Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics
Phase: NA
Conditions: Tobacco Smoking
Sponsor: Johns Hopkins University

 
 
 
 
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Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics 
 
 
March 17, 2022 
 
NCT04796961

 
 
 
 
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Date: March 17, 2022 
Principal Investigator: Gail Daumit 
Application Number: IRB00231836 
 
Protocol – Promoting Evidence-Based Tobacco Cessation Treatment  
in Community Mental Health Clinics 
 
*************************************************************************************************** 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
 
Tobacco smoking is the single largest contributor to premature mortality among persons with serious mental 
illness (SMI).1,2 An estimated 53% of US adults with SMI – six million individuals – smoke tobacco,3 
compared to 15% of US adults overall.4 Overall US smoking rates have declined dramatically over the past 50 
years, but smoking has persisted at consistently high rates among those with SMI.5 The vast majority of persons 
with SMI who smoke would like to quit,6 and combination pharmacotherapy and behavioral counseling is 
effective and safe for people with SMI,7-10 increasing abstinence rates up to 7-fold over behavioral counseling 
alone.8,11 Provision of effective evidence-based smoking cessation treatment could reduce substantially the 
premature mortality experienced by people with SMI, however few in this group receive evidence-based 
treatment.12-15 
 
In two large Maryland healthcare systems, fewer than 5% of persons with schizophrenia who smoke are 
prescribed evidence-based smoking cessation pharmacotherapy;13,14 limited available research shows similarly 
low rates in other states.12,15 Rates of behavioral smoking cessation counseling are also low.16 As many people 
with SMI receive the majority of their healthcare in the specialty mental health sector,17-19 it is critical to 
increase mental health providers’ delivery of evidence-based smoking cessation treatment. Strategies to achieve 
this goal will need to overcome knowledge and self-efficacy barriers among mental health providers, including 
skepticism that people with SMI want to quit smoking, misperceptions about cessation treatment efficacy and 
safety for this group, and low self-efficacy to deliver evidence-based smoking cessation treatment for 
consumers with SMI.12,20-23 Mental health providers may also perceive smoking cessation treatment as outside 
their scope of practice.12,20-23 Clinic-level barriers to treatment, such as lack of systems for assessing smoking 
status and willingness to quit among consumers with SMI, may also need to be addressed.20,21 No published 
studies have evaluated implementation strategies to increase mental health providers’ delivery of evidence-
based smoking cessation pharmacotherapy and counseling for people with SMI. 
 
This is a R34 pilot study funded by NIMH as part of the Johns Hopkins NIMH P50 Center to Accelerate 
Translation of Interventions to Decrease Premature Mortality in Series Mental Illness. This is a pilot study to 
assist and study the implementation of evidence-based smoking cessation treatment in community mental health 
clinics in Maryland over 12 months. In this study, we will develop and test an implementation intervention 
designed to improve mental health providers’ knowledge, self-efficacy and delivery of evidence-based smoking 
cessation treatment. The implementation intervention includes both synchronous and asynchronous training 
modules, including using an avatar practice module for motivational interviewing skills, a tobacco smoking 
identification and cessation protocol, expert consultation, coaching and organizational strategy meetings. The 
study is guided by Gurses et al.’s interdisciplinary framework of clinicians’ compliance with evidence-based 
guidelines.24 
 
The study will result in a set of training and implementation tools and resources for community mental health 
clinics to address tobacco smoking. Results also will inform the future design of a large-scale trial testing 
strategies to increase delivery of evidence-based smoking cessation treatment for SMI in community mental 
health settings. 

 
 
 
 
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2. 
Objectives  
 
The specific aims are:  
 
Aim 1: To inform implementation intervention development, examine barriers to evidence-based 
smoking cessation treatment in community mental health clinics serving consumers with SMI. 
1. What do providers in a community mental health organization perceive as the key barriers to delivery of 
evidence-based smoking 
cessation treatment, and what strategies could help to overcome these barriers? 
 
Aim 2: Assess the implementation intervention’s effects on providers’ knowledge, self-efficacy, and 
delivery of evidence-based smoking cessation treatment and preliminary measures of consumers’ 
abstinence from tobacco smoking. The intervention will: 
1. Increase providers’ knowledge of smoking cessation treatment for consumers with SMI. 
2. Increase providers’ self-efficacy to deliver evidence-based smoking cessation treatment. 
3. Increase providers’ delivery of the four key components of evidence-based smoking cessation treatment: 
assessment of smoking status & willingness-to-quit, pharmacotherapy prescribing, and behavioral 
counseling.   
4. Increase abstinence from tobacco smoking among consumers with SMI. 
 
Aim 3: Assess the acceptability, appropriateness, and feasibility of the implementation intervention to increase 
delivery of evidence-based smoking cessation treatment: 
1. The implementation intervention will be perceived as acceptable, appropriate, and feasible by community 
mental health clinic providers. 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, drug or 
device, and any other relevant information to justify the research) 
 
Persons with serious mental illness (SMI) have a mortality rate three times higher than those without SMI,2,25-27 
primarily due to cardiovascular disease (CVD),28-31 and tobacco smoking is the single largest contributor to 
CVD and premature mortality in this population.1,2 Fifty-three percent of US adults with SMI smoke tobacco,3 
compared to 15% of US adults overall.4 Smoking prevalence is highest among adults with schizophrenia, with 
estimates of >60%.32 Smoking cessation has significant benefits: after one year of abstinence from tobacco 
smoking, risk of myocardial infarction is reduced by 50%, and smoking cessation in mid-life eliminates 90% of 
smoking-related mortality risk.33,34 Combination pharmacotherapy (3 efficacious options are available: 
varenicline, bupropion or nicotine replacement therapy (NRT)) and behavioral counseling is effective cessation 
treatment for smokers with SMI,7-10 but estimates suggest that fewer than 5% of smokers with SMI receive 
pharmacotherapy,12-15 and rates of behavioral counseling – which, alone, is not effective cessation treatment for 
smokers with SMI10 – are also low (≈12%).16 
 
Research shows modifiable knowledge and self-efficacy barriers to mental health providers’ delivery of 
evidence-based smoking cessation treatment.12,20-23 While 65-80% of smokers with SMI want to quit,6 in a 
recent study 77% of mental health providers believed smokers with SMI are not interested in quitting.22 
Providers’ disproven but persistent concerns that cessation may increase SMI symptoms and/or disrupt 
psychotropic medication regimens and their uncertainty about the safety of smoking cessation pharmacotherapy 
may also impede treatment.12,22 In 2009, case reports35-37 of adverse psychiatric side effects led to black box 
warnings on varenicline and bupropion. These warnings were removed in December 2016 after cohort and 
clinical trial evidence showed no increased risk of adverse psychiatric events among people with SMI.8,13,14,38 
While few mental health providers feel comfortable delivering cessation treatment, they report high willingness 
to do so if they were to receive training.22 Mental health clinic-level barriers, including lack of systems for 
assessing and tracking consumers’ smoking status and willingness-to-quit, may also need to be addressed.20,25  

 
 
 
 
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Few mental health providers deliver evidence-based smoking cessation treatment and many mental health 
clinics lack standard systems for screening, monitoring, and treating tobacco smoking.12,22 Community mental 
health settings are often under-resourced and providers face multiple competing demands and smoking 
cessation has not historically been an organizational priority. As noted above, mental health providers may face 
knowledge and self-efficacy barriers that impede their delivery of evidence-based smoking cessation 
treatment.12,20-23 Nonetheless, mental health providers’ extensive experience working with consumers with SMI 
makes them optimally positioned to deliver effective cessation treatment for tobacco smoking, the leading cause 
of premature mortality among people with SMI. 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
b. Study duration and number of study visits required of research participants. 
 
Currently this protocol is being submitted as a study where all study procedures are delivered remotely. If and 
when COVID-19 restrictions are lifted, we may submit a petition to have some of the study activities in-person 
as appropriate. 
 
Overview: We will work with 5 community mental health clinics in Maryland. This project’s goal is to 
implement evidenced-based tobacco smoking cessation treatment in community mental health clinics serving 
the population of persons with serious mental illness. Tobacco smoking cessation treatment involves behavioral 
counseling and pharmacotherapy. The main outcome of the project is the utilization of 4 evidence-based 
practices in the clinic setting: 1) screening for tobacco use in all patients, 2) an assessment of willingness to quit 
for those who smoke, 3) referral and utilization of behavioral counseling for those interested in cutting down or 
quitting smoking, 4) receipt of pharmacotherapy for those interested in cutting down or quitting smoking. The 
community mental health clinics are already providing some treatment for smoking cessation for their patients.  
The evidence-based practices in this project are within their scope of practice. The implementation intervention 
is 12 months.  
 
Study sites and participants: We plan for five community mental health clinics in Maryland to participate in 
this study. The clinics serve populations with serious mental illness. Participants for data collection and the 
implementation intervention will be employees of the community mental health organization including leaders, 
mental health providers (psychiatrists and/or nurse practitioners, licensed counselors, psychologists, social 
workers), primary care providers and other staff. We estimate N=120 employee participants across the five 
sites. Employees may take part in different parts of data collection, depending on their role in the clinic. Patients 
with serious mental illness seen in the clinic are also study participants as their data will be analyzed. 
 
Description of Implementation Intervention: The multicomponent implementation intervention is designed to 
improve providers’ knowledge, self-efficacy and delivery of evidence-based smoking cessation treatment for 
smokers with SMI. The intervention includes training on evidence-based smoking cessation treatment, 
including an innovative online avatar motivational interviewing practice module; a tobacco smoking 
identification and cessation protocol; expert consultation for prescribers and therapists; coaching; and 
organizational strategy meetings. A more detailed description of each component is outlined below.  
 
Tobacco smoking identification and cessation protocol: Our team has developed a tobacco smoking 
identification and cessation protocol to assist providers in delivering evidence-based smoking cessation 
treatment. This protocol includes a resource guide that provides an overview of the IMPACT study and will 
help clinicians navigate their work on the project, a manual for delivering smoking cessation behavioral 
counseling sessions and pharmacotherapy, and willingness-to-quit guides to help facilitate brief smoking 
cessation conversations based on patient responses to the tobacco smoking status and willingness-to-quit 
assessment.  

 
 
 
 
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Expert consultation: Expert consultation will be available for prescribers and therapists to discuss issues and ask 
questions related to smoking cessation pharmacotherapy and behavioral counseling. Study team members who 
are experts in smoking cessation pharmacotherapy and behavioral counseling will be available during the 12-
month intervention to conduct as-needed phone or email consultation with smoking cessation medication 
prescribers and therapists providing smoking cessation behavioral counseling.  
 
Coaching: Coaching will be available for providers to discuss specific patient cases and develop smoking 
cessation behavioral counseling skills. Coaching will be offered monthly (via Zoom/phone) for one hour in 
groups at each site and as needed individually, with the expectation that providers attend at least one session per 
quarter. Coaching sessions will take a case management approach, focusing on overcoming barriers to 
providing evidence-based smoking cessation treatment.  
 
Organizational Strategy Meetings (OSMs): Organizational Strategy Meetings are designed to improve 
engagement in practice change. These meetings will occur every 1-3 months and consist of a 3-4 member clinic 
leadership team, including providers and staff leaders. OSMs will be a chance for the study team to work with 
the clinic to identify organizational-level implementation strategies, share feedback, and discuss implementation 
barriers and strategies to overcome identified barriers.  
 
Training: Study team members will conduct trainings (Table 1) by Zoom while the study is remote. All provider 
participants in the IMPACT project first will complete the pre-recorded online training modules. Then, there 
will be separate real-time trainings for therapists and prescribers (psychiatrists/nurse practitioners/primary care 
physicians). Trainings will be housed on the ETHOS Online Management System platform. See Table 1 for 
training outline.  
 
The real-time motivational interviewing training is supplemented with an online avatar practice module.39,40 The 
online avatar practice module includes a 15-minute didactic component where providers learn about 
motivational interviewing and techniques that can be used to guide clients with serious mental illness toward 
health changes and 15-minute practice conversations where providers take on the role of virtual provider avatar 
and practice the use of motivational interviewing techniques in simulated conversations about smoking 
cessation with consumer avatars on the Kognito platform. We will recommend that providers practice weekly 
for the first three months. An online dashboard will give providers an individualized report on their 
performance each time they practice.  
 
Table 1. Training 
Prescribers  
Therapists  
Online Training Modules (1 hr): 
Module 1: Why IMPACT?  
Module 2: Evidence-based treatment for smoking cessation 
for persons with SMI 
Module 3: Assessing Smoking Status Willingness to Quit  
Module 4: Pharmacotherapy for Smoking Cessation  
Real-time Trainings (Zoom) (2 hrs): 
Training 1 (1hr): Facilitating smoking cessation 
conversations 
Training 2 (1hr): Motivational Interviewing Approach to 
Pharmacotherapy 
Online Motivational Interviewing Avatar 
(Recommended weekly 15-minute practice sessions for 3 
months and then as needed/desired) 
Online Training Modules (1hr): 
Module 1: Why IMPACT?  
Module 2: Evidence-based treatment for smoking cessation 
for persons with SMI  
Module 3: Assessing Smoking Status Willingness to Quit  
Module 4: Pharmacotherapy for Smoking Cessation  
Real-time Trainings (Zoom) (4 hrs): 
Training 1 (2hrs): Facilitating Smoking Cessation 
Conversations and an Overview of Behavioral Counseling 
Training 2 (2hrs): Motivational Interviewing Approach to 
Smoking Cessation Behavioral Counseling 
Online Motivational Interviewing Avatar 
(Recommended weekly 15-minute practice sessions for 3 
months then as needed/desired) 
 
Data Collection: 

 
 
 
 
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Study data collection is outlined in Table 2 and in more detail below. Study team involvement in data collection 
is all virtual/remote.  
 
Table 2. Study Data Collection 
Who 
Estimated 
Time 
When 
Qualitative Data Collection  
Provider Interviews  
Select providers/clinic 
director (~6 per site) 
30 minutes 
Baseline, 12 
months 
Survey Measures 
Demographic Characteristics: age, sex, race, ethnicity, length of 
time at program, role in program, years at clinic, work hours, 
previous Motivational Interviewing training 
All providers, clinic staff 
including leaders (~30 per 
site) 
~5 minutes 
Baseline 
Implementation Climate: This is a measure of the degree to 
which an organization supports evidence-based practice 
implementation 
All providers, clinic staff 
including leaders (~30 per 
site) 
~3 minutes 
Baseline 
Acceptability, Appropriateness, and Feasibility of the 
Intervention Implementation Strategies:  Measured with a brief 
4-item practice instrument (AIM, IAM, FIM)41 
All providers, clinic staff 
including leaders (~30 per 
site) 
~5 minutes 
Baseline, 12 
months 
Acceptability, Appropriateness, and Feasibility of the 
Evidence-Based Practice: Measured with a brief 4-item practice 
instrument (AIM, IAM, FIM)41  
All providers, clinic staff 
including leaders (~30 per 
site) 
~5 minutes 
Baseline, 12 
months 
Clinic Social Network: A 4-question survey used to collect data 
about social networks  
All providers, clinic staff 
including leaders (~30 per 
site) 
~10 minutes 
Baseline, 6, 12 
months 
Knowledge of Evidence-Based Smoking Cessation Treatment: 
A 16-item scale developed by our team to assess knowledge 
All providers (~25 per 
site) 
~10 minutes 
Baseline, 12 
months 
Self-Efficacy to deliver evidence-based smoking cessation 
treatment  
All providers (~25 per 
site) 
~5 minutes 
Baseline, 12 
months 
Motivation Measures: Degree to which providers agree or 
disagree with statements that deal with aspects of the intervention 
to improve use of evidence-based smoking cessation treatment.  
All providers (~25 per 
site) 
~3 minutes 
Baseline, 12 
months  
Beliefs about Motivational Interviewing Questionnaire  
All providers (~25 per 
site) 
~2 minutes 
Baseline, 3, 6, 12 
months 
Importance and Confidence of Using Motivational 
Interviewing 
All providers (~25 per 
site) 
~2 minutes 
Baseline, 3, 6, 12 
months 
Perceived Usefulness of Motivational Interviewing Avatar 
All providers (~25 per 
site) 
~2 minutes 
12 months 
Fidelity Measures 
Avatar Motivational Interviewing Performance 
Measurements: from use of motivational interviewing techniques 
in simulated online conversations 
All providers (~25 per 
site) 
Recommended 
weekly 15-min 
practice 
sessions 
Baseline, 3, 6, 12 
months 
Fidelity to Motivational Interviewing: Standardized Actor 
Interviews will be conducted to assess fidelity to motivational 
interviewing. 
Fidelity to behavioral smoking cessation counseling: 
Standardized Actor Interviews will be conducted to assess fidelity 
to smoking cessation behavioral counseling sessions 
All providers (~25 per 
site) 
30 minutes 
3, 6, 12 months 
Smoking and Smoking-Cessation Measures 
These are our primary measures of fidelity to evidence-based 
smoking cessation treatment. 
Guideline-concordant smoking cessation treatment: Measures 
will be calculated at site & provider levels 
Smoking status assessment rates: % of visits where smoking 
status assessment is documented. 
Willingness-to-quit assessment rates: % of visits where 
willingness-to-quit assessment is documented. 
Prescription Rates: % of willing-to-quit smokers prescribed, or 
offered but refused, cessation pharmacotherapy.2 
Behavioral Counseling Rates: (1) % of not willing-to-quit 
All mental health 
consumers (patients) 
(~3000 per site) 
 
Baseline through 
12 months 

 
 
 
 
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smokers given brief behavioral counseling to increase willingness-
to-quit; and (2) % of willing-to-quit smokers who were referred to 
the clinic’s cessation counselor.2 Among willing-to-quit smokers 
referred the counselor, we will also measure the number of 
counseling sessions completed. 
 
7-day abstinence: % of willing-to-quit consumers abstinent for ≥7 
days self-report, documented in the EMR  
All mental health 
consumers (patients) 
(~3000per site) 
 
Baseline through 
12 months 
Other Patient Measures 
Year of birth, gender, race/ethnicity, primary mental health 
diagnosis, hospitalization during the study period 
All mental health 
consumers (patients) 
(~3000 per site) 
 
Baseline through 
12 months 
 
Qualitative Data Collection 
 
Provider Interviews: Study team members will conduct up to 40 (8 per site) 30-minute interviews with the clinic 
director and approximately 7 other providers at each site at baseline and 12 months. Interviews will elicit 
providers’ perceptions of: barriers to smoking cessation treatment and implementation strategies to overcome 
barriers. Interviews will obtain information on how the 5 work system elements (people, tasks, tools and 
technologies, environment and organization) influence delivery of evidence-based smoking cessation treatment 
for consumers with SMI. Semi-structured interviews will be conducted using a standard protocol for both pre-
implementation (baseline) and post-implementation (12 months). Interviews will be audio-recorded, and 
recordings will be transcribed using Production Transcripts, Inc. 
 
Surveys 
Surveys will be administered via email with instructions and a link to the surveys in REDCap. Surveys may also 
be delivered in hard copy if needed and mailed back to the study team. We will recruit and survey the 
staff/providers at the 4 community mental health clinic study sites. 
 
Demographic Characteristics: Will include age, sex, race, ethnicity. We will also ask about their current role in 
the at the clinic, years worked at the clinic, work hours, and any prior Motivational Interviewing training. This 
survey is 11 questions.  
 
Implementation Climate: Ehrhart’s implementation climate scale;42 overall score of 4 = excellent 
implementation climate. This is a measure of the degree to which an organization supports evidence-based 
practice implementation.  
 
Acceptability, Appropriateness, and Feasibility of the Intervention Implementation Strategies: Acceptability, 
feasibility and appropriateness of the intervention implementation strategies (IMPACT smoking cessation 
program, trainings, avatar, resource manuals, organizational strategy meetings, coaching) will be measured with 
validated 4-item measures.41  
 
Acceptability, Appropriateness, and Feasibility of the Evidence-Based Practices: Acceptability, feasibility and 
appropriateness of the evidence-based practices (smoking status and willingness-to-quit assessment, 
pharmacotherapy, behavioral counseling, brief motivational enhancement counseling will be measured with 
validated 4-item measures.41  
 
Clinic Social Network: This is a 4-question survey used to provide information about how people interact in 
each clinic. The survey will include a staff list in order to identify co-workers that regularly interact. Once data 
has been collected, names from the staff list will be deleted. 
 
Knowledge of Evidence-Based Smoking Cessation Treatment: This is a 16-item scale developed by our team to 
assess knowledge of evidence-based smoking cessation treatment (e.g. that most people with SMI want to quit 
and that varenicline is safe and effective for people with SMI). 

 
 
 
 
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Self-Efficacy: Assessing self-efficacy to deliver evidence-based smoking cessation treatment measured as a 
numeric score created by averaging 10 items adapted from Compeau & Higgins’ task-focused self-efficacy 
scale43 (score>8 = high self-efficacy). 
 
Motivation Measures: Measured by assessing the degree to which providers agree or disagree with each 
statement, and the degree to which providers find each item important or not important. Statements deal with 
aspects of the IMPACT intervention to improve use of evidence-based smoking cessation treatment. 
 
Beliefs about Motivational Interviewing Questionnaire: A 7-question survey assessing the extent to which each 
person agrees with statements about motivational interviewing.  
 
Importance and Confidence of Using Motivational Interviewing: A 6-question survey assessing the importance 
and confidence each person has with motivational interviewing.  
 
Perceived Usefulness of Motivational Interviewing Avatar: A 6-item survey assessing the impact of the avatar 
on each person’s use of motivational interviewing and performance in the study. 
 
 
Fidelity Measures 
Avatar Motivational Interviewing Performance Measurements: Providers will conduct 15-minute practice 
conversations where they practice use of motivational interviewing techniques in simulated conversations about 
tobacco smoking cessation with patient avatars. An online dashboard will give providers an individualized 
report on their performance each time they practice.  
 
Fidelity to Motivational Interviewing: Standardized Actor Interviews: Providers will conduct 30-minute audio-
recorded phone interviews with standardized patient actors. These standardized patient actors are trained actors 
playing roles of patients with SMI who smoke. Used to assess fidelity to motivational interviewing. 
 
Fidelity to behavioral smoking cessation counseling: Standardized Actor Interviews: Providers will conduct 30-
minute audio-recorded phone interviews with standardized patient actors. These standardized patient actors are 
trained actors playing consumers with SMI who smoke. Used to assess fidelity to smoking cessation behavioral 
counseling sessions. 
 
Smoking and Smoking Cessation Processes of Care, Patient Measures 
Providers will document smoking-related processes of care during the study (see IMPACT Study Medical 
Record Variables document). We will work with each community mental health clinic on how providers will do 
this. At Johns Hopkins, this information will be entered into EPIC using smart forms and adapting current clinic 
note templates. For other study clinic sites, data will come from a combination of electronic health records and 
from REDCaP surveys that clinic provider participants complete when they assess smoking status or provide 
smoking cessation treatment. If the other sites are not able to change their electronic health records to collect 
smoking cessation processes of care or provide documentation of smoking cessation processes of care directly 
to us, we plan to use REDCaP to supplement available electronic health record data. We describe in more detail 
below in the data management section.  
 
Data Management:  
Qualitative data. Interview data will be audio or video-recorded and recordings will be transcribed using 
Production Transcripts, Inc or another approved Johns Hopkins vendor. Names will be removed from 
transcripts. Recordings will be stored in a Johns Hopkins secure network drive and will be destroyed when 
analyses are complete. Standardized actor interview recordings will be reviewed by experts in motivational 
interviewing and smoking cessation behavioral counseling to assess for fidelity to motivational interviewing 

 
 
 
 
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practices and fidelity to IMPACT smoking cessation behavioral counseling sessions. These recordings will be 
stored in a Johns Hopkins secure network drive or OneDrive. 
 
Quantitative data. Each participant will be assigned a unique study ID number for data collection. Study team 
members are trained to protect integrity and confidentiality of the data. Staff and provider questionnaire data 
will be stored in a Johns Hopkins REDCap database. Kognito, a health simulation company, developed the 
avatar simulations for this project and hosts the avatar training platform and dashboard. Avatar performance 
measurement data for motivational interviewing practice conversations is accessible only by the individual 
study participant (provider) and the study team, not shared outside Kognito. Kognito stores data securely behind 
two firewalls.  
 
 
 
Figure. Data sources, management and security.  
 
 
 
 
 
This figure describes planned data management and security for this study. We developed this plan with Bonnie 
Woods, IT Director for the Johns Hopkins ICTR. The ICTR/CCDA will serve as an honest broker both for data 
coming from Johns Hopkins and from non-Johns Hopkins clinic sites. They will create limited datasets for 

 
 
 
 
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patient data for study team use on a study team SAFE Desktop including linking REDCap process of care data 
from to the appropriate patient. REDCap: We will store questionnaire data from staff/providers who agree to 
participate in the study in a Johns Hopkins REDCap database, restricted by study site. REDCap will also be 
used if needed for providers at non-Johns Hopkins study sites to document processes of care information for 
smoking cessation treatment to supplement data from electronic health records. One site (Vesta) plans to use a 
spreadsheet to document deidentified process of care data to be placed on a Johns Hopkins OneDrive.  EPIC: 
Johns Hopkins EPIC data from smartforms developed for this project and from clinic notes will be used for 
process of care information at the Johns Hopkins site. Additional data from EPIC will be used including for 
demographics, medications, and information about number of outpatient encounters. (see IMPACT Study 
Medical Record Variables document). Weekly reports of process of care data will be provided to the study 
team, not identifying patients. SFTP: Electronic medical record data from non-Johns Hopkins study sites will be 
transmitted to Johns Hopkins through SFTP. The ICTR/CCDA will serve as an honest broker and store data on 
a CCDA Safe Desktop while preparing the limited datasets for the study team.  
 
 
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable.  
Not applicable 
 
Justification of why participants will not receive routine care or will have current therapy stopped. 
Not applicable 
 
d. Justification for inclusion of a placebo or non-treatment group  
Not applicable 
 
e. Definition of treatment failure or participant removal criteria. 
Not applicable 
 
f. Description of what happens to participants receiving therapy when study ends or if a participant’s 
participation in the study ends prematurely. 
Not applicable 
 
5. 
Inclusion/Exclusion Criteria 
Community mental health clinic staff (e.g., licensed counselor, psychologist, social worker, nurse 
practitioner, physician, organizational leader, clinic director, administrative assistant) at one of the 4 
community mental health clinic study sites. All are 18 years and older and English-speaking. 
 
Clinic patients are by definition persons with serious mental illness seeking treatment at community 
mental health outpatient clinics. All are 18 years and older.  
 
6. 
Drugs/ Substances/ Devices – Not applicable 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are changed. 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
 
7. 
Study Statistics 
a. Primary outcome variable and analytic plans.  
 
We will conduct three main analyses. First, we will assess the effects of the implementation intervention 
(baseline and 12 months) on providers’ knowledge and self-efficacy, the mechanisms through which the 

 
 
 
 
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implementation intervention is designed to improve delivery of evidence-based smoking cessation treatment, 
using a generalized linear mixed effects modeling approach. The mean model will include a binary pre/post 
indicator, fixed effects for the four study sites, and provider demographic characteristics. Second, we will 
evaluate the effects of the implementation intervention (baseline and 12 months) on consumer level guideline-
concordant care and 7-day smoking abstinence outcomes using a multi-level modeling approach. Third, we will 
assess mediators and moderators. Specifically, we will test whether providers’ knowledge and self-efficacy 
mediated the implementation intervention’s effects on consumer outcomes by estimating the magnitude of 
attenuation on intervention effects in the multi-level models of consumer outcomes with versus without these 
potential mediators. We will also assess the potential moderating effects of implementation climate by adding 
appropriate interaction terms to main models. We will use descriptive statistics to analyze survey measures of 
staff perceptions of the acceptability, feasibility and appropriates of the implementation intervention strategies 
and the IMPACT evidence-based practices. Interview transcripts will be analyzed in NVivo V.11, using 
inductive coding to identify key themes. Survey analysis will be done using Stata 14 or SAS software.  
 
To analyze the standardized actor interviews, we will use the Motivational Interviewing Treatment Integrity 
(MITI) rating system and our IMPACT Smoking Cessation Counseling Session skills Assessment Form. For 
MITI: We will MITI code random 30-minute segments of audio-recorded interactions with standardized patient 
actors. Standardized consumer scenarios will be scripted to reflect the kind of situations community mental 
health clinicians would likely encounter with clients; this method has predictive validity in terms of providers’ 
performance with real patients.44 “Global” scores provide benchmarks of “fair” or “good” on the technical (e.g. 
capacity to elicit motivations for change) and relational (person-centered) aspects of motivational interviewing. 
“Behavior Counts” are tallies of 10 specific clinician behaviors, e.g. giving information and “persuading with 
permission.” Summary measures indicate the degree to which clinicians are motivational interviewing adherent 
(e.g. affirm, emphasize autonomy, seek collaboration), motivational interviewing non-adherent (e.g., confront, 
persuade), and show an appropriate ratio of questions to reflections. For fidelity to evidence-based smoking 
cessation treatment: all interviews will be scored by our team to assess individual clinician’s skills 
implementing the intervention.  
 
b. Secondary outcome variables. N/A 
c. Statistical plan including sample size justification and interim data analysis. N/A 
d. Early stopping rules. N/A  
 
8. 
Risks 
 
Risk of loss of confidentiality and negative implications for employment are the main risks. We expect 
these risks to be extremely low. Plans to minimize this risk are described below.  
 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency.  
 
For the implementation intervention, community mental health clinic providers (including primary care 
providers)  are already providing care including some smoking cessation treatment for their patients with 
serious mental illness. For this project, we will work with community mental health clinic providers to 
implement evidence-based best tobacco smoking cessation practices. The evidence-based practices in this 
project are based on current guidelines and are within the clinicians’current scope of practice. Thus, we do not 
expect there to be an increased risk for clinic patients.  
 
Community mental health clinic providers and staff may become tired or bored during surveys or interviews.  
 
b. Steps taken to minimize the risks. 
 
Community mental health clinic leaders, providers and staff will be appropriately recruited and informed of the 
study by the study team with waiver of documentation of informed consent. The study team will inform them 

 
 
 
 
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that they do not have to answer any questions they do not want to, and that their employment or evaluations will 
not be affected by their responses.  
 
c. Plan for reporting unanticipated problems or study deviations. 
 
Dr. Daumit, internist with experience in working with persons with SMI and staff in community mental health 
settings, will be responsible for data safety and monitoring. If new guidelines for smoking cessation treatment 
were to be released during the study period, we will make any appropriate modifications in protocols (resource 
guides, manuals), during coaching sessions and expert consultation, and communicate with the study sites. If 
safety issues about management of smoking cessation treatment in individual clients arise, Dr. Daumit will 
communicate with the provider or clinic director as appropriate. Any unanticipated problems will also be 
reported to the IRB. We expect any issues to be rare.  
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
Risk of loss of confidentiality is the main risk. We expect this risk to be extremely low, as we will be taking 
multiple safeguards to protect the data. To protect against breach of confidentiality, all information will be 
considered confidential. This confidentiality will be assured through several mechanisms.   
 
As per above, community mental health providers, primary care providers and staff will be appropriately 
recruited and informed of the study by the study team with waiver of documentation of informed consent. The 
study team will inform them that they do not have to answer any questions they do not want to, and that their 
employment or evaluations will not be affected by their responses. Data will not be presented in such a way that 
identity can be inferred. As described in Data Management, data will be stored in Johns Hopkins secure drives. 
Folders and spreadsheets will have password protection. For qualitative data, each interviewee will be assigned 
a study identifier. The link to the study ID will be held in a locked file. Interview transcripts will have names (if 
mentioned during interview) removed, and no participants will be identified by name in any publications. For 
quantitative data, each staff participant will be assigned a unique study ID number for data collection and data 
will be stored in REDCap. The study team will receive limited datasets for patient data on SAFE Desktop.  
 
 
e. Financial risks to the participants. N/A 
 
9. 
Benefits 
a. Description of the probable benefits for the participant and for society. 
 
There is no benefit to individual participants. This research will help stakeholders have a greater understanding 
of the organizational and provider-level barriers to delivery of evidence-based smoking cessation treatment in 
community mental health settings. This research will also inform development of the implementation 
intervention tested in this R34.  
 
10. 
Payment and Remuneration 
a. Detail compensation for participants including possible total compensation, proposed bonus, and 
any proposed reductions or penalties for not completing the protocol. 
 
Study participants will be paid $50 for completing each interview. Providers will be paid $25 for each 
standardized actor interview. All study participants will be compensated $20 for completion of surveys 
administered at baseline data collection and 12 month data collection and $10 for completion of surveys at 3 
and 6 months. Providers will receive $50 for documenting smoking related processes of care during the study. 
 
11. 
Costs  

 
 
 
 
Page 13 of 15 
 
a. Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify who will 
pay for them.  
 
There are no costs to participants.  
 

 
 
 
 
Page 14 of 15 
 
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