMIZATION 
26 
10.3 
BENEFITS 
26 
10.4 
RISK BENEFIT ASSESSMENT 
26 

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10.5 
INFORMED CONSENT PROCESS / HIPAA AUTHORIZATION 
27 
11 
RESOURCES NECESSARY FOR HUMAN RESEARCH PROTECTION 
2627 
11.1 
QUALIFICATIONS OF INVESTIGATORS 
26 
11.2 
RESEARCH STAFF 
26 
12 
STUDY FINANCES 
27 
12.1 
FUNDING SOURCE 
27 
12.2 
CONFLICT OF INTEREST 
27 
12.3 
SUBJECT COMPENSATION 
27 
13 
PUBLICATION PLAN 
28 
14 
REFERENCES 
29 
 

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1 
Study Summary 
 
Title 
Testing an Organizational Change Model to Address Smoking in Mental Healthcare 
Short Title 
Organizational Change Model to Address Smoking 
IRB Number 
823871 
Methodology 
This cluster randomized trial will be conducted in 14 Philadelphia community mental health clinics 
(CMHCs). Clinics will be randomized to either Addressing Tobacco Through Organizational Change 
(ATTOC) or Usual Care (UC) treatment groups and will be matched according to the following criteria:  
• 
Size  
• 
Organizational motivation 
Study Duration 
The estimated duration of participation for all subjects is 60 months. Individual study subject 
participation will last approximately 56 weeks. 
Study Center(s) 
The University of Pennsylvania will serve as the primary project location, and all recruitment and data 
collection efforts will be executed by University of Pennsylvania staff members. A subcontract has been 
established with the University of California – San Diego and University of New Mexico to oversee the 
implementation of the ATTOC intervention. 
Objectives 
Primary: 
• 
Aim 1: To evaluate the effects of the ATTOC intervention on provider adherence to the United 
States Public Health Service (USPHS) clinical practice guidelines for treating tobacco use 
disorder (TUD).  
• 
Aim 2: To assess the effects of the ATTOC intervention on rates of client smoking.  
• 
Aim 3: To evaluate the effects of the ATTOC intervention on client mental health functioning 
and quality of life (QOL).  
Secondary: 
• 
Aim: To assess the cost-effectiveness of the ATTOC intervention.  
Exploratory: 
• 
Aim 1: To assess changes in cultural and systemic barriers to treatment as mediators of the 
effects of the ATTOC model on provider adherence to guidelines for treating TUD and client 
smoking. 
• 
Aim 2: To inform model dissemination, we will identify components of the ATTOC intervention 
that predict greater change in provider adherence to guidelines for treating TUD and client 
smoking. 
Number of 
Subjects 
Recruitment will include14 CMHC sites with projected subject recruitment totals of ~280 clinic 
personnel and ~700 clients across all sites. 

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Main Inclusion 
and Exclusion 
Criteria 
Agency Inclusion Criteria: 
• 
Use of an electronic health record (EHR) system 
• 
Must report client prescription data to Community Behavioral Health (CBH) 
• 
Must have at least 12 personnel who have clinical interactions with clients 
Personnel Subject Inclusion Criteria:  
• 
Must be 18 years of age or older 
• 
Must carry out clinical or supervisory duties 
• 
Must demonstrate the ability to communicate in English and provide written or verbal informed 
consent 
Client Subject Inclusion Criteria: 
• 
Must be 18 years of age or older 
• 
Must report daily average smoking of 5 cigarettes/day for the past 6 months  
• 
Must have a documented DSM Axis I or II disorder 
• 
Must demonstrate the ability to communicate in English and provide written or verbal informed 
consent 
Client Subject Exclusion Criteria: 
• 
Exclusive use of electronic cigarettes  
Intervention  
The trial will test a training intervention (ATTOC) designed to address organizational level change to 
promote improved treatment of nicotine dependence compared to usual care.  
Statistical 
Methodology 
• 
Sample characteristics will be assessed by treatment arm and site with chi-square or 
regression for their relationship to completion of outcomes (variables related to treatment arm 
or completion of follow-ups may be covariates in analyses.) 
• 
Fidelity and adherence measures will be evaluated across treatment arms, and the measures 
can be included in primary analyses. 
• 
Rate of missing data will be assessed as related to a range of variables using chi-square and 
regression and using appropriate methods for dealing with missing data. 
Data and Safety 
Monitoring Plan  
The study will be monitored by the PIs and co-investigators, and regulatory committees at the 
University of Pennsylvania (i.e., IRBs, OHR) as well as by a study specific Community Advisory 
Council and the Philadelphia Department of Public Health Institutional Review Board. During the 
course of the study, safety and data quality monitoring will be performed on an ongoing basis by the 
Principal Investigators and the study staff.  
2 
Introduction 
The information that follows constitutes the research protocol for the Testing an Organizational Change Model to Address 
Smoking in Mental Healthcare study. This study will be conducted in compliance with the provisions set forth in this document. 
This study will also be conducted in full accordance with all applicable University of Pennsylvania Research Policies and 
Procedures, Good Clinical Practice Standards and all applicable Federal and state laws and regulations including 45 CFR 46, 
21 CFR Parts 50, 54, 56. All episodes of noncompliance will be documented. 
 
Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000, the rate of smoking among 
persons with a serious mental illness (SMI) remains 2-3 times greater than in the general population [1]. Further, even the recent 
small decline in smoking rates that has been reported in the general population in the past decade has not occurred among 
smokers with an SMI [2]. In fact, 44% of all the cigarettes consumed in the US are by individuals with a psychiatric disorder [3] 
and the primary cause of death among Americans with an SMI is a tobacco-related disease [4, 5]. Unfortunately, smokers with 
an SMI are typically excluded from smoking cessation clinical trials, < 25% of smokers with an SMI receive evidence-based 
treatment for their tobacco use disorder (TUD; [6-8]), and mental health clinicians, compared to other specialists, are 

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significantly less likely to address TUD in their practice [9]. Transforming the mental healthcare system to integrate and adhere 
to evidence-based guidelines for the provision of TUD treatment is a priority of the National Institute of Mental Health (NIMH; [1]) 
and is a critical component of a national effort to meet Healthy People 2020 target goals for tobacco use 
(www.healthypeople.gov). 
 
Indeed, current FDA-approved medications and guideline-based behavioral treatments for TUD can be as safe and efficacious 
for smokers with an SMI as they are for the general population [10], including varenicline for smokers with schizophrenia [11], 
major depression [12], or bipolar disorder [13]. Further, there are compelling reasons to expect that integrating smoking 
cessation treatment within community mental healthcare may be an especially effective strategy for addressing TUD among 
those with SMI. For instance, community mental healthcare providers have frequent and prolonged contact with their clients, 
who see them as a primary source for their healthcare [14-16]. Yet, cultural practices and beliefs (e.g., giving cigarettes to 
clients as behavioral reinforcers; a disconnection of mental health and wellness, the unsubstantiated belief that smoking 
cessation will cause psychiatric decompensation) and systemic issues (e.g., lack of training, ineffective use of an EHR, clinic 
personnel smoking behavior) are barriers to the treatment of TUD within the mental healthcare system [14, 17]. Thus, the 
adoption, implementation, and sustainability of evidence-based treatment for TUD within public mental healthcare clinics 
requires an organization-level intervention that adequately addresses the essential barriers that hinder effective care [8]. Our 
preliminary studies in community healthcare settings have shown that implementing organization-level interventions reduces 
barriers to integrating evidence-based TUD treatment and improves clinician adherence to treatment guidelines [18, 19]. Here, 
we propose, for the first time, use of a randomized clinical trial design, to examine our Addressing Tobacco Through 
Organizational Change (ATTOC) organization-level treatment model for improving adherence to US Public Health Service 
(USPHS; [20]) guidelines for treating TUD and reducing smoking rates among those with an SMI receiving care at community 
mental healthcare clinics.  
2.1 
Study Significance and Rationale 
The Challenge: Between 1960 and 2000, the US adult smoking rate dropped from >50% to about 20% [21]. This stands as a 
monumental public health achievement and was driven by enhanced public education concerning the adverse health effects of 
smoking, the development of efficacious behavioral treatments and medications, and enhanced public health policies. Yet, this 
success has, at best, plateaued or, at worst, come to a complete stop; indeed, the US adult smoking rate has remained at about 
20% for the past decade [21]. Without dramatic initiatives directed towards reducing the US rate of tobacco use, it is not likely 
that we will attain the Healthy People 2020 target for adult tobacco use of 12%. 
 
Possible Solutions: There are likely several reasons for the stalled progress in smoking cessation rates over the past decade. 
Because only 1/3 of smokers who use evidence-based treatments for TUD (counseling and medication) are able to quit smoking 
[20], new treatments, or novel ways to use existing treatments, are needed, with work in this area ongoing [22, 23]. The impact 
of novel and existing treatments, however, depends on clinicians providing, and smokers using, such treatments. Regrettably, 
the rates of utilization of evidence-based treatments for TUD are as low as 6% [24]. And, despite the availability of evidence-
based treatment guidelines [20] and the fact that nearly 70% of all smokers interact with, and respect the advice given to them 
by a healthcare provider, large national surveys show that 1/3-1/2 of clinicians do not provide smokers with evidence-based 
treatments for TUD [9]. A fundamental way to reduce US smoking rates is to increase healthcare provision and smoker uptake 
of evidence-based treatments for TUD. 
 
Targeted Solutions: The under-utilization of evidence-based treatments for TUD is a particular public health problem among 
smokers with a serious mental illness (SMI). Smokers with an SMI are excluded from enrollment in most efficacy trials of 
treatments for TUD [25] and most clinicians working with persons with an SMI do not address TUD during their clinical 
encounters. In a national study of ~10,000 clinical encounters with a psychiatrist, 12% of clients who smoke were offered TUD 
treatment [26]. Other studies have found rates of TUD treatment among those with an SMI to be as low as 9% [27]. In fact 
psychiatrists are less likely to treat TUD than other physicians [28, 29]. More recent studies indicate that rates of TUD treatment 
for those with an SMI have increased but are no greater than ~25% [6, 7, 30, 31] and psychiatrists are still significantly less likely 
than primary care physicians to assist clients in quitting smoking [9]. A recent study showed that outpatient psychiatrists provide 
cessation counseling for 23% of clinic visits and provide nicotine replacement therapy (NRT) for <1% of clients [8]. Despite 
consensus from the USPHS [20], the American Psychiatric Association [32], and the NIH supporting the use of the same 
evidence-based cessation treatments used in the general population of smokers for those with an SMI, these smokers are 
inadequately treated for their TUD and remain one of the most under-served groups of smokers in the US. 
 
The Consequences: The inadequate provision of evidence-based treatments for TUD among persons with an SMI contributes to 
a rate of smoking in this sub-group of Americans that is 2-3 times greater than the general US population [1, 17, 33]; the 
smoking rates among individuals with  PTSD, generalized anxiety disorder, major depression, dysthymia, bipolar disorder, or a 
psychotic disorder are: 45%, 46%, 37%, 38%, 69%, and 49%, respectively [1]. Although individuals with a psychiatric disorder 
comprise 7% of the US population, they account for 44% of the entire US tobacco market [3]. This rate of tobacco use translates 
into greater morbidity and mortality for clients with an SMI vs. the general population [34-36]. Compared to age- matched 
controls, individuals with an SMI are twice as likely to be diagnosed with cancer or cardiovascular and respiratory diseases [37, 
38]. Compared to clients with an SMI who do not smoke, smoking clients with an SMI show increased medical comorbidity, 
psychiatric symptoms, hospitalizations, substance abuse, and medication dosage increases [39-41]. The leading cause of death 
among Americans with an SMI is a tobacco- related disease [4, 5]. Finally, tobacco (not nicotine) induces the cytochrome P450 

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enzyme (CYP1A2) and speeds metabolism of many antipsychotics, anti-depressants, and anxiotlytics [39]. As such, smokers 
with an SMI require higher doses of medication than non-smokers with an SMI, increasing side effects and costs [16]. 
 
Barriers to Treating TUD among those with an SMI: The high rate of smoking among those with an SMI may be related to 
shared genetic factors between TUD and an SMI and the subjective benefits of nicotine (e.g., reduced negative affect, enhanced 
cognitive function) [16]. However, systemic and cultural factors endemic to many agencies that care for clients with an SMI 
undermine care and support tobacco use in this population [14, 17, 42]. For example, almost 1/4 of US psychiatric hospitals 
permit client smoking on premises [43] and smoking is often used as an incentive for pro-social behavior or treatment 
compliance [14]. 
 
Systemic Barriers: Table 1 lists structural and personnel barriers to TUD treatment in studies of mental healthcare facilities [14, 
17, 44]. These agencies under-utilize centralized methods to identify, track, and treat smokers, lack the expertise needed to 
provide effective care, and support policies that undermine TUD client care. These barriers reduce the likelihood that personnel 
will provide TUD treatment [9, 20] and specific strategies for each barrier have been suggested [15, 45]. Cultural barriers involve 
adopting a harm reduction perspective regarding TUD among clients with an SMI, meaning that smoking is seen as less harmful 
than the assumed consequences of cessation: decompensation, depression, self-injurious behavior, use of alcohol or illicit 
drugs, and removal of an effective coping strategy [14, 42, 44]. These beliefs decrease the likelihood that healthcare personnel 
will provide TUD treatment [31] and are considered essential targets for promoting clinician adherence to treatment guidelines 
[42]. These beliefs are contrary to existing data (e.g., quitting smoking does not lead to decompensation [46-50] but is 
associated with improved psychiatric functioning [25]). 
 
Model of Organization Change to Promote TUD Treatment for those with an SMI: Adequately addressing the barriers to the 
provision of treatments for TUD among clients with an SMI will require innovations in clinical systems and culture [15, 45] that 
should be guided by organization change theory [51]. Organizational Development Theory (ODT) is a framework for guiding the 
implementation of system-wide interventions using behavioral science strategies to improve the effectiveness of an organization 
[52]. ODT interventions focus on 3 organizational characteristics to facilitate organizational change: 1) organizational climate 
(i.e., beliefs of the organization established by organization leaders), 2) organizational culture (i.e., assumptions, values, and 
behavioral norms); and 3) organizational capacity (i.e., the adequacy of resources to meet organizational goals; [52]). Within an 
ODT framework, implementing and evaluating an organizational level intervention involves the use of external experts to: 1) 
diagnose (identify areas in need of improvement and potential causal factors); 2) develop change plans (i.e., identify strategies 
to resolve concerns raised during diagnosis); 3) conduct interventions (i.e., implement change plans); and 4) oversee 
evaluations (i.e., assess rate of implementation and improvement in areas identified during diagnosis [53-55]). 
 
The Addressing Tobacco Through Organizational Change (ATTOC) model is a systems-level intervention to address systemic 
and cultural barriers that undermine assessment and treatment of TUD [51]. In this innovative way, ATTOC assumes that 
effective organizational change requires more than clinic personnel training; it also requires the application of organizational 
theory to address attitudinal and system barriers and promote a culture in which tobacco use is not accepted or supported [16] 
and that TUD treatment is integrated into standard practice. Consistent with ODT, ATTOC is implemented in 3 phases (Table 2): 
preparing for, implementing, and sustaining change. By addressing cultural barriers and strengthening the care system (e.g., 
integrated treatment), ATTOC intends to have sustained benefits beyond the intervention.  
 
ATTOC has been implemented as a quality improvement initiative in >100 mental health and addiction setting, including VA 
community-based outpatient clinics, Psychosocial Rehabilitation Clubhouse settings, and mental health centers in China. 
Recently, the Connecticut Dept. of Public Health used ATTOC in 9 outpatient mental healthcare agencies (see Preliminary 
Studies). While these projects show the feasibility and potential impact of implementing ATTOC in the type of setting proposed 
in this application, there has been little systematic evaluation of the model’s impact on client tobacco use or other important 
clinical outcomes and no study to date has used a randomized trial design with a control group. The lone published evaluation of 
Table 1. Systemic and Cultural Barriers to Implementing TUD Treatment for Clients with SMI and Potential 
Barriers 
Solution 
Systemic 
Lack of resources to treat TUD 
Integrated treatment within Wellness Programs and 
linkage to no- cost pharmacotherapy via Medicaid 
Lack of knowledge for treating TUD 
Provision of expert training program 
Allowing smoking around and within the agency 
Assistance with establishment of smoke-free site 
Tobacco use by mental health agency personnel 
Education about effects of clinic personnel smoking & help 
with personnel cessation 
Lack of systems to identify clients who smoke  and track 
provision of treatment 
Modify existing electronic medical record to assess, track, 
and treat tobacco use 
Cultural 
Provider beliefs: persons with SMI are not interested in 
treatment or cannot understand benefits of cessation 
Education concerning quit motivation, quit rates, and 
recognition of the benefits of quitting 
Provider beliefs: smoking ensures mental stability & 
cessation will worsen SMI symptoms 
Education concerning the evidence that smoking cessation 
does not worsen mental health functioning 
Provider beliefs: treating TUD is not their responsibility 
Site leadership to make provision of TUD treatment a 
responsibility 

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ATTOC was conducted in the context of in-patient substance abuse treatment and used a non-randomized, single-arm, 
prospective design [18] [see also Preliminary Studies section for our pilot studies]. Three residential, substance abuse treatment 
sites received the   ATTOC intervention. Clinician behavior and client tobacco use was assessed pre- and post-intervention, and 
at a 6- month follow-up. On an organizational level, clinician beliefs about treating TUD became significantly more positive and 
clinician provision of NRT significantly increased post-intervention (verified by clients). On an individual level, significant post-
treatment improvements were reported in: client willingness to quit and use of TUD treatments. Tobacco use rates among 
clients, however, were not significantly lower post-intervention. Several reasons could explain this but, most notably, clients 
remained at the clinic for a mean of 6-7 weeks and, thus, were exposed to an enhanced model of care for a short time. Also, 
and perhaps most important, subjects in the pre-post evaluations were different inpatient cohorts. Further, bupropion, 
varenicline, and combination NRT were not offered as treatment options, each of which is superior to nicotine patch [20]. Lastly, 
policy changes, including on-campus tobacco use, were challenging to implement in a residential treatment setting (although we 
have shown this is feasible [56]). While these data support the feasibility and impact of ATTOC on key barriers to cessation, 
studies – using a randomized design, tracking individual client outcomes, targeting out-client settings that provide sustained 
care, and promoting more effective medications are needed to fully evaluate the ATTOC model for addressing TUD among 
those with an SMI. 
 
Community Mental Healthcare is Optimal Setting: ATTOC may be well-suited to community mental healthcare settings. First, 
individuals with SMI view community mental healthcare providers as a primary source for healthcare and TUD treatment [57]. 
Very few individuals with an SMI receive consistent medical care or have a designated primary care physician [14]. Surveys of 
those with an SMI show that those who smoke would appreciate greater assistance from their mental health counselor to quit 
smoking [58]. Second, community mental healthcare providers have frequent and prolonged contact with their clients, often 
lasting years, allowing for repeated and extended TUD treatment, which may be more effective vs. short-term treatment [59], 
and allow for close monitoring of responses to pharmacotherapy and  cessation, ensuring safety, adherence, and adjustments to 
psychiatric medications [14]. Third, community mental healthcare staff has extensive training in, and experience with, providing 
behavioral and pharmacological addiction treatment [15]. Agencies have successfully integrated addiction treatment within their 
standard of care (e.g., [60]) and an integrated model can be more effective for reducing tobacco use than referring clients to 
outside services [50]. Fourth, community mental healthcare agencies have incorporated Wellness and Recovery initiatives into 
standard care, within which TUD treatment can be integrated [14-16, 61, 62]. Many community mental healthcare facilities, 
including those in Philadelphia (http://www.dbhids.org/recovery-transformation-papers), have moved beyond managing 
symptoms to include issues such as diet, exercise, stress management, and annual medical and dental visits [63, 64]. Lastly, 
while community mental healthcare clinics are autonomous, they are often overseen by centralized administrative agencies. In 
2012, Philadelphia established The Evidence-Based Practice and Innovation Center, a group of academics, city officials, and 
community mental health experts, to coordinate the implementation of effective innovations into care throughout the mental 
healthcare system (see letter of support). This aspect of community mental health services can be leveraged to facilitate 
dissemination of the training program should it be shown to be efficacious in the present trial. 
 
Innovation: This study is innovative in several ways. First, this will be the first evaluation of ATTOC within outpatient community 
mental healthcare using a single client cohort and a randomized controlled trial design. If our main hypotheses are supported, 
the trial results may encourage evidence-based innovation in how TUD is treated within community mental healthcare 
organizations. 
Second, 
while 
we 
will 
evaluate changes in barriers and clinician 
behavior, as done previously, we will also 
assess, for the first time, changes in 
individual smoking behaviors, mental health 
functioning and QOL, as well as cost-
effectiveness 
following 
ATTOC 
implementation. Third, we will use the EHR 
to implement smoking cessation treatment 
and 
to 
monitor 
key 
outcomes 
(e.g., 
prescription data). By implementing the trial 
within public mental healthcare clinics, the 
study uses existing infrastructure as a 
laboratory to assess a model to enhance 
clinician practice and reduce client smoking 
rates, which increases generalizability and 
could lead directly to clinical innovations on 
a national scale. 
 
Summary: If we are to meet the Healthy 
People 2020 target goal for smoking of 12%, 
a national strategy must include methods to 
increase clinician provision and smoker use 
of evidence-based treatments for TUD, 
especially among under-served groups. Systemic and cultural barriers within mental healthcare organizations undermine 
effective treatment for TUD among those with an SMI and require comprehensive organization-level interventions. Preliminary 
data suggest that the ATTOC model improves clinician provision and client use of treatments and implementing ATTOC in 

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outpatient community mental healthcare may capitalize on unique benefits of this context. Thus, we propose the first 
randomized controlled trial to evaluate the ATTOC model for reducing tobacco use rates among those with an SMI. The trial 
results may facilitate national dissemination of the ATTOC model within community mental healthcare agencies, providing an 
essential strategy to help achieve the Healthy People 2020 tobacco use goals. 
2.2 
Relevant Literature 
Smoking Cessation Research: Drs. Schnoll and Leone have led TUD trials for ~2 decades [19, 59, 65-71]. Dr. Schnoll has 
tested methods to train oncologists to treat TUD [71] and Drs. Schnoll and Leone have examined predictors of clinician 
adherence to TUD treatment guidelines [19, 72-76]. Dr. Schnoll co-led efforts to devise TUD treatment guidelines ([77]; 
http://www.asco.org/sites/default/files/tobacco_cessation_guide.pdf) and Dr. Leone co-chairs the Philadelphia Tobacco Control 
Coalition, a partnership of the Philadelphia Department of Health (DoH), community leaders, and academics to improve the 
treatment of TUD. Dr. Ziedonis’ career has focused on treating TUD among those with SMI and on implementation science. He 
has co-led treatment guideline development for the American Psychiatric Association (APA) and led the NIMH report on TUD 
among those with an SMI [1]. He has developed, implemented, and evaluated TUD treatments for those with an SMI [51, 58, 63, 
78-80], including Learning About Healthy Living (LAHL; a guide for implementing TUD treatment for those with SMI) which is 
part of ATTOC [81]. Dr. Evins is an expert in the treatment of TUD among those with SMI, having led studies of TUD treatments 
in this context for >15 years [49,82-84], including a recent study of extended use of varenicline for those with SMI [85]. She has 
developed clinical treatment guidelines relevant to this population which will be included in the ATTOC training [86]. 
 
Pilot Study to Improve Treatment of TUD in Philadelphia DoH Clinics: Drs. Leone and Schnoll completed a single-arm study to 
assess the effects of a training program in TUD treatment on clinician behaviors. The study was implemented in DoH clinics that 
primarily serve low-income, minority populations (e.g., 26% of clients below poverty line; 57% African American or Hispanic). In 
9 months, 217 clinicians were recruited and completed a baseline assessment of “simple” (asking about tobacco use, advising 
cessation) and “complex” (providing medication, quit-line referral) TUD treatment behavior. Training, based on the ATTOC 
model, involved a clinic visit to provide instruction in TUD treatment, educational material, and discussions to address beliefs 
that may undermine the provision of TUD treatment, access to a training website, 3 reminder letters, and a follow-up visit to 
reinforce training. At a 2-month post-treatment assessment, clinician treatment of TUD increased for “simple” (p=.04; 11% 
improvement) and “complex” (p<.001; 30% improvement) behaviors [19]. This study demonstrates our ability to collaborate with 
the DoH to implement organizational change interventions within health clinics that assist primarily under-served communities. 
 
Preliminary Data from Philadelphia DoH Mental Healthcare Clinics: Drs. Leone and Schnoll initiated the pilot clinician training 
program described above with community mental health clinics (CMHCs; http://smokefreephilly.org/quit-now/for-mental-health-
professionals/). So far, we have recruited 167 mental healthcare clinicians from 10/40 agencies approached (25%) and followed 
the methods described above. While data collection is ongoing, our preliminary findings in the context of mental healthcare are 
similar to what we found in primary care, with upwards of a 14% increase in “complex” TUD treatment behavior (e.g., connecting 
clients to TUD treatment; p = .02). These data demonstrate the potential effects of ATTOC in Philadelphia community mental 
healthcare and show the feasibility of recruiting clinics for the proposed study. 
 
Preliminary Data from Connecticut DoH Mental Healthcare Clinics (http://communicare-ct.org/page/13752-Tobacco-Cessation): 
We now have data from the evaluation of ATTOC in 9 outpatient mental healthcare agencies. A baseline assessment showed 
virtually no screening, assessment, or treatment of TUD across agencies. Following implementation of ATTOC, agencies 
enrolled 1761 clients in TUD treatment; of the 50% of clients attempting to quit, 60% used FDA-approved TUD medication. 
Significant effects were found at follow-up for 30-day point prevalence cessation (13% quit rate) and reduction in daily smoking 
among those non-abstinent (mean reduction=3-4 cigarettes/day). Another 31% of the 1761 engaged in lower motivation 
treatment options (LAHL) and demonstrated significant reduction in smoking and 7% of these entered the quitters program and 
quit smoking. The level at which ATTOC was implemented was assessed, in a way consistent with how we propose for 
Exploratory Aim 2. A dose-response-like effect was found: the agencies that used more of the ATTOC model showed the largest 
degree of systems change (e.g., documentation of smoking, development of TUD treatment programs), vs. agencies that 
implemented fewer elements. On an individual level, agencies that used the most ATTOC elements enrolled 72% of their clients 
in TUD treatment, vs. agencies that used fewer ATTOC elements (35%), or none of the ATTOC model (11%). 
 
Organization Change Research: Dr. Ziedonis developed ATTOC and has led several organization- level evaluations of its 
impact [18]. He has led or co-led initiatives to improve TUD treatment for those with an SMI for the RWJF, NIMH, NIDA, MA 
Department of Mental Health, Veteran’s Affairs Health Care, the APA, the Smoking Cessation Leadership Center, and 
SAMHSA, and served on the IOM’s committee on TUD in the VA/DOD. Dr. Kimberly is an expert in healthcare management and 
organizational change and has consulted for private companies, healthcare organizations, and government agencies, including 
the IOM. He is the author of books on organizational innovation in the healthcare industry [87], on training public health leaders 
[88], and on organizational interventions to improve the quality of mental healthcare and addiction treatment [89, 90]. 
 
Community-based Mental Healthcare: Mental healthcare for all Medicaid-enrolled Philadelphians is managed through 
Community Behavioral Health (CBH), a quasi-governmental agency within the city DoH. CBH, in turn, contracts with the 
Philadelphia Coalition, the Philadelphia Alliance, and the Mental Health Association of Southeastern Pennsylvania (MHASP), 
which oversee >70 of the individual agencies that provide community mental healthcare for the City’s 470,000 Medicaid 
recipients. While CBH authorizes payments, regulates and manages provider agencies, and serves as a central data repository, 
the Alliance, Coalition, and MHASP represent >70 individual CMHCs and oversees educational initiatives and policies across 

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the CMHCs (see letters of support). Further, the PENN Center for Mental Health Policy and Services Research (CMHPSR) 
conducts research to enhance the delivery of mental healthcare and has partnered with CBH, the Coalition, and the Alliance. Dr. 
Mandell, the CMHPSR Director, has a 15-year history of partnering with CBH to improve outcomes for those served in the public 
mental healthcare system. Currently, Dr. Mandell is collaborating with CBH to identify innovative methods to enhance youth 
mental healthcare [91]. CMHPSR support initiatives that bring together academics, government, and mental health agencies to 
implement and evaluate system changes. 
 
Cost-effectiveness Research: Dr. Polsky is the Executive Director of the Leonard Davis Institute of Health Economics at PENN. 
His research involves the economic evaluation of medical and behavioral health interventions, including CEA of treatments for 
opioid dependence and alcohol treatment. He is coauthor of the definitive book on the subject, “Economic Evaluation in Clinical 
Trials”. 
 
Community Advisory Council (CAC): This study will be supported by a council with expertise in community mental healthcare 
and research, comprised of: Dr. Mandell, Dr. Neimark, Ms. O’Rourke, Ms. Brummans, and Mr. Brody. Council members have >3 
decades of research, clinical, administrative, and educational experience within community mental healthcare and will assist 
with recruitment, implementation, measurement and intervention refinement, accrual/retention monitoring, and the dissemination 
of findings. 
3 
Study Objectives 
Achieving the Healthy People 2020 target goal for tobacco use requires efforts to lower the rate of tobacco use among those 
with an SMI. This necessitates identifying novel and impactful methods for increasing the provision of evidence-based TUD 
treatment in the context of community mental healthcare, including FDA-approved medications and guideline-based behavioral 
interventions. Unfortunately, systemic and cultural barriers within public mental healthcare organizations hinder the assessment 
and treatment of TUD within these organizations, contributing to an excessive rate of tobacco use and high rates of morbidity 
and mortality in this sub-group of Americans. This trial will evaluate our organization-level tobacco control program for reducing 
these practice barriers, promoting evidence-based care, and reducing smoking rates for those with an SMI, and doing so without 
worsening mental health and in a cost-effective manner. If this approach is shown to be effective, cost-effective, and safe, it can 
serve as a model for the nation’s community mental healthcare infrastructure, representing a powerful initiative to address 
tobacco use in a highly under-served sub-group of smokers, and support efforts to attain the Healthy People 2020 goals 
regarding tobacco use. 
3.1 
Primary Objectives 
• 
Aim 1: To evaluate the effects of the ATTOC intervention on provider adherence to the USPHS clinical practice 
guidelines for treating TUD. Hypothesis: At the end of the intervention and at a 3-month follow-up, rates of adherence 
to guidelines for treating TUD will be greater among clinic personnel that receive the ATTOC intervention vs. clinic 
personnel in usual care. 
• 
Aim 2: To assess the effects of the ATTOC intervention on rates of client smoking. Hypothesis: At the end of the 
intervention and at a 3-month follow-up, rates of client smoking cessation will be significantly greater in clinics that 
receive the ATTOC intervention than among clients treated with usual care. 
• 
Aim 3: To evaluate the effects of the ATTOC intervention on client mental health functioning and quality of life (QOL). 
Hypothesis: Using non-inferiority testing, at the end of the intervention and at a 3-month follow-up, there will be no 
significant degradation in mental health functioning or QOL among clients who receive care at clinics that received the 
ATTOC intervention than among clients treated with usual care. 
3.2 
Secondary and Exploratory Objectives 
• 
Secondary Aim: To assess the cost-effectiveness of the ATTOC intervention. Hypothesis: ATTOC will have a favorable 
incremental cost-effectiveness ratio measured as dollars/quitter and dollars/life-year saved. 
• 
Exploratory Aim 1: We will assess changes in cultural and systemic barriers to treatment as mediators of the effects of 
the ATTOC model on provider adherence to guidelines for treating TUD and client smoking. 
• 
Exploratory Aim 2: To inform model dissemination, we will identify components of the ATTOC intervention that predict 
greater change in provider adherence to guidelines for treating TUD and client smoking. 
4 
Investigational Plan  
4.1 
General Design 
This cluster-randomized trial will be conducted with 14 Philadelphia CMHCs, 7 randomized to ATTOC and 7 to usual 
care (UC). Following randomization, study staff will visit sites to recruit clinic personnel and clients over a 4 to 6 week period. 
Those eligible will complete informed consent and HIPAA forms and a baseline assessment to establish pre-intervention levels 
on all measures (baseline). After 4-6 weeks, the ATTOC intervention will be implemented over 9 months, from Week 1 to Week 
36 (with UC at the control sites). Two mid-intervention assessments (Weeks 12 and 24) will allow for performance feedback (see 
Outcomes Data) and mediational analyses. Week 36 (end-of-treatment; EOT) and 52 (3-months post-EOT) assessments will 
allow for evaluation of changes on outcomes between groups over time. All measures will be conducted at the respective CMHC 

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(or over the phone if necessary) and 7-day point prevalence smoking cessation will be verified using a breath carbon monoxide 
(CO) monitor (abstinence = < 8ppm; [93]). Figure 1 illustrates the study design.  
 
 
4.2 
Randomization to Interventional Group 
Although randomization and inclusion criteria will increase comparability between arms, sites will be matched by: 1) size (i.e., 
moderate [15-30 personnel; 110-249 clients] vs. large [>30 personnel; >249 clients]) 2) organizational motivation (e.g., < 30 vs. 
≥ 30 on sum of all 12 items from  the Organizational Readiness for Implementing Change [ORIC] measure [92]). We will try to 
enroll >2 sites (1/arm) that do not respond to initial invitations to enroll to include CMHCs with low readiness to implement 
change. Using the ORIC and outreach to sites with low motivation, we hope to reduce the potential of over-volunteering that can 
limit generalizability. If a CMHC has multiple locations, all locations will be randomized to the same arm but they will be 
considered 1 of the 14 randomized sites. Once eligible and interested sites are identified, using the small-sample equivalent to 
matching on stratification data, they are randomly assigned to UC or ATTOC. Computerized randomization within our Data 
Management System (DMS) will be provided by Dr. Wileyto. Once randomized, participants (personnel and clients) will be 
recruited for the trial. 
4.3 
Rationale for Study Design 
An alternative design would involve randomization of clients and providers within the agencies. Although that could avert 
potential confounds attributable to differences between agencies, we considered the risk of contamination – and, thus, a threat 
to internal validity – from such a design to be too probable. While an agency-level randomization may be subject to confounding 
as well, we will match the agencies on key variables before randomization to increase control over potential treatment 
confounds and we will use appropriate analytic models to account for this potential confounding (see Data Analysis). We also 
considered either: 1) not including a control arm; or 2) providing a more potent control arm, but considered the present design 
one that would allow for more convincing conclusions about the effects of ATTOC vs. current practice. Thus, we viewed the 
proposed design to be the ideal balance between internal and external validity. 
 
4.4 
COVID-19 Adjustments 
Due to the COVID-19 pandemic, all sessions are being done remotely at this time. If a client reports abstinence, they 
will be asked to come to the office to do a CO reading. They will be compensated an additional $10 if they travel to the office. 
This applies to Week 12, 24, 36, and 52 sessions. 
4.5 
COMHAR Clinic 
Due to the COVID-19 pandemic, the recruitment and enrollment process had to be adjusted since the clinic is largely running via 
telemedicine. Clinic leadership will send a letter informing their clients of the study and what it entails. A research assistant’s 
number will be listed if they wish not to be contacted. After two weeks, the research team will begin to reach out to clinic clients 
to conduct an eligibility screen. If the client is eligible and wants to participate, a time will be scheduled for the baseline session. 
A CO reading will not be conducted at baseline. The consent will be read aloud in its entirety to patient participants. The 
baseline session will be conducted remotely (over the phone or video chat) and participants will then give their verbal consent. 
The research staff member will note in the consent form that the participant affirmed their consent, as well as the date of the 
consent. The consent document will also be sent to participant, either over email or through the mail. For clinic personnel 
participants, reviewing the consent form will be completed using a RedCap survey. Once the consent is signed, a research staff 
member will electronically sign it. Staff will email the survey link to them and the subjects will indicate within the RedCap survey 
if they wish to participate and will then be prompted to enter their First and Last name and sign the form using their finger or 
mouse. Subjects will be able to download their signed version of the form from RedCap, and staff will also download a version to 

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be saved to the electronic regulatory binder on our secure server, or, printed and placed in our physical binder. In order to make 
things more convenient and efficient, the study questionnaires for clinic personnel enrolled in the study will be on REDCap. A 
CO reading for clients will not be collected at baseline. Participants who report abstinence at week 12, 24, 36, or 52 will be 
asked to come to our office for a CO reading. The CO reading will be done outside and the staff will try to maintain social 
distance as much as possible. The participant will be given an additional $10 for travel compensation. The training session for 
the personnel will be conducted over video chat (could be split up into two sessions on different days) before the recruitment 
period is over. These same procedures will be used at the Merakey clinic.  
 
4.6 
Study Timeline 
Providing ATTOC or UC will occur sequentially from Months 7-36 (end of Year 3): 3 sites in months 7-16, 4 sites in months 17-
26, 4 sites in months 27-36, and 3 sites in months 37-48. Data collection, analysis, and reporting will occur in Years 4-5 (see 
Table 3). 
 
Table 3. Study Timeline 
Tasks/Months 
1 
12 
24 
36 
48 
60 
Refine/test DMS, Train Staff (1-6) 
X-X 
Recruitment/baselines (7-36) 
X  ---------------- X 
Treatment (7-36) 
X  ----------------- X 
Outcome assessments (12-48) 
X  --------------------- X 
Analysis/manuscripts (48-60) 
X  ---- X 
 
4.7 
Study Measures 
Screening 
• 
Community Mental Health Clinic Eligibility Screen: The assessment will be completed by a CMHC leader such as a 
CEO and contains questions that will assess eligibility criteria as well as organizational readiness (the latter will be 
accomplished with the ORIC). The results of this assessment will be taken into account during clinic intervention 
randomization.  
o 
Organizational Readiness for Implementing Change (ORIC): This psychometric assessment measures 
change commitment and change efficacy [92] in prospective CMHCs. This assessment includes a scale with 
12 questions.   
• 
Clinic Leadership Informed Consent Acknowledgement: A designated clinic leader will review the informed consent 
and will complete the inform consent acknowledgement form. This form was devised to help ameliorate possible 
concerns regarding undue coercion surrounding clinic personnel recruitment. This form is included for review by the 
personnel participants during the informed consent process.  
• 
Client and Personnel Eligibility Screen: These brief assessments contain questions based on inclusion and 
exclusion criteria to ensure study eligibility.  
Covariates 
• 
Client Psychiatric History: Among clients, we will collect self-reported data on past and current psychiatric 
conditions/diagnoses, duration of illness, and lifetime frequency of psychiatric hospitalizations. Psychiatric diagnosis 
will be confirmed via data requested from CBH.  
• 
COVID-19 Quitting Experience Questionnaire: The purpose of this survey is intended to capture the participant’s 
experience quitting smoking during the COVID-19 pandemic. The survey will be administered at baseline for personnel. 
The survey will include 24 questions recommended by the NIH for research pertaining to COVID-19, 11 questions 
related to smoking behavior and the pandemic formulated by staff, and the PHQ-2 and GAD-2 measures for 
depression and anxiety symptoms (4 questions total). 
 
Mediators:  
• 
Smoking Knowledge, Attitudes, and Practices (S-KAP): This survey is composed of 5 scales that assess systemic 
and cultural barriers to smoking cessation. These scales measure clinician practices, knowledge regarding smoking 
risks, barriers, attitudes and efficacy [103]. Systemic barriers include provider: 1) access to resources to treat TUD; 2) 
level of knowledge to treat TUD; 3) implementation of smoking cessation policies such as a smoke-free campus; and 4) 
use of the EHR to document and track client smoking and treatment. Cultural barriers include provider beliefs about: 
client interest in smoking cessation, client ability to quit smoking, client ability to understand the benefits of smoking 
cessation, client mental health consequences from cessation, and smoking cessation treatment being their 
responsibility. These Likert-type measures are sensitive to change following implementation of ATTOC [18] and have 
good psychometric qualities [94, 103]. This survey will also be used to measure outcomes data (items measuring the 
rate of: asking clients about smoking, advising them to quit, providing assistance with quitting, and arranging visits to 
track progress; a total adherence score can be calculated [18].) 
• 
Smoking Knowledge, Attitudes, and Services (S-KAS): This survey is essentially a client version of the S-KAP and 
will be used to measure systemic and cultural barriers to smoking cessation from the client’s perspective. The survey 

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contains 4 Likert-type scales that measure client knowledge regarding smoking risks, attitudes about quitting smoking 
as related to the clinic setting, and assessments of clinician and program services, respectively [105]. 
 
Treatment Data:  
• 
ATTOC Intervention Adherence Tool (“The Dashboard”): This web-based tool is used by the study team to track 
and monitor compliance and progress on the 10 ATTOC steps – on an organizational and on an individual (clinician) 
level. This adherence measure is used to determine the level of compliance with ATTOC steps so that variability across 
sites in the implementation of ATTOC can be included in analyses and to guide performance feedback. The dashboard 
is a visual figure with a numeric indicator using red (no movement), yellow (some progress), and green (completed) 
colors that enables staff to see progress on key metrics of change. Data are gathered through staff self-report and 
chart reviews, study measures, and the environmental scan. On an organizational level, examples of metrics include: 
the selection of a site champion, the use of change and communication plans, the implementation of change plans, 
additional staff training, the provision of TUD treatment (counseling, referrals, pharmacotherapy), the establishment of 
a smoke-free campus or progress in establishing smoking restrictions, use of no-smoking signage, inclusion of TUD 
treatment within SOPs, and provision of TUD treatment brochures. On an individual level, examples of metrics include: 
the provision of TUD counseling, number of referrals to smoking cessation treatment programs including the Quit-line, 
and the provision of pharmacotherapy. This dashboard assessment reflects metrics of overall organizational and 
individual clinician change and is used as a covariate in analyses of study aims and to guide performance feedback to 
clinic leadership, site champions, and clinicians. We will also include a measure of fidelity to determine whether the 
ATTOC model was implemented as intended. This measure includes: attendance at on-site training sessions, logging 
onto the ATTOC program training website, and participation in training teleconference/video calls. The fidelity measure, 
analogous to a measure of treatment dose, will be expressed as a proportion of the number of training hours received 
and used as a potential covariate. All personnel participants are expected to interact with the Dashboard and update 
the metrics. The chosen site champion will be responsible for reviewing the metrics prior to scheduled training sessions 
and will summarize the findings for the group.  
• 
ATTOC Change Plan: This instrument assesses the following: 1) agency goals 2) identifying key clinic leadership and 
champions 3) environmental scan 4) recording the change plan drafting process 5) recording the communication plan 
drafting process 6) setting client goals 7) setting staff goals 8) setting environmental goals 9) documenting clinic policy 
changes 10) identifying supportive activities to sustain organizational change. Once the leadership group and tobacco 
champion are identified, these individuals are tasked with meeting regularly (as the group deems fit) to hone the 
Change Plan over time. The tobacco champion serves in a secretary capacity to record meeting minutes and/or 
progress notes that will be presented to the ATTOC consultation team for review.   
o 
ATTOC Environmental Scan: An Environmental Scan provides a structured tool to assess: the strengths, 
weaknesses, opportunities, and threats to the new business plan or idea.  The ATTOC approach applies this 
tool in order to assess an agency’s preparedness to address tobacco, including past successes and efforts 
already underway on this issue.  The Environmental Scan can be used to assess changes in organizational 
preparedness and inform potential improvements during the course of planning, implementation, and 
sustaining changes.  This can assist the agency as they work on their change plan.  The Environmental Scan 
focuses on four key areas of the ATTOC intervention:  
 
Agency’s campus and inside the buildings / Environmental Tobacco Control Efforts 
 
Client Assessment and Treatment 
 
Staff Competencies, Smoking, and Attitudes 
 
Tobacco-Related Policies for Clients, Staff, and the Agency.    
 
This Environmental Scan enables the ATTOC consultation team to objectively document current tobacco-
related activities and to subjectively assess preparedness for further improvements. In order to complete this 
form and the evaluation, the assessment process includes conducting a "walk through" of both the inside and 
outside of your agency, speaking with staff and clients, and also reviewing existing clinical charts and policies.   
 
Each of the four key areas receives a preparedness rating ranging from a“1” (not prepared) to “5” (highly 
prepared).  For each area, there is a preparedness rating “key” providing a short description   of general 
characteristics that constitute each rating.  This key can serve as a guide for the consultant team when 
assigning preparedness scores.   
 
At the conclusion of the Environmental Scan, an overall client, staff, environment, and agency ratings are 
given.  The ATTOC Consultant team rejoins the Leadership Team to discuss the agency’s observed 
preparedness to address tobacco and to begin to formulate the agency’s change plan to identify specific 
objectives for tobacco assessment, treatment, and policies.    
 
o 
ATTOC Communication Plan: Step 5 of the ATTOC Approach addresses the importance of supporting the 
Change Plan by developing a Communication Plan to facilitate internal and external communication needs. It 
is a way to communicate with stakeholders, determine channels for feedback, and to communicate new 
policies and procedures.  This tool is used to familiarize the personnel participants with current clinic 
communication processes and resources and provides a framework for designing a new plan of action in this 
area.  
 

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Outcomes Data:  
• 
Client Prescription Data: Client participant prescription data (for cessation medications or NRTs) will be requested 
from CBH.  
• 
Time Line Follow-Back (TLFB): This assessment utilizes a structured interview method to assess smoking rates. 
Using a calendar with sufficient days from the prior assessment time point, study staff work with the participant to 
formulate a clear picture of whether abstinence was achieved each day. The purpose of the interview will be to 
reconstruct the participant’s smoking practices, on a daily basis if possible.  Beginning with current smoking habits, the 
staff member prompts the participant to recall previous smoking rates in a backward chronological fashion.  
• 
CO Form: This assessment collects the CO reading (in parts per million) as well as smoking rate in the 24 hours 
preceding data collection and the time since the participant’s last cigarette. 
• 
Revised Behavior and Symptom Identification Scale (BASIS-R): Clients will complete the Revised Behavior and 
Symptom Identification Scale (BASIS-R), a 24-item assessment of mental health functioning [108] that yields a total 
score and subscale scores for: depression, interpersonal relationships, self-harm, emotional liability, psychosis, and 
substance abuse. 
• 
Client Hospitalization Assessment: We will assess the frequency and duration of any illness-related in- client 
hospitalization. This self-report measure will be confirmed via data requested from CBH.  
• 
Short-Form Health Survey (SF-12):  This survey will assess physical and mental QOL of client participants [109, 110]. 
• 
Treatment and Client Costs: These costs will be estimated by multiplying the counts of resources used by the unit 
costs of those resources (the resource costing method [111, 112]), which summarizes the health care services used 
from the perspective of society (e.g., TUD treatment delivery time), not only protocol costs. ATTOC direct costs will be 
considered as will non-study medical services costs, recorded on a validated scale [113]. 
 
See Table 4 under Study Procedures for study events and associated measures. 
 
 
4.8 
Study Endpoints  
4.8.1 
Primary Study Endpoints 
For Aim 1, we will assess adherence to guidelines for treating TUD as done previously [18, 31, 72, 73]. This measure, 
developed by Delucchi et al. [103], assesses components of the USPHS guideline [20]. Items measure the rate of: asking clients 
about smoking, advising them to quit, providing assistance with quitting, and arranging visits to track progress. A total adherence 
score can be calculated [18]. We will supplement this measure with questions about the content, nature, and intensity (in terms 
of time) of behavioral counseling provided. Clinician adherence will be assessed from the client perspective as well, using the 
client version of this scale [105], EHR adherence data will be accessed (e.g., documenting smoking status, use of 
pharmacotherapy), and prescription data (provided and filled) will be accessed by CBH.  
 
For Aim 2, smoking status is assessed using self-reported 7-day point prevalence and CO to verify self-report [66, 106], with 
abstinence=self-reported abstinence for >7 days prior to the weeks 36 and 52 assessment and a breath CO <8ppm at the time-
point [98, 99]. Participants are assumed to be smoking if they self-report to be smoking at the time-point, do not provide self-
report or CO data at the time-point, or provide a breath sample at the time-point that is >8ppm [93]. Secondary outcomes will 
also be assessed (e.g., smoking status at week 12, smoking rate [number of cigarettes/day]). 
 
For Aim 3, client mental health will be measured using several indicators [107]. We will assess the frequency and duration of 
any illness-related in- client hospitalization (available through the EHR). Clients will complete the Revised Behavior and 
Symptom Identification Scale (BASIS-R), a 24-item assessment of mental health functioning [108] that yields a total score and 
subscale scores for: depression, interpersonal relationships, self-harm, emotional liability, psychosis, and substance abuse. The 
Short-Form Health Survey (SF-12) will assess physical and mental QOL [109, 110]. 
4.8.2 
Secondary Study Endpoints 
Costs will be estimated by multiplying the counts of resources used by the unit costs of those resources (the resource costing 
method [111, 112]), which summarizes the health care services used from the perspective of society (e.g., TUD treatment 
delivery time), not only protocol costs. ATTOC direct costs will be considered as will non-study medical services costs, recorded 
on a validated scale [113].  
5 
Study Population and Duration of Participation  
Within each recruited CMHC, there will be two groups of study participants per study arm: clinic personnel and clinic clients. 
Inclusion and exclusion criteria will be limited to demonstrate the benefits of a system-wide model of care that addresses both 
skills and culture in the real-world. A total population sampling strategy [31] will be used so that all supervisory and clinical staff 
(part-time, full-time, paid or volunteer) will be eligible, including medical staff, case managers, and clinical supervisors. Past 
studies report a >90% rate of participation using such methods [44, 94]. 
 
We have a long track record of ensuring appropriate representation of women and minorities in our smoking cessation clinical 
trials. For instance, three of our past smoking cessation clinical trials had samples that were comprised of 43-56% women [58, 

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65, 66]. Likewise, we have completed several smoking cessation clinical trials with samples that were comprised of 31-60% 
African Americans [69, 68]. Given our track record and the gender and race/ethnicity breakdown of the CBH agencies, we 
expect the following sample composition: 1) For personnel, we expect that at least 60% of the sample will be women and 25% 
will be representatives of racial/ethnic minority groups; and 2) For clients, we expect that at least 40% of the sample will be 
women and 60% will be representatives of racial/minority groups. 
5.1 
Duration of Study Participation  
The duration of study participation including screening/baseline assessments to follow-up will be approximately 56 weeks.  
5.2 
Total Number of Subjects and Sites  
A total of 14 CHMC sites will be recruited for the trial. At each site, 12-30 staff and about 50 clients will be recruited (Total N: 
Staff = ~280; Clients = ~700). Procedures will be standardized across sites.  
5.3 
Inclusion Criteria 
Participating CMHCs must meet the following criteria for enrollment: 
1. 
Must use an electronic health record (EHR) 
2. 
Must report client prescription data to Community Behavioral Health (CBH) 
3. 
Must have at least 12 personnel who have clinical interactions with clients 
 
Clinic personnel participants must meet the following criteria for enrollment: 
1. 
Must be 18 years of age or older 
2. 
Must perform clinical care or supervisory duties 
3. 
Must demonstrate the ability to communicate in English and provide written or verbal informed consent 
 
 
Clinic client participants must meet the following criteria for enrollment: 
1. 
Must be 18 years of age or older 
2. 
Must report daily average smoking of 5 cigarettes/day for the past 6 months 
3. 
Must have a documented DSM Axis I or II disorder 
4. 
Must demonstrate the ability to communicate in English and provide written or verbal informed consent 
5.4 
Exclusion Criteria 
The following would exclude a prospective clinic client participant from enrollment: 
1. 
Exclusive use of electronic cigarettes (dual use with standard cigarettes will not be exclusionary) 
 
There will be no exclusion based on gender or race/ethnicity, consistent with our demonstrated ability to recruit 
representative samples in terms of demographic characteristics [23, 66].  
5.5 
Subject Recruitment  
The study will be implemented within Philadelphia’s CBH provider network, which encompasses the >300 CMHCs that provide 
care to the city’s >470,000 Medicaid recipients. The CBH Chief Medical Officer, and the Executive Directors of the Philadelphia 
Coalition, the Philadelphia Alliance, and MHASP, which represent >70 CMHCs and oversee educational initiatives within the 
agencies, will assist with recruiting agencies. A notice describing the opportunity to enroll in the study will be sent from Dr. 
Neimark, Ms. O’Rourke, Ms. Brummans, and Mr. Brody to CMHC directors, with instructions on how to ascertain information or 
to enroll (monthly meetings are also held by the Alliance, Coalition, and MHASP with CMHC CEOs and the research team has 
and will attend these meetings to publicize the study).  
 
Clinic recruitment will include a brief survey including the ORIC measure to collect stratification data to reduce the risk for 
selection bias and increase the probability of generalizability. Dr. Neimark, Ms. O’Rourke, Ms. Brummans, and Mr. Brody will 
attempt to enroll >2 sites (1/arm) that do not respond to invitations. To assess sample generalizability, we will compare enrolled 
site characteristics (e.g., size, composition) to data available for all CMHCs at CBH. Each agency maintains a staff of 12-40 and 
a client load of >200-300, indicating that recruiting 14 sites will meet recruitment goals. While we opted for this prospective 
recruitment method to facilitate accurate stratification (vs. identifying all sites up-front), our pilot work recruited >167 mental 
healthcare clinicians for a training in treating TUD in one year and an ongoing trial with PENN and CBH to promote evidence-
based treatment for youth mental illness used this approach to recruit 23 clinics [91]. 
 
Once sites are randomized, we will use a 4 to 6 week window for subject recruitment. This will allow study staff to recruit in-
person for multiple days and across several weeks to ensure that we access all site personnel and a representative sample of 
clients. We have experience recruiting in clinic settings [59, 71] and have 2 ongoing studies that follow such procedures (R01 
CA165001; R01 DA033681). If the 4-6 week period is not sufficient time to recruit a participant sample, the Principal Investigator 
reserves the right to lengthen the recruitment window by 4-6 weeks. The Principal Investigator may also need to under-enroll 
clinic personnel or client participant groups at certain sites due to organizational constraints. This under-enrollment will be 
supplemented at larger clinics by over-enrolling participants at other sites. In order to prevent possible retribution again clinic 

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personnel on the part of clinic leadership, we will not disclose the enrollment decisions of clinic personnel, and we will offer 
smoking cessation resources to the clinic. 
 
To recruit personnel, we will use staff meetings, electronic and written communication, and hold study-specific meetings. To 
recruit clients, as done now (R01 CA126969), but modified as needed upon advice from the Community Advisory Council, our 
Research Assistants (RAs) will assess every scheduled client for interest and eligibility using clinic schedules to approach 
clients prior to or after appointments. We post program flyers and brochures in clinics as well. Participants who are eligible and 
interested in the study will be scheduled for an intake session. To assess external validity, eligible personnel and clients who 
refuse entry will be compared to those who enroll based on available data (e.g., smoking status, years employed, nature of 
SMI). 
5.6 
Vulnerable Populations 
Population protected under HHS regulations 45CFR46 Subparts B, C, & D Study Procedures:  Clients of the clinic who are 
pregnant at the time of baseline assessments will not be eligible for the study, as clients must also smoke cigarettes to be 
eligible. These women will be advised to notify the study staff if they become or intend to become pregnant during the study 
period.   Personnel of the clinic who are pregnant at the time of baseline assessments will be eligible for the study if they confirm 
that they do not smoke cigarettes. 
 
Populations vulnerable to undo influence or coercion: Educationally or economically disadvantaged persons are included but not 
solely targeted for recruitment. Cognitively impaired persons are not included in the current study.  Because of our recruitment 
efforts for this study, it is possible that University of Pennsylvania employees and students may be invited to participate.  Status 
of participation in the study will be independent of the subject’s work or school activities.  
 
The study consent will include language that informs clinic client participants that their care will not be affected if they choose not 
to participate in the study or withdraw after enrollment. Likewise, clinic personnel participants will be informed that they may 
freely choose not to participate in the study or withdraw after enrollment. The consent will be read aloud in its entirety to patient 
participants and clinic personnel participants. If the baseline session is being conducted remotely (over the phone or video chat), 
participants will then give their verbal consent. The research staff member will note in the consent form that the participant 
affirmed their consent, as well as the date of the consent. The consent document will also be sent to participant, either over 
email or through the mail. Clinic leadership will sign an informed consent acknowledgement form which states that clinic 
personnel employability will not be impacted as a result of research enrollment decisions. 
6 
Study Procedures 

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. 
 
6.1 
Participant Screening 
A 4 to 6-week time-period was selected for participant recruitment, completion of informed consent and HIPAA documents, 
including clinic and participant eligibility determination and the completion of baseline assessments. This window for 
recruitment was selected to ensure access to all site personnel and to recruit the sample of clients. For site personnel, the site 
directors will distribute information about enrolling in the study via flyers and brochures and email messages. In addition, study 
research staff members will provide brief weekly presentations to the clinic personnel to inform them of the study. Given the 
support from CBH, the Alliance, the Coalition, the MHASP, and the CMHC directors, we expect a 90-100% rate of recruitment 
as seen in past studies [44, 94]. For clients, trained study staff will visit the clinic daily during the recruitment period and will use 
clinic schedules to identify prospective participants.  
6.1.1 
Baseline 
Eligible and interested client and clinic personnel participants will complete informed consent and HIPAA documents and 
baseline assessments. Following receipt of informed consent and HIPAA authorization, a baseline assessment will be 
completed The baseline assessments will collect a broad range of data, including demographics and smoking history for both 
participant groups and psychiatric history data for client participants. Client participants will also complete a smoking status 
review (CO Form), the BASIS-R, SF-12 and a hospitalization assessment. Additionally, personnel participants will complete the 
Smoking Knowledge, Attitudes, and Practices (S-KAP) survey and client participants will complete the Smoking Knowledge, 
Attitudes, and Services (S-KAS) survey. [105]. At UC clinics, baseline assessments help ensure that any differences across UC 
sites at baseline can be controlled for in subsequent analyses.  Compensation for the baseline session will be distributed when 
baseline questionnaires have been completed.   For those participants (either personnel or clients) who complete the informed 
consent and HIPPA documents, but cannot complete the baseline assessments until a later date, payment will be deferred until 
baseline questionnaires have been completed.  An appointment will be made with the participant to ensure that all session 
questionnaires are completed and compensation provided. 
6.1.2 
Pre-Week 1 Phone Call (ATTOC Clinics Only) 
Clinic CEOs and executive directors at ATTOC randomized clinics will be asked to identify a Tobacco Champion/Leadership 
group that provides continual on-site advocacy and support for the change plans and culture change, including ongoing 
performance feedback and coaching to clinic staff. A pre-site visit video-conference (or teleconference) call with the agency 
champion and leadership group prepares for Week 1. During this call, the study team will inquire about clinic resources and may 
request written policies for review. The team will also use this time to assess the leadership’s support for the study and offer 
recommendations for preparing clinic staff to engage in the program.  
6.2 
Study Intervention Phase  
6.2.1 
Overview of Interventions 
Usual Care (UC): Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure 
standardization across UC sites, Dr. Schnoll and/or Dr. Leone will provide a 1-day training seminar that will include written 
materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines. This 
minimal treatment condition was selected to facilitate the evaluation of the ATTOC training program on key outcomes relative to 
current clinical practice and organizational culture and climate. UC site personnel and clients will also be compensated for the 
time and effort required to complete assessments, which should also lower the risk for study withdrawal. 
 
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps (Table 2) to guide sites through 
cultural change and implementation of evidence-based practice. ATTOC is flexible to accommodate the unique needs, barriers, 
resources, and goals of an agency. Each organization begins at its own starting point based on what it has already 
accomplished (although, from our experience, most agencies are similarly not systematically addressing TUD at baseline), so 
the ATTOC intervention starts with diagnosis and proceeds to intervention and evaluation, consistent with ODT. Across the 
steps within the phases, 7 core strategies are used: 1) Meetings, calls, and video-conferences to prepare for and implement the 
intervention; 2) On-site consultation and technical assistance, including an Environmental Scan and training; 3) Formation of the 
agency’s Tobacco Champion/Leadership to support culture and practice change, including the use of a “dashboard” assessment 
to provide performance feedback; 4) Implementation of the agency’s change plan to achieve its Client, Staff, and Environmental 
goals; 5) Formal training/technical assistance in the treatment of TUD at the agency with ongoing monitoring, feedback, and 
coaching by champions; 6) Sustained consultations, including the use of the dashboard assessment to monitor organizational 
change and provide performance feedback to clinicians; and 7) Web-based support. The ATTOC intervention will be 
implemented over 9-months via 10 sessions (as in ongoing ATTOC initiatives): 2 in-person/on-site and 8 by video-conference 
(or teleconference) (see: http://www.umassmed.edu/psychiatry/attoc.aspx).  Due to the fact that many community mental health 
clinics provide fee-for-pay service, the study has budgeted up to $1,500 per site, depending on the need of the site.  This 
compensation is meant to offset the cost associated with lost time and effort due to study participation on the part of clinic 
personnel. 
 

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6.2.2 
Week 1 
Usual Care (UC): Clinics will take part in a 1-day training session with Dr. Schnoll and/or Dr. Leone. 
 
ATTOC Intervention: Week 1 is a 3-day on-site technical assistance and training visit for clinic personnel. Site personnel are not 
required to attend the entire 3-days and training sessions are divided into blocks so that normal agency functions can occur). 
This visit involves the following components: 
• 
Meet with agency Executive Director/CEO to review ATTOC phases and steps, establish a shared vision, enlist 
support, and establish the commitment to climate and culture change (step 1); 
• 
Meet with Tobacco Champion/Leadership Group to establish a collaborative and shared plan for training and culture 
change that is consistent with ATTOC and the needs of the individual agency (step 2); 
• 
Perform an Environmental Scan (step 3), which includes meeting with agency leaders, staff, and clients for a baseline 
organizational assessment, providing realistic targets for change across 3 domains: 1) the client-level assessment 
evaluates client flow, clinical charts, and use of current tobacco treatment, 2) the staff-level assessment evaluates 
staff smoking and treatments available to staff, level of prior training on TUD, and staff attitudes/beliefs towards 
this initiative and TUD treatment; and 3) the environmental assessment evaluates the indoor and outdoor spaces 
of the agency for evidence of tobacco use, available literature to support TUD recovery, and agency policies. The 
Environmental Scan includes a walk-around the facility, interviews with staff and clients, and chart reviews to 
assess documentation of tobacco use and treatment. This evaluation creates a baseline assessment of the core 
goal areas for the ATTOC intervention, helps assess organizational readiness, and provides important information 
for the Change Plan (step 4). A central feature of ATTOC is the “dashboard”, a formal comprehensive measure 
with indices of each aspect of the Environmental Scan, such as existing policy and adherence to TUD clinical 
guidelines. Subsequent dashboard assessments are used by the agency Champion/Leadership and ATTOC 
consultants to gauge progress and guide performance feedback. 
• 
Written Change Plans and time-lines are provided based on the Environmental Scan and the initial dashboard 
assessment, material required for change is prepared, and a written communication plan is provided which guides 
efforts to promote culture change (steps 4 and 5); 
• 
The implementation of the change plans, involving clinical training, TUD treatment service development, and 
environmental changes, is initiated (steps 6-8). The specific beliefs that may pervade the agency and undermine 
willingness to treat TUD are articulated and addressed. The potential effect of staff tobacco use is discussed and 
treatment options are provided. Consultants then work with the agencies to modify existing EHRs to ensure 
assessment of TUD, documentation of treatment plans, and recording of follow-up assessments. TUD 
assessments include self-report [97] and CO monitors (provided to agencies), the latter of which can be used to 
verify self-report, motivate and reinforce change, and evaluate treatment progress. 
• 
Although only one strategy within the ATTOC model (to build capacity), agency staff are given formal training in the 
assessment and treatment of TUD, with a focus on integrating TUD treatment within existing wellness programs. 
Training content is based on USPHS guidelines [20] and supplemented with population specific studies (e.g., [12]). 
The ATTOC training includes tailored approaches for the target population based on varying levels of motivation 
and mental illness, including prescriber education. Dr. Ziedonis has authored national guidelines on TUD treatment 
in this population and currently leads a national initiative by the APA, which will inform training. Dr. Eden Evins will 
consult on this training since she has developed formal treatment recommendations, from her own clinical trial 
work in this area and the work of others, to devise best practice recommendations for smoking among those with 
SMI, which consider personalized treatment based on client diagnosis, current psychiatric medications, and 
residual symptom profile. This training content will be built upon the content already provided focusing on the 
specific needs of smokers with SMI (e.g., anhedonia and cognitive deficits) and on studies with this population that 
support unique treatment approaches (e.g., more intense and extended treatments; [85]. Drs. Evins and Ziedonis 
will refine training content for in-person and web-based training. Evidence-based behavioral interventions and FDA 
approved TUD medications that can be tailored appropriately for those with SMI are described [20]. (Note. As 
Medicaid participants, all clients in this trial are eligible for no-cost pharmacotherapy and counseling for their TUD; 
employees are eligible for no-cost NRT and counseling.) Combining TUD medications to improve efficacy is 
discussed as is the importance of combined behavioral and pharmacological treatments. Tailoring treatment based 
on the client’s level of quit motivation is emphasized. Treatment options for less motivated clients, based on 
USPHS guidelines, include providing use of the LAHL guide and motivation interventions (the 5R’s: Relevance, 
Risks, Rewards, Roadblocks, Repetition). Assessment and promotion of treatment adherence is emphasized and 
a medical management approach to enhancing treatment compliance, which formally assesses reasons for non-
adherence using scenarios and uses specific strategies to enhance compliance (see [98]), is taught. While e-
cigarettes may be safer than combustible tobacco, the lack of product regulation and data on their ability to 
promote tobacco cessation, support ATTOC’s training that encourages abstinence from all tobacco products and 
use of only FDA-approved TUD medications. Key assessments (e.g., triggers) are taught. Advanced trainings are 
provided (e.g., “train the trainer”) to promote sustainability. The ATTOC team empowers the tobacco 
champion/leadership team to continue training and culture change through ongoing support/assistance. 
• 
Lastly, assistance with the establishment of a tobacco-free workplace and campus is initiated if that is an organizational 
goal. This involves setting a date for campus change, including development of staff communications, appropriate 
signage, treatment support, and trouble-shooting potential obstacles. Some agencies may choose to restrict use to 
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6.2.3 
Weeks 4 and 8 
Usual Care (UC): No study procedures are completed. 
 
ATTOC Intervention: Sessions at Weeks 4 and 8 are provided via video-conference (or teleconference) to continue training 
activities initiated in Week 1 and address concerns, obstacles, or problems that have emerged during implementation. Agency 
staff is provided with access to an interactive web-site administered by Dr. Ziedonis, which provides information, tools, and 
materials for training and treatment. Site tobacco champions are instructed in using the “dashboard” assessment of clinician and 
agency performance, relative to benchmarks, in order to provide formal performance feedback.  
6.2.4 
Week 12 
Usual Care (UC): Participants complete assessments. Clinic personnel will complete the S-KAP and clients will complete the S-
KAS, which allow for exploratory mediation analyses. These ~30 minute assessments will be conducted in person at the sites by 
the trained study staff. 
 
ATTOC Intervention: This 2-day on-site visit to conduct a follow-up Environmental Scan evaluates early changes in outcomes 
and provides further training and technical assistance. During this visit, dashboard data are used to provide performance 
feedback to site personnel. The feedback: 1) reviews the change and communication plans, including the benchmarks for 
adherence to TUD treatment guidelines; 2) presents a graphical display of clinician adherence to treatment guidelines; and 3) 
offers coaching for clinicians with unacceptable adherence and positive reinforcement to clinicians with acceptable adherence. 
Data support performance feedback for improving clinician use of evidence-based treatment [99], even for TUD [100], but this 
will be the first time this technique is used to address TUD treatment in community mental healthcare. Participants will also 
complete assessments. Clinic personnel will complete the S-KAP and clients will complete the S-KAS, which allow for 
exploratory mediation analyses. These ~30 minute assessments will be conducted in person at the sites by the trained study 
staff. 
6.2.5 
Weeks 16 through 52 
Usual Care (UC): No study procedures will be performed at Weeks 16, 20, 28, or 32. At Week 24, clinic personnel will complete 
the S-KAP and clients will complete the S-KAS, BASIS-R, and SF-12. At Week 36 (EOT) and 52, clinic personnel will complete 
the S-KAP and clients will complete the S-KAS, BASIS-R, SF-12, hospitalization assessment and smoking status review (self-
reported TLFB and CO reading). Treatment and client costs will also be assessed as one of the outcomes variables measured 
at Week 36 and 52. 
 
ATTOC Intervention: Sessions spanning weeks 16 through 36 are provided via video-conference (or teleconference) to assess 
dashboard data, reinforce training initiated in past sessions, and address concerns or obstacles that emerged during 
implementation. Formal performance feedback (based on dashboard data) to the clinics is again provided. Updated policies and 
SOPs are given to staff (step 9). These “booster” sessions to continue performance feedback promote sustainability of 
organizational change (step 10). 
 
Assessments will occur at weeks 1 2  and 24 to facilitate the performance feedback (e.g., clinical practices, barriers, client 
smoking) and to allow for exploratory mediation analyses using the S-KAP and S-KAS surveys. These ~30 minute assessments 
will be conducted in person at the sites by the trained study staff. 
 
At Week 24, clinic personnel will complete the S-KAP and clients will complete the S-KAS, BASIS-R, and SF-12. At Week 36 
(EOT) and 52, clinic personnel will complete the S-KAP and clients will complete the S-KAS, BASIS-R, SF-12, hospitalization 
assessment and smoking status review (self-reported TLFB and CO reading). Treatment and client costs will also be assessed 
as one of the outcomes variables measured at Week 36 and 52.  
 
At Week 36 (EOT), ATTOC clinics will be congratulated on completing the program with certificates of completion.  Both 
individuals participating as personnel, in addition to the clinic as a whole, will be awarded these certificates.  Clinic personnel will 
be notified that they will be able to contact Dr. Ziedonis with any follow-up questions or concerns.  In addition, ATTOC clinics will 
be given the option of receiving information about other area ATTOC clinics, to allow for communication and collaboration 
between them. 
 
6.3 
Session Windows  
Intervention treatment sessions for clinic personnel will occur +/- 1 week from the study timeline date to account for scheduling 
needs of clinics and trainers. In-person ATTOC sessions at Week 1 and 12 may be scheduled +/- 2 weeks from the study 
timeline date as travel arrangements must be made for the UCSD study team. If a personnel participant at an ATTOC 
randomized clinic is not available to attend any interventional study session (Weeks 1-36), the intervention will not be repeated 
for individuals.  
 
Personnel participants who miss an assessment session or are unable to complete an assessment within the allotted session 
time are afforded a +/- 1 week study window to complete the assessments by phone. If there are extenuating circumstances that 
would cause personnel participants to miss a study session (e.g., end of an employment period), personnel sessions may be 

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completed earlier than the +/- 1 week session window.  All client participant assessments will have a window of +/- 1 week to 
complete treatment and outcomes assessments for weeks 12, 24, 36, and 52. Participants may choose to complete the 
assessments in person or by phone.  
 
Session windows may be extended with prior authorization from PI at his discretion. Session window extensions will not be 
considered reportable deviations. 
6.4 
Subject Withdrawal  
Clinic personnel or client participants may choose to withdraw from the study at any time. They do this by providing verbal or 
written communication to this effect. Withdrawal from the study will not impact employment status (clinic personnel) or access to 
care (clinic clients) within the clinic. The Principal Investigator may withdraw subjects who violate the study plan, to protect the 
subject for reasons related to safety or for administrative reasons.  It will be documented whether or not each subject completes 
the study. Subjects who withdraw early will be contacted to complete a final visit (Week 52) to collect final evaluations and 
assess adverse events.   
 
To increase retention and adherence we will: 1) conduct interventions at the clinic; 2) conduct assessments during scheduled 
clinic visits or by phone; and 3) as is standard in TUD trials [65, 66], provide financial compensation for assessment completion. 
Although we expect that a small percentage of personnel and clients will leave their agencies, based on our past trials [71] and 
preliminary research with DoH clinicians [19], we expect that <15% of personnel and clients will withdraw from the trial or be 
lost-to-follow-up and ~85% of assessments will be completed, which exceeds past trials (e.g., [102]). As is advised in smoking 
cessation trials [101], intent-to-treat (ITT) will be used for Aim 2. Should, in the unlikely event, a CMHC withdraw from the trial, 
our time-line and prospective recruitment will allow replacement with a new CMHC. 
7 
Statistical Plan 
All data are maintained on password-protected computers within a DMS that uses ORACLE and MS ACCESS to permit web-
based real-time data entry, storage, and QA  
7.1 
Sample Size and Power Determination 
For cluster-randomized designs, clinic is the unit of randomization and the unit of analysis is the individual. Power is reduced by 
variability among clinics, represented by the intra-class correlation (ICC), analogous to an R-squared. The size of the individual 
sample affects precision within clusters and certain outcomes are less susceptible to potential confounding vs. others (e.g., 
smoking rates vs. provider adherence) since they are more independent.  
 
For Aim 1, the analysis will compare ATTOC to UC on weeks 36 (EOT) and 52 rates of adherence to guidelines for treating 
TUD. The sample size was determined by assessing the mean change in practice behavior detected in Guydish et al. [18]. 
Given the expectation from that trial that the UC mean level of practice will be 2.36 (SD=.87), the present sample of N=14 
agencies (with 280 subjects) provides 80% power (α=.05) to detect an effect if practice behavior increases by 0.32 (on a 5-point 
scale) if the ICC is 0. But if our ICC is .05, .10, or as high as .15, we have 80% power (α=.05) to detect a difference between 
ATTOC and UC of 0.44, 0.54, and 0.62, respectively. If 15% of the personnel are lost-to-follow-up, we will have 80% power 
(α=.05) to detect an effect if practice behavior increases by 0.34 for ICC=0, by 0.46 for ICC=.05, by 0.56 if ICC=0.10, and by 
0.63 if ICC=.15. The effects of ATTOC were stronger at the 3-month follow-up (mean change of 0.51), vs. EOT [18], so the 
current power is adequate for both time-points. Likewise, because the client sample will be more than twice as large as the clinic 
staff sample, we will have greater than 80% power to detect differences using the measure of physician adherence collected 
from clients.  
 
For Aim 2, the analysis will compare the rates of smoking cessation between the ATTOC intervention and UC at weeks 36 and 
52. We can expect that UC cessation rate will be < 2% [18]. With 14 sites (n=700 clients, ITT), we have 80% power (α=.05) to 
detect a difference between ATTOC and UC of 4% with an ICC=0. But if our ICC is .05, .10, or as high as .15, we have 80% 
power (α=.05) to detect a difference between ATTOC and UC of 10%, 15%, and 19%, respectively, with 14 sites and n=700 
client (ITT). 
 
For Aim 3, the analysis will use non-inferiority testing to compare mental health and QOL across ATTOC and UC at weeks 36 
and 52. Standard statistical tests, which may yield a non-significant comparison of means or proportions, cannot be used to 
claim that the treatments are equal since “the absence of evidence is not evidence of absence”. Among persons with SMI, the 
rate of psychiatric hospitalization nationally is 11.4% [114], which may represent UC (i.e., 88.6% of UC subjects will not have a 
hospitalization across the 52 weeks). One study found that 3.3% of clients with an SMI treated for TUD had a psychiatric 
hospitalization [48] or that 96.7% of clients treated for TUD did not experience a psychiatric hospitalization. We assume 14 sites 
(700 clients), with potential loss of 15% to follow-up, and assume approximately 90% non-hospitalization in the UC group.  We 
will set our non-inferiority floor 20% below the US rate, which yields 80% power to detect non-inferiority if the ICC is as much as 
0.15 (more power if ICC is less than 0.015).   
 
 
A trial with smokers with an SMI reported baseline BASIS-R scores of 2.1 (SD=0.8) and SF-12 scores of 48.7 (SD=12.5) for the 
physical sub-scale and 27.8 (SD=12.9) for the mental sub-scale, which estimates UC [107]. Given the sample of 14 sites (700 

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clients) and potential 15% loss to follow-up, we have 80% power (α=.05) to detect non-inferiority if the results for the ATTOC 
arm differ from UC by as much as 0.19 on the BASIS-R, when ICC=0, and by 0.50 when ICC=0.15. 
7.2 
Statistical Methods 
We will assess sample characteristics by treatment arm and site with chi-square or regression. These variables will also be 
examined for their relationship to completion of outcomes. Variables related to treatment arm or completion of follow-ups (p<.10) 
may be covariates in analyses. Fidelity and adherence measures will be evaluated across treatment arms, and the measures 
can be included in primary analyses. We will examine if the rate of missing data is related to a range of variables using chi-
square and regression and use appropriate methods for dealing with missing data (e.g., [115]). Analyses will assume that all 
subjects for whom smoking outcome data are unavailable are smokers (ITT) but we can also conduct a “completers-only” 
analysis. Because this is a cluster-randomized trial, the observations within a cluster cannot be considered totally independent. 
Variation among clusters may be confounded with treatment because clusters are nested within treatment. We will account for 
this clustering using hierarchical linear models (mixed models), estimating separate variance components for random site effects 
within treatment. Lastly, since we cannot guarantee that clinicians will be blind to their clients enrolling in this study, we will 
include a statement in personnel consent forms asking that they refrain from asking their clients if they are enrolled in the study. 
7.2.1 
Analysis of Outcomes of Interest 
The effects of the ATTOC model on provider adherence to guidelines for treating TUD: We hypothesize that the ATTOC 
intervention will increase adherence to guidelines for treating TUD vs. UC. The outcome is continuous and the hypothesis will be 
tested by a treatment arm term in a mixed-models linear regression model that may include covariates. Mixed models may 
account for individual level clustering inherent in longitudinal studies and site level clustering. Outcomes of the analysis will be 
characterized by regression coefficients and confidence intervals. Significance will be determined from a z-score corresponding 
to the treatment variable. Although level of adherence at 36 and 52 weeks will represent our primary outcome variables, similar 
regression analyses will be performed for assessments at Weeks 12 and 24. Also, we can examine models of specific clinician 
practices (e.g., identifying smoking, recommending pharmacotherapy) and examine adherence from the client perspective and 
based on adherence data ascertained from the EHR. 
 
The effects of the ATTOC model on client smoking: The hypothesized effect of treatment arm (i.e., the difference in quit rates 
between subjects receiving the ATTOC intervention or UC) will be tested by a treatment arm term in a mixed-models logistic 
regression model with covariates. Outcomes of the analyses will be characterized by odds ratios (e.g., odds of quitting smoking) 
and 95% confidence intervals. Although quit-rates at the end of 36 and 52 weeks will represent our primary outcomes, similar 
analyses will be performed for other assessments of quit rates (e.g., at Weeks 12 and 24). In addition, as many participants will 
fail to become abstinent, we will explore the use of zero-truncated negative binomial regression for count data to examine the 
main effects of treatment arm on changes in smoking rate at all assessment time-points. 
 
The effects of the ATTOC model on client mental health functioning and QOL: We will compare treatment arms in terms of the 
frequency of hospitalizations (binary) and mental functioning evaluations (continuous) over 52 weeks. Again, we will use mixed 
models to account for clustering, while accommodating either the binary outcome with logistic regression or the continuous 
measures with linear regression. Equivalence uses two one-sided tests against lower and upper equivalence bounds. The null 
hypothesis is that the groups are not equivalent and are determined to be equivalent when the mean or proportion is significantly 
different from both boundaries. We will use this approach to determine whether hospitalization rates are higher (null) in the 
ATTOC group or equivalent, and whether mental functioning is lower in the ATTOC group (the null) or equivalent. All 
hypotheses will be tested at alpha=0.05 (0.025 for any one sided non-inferiority test). 
 
The cost-effectiveness of the ATTOC program vs. UC: We will compare the societal cost (i.e., the sum of all measured 
categories of costs, including treatment and indirect costs) and effects of ATTOC vs. UC. If one treatment is found to be more 
costly and more effective, there is a trade-off between the additional effectiveness and additional resources needed to achieve 
those outcomes. This trade-off is represented by the incremental cost-effectiveness ratio (ICER), which is a ratio of the 
difference between mean costs in each treatment group and the difference between the cessation rates across treatment arms 
at weeks 36 and 52. This ratio will represent the additional cost of ATTOC vs. UC to produce an additional quitter. The quit rate 
outcome measure is used in our primary measure of cost-effectiveness because it is measured directly and because it can be 
compared against economic evaluations of other smoking interventions. Hypothesis testing for an ICER involves determining 
whether the ICER is significantly < the maximum acceptable ICER. Unfortunately, the maximum willingness to pay for a quit is 
unknown. However, $50,000 is accepted as a maximum ICER for the outcome of cost/life year saved, but wide bands around 
this value are common. This outcome looks at cost-effectiveness of the intervention over a lifetime. Because this is a relatively 
brief trial we will use a simulation-based analysis to project effects of quitting into long-term mortality and costs [116], employing 
standard assumptions and parameters [117]. Because this projection is based on parameters that have wide ranges, we will 
conduct a sensitivity analysis to assess the sensitivity of our estimates of costs and cost-effectiveness to the speculative nature 
of some of the values used in the analysis. We will consider how cost-effectiveness may change with different: 1) costs of 
treatment; 2) methods to handle attrition of cost data; and 3) ceiling ratios. Because of the poor statistical properties of the ICER 
as with ratios [118], we will transform the ratio into incremental net monetary benefits (INMB) with the following: [L*E]-C where 
L=ceiling ratio, E=difference in mean effects, and C=difference in mean costs. The hypothesis test that the ICER is < the ceiling 
ratio is equivalent to the hypothesis test that the INMB is >0. The INMB standard error is estimated with the formula in Willan 
[119] and amounts to the typical statistical formula for standard error. The hypothesis is that the ICER will be cost effective if the 

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INMB expression of cost/life year saved is >0 at an α <0.05. We will also judge the cost-effectiveness ratio as being acceptable 
if the confidence interval for the INMB excludes 0. 
 
Exploratory Aims: The effects of treatment arm on potential mediators (barriers) will be assessed using linear regression-based 
structural equation modeling (SEM). It is hypothesized that treatment arm will yield significant differences in proposed mediators 
which will predict week 36 and 52 quit rates and adherence to treatment guidelines. We will examine changes in mediators from 
baseline to week 8. After first demonstrating that treatment arm affects adherence and quit rates (Aims 1 and 2), these effects 
will be partitioned into mediated and unmediated effects, via path analysis and SEM. Specific hypotheses will be tested by using 
chi- square difference tests that contrast the overall fit of this full model with more parsimonious nested models in which specific 
predictive effects are fixed to zero (e.g., an unmediated path). Model goodness-of-fit indices will be contrasted to guide 
interpretation of results and determine the practical significance of statistically significant differences. Modification indices will be 
examined to guide model interpretation and modification and binary and continuous variables can be handled by Stata. This 
approach allows us, in principle, to test whether treatment effects on Aim 1 and 2 outcomes are due to specific mechanisms 
(e.g., reduction in barriers). 
 
Given the necessary complexity of the ATTOC intervention to promote broad, sustainable organizational change, we will use 
SEM to identify and measure the key elements of ATTOC related to improved outcomes (clinician behavior and client smoking) 
as has been suggested [18]. We will use the ATTOC Intervention Adherence Tool (i.e., “The Dashboard”) to determine each 
site’s compliance with ATTOC’s steps (e.g., the selection of a site champion, the preparation of change and communication 
plans, the implementation of change plans including SOPs, the provision of TUD treatment, the establishment of a smoke-free 
campus or progress in establishing smoking restrictions). First, we can use SEM with binary predictors (e.g., identified a tobacco 
champion or not) to determine the relative impact of implementing each ATTOC element so that policy-makers can select a 
smaller, more manageable number of organizational change elements within ATTOC to implement; this may be especially 
relevant for disseminating ATTOC to sites which already successfully perform certain aspects of ATTOC already. Second, we 
can use SEM again to calculate the individual and combined impact of implementing ATTOC elements on outcomes, analogous 
to determining the “dose” effect of implementing various levels of ATTOC. These analyses will help policy-makers know the 
likely size of effects from implementing various ATTOC elements and make decisions about what their agency requires. 
8 
Safety and Adverse Events 
8.1 
Data Safety Monitoring Plan (DSMP) 
For this study, we will use established PENN procedures and infrastructure for data and safety monitoring. During the course of 
the study, safety and data quality monitoring will be performed on an ongoing basis by the Principal Investigators and the study 
staff. Study staff members are responsible for collecting and recording all clinical data using the established MOP. This includes 
ensuring that all source documents exist for the data on the Case Report Forms, ensuring all fields are completed appropriately, 
and ensuring that all corrections are done according to Good Clinical Practice (GCP). Any inconsistencies/deviations will be 
documented. The study Key Personnel, which include physicians (Leone) and psychiatrists (Ziedonis), will review data on an 
ongoing basis and will document reviews by initialing and dating reports. Study staff members conduct 100% quality assurance 
on data, comparing all hard copy data to computer files. 
 
Staff training will consist of an explanation of the protocol and review of the Case Report Forms. In addition, the duties of each 
staff person will be outlined and all applicable regulations will be reviewed. Mock sessions with critical feedback will be 
conducted. The MOP will be used for staff training and to guide procedures throughout the trial. Senior personnel will supervise 
junior staff and provide re-training in the study protocol as needed. Dr. Ziedonis will oversee the staff implementing the ATTOC 
intervention and Drs. Schnoll and Leone will oversee the staff handling recruitment and data collection and management. 
 
Enrollment will be complete when 280 personnel and 700 clients are consented and complete the study. Monitoring days will be 
conducted periodically throughout the study. The monitoring is conducted by the PENN IRB and the PENN Office of Human 
Research (see www.med.upenn.edu/ohr). These audits are typically conducted annually and involve the review of regulatory 
documents, the ascertainment and documentation of informed consent, the compliance with the study protocols, and the 
completion of CRFs. 
 
Monitoring for Adverse Events (AE) will be conducted by the study staff and the PI and co-investigators. Study staff will 
administer standardized assessments to evaluate mental health and QOL (BASIS-R and SF-12, respectively). Participants will 
be queried to provide open ended descriptions of any adverse event which occurred since the previous assessment.). Should a 
report rise to the level of a potential Adverse Event, the decision on the course of action for the participant will be decided by Dr. 
Leone after review of the report. Participants will be monitored for the development of adverse events by administering these 
scales at 5 time-points during the study. In addition, both personnel and clients will be given contact information should they 
need to reach a member of the study between assessment time-points. The Research Team will clinically follow all subjects who 
are discontinued due to a serious adverse event until it resolves and becomes completely stable, unless a referral to another 
physician (i.e., specialist) is clinically indicated or requested by the subject. All AEs and SAEs will be documented on an 
Adverse Events Case Report Form. This information will, in turn, be reported immediately to all necessary regulatory 
committees. All serious adverse events will be reported within 24 hours to senior study staff. These events will be maintained in 
a unique data base and reviewed monthly by senior study staff. 
 

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Ms. Ware and staff RAs will be responsible for monitoring data integrity as data are collected. This includes ensuring that source 
documents exist for the data on the Case Report Forms, ensuring all fields are completed appropriately, all corrections are done 
according to GCPs and any inconsistencies/deviations are documented. 
8.2 
Internal Monitoring and Auditing 
The study will be monitored by the PIs and co-investigators, and regulatory committees at PENN (i.e., IRBs, OHR) as well as by 
a Community Advisory Council and the Philadelphia Department of Public Health Institutional Review Board. The following 
monitoring activities will be conducted according to standard operating procedures. These activities will be performed in 
association with database auditing and facilities monitoring by the PENN OHR and/or study staff. 
 
Initial Assessment Monitoring: PENN OHR will conduct a manual review of source documents and Case Report Forms (CRFs) 
for a random subset of participants enrolled in the study. This inspection is the visual comparison of source documents to CRFs 
in a quantitative assessment of accuracy based on the number of data fields. A brief, internal report will be generated to 
describe findings. If the data are less than acceptable, additional cases are requested, with appropriate counseling/training for 
staff. 
 
Protocol Monitoring: Protocol monitoring includes a survey of those activities that are associated with protocol adherence such 
as study visit deviation and violation of inclusion/exclusion criteria. A specific protocol monitoring plan will be used. All accrued 
cases will be subjected to protocol monitoring throughout the duration of the trial. 
 
Database Auditing: Ms. Ware and RAs will review data entered into the database versus that recorded on the CRFs. All accrued 
cases will be subjected to database auditing throughout the duration of the trial. Depending on the data management findings, 
re-training will be provided, should problems such as increased errors be detected. 
 
Data Auditing: Ms. Ware and staff RAs will review safety data recorded on the CRF versus that contained on the actual source 
document (client chart, EHR). All accrued cases will be subjected to auditing throughout the duration of the trial. A Regulatory 
Binder Review by OHR will include the following essential documents: IRB Protocol, Consent Form and Amendment Approvals, 
IRB Closure Letter, List of Authorized Signatures, Laboratory Certifications, Protocol and Amendment Signature Pages, 
Financial Disclosure Questionnaires, and Monitoring Log. Additional monitoring by OHR may include: source documentation 
verification; adverse event documentation; and facility assessment. 
 
Data Security: Using network firewall technologies, the database will prevent the three major sources of data security problems: 
unauthorized internal access to data, external access to data, and malicious intent to destroy data and systems. Controlled user 
access will ensure that only appropriate and authorized personnel are able to view, access, and modify trial data. All 
modifications to data will document user access and data associated with the modification, as well as values prior to 
modification. 
 
IRB Monitoring: The protocol will be reviewed by the PENN IRB and will only be implemented after successful approval from the 
IRB. Annual reporting and auditing will be conducted by the IRB. All procedures will be approved by the IRB. A protocol-specific 
Data Safety Monitoring Board will be used for this trial as well (see below). The PENN IRB will ensure participant safety and 
data integrity in collaboration with the DSMB and the Community Advisory Council. 
 
Evidence of Training in Human Subject Research: All personnel working on this project will be required to review the protocol, 
complete training in the protection of human subjects (developed and implemented by the PENN and NU IRB), and undergo 
training. 
 
The investigator will permit study-related monitoring, audits, and inspections by the EC/IRB, the sponsor, government regulatory 
bodies, and University compliance and quality assurance groups of all study related documents (e.g. source documents, 
regulatory documents, data collection instruments, study data etc.).  The investigator will ensure the capability for inspections of 
applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, etc.). Participation as an investigator in this study implies 
acceptance of potential inspection by government regulatory authorities and applicable University compliance and quality 
assurance offices. 
8.3 
Reporting of Adverse Events and Unanticipated Problems 
The Investigator will promptly notify the Penn IRB of all on-site unanticipated, Adverse Events that are related to the research 
activity. Other unanticipated problems related to the research involving risk to subjects or others will also be reported promptly. 
Written reports will be filed using the HS-ERA and in accordance with the Penn IRB timeline of 10 working days.  
9 
Study Administration, Data Handling and Record Keeping 
9.1 
Confidentiality 
Since self-report and medical data will be collected and stored as part of this study, it is possible that subject privacy or 
confidentiality can be threatened. To address this concern, the Data Management System has set up several safeguards to 
prevent unauthorized access to study data. An automatically  generated  index  number  is  assigned  to  a  subject’s  study  

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identification  number  (unique for personnel and clients). A linked subject identification table is created for the storing of subject 
name, address and telephone contact information. This table uses the automatically generated index number rather than the 
study identification number. The master subject map and subject identification information tables are maintained in a separate 
database. Using this method, no identifying subject information is directly linked to medical information or other study data. For 
our multi-site trials, we have long-established protocols to guard against improper use of hard copies of data (e.g., locked files, 
numeric coding procedures). The present research team has not experienced the unauthorized use of study data. A web-based 
data collection procedure will minimize the possibility of loss of privacy or confidentiality. The risk of a potential breach of 
confidentiality is addressed in the informed consent documents. 
9.2 
Sources of Research Material 
• 
Questionnaires assessing demographic characteristics, smoking history and behaviors, nicotine dependence (among 
smokers) among personnel and clients; employment characteristics (e.g., type of position, duration at agency) among 
personnel; System and cultural barriers to the provision of nicotine dependence treatment (among personnel); Fidelity 
measures to assess implementation of the ATTOC intervention (among personnel); Questionnaire assessments of 
client mental health and QOL 
• 
Past and current psychiatric diagnoses, including duration of illness and frequency of hospitalizations, and compliance 
with agency appointments (among clients) is collected by self-report. Diagnosis and hospitalization information is 
verified via data requested from CBH 
• 
Prescription data is requested from CBH (clients) 
• 
Treatment metric data entered by ATTOC personnel participants via online “Dashboard” 
• 
Change Plans documentation and progress notes and ATTOC consultant environmental scan visual surveying 
• 
Self-reported smoking behavior is bio-verified with CO samples using Vitalograph CO monitors (clients) 
9.3 
Computers and Databases 
Key personnel at PENN have personal computers linked to a common computer server within the PENN CIRNA. The CIRNA 
maintains a LAN to allow for remote access to common software and computer files. This LAN maintains all necessary 
communications, word-processing, and data management systems (DMS). Data (for all studies, including the one proposed 
here) are maintained on password-protected computers and are maintained on a DMS overseen by Ms. Ware. The DMS uses 
ORACLE and MS ACCESS to permit real-time data entry, storage, and QA by web-based access and scannable forms, which 
increases standardization. We have >10 years of experience with this DMS for similar trials. The DMS constructs semantic 
constraints on fields, and is used for data entry, storage, retrieval, and security. The DMS uses visit dates (e.g., Baseline, Week 
1, Week 52) to list procedures and measures to be ascertained. The DMS mimics the appearance of CRFs completed at visits. 
Each visit date is “mile-stoned” (e.g., completed, scheduled, missed). During data entry, validation occurs via built-in 
mechanisms (e.g., Range Checks - data range restricted). Daily backups occur to protect against corruption or deletion. 
Protection of privacy is ensured by: minimizing use of identifying information, use of ID numbers vs. names, keeping all data in 
locked files, and restricting access to the dataset linking names with ID numbers. Currently, this DMS is used for several multi-
site smoking cessation clinical trials (e.g., R01 DA025078; R01 CA165001). This web-based DMS allows for the simultaneous 
running of the trial at multiple sites using standardized systems. The same system will be used for the proposed trial. 
10 
Ethical Considerations 
10.1 
Risks 
The proposed trial will test a training intervention designed to address organizational- level change to promote improved 
treatment of nicotine dependence. Implementation of the training program, and the measures required to evaluate impact, are 
associated with the risks that are described below. 
 
Training: Some personnel may experience frustration or concern about the need to address their agency’s approach to treating 
nicotine dependence. There may be some discomfort in discussing issues surrounding attempts to improve agency practices 
and addressing organizational climate and culture which serve as barriers to improvement. Study staff who have a great deal of 
experience working with organizational change initiatives such as this, as well as psychiatric populations, can manage these 
cases should they arise. 
 
Assessments: Some participants may experience some emotional distress during the assessments since these measures 
assess agency culture and climate (for personnel) and mental health (clients). In our experience, these events happen very 
rarely and in almost all cases are short-lived and of low intensity, lasting for 1-2 weeks. Study staff who have a great deal of 
experience working with organizational change initiatives such as this, as well as psychiatric populations, can manage these 
cases should they arise. 
 
Threats to Privacy/Confidentiality: Since self-report and medical data will be collected and stored as part of this study, it is 
possible that subject privacy or confidentiality can be threatened. To address this concern, the Data Management System has 
set up several safeguards to prevent unauthorized access to study data. An automatically  generated  index  number  is  
assigned  to  a  subject’s  study  identification  number  (unique for personnel and clients). A linked subject identification table is 
created for the storing of subject name, address and telephone contact information. This table uses the automatically generated 
index number rather than the study identification number. The master subject map and subject identification information tables 

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are maintained in a separate database. Using this method, no identifying subject information is directly linked to medical 
information or other study data. For our multi-site trials, we have long-established protocols to guard against improper use of 
hard copies of data (e.g., locked files, numeric coding procedures). The present research team has not experienced the 
unauthorized use of study data. A web-based data collection procedure will minimize the possibility of loss of privacy or 
confidentiality. The risk of a breach of confidentiality is addressed in the informed consents.  
10.2 
Risk Minimization 
The following methods will be employed to minimize participant risk. 
 
Oversight and Monitoring: The PENN IRB will monitor the protection of human subjects and the safe and secure collection and 
storage of data. This committee assesses all studies before study initiation and then reviews protocols annually. The committee 
ensures the scientific, technical, and statistical soundness of the research and guarantees that methods for the ethical and safe 
treatment of human subjects are in place. The committee scrutinizes the scientific and ethical aspects of protocols and provides 
for an objective and ongoing assessment of the study’s scientific and ethical integrity. We will comply with all of the data and 
safety procedures outlined in the Data Safety Monitoring Plan and will seek regular recruitment advice from our Community 
Advisory Council. 
 
Minimization of Training and Assessments Risks: If during training or upon assessments, a participant exhibits significant 
frustration or concern, Key Personnel on the Research Team (Schnoll, Leone, Ziedonis, Neimark, or Mandell) will work with the 
participant to ensure that their concerns are appropriately addressed. Dr. Ziedonis and his team have the experience and skill 
needed to ensure that any serious concern expressed by personnel is adequately addressed in a way that minimizes any risk to 
the participant; this may include a private meeting with the participant or additional assurances that the agency is committed to 
understanding and working with the participant’s concerns. Additionally, should any assessment trigger any distress among 
clients or personnel, Key Personnel will be available to mitigate and resolve this concern in a way that reduces participant risk, 
including explaining the rationale behind measures and providing additional support for mitigating the source of the distress. 
 
Quality Assurance Procedures and Participant Confidentiality: All subjects will be screened for eligibility using formal study forms 
and the Principal Investigator will regularly audit accrual to ensure that participants meet eligibility criteria. In addition, the Study 
Coordinator will audit all study files to ensure that questionnaires completed by subjects contain all items. Lastly, to protect 
confidentiality, all data will be numerically coded and information linking the numeric code to the subject’s name will be kept in a 
secured file cabinet and office. In addition, computer data files will be stored on password-protected computers and 
communication among the staff will use participant code numbers, not names. No information concerning data will be presented 
with participant names. Data will be collected in a private room or via telephone. 
 
Undue Influence/Coercion and Enrollment Status: In order to protect personnel participants from possible undue influence and 
coercion regarding enrollment in our study, the voluntary nature of the study is stressed throughout the informed consent 
documents. With regard to clinic leadership, we assess their willingness to ensure that personnel employability will not be 
affected at the time of pre-enrollment (within the ORIC assessment), and we ask a designated clinic leader to sign an informed 
consent acknowledgement form. This document asks the clinic leader to acknowledge that s/he has read and approved the 
consent form and agrees on behalf of the clinic to reduce undue influence due to employability risks. This signed form will be 
presented to clinic personnel at the time of informed consent to address this potential concern. The consent will also state that 
the study team cannot conceal personnel enrollment decisions after the study treatment phase is initiated. If the clinic is 
disqualified during the enrollment period due to under-enrollment, personnel enrollment decisions will not be disclosed to clinic 
leadership. 
 
Adverse Event Reporting: In accordance with NIH and IRB guidelines, this protocol will employ the following mechanisms for 
adverse event reporting: 1) alert the IRB of any and all reports of serious adverse events; 2) informing all members of the study 
team of any and all reports of serious adverse events; and 3) notification to NIH of any actions taken by the IRB with regard to 
data safety monitoring. 
10.3 
Benefits 
Summarize the potential benefits, if any, from trial participation. Benefits should be broken down into those, which are direct 
benefits (to the subject directly from participating) and indirect benefits (benefits to individual or society as a hole in the future). 
10.4 
Risk Benefit Assessment 
The potential benefits of this study outweigh the potential risks. Individuals with serious mental illness (SMI) have exceedingly 
high rates of tobacco use and salient system and cultural barriers within mental healthcare organizations impede effective care. 
This will be the first controlled, randomized trial to evaluate the effects of the ATTOC model on clinician adherence to treatment 
guidelines, client smoking, and client mental health and QOL. If this approach is shown to be effective and safe, it can serve as 
a model for the nation’s community mental healthcare infrastructure, representing a powerful initiative to address tobacco use in 
an under-served sub-group of smokers, and support efforts to attain the Healthy People 2020 goals regarding tobacco use. 

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10.5 
Informed Consent Process / HIPAA Authorization  
Subjects will hear a study description where all study procedures, risks, and information about the study medication will be 
reviewed. Subject questions will be answered. The consent will be read aloud in its entirety to patient participants and clinic 
personnel participants. Following this presentation, the combined informed consent and HIPAA form will be completed by client 
or personnel participants. Personnel participants will review an informed consent acknowledgment form sign by a clinic leader 
and will complete a consent form. If the baseline session is being conducted remotely (over the phone or video chat), 
participants will then give their verbal consent. The research staff member will note in the consent form that the participant 
affirmed their consent, as well as the date of the consent. The consent document will also be sent to participant, either over 
email or through the mail. 
 
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.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, retains the ability to use all 
information collected prior to the revocation of subject authorization.  For subjects that have revoked authorization to collect or 
use PHI, attempts should be made to obtain permission to collect at least vital status (i.e. that the subject is alive) at the end of 
their scheduled study period. 
 
The following personal health information will be collected as part of this study: 
1. 
Name 
2. 
Address 
3. 
Date of Birth 
4. 
Phone number(s) 
5. 
Electronic mail address 
6. 
Social Security number (W-9 Form) 
7. 
Medical record number 
8. 
Pharmacy prescription information 
9. 
Dates of procedures and events (such as hospital admissions and discharges) relevant to side effect and adverse 
event reporting 
 
The following individuals and organizations may use or disclose personal health information: 
• 
The Principal Investigator (PI) and research staff 
• 
The University of Pennsylvania Institutional Review Boards (the committees charged with overseeing research on 
human subjects) 
• 
The University of Pennsylvania Office of Regulatory Affairs 
• 
The University of Pennsylvania Office of Human Research (the office that monitors research studies) 
• 
Authorized members of the University of Pennsylvania, the UPHS and School of Medicine workforce that may need to 
access your information in the performance of their duties (for example: for research oversight and monitoring, to 
provide treatment, to manage accounting or billing matters, etc.) 
• 
Research collaborators at the University of New Mexico  
• 
National Institutes of Health 
• 
Philadelphia Department of Public Health Institutional Review Board 
 
The Principal Investigators or research staff will inform participants if there are any changes to the list above during their active 
participation in the trial. 
 
Authorization for use of personal health information for this specific study does not expire while the study is active (about 5 
years). Paper research records are saved in an archive for 10 more years and are then destroyed. Study participant contact 
information may be held in a research database.  However, the School of Medicine may not re-use or re-disclose information 
collected in this study for a purpose other than this study unless: 
• 
The participant has given written authorization  
• 
The University of Pennsylvania’s Institutional Review Board grants permission 
• 
As permitted by law 
11 
Resources Necessary for Human Research Protection 
11.1 
Qualifications of Investigators 
Robert A. Schnoll, Ph.D. (Principal Investigator): Dr. Schnoll has lead a laboratory devoted to collaborative and independent 
research on treatments for nicotine dependence. Dr. Schnoll has developed and studied behavioral interventions for nicotine 

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dependence, conducted numerous clinical trials of medications for nicotine dependence, and specialize in evaluating novel ways 
to improve treatments for nicotine dependence as well as studying treatments for nicotine dependence among clinical 
populations, including cancer clients, smokers with HIV/AIDS, pregnant smokers, and smokers with serious mental illness. Dr. 
Schnoll has conducted several large, multi-site clinical trials and trials that evaluated methods for training clinicians to treat 
nicotine dependence. Dr. Schnoll has expertise in conducting multi-site smoking cessation clinical trials, understanding clinician 
behavior with regard to the treatment of nicotine dependence, implementing organizational interventions to promote nicotine 
dependence among clinicians treating under-served communities, and with delineating clinical treatment guidelines for treating 
tobacco dependence in clinical populations. 
 
Douglas M. Ziedonis, M.D., M.P.H. (Sub-award Prinicipal Investigator): Dr. Ziedonis has lead and advised on numerous 
international, national and local initiatives on tobacco addiction and mental illness and has been supported by NIH funding 
during the past 20 years, including projects to develop, implement, and evaluate treatment and organizational change 
interventions to enhance clinical treatment of tobacco use disorder. Dr. Ziedonis has successfully helped hundreds of agencies 
across the nation and internationally with the Addressing Tobacco Through Organizational Change (ATTOC) approach and 
training on the Evidence Based Tobacco Use Disorder treatments. Dr Ziedonis has extensive NIH and other research grant 
experience related to the ATTOC approach, including working with similar clinical treatment agencies in providing technical 
assistance and training, which will inform and support the goals of this study. Dr. Ziedonis has led / co-led numerous efforts to 
evaluate the impact of this ATTOC model and initiatives to improve treatment for Tobacco Use Disorder (TUD) among those 
with an SMI for the Robert Wood Johnson Foundation, NIMH, NIDA, MA Department of Mental Health, Veterans Affairs Health 
Care, the American Psychiatric Association, the Smoking Cessation Leadership Center, and SAMHSA. 
11.2 
Research Staff 
The following research staff will be directly involved with the implementation and execution of the current study: 
 
Name 
Study Role 
Robert A. Schnoll, Ph.D. 
Principal Investigator, University of Pennsylvania 
Douglas M. Ziedonis, M.D., M.P.H 
Sub-award Principal Investigator, University of New Mexico 
Frank T. Leone, M.D. 
Co-investigator and Study Physician, University of Pennsylvania 
David S. Mandell, Sc.D. 
Co-investigator, University of Pennsylvania 
Daniel E. Polsky, M.P.P., Ph.D. 
Co-investigator, University of Pennsylvania 
E. Paul Wileto, Ph.D. 
Co-investigator and Statistician, University of Pennsylvania 
A. Eden Evins, M.D., M.P.H. 
Research Consultant, Harvard University 
Mackenzie Quinn, B.A. 
Research Study Project Manager, University of Pennsylvania 
Anna-Marika Bauer, B.A. 
Research Study Project Manager, University of Pennsylvania 
Nathaniel Stevens 
Research Staff, University of Pennsylvania 
Gabrielle Barrila 
Research Staff, University of Pennsylvania 
ShelDan Dalsimer, B.A 
Research Staff, University of Pennsylvania 
Michelle An 
Research Staff, University of Pennsylvania 
Scott Siegel, Ph.D., MHCDS 
Research Staff, Christiana Care Health System 
Sue Ware, B.S. 
Database Manager, University of Pennsylvania 
Brian Isakson, Ph.D 
Andrew Sussman, Ph.D 
Michelle Harkins, M.D. 
Amy Bachyrycz, PharmD 
Prjakta Adsul, MBBS, Ph.D 
Thomas Anthony Chavez, Ph.D. 
Orrin B Myers, PhD 
Cesar Javier Ojeda, MBA 
 
Co-investigator, University of New Mexico 
Co-investigator, University of New Mexico 
Co-investigator, University of New Mexico 
Co-investigator, University of New Mexico 
Co-investigator, University of New Mexico 
Co-investigator, University of New Mexico 
Statistician, University of New Mexico 
Research Staff, University of New Mexico 
 
 
 
Other individuals will provide supportive services not directly related to the execution of the study including CMHC recruitment 
consultations (Cherie Brummans, M.B.A., Rosemary O’Rourke, M.Ed., Michael Brody, M.S.W. and Geoffrey Neimark, M.D., 
M.S.) and web development (Sharon Kershaw). 
12 
Study Finances 
12.1 
Funding Source 
This study is financed through a grant from the National Cancer Institute. This study has a sub-contract with University of 
California – San Diego and University of New Mexico to oversee the implementation of the intervention (Dr. Douglas Ziedonis, 
PI). 

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12.2 
Conflict of Interest 
All University of Pennsylvania Investigators will follow the University of Pennsylvania Policy on Conflicts of Interest Related to 
Research.  
12.3 
Subject Compensation 
Clinic personnel and client participants will be compensated for participation (see Participant Compensation Schedules below). 
Compensation will be provided in-clinic or by check.  
 
Clinic Personnel 
Participant Compensation Schedule* 
Session 
Time Point 
Time and Effort 
Reimbursement 
1 
Baseline 
$20 
2 
Week 1 
- 
3 
Week 4 
- 
4 
Week 8 
- 
5 
Week 12 
$20 
6 
Week 16 
- 
7 
Week 20 
- 
8 
Week 24 
$20 
9 
Week 28 
- 
10 
Week 32 
- 
11 
Week 36 
$20 
12 
Week 52 
$20 
Total 
$100 
*Per person 
 
 
 
 
 
 
13 
Publication Plan 
We will follow standard methods for publishing the results of this study and in accordance with any publication policies of the 
University, Department, Division or Research Center. 
Clinic Client 
Participant Compensation Schedule 
C
ti
S h d l
Session 
Time Point 
Time and Effort 
Reimbursement 
Travel Reimbursement 
1 
Baseline 
$20 
$10 
2 
Week 12 
$20 
$10 
3 
Week 24 
$20 
$10 
4 
Week 36 
$20 
$10 
5 
Week 52 
$20 
$10 
Subtotal 
$100 
$50 
Total 
$150 

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14 
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Mental Health report. Nicotine Tob Res, 2008; 10(12):1691-1715. 
2. 
Cook BL, Wayne GF, Kafali EN, Liu Z, Shu C, Flores M. Trends in smoking among adults with mental illness and 
association between mental health treatment and smoking cessation. JAMA, 2014; 311(2):172-182. 
3. 
Grant BF, Hasin DS, Chou SP, Stinson FS, Dawson DA. Nicotine dependence and psychiatric disorders in the 
United States: results from the national epidemiologic survey on alcohol and related conditions. Arch Gen 
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4. 
Brown S, Inskip H, Barraclough B. Causes of the excess mortality of schizophrenia. Br J Psychiatry, 2000; 
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5. 
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6. 
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7. 
Essenmacher C, Karvonen-Gutierrez C, Lynch-Sauer J, Duffy SA. Staff's attitudes toward the delivery of tobacco 
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8. 
Rogers E, Sherman S. Tobacco use screening and treatment by outpatient psychiatrists before and after release 
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Tong EK, Strouse R, Hall J, Kovac M, Schroeder SA. National survey of U.S. health professionals' smoking 
prevalence, cessation practices, and beliefs. Nicotine Tob Res, 2010; 12(7):724-733. 
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