Implementation Science to Reduce the Disparity in Tobacco Treatment Among Individuals With Serious Mental Illness (ISRAISE)
Phase: NA
Conditions: Smoking, Smoking Cessation, Tobacco Use Cessation
Sponsor: Washington University School of Medicine

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Implementation Science to reduce the disparity in tobacco treatment among individuals 
with serious mental illness (IS-RAISE) 
  
  
  
Washington University School of Medicine  
Department of Psychiatry  
  
Version date: 11/22/2023 
Version Number: 1 
  
  
  
  
  
Principal Investigator:  
 
Li-Shiun Chen, MD, ScD, MPH 
Phone: (314) 362-3932  
Email: li-shiun@wustl.edu   
 
 
 
Funding Source:  
 
 
NCI P50CA244431 
 
 
 
 
 
 

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1. Background and rationale ....................................................................................................3 
2. Objectives ..............................................................................................................................3 
3. Participant selection ..............................................................................................................4 
3.1 Eligibility Criteria ............................................................................................................4 
3.2 Inclusion of women and minorities .................................................................................4 
4. Recruitment and informed consent ...................................................................................4 
4.1 Recruitment .....................................................................................................................4 
4.2 Informed Consent ............................................................................................................4 
5. Registration procedures ........................................................................................................5 
6. Methods .................................................................................................................................5 
6.1 Study overview .................................................................................................................5 
6.2 Retrospective EHR query .................................................. Error! Bookmark not defined. 
6.3 Patient participation .......................................................... Error! Bookmark not defined. 
6.4 Renumeration ..................................................................................................................8 
6.5 Enrollment ............................................................................. Error! Bookmark not defined. 
7 Risks and Benefits ..................................................................................................................8 
8. Regulatory and reporting requirements...............................................................................8 
9. Statistical Considerations ..................................................................................................9 
10. REFERENCES ....................................................................................................................9 
 
 
 
 
 

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1. Background and rationale  
 
Individuals with SMI have a much higher smoking prevalence (60% vs. 15%)1-5 and die 
25 years earlier compared to the general population.6 Despite the fact that SMI patients express 
interest in and have success with evidence-based smoking cessation treatment,7-10 inadequate 
provision of treatment in community mental health centers (CMHCs) contributes to high 
smoking prevalence and related health consequences among the mentally ill.11-14 
Patients with serious mental illness (SMI) receive care in Community Mental Health 
Center (CMHC) settings and psychiatry clinics, and they frequently smoke and suffer from 
smoking-related harms.4-6  Growing evidence shows that patients with SMI respond to smoking 
cessation treatment. 15, 16 Despite the profound health costs associated with smoking in SMI 
patients and evidence that smoking cessation is effective in this population, 7, 8, 10 evidence-based 
treatment (EBT) for smoking cessation remains infrequently provided in CMHCs, 11-13which 
represents a missed opportunity to reduce the morbidity and mortality associated with smoking 
in this highly affected population. This treatment gap exists in CMHCs in our region.  
Our study addresses a critical need for real-world interventions that can function in 
CMHCs and psychiatry clinics to address these medically underserved communities. If 
successful, this will result in a model that has potential to be disseminated to other under-
resourced CMHC settings. This study will test an intervention that has the potential to make 
improvements in tobacco treatment and ultimately reduce cancer in the SMI patients. For this 
trial we will recruit broadly at Washington University Psychiatry Clinics. These clinics 
predominately serve SMI patients. 
 
2. Objectives  
 
Aim 1: test the effect of nudges to quit on patient receipt of tobacco treatment.  
The investigators hypothesize patient receipt of tobacco cessation treatment such as medication 
and counseling will be higher after delivery of nudges to quit over usual care.  
 
Aim 2, the investigators will test the effect of nudges to quit on smoking behaviors.  
The investigators hypothesize that smoking behaviors will decrease and quitting behaviors will 
increase in the nudges to quit group compared to usual care.  
 
Aim 3, the investigators will evaluate the feasibility and preliminary effect of this pilot project 
for a future R01 proposal to systematically evaluate this multilevel intervention adapted for 
CMHCs and psychiatry clinics.  
 
 
 
 
 

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3. Participant selection  
3.1 Eligibility Criteria 
Inclusion Criteria: 
1. Patient of participating clinic 
2. Current smoker, >5 cigarettes per day 
3. Age 18 years or older 
4. Can speak and understand English 
  
Exclusion Criteria: 
1. Active use or receipt of smoking cessation medication or smoking cessation counseling 
(within the past 30 days)   
 
3.2 Inclusion of women and minorities 
 
Women and members of all races and ethnic groups are eligible for this study.  
 
4. Recruitment and informed consent 
 
Research team members plan to recruit, consent, and enroll patients of the participating clinics into 
the study. 
 
4.1 Recruitment 
A study team member will identify patients who are potentially eligible via Epic or patient list 
provided by clinic and will:  
1. Mail the individual a letter and/or flyer inviting the individual to participate in the study. A phone 
number and email address will be provided for the individual to indicate interest in the study to the 
study team. 
2. Call the potential participant. A study team member will use a verbal script to describe the study, 
and address any questions the potential participant may have.  
3. Send an invitation via MyChart to participants, if applicable.  
4. Patients will be recruited by fliers posted in the clinic (with clinic prior approval).  
 
If participants are interested in the study they will be screened for eligibility using a script and a 
research team member will collect eligibility information and consent as approved by IRB.  
 
4.2 Informed Consent 
Participants will have the opportunity to give consent verbally over the phone without 
documentation of signature or in person with documentation of signature at a study location 
outside of the clinic. If consent is attained over the phone, the study team member will review the 
consent, obtain verbal consent, and mail a copy to the participant. If consent is attained in person, 
a research member will review the paper information consent. We will ask the patient to indicate 
participation by signed consent form. There will be an opportunity for the participant to ask the 
research team questions and the study team will document assent, including questions asked, using 
the consent documentation instrument in REDcap. The research team member who discusses the 
consent with the participant will document the conversation. After any questions are addressed 

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and the consent is complete, a copy of the consent will be delivered to the participant.  To reduce 
the possibility for coercion, participants will have as much time as they desire to consider enrolling 
in the study including the opportunity to thoroughly review the consent materials with 
knowledgeable members of the research team, and with family and/or friends as appropriate and 
sufficient time to have all questions answered.  
 
5. Registration procedures 
 
This study will register summary accrual statistics to the Siteman Cancer Center OnCore Database. 
On a quarterly basis, accrual should be grouped according to the demographic data 
collected. Demographic information includes gender, age, ethnicity, and race.  If any piece of 
demographic information was not collected for those categories, choose unknown.  
 
1. In OnCore, navigate to the PC Console for this study and enter the dates of the quarter for 
which you are entering accrual statistics. (These dates must be inclusive of the same year, 
e.g. 1/1/2020 – 3/31/2020, not 12/31/2019 – 3/31/2020.) 
2. Then, enter the accrual number for any subjects who are in the same demographic groups 
of race, ethnicity, gender, and age group. For example, if you have accrued two white non-
Hispanic males in their 50s, you will enter that demographic as an accrual group of 2. If 
you have also accrued an Asian female in her 40s, you will enter her as a separate accrual 
group (you would enter “1” for the accrual number.) 
3. In addition, you will enter “Research Center” in the drop-down field for “Internal Accruing 
Reporting Group” and “No disease” in the drop-down field for “Disease Site.” 
 
Complete instructions can be accessed in the OnCore Users’ Manual:  
https://cbmiapps.wustl.edu/confluence/display/OSS/6.+Summary+Accruals 
 
6. Methods  
6.1 Study overview 
The overarching goal of this pilot project is to reduce the disparity in the treatment of tobacco 
use among patients at psychiatry clinics with low burden, multi-level implementation strategies, 
a important need reflected in existing evidence and a recent survey of community needs. The 
investigators propose a pilot randomized trial of 60 patients. Patients will be randomized with 
1:1 allocation to usual care vs. intervention “Nudges to Quit”.  
 
TRIAL OVERVIEW 
Recruit, Screen,  
Consent 
Baseline 
Follow Up  
Follow Up  
  
  
  
Timeline  
Prior to baseline 
Day 0 
Month 3 
Month 6 
Location 
Phone 
Zoom/ Phone/ Study 
Lab 
Zoom/ 
Phone/ 
Study Lab 
Zoom/ 
Phone/ 
Study Lab 
Remuneration 
- 
$50  
$50  
$50  
COMMUNICATIONS 
  
  
  
  

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Mail Recruitment Letters/ Call 
to recruit/ Flyers  
X 
  
  
  
ADMINISTRATIVE 
  
  
  
  
Screening/ Eligibility Check 
X 
X 
  
  
Informed Consent 
X 
X 
  
  
Contact Information  
  
X 
  
  
ASSESSMENTS AND DATA 
  
  
  
  
Demographics  
  
X 
  
  
Smoking History/Status 
  
X 
X 
X 
Smoking Treatment History and 
Interest 
  
X 
X 
X 
Bioverified point prevalence 
abstinence (patients reporting 
abstinence) 
 
 
X 
 
 
Use of Nicotine and Tobacco 
  
X 
X 
X 
FTND 
  
X 
X 
X 
WSWS 
  
X 
X 
X 
Credibility, Acceptablity and 
Expectancy 
  
X 
X 
X 
Readiness to Quit 
  
X 
X 
X 
FTND= Fagerström Test for Nicotine Dependence, WSWS= Wisconsin Smoking Withdrawal Scale; NTQ - Nudges to Quit; 
UC- usual care 
 
 
6.2 Patient participation 
Patients who participate will be asked to complete 3 assessments either over the phone, in person 
on paper or via secure redcap questionnaire administered by a research team member. Patients 
will be asked to complete a pre-appointment tobacco treatment needs assessment (baseline). This 
assessment will collect demographic, smoking, and treatment information about the patient (see 
trial overview table), and in part  will be used as decision support for their provider via nudge 
creation. If patients are randomized to nudges to quit their provider will receive the nudge within 
one week post pre-appointment tobacco treatment needs assessment. At three month and three 
six months, the study team will assess tobacco treatment and smoking behaviors such as 
readiness to quit, smoking abstinence, smoking quantity, and quit attempts. If patients are 
randomized to usual care, the provider will receive the nudge following three month assessment.   
 
These assessments will occur at study visits outside of regular clinic visits.  
 
 
6.3 Enrollment 
Patients will be randomized after completion of baseline assessment to either usual care or 
“nudges to quit”. Once randomization occurs, the participant will be considered enrolled. 
 
6.4 Intervention:  
Nudges to Quit-  
a. Patient:  

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i. Content: Patients will receive a basic handout (example attached) for patient 
education on evidence-based Guideline-recommended tobacco treatment and a nudge 
report based on patient reported treatment needs (example attached). 
ii. Delivery methods:  
a. Mailed and Email Delivery: A patient handout and patient nudge to quit mailed 
and/or emailed (password protected with pin number, if emailed) to participants.  
b. Verbal Delivery: A study team member will deliver the patient nudge with a brief 
coaching interaction based on the public health service guidelines and 5A’s 
approach. 
iii. Timing: We will deliver the intervention report on the day of or <=7 days of the 
baseline visit. A booster intervention report will be mailed and/or emailed in 1 month 
following the baseline visit. 
b. Provider :  
i. Content: Providers will receive a nudge report (example attached) based on patient 
reported treatment needs. For example, providers will receive a nudge message 
informing them of their patients’ cigarettes smoked per day, interest in medication and 
free smoking cessation programs, and guidance on what they can do to help their 
patient. Attached to the message will be a triage card that encourages providers to give 
advice and refer. Triage cards will also correspond to patient interest profiles. 
ii. Delivery Methods: The providers of the participants will be sent via secure email 
and/or inbasket message. 
iii. Timing: We will deliver the intervention report on the day of or <=7 days of the 
baseline visit. A booster intervention report will be mailed and/or emailed in ~1 month 
following the baseline visit. 
 
Usual Care:  
a. Patient: 
i. Content: Patients will receive a basic handout (example attached) for patient 
education on evidence-based Guideline-recommended tobacco treatment.   
ii. Delivery Methods: 
a. 1. Mailed and Email Delivery: A patient handout and patient nudge to quit will be 
mailed and/or emailed (password protected with pin number, if emailed) to 
participants.  
b. Verbal Delivery: A study team member will deliver the patient nudge with a brief 
coaching interaction based on the public health service guidelines and 5A’s 
approach. 
iii. Timing: We will deliver the intervention report on the day of or <=7 days of 3 month 
visit.  
b. Provider:  Providers will maintain their usual care without receiving any reports.  
 
 INTERVENTION  
Arm 1:  
Nudges to Quit 
(NTQ)  
Arm 2:   
UC  
Patient level  
Patient Basic Handout  
(mail, email and verbal delivery by a research team 
member if applicable)  
X  
X  

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Patient Nudges to quit report (mail, email and verbal 
delivery by a research team member if applicable)  
X  
 
Provider level (Patient will provide consent for us to send the report to their doctor)  
Provider Nudges to quit report (email and inbasket 
message, if applicable)  
X  
 
Timing of intervention  
Baseline (<=7 days 
within enrollment) 
and   
Booster (1 month)  
Baseline (<=7 
days within 
enrollment) and   
 
 
1. Outcomes will be assessed at 3 months post-intervention.    
2. After 3 months, patients in Arm 2 (UC) will receive NTQ intervention. Patients in Arm 1 will 
continue with their study participation with no change. This will allow the Arm 2: UC to receive 
the intervention at a delayed timing. This will allow additional secondary comparisons (e.g., 
patients assigned to the UC arm may have increased treatment as they transition from UC to 
NTQ intervention.)   
3. At 6 months patients in both arms will receive the 6 month follow up assessment.   
 
6.5 Remuneration 
Patients will receive a $50 gift card for each assessment completed (3 assessments = $150).  
 
6.6 Retrospective EHR query 
De-identified EHR data will be queried, as approved by IRB. We will examine patient smoking 
prevalence, diagnosis codes, and proportion receiving tobacco treatment (medication and 
counseling) from EHR data. Data will be provided as approved by the Washington University 
Institutional review board. 
7. Risks and Benefits 
Participants may or may not benefit from being in this study. However, we hope that, 
in the future, other people might benefit from this study because knowledge generated 
from this research could advance the delivery of smoking cessation treatment. 
 
Participation in this study does not entail any risks that are greater than those ordinarily 
encountered in daily life. It is possible that a participant will feel uncomfortable during 
the assessment. If that is the case, they can refuse to answer that particular question or 
discontinue the assessment altogether. 
 
There is a risk of breach of confidentiality. All reasonable steps will be taken to ensure 
that patient privacy is maintained.  
 
8. Regulatory and reporting requirements 
 
We expect that the occurrence of a serious adverse event as it relates to these study interventions 
to be extremely rare. If a breach of confidentiality were to occur, it would be reported to 
QASMC and HRPO within 10 days of notification. 
 

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This study does not require QASMC audit or submission of DSM reports.  
In case of severe adverse events requiring immediate attention the study team will have a call 
schedule to ensure an on-call clinician and a back-up clinician are always available for the study 
team for safety assessment. If both the on-call clinician and back up clinician cannot be reached, 
the staff will recommend the participant to contact their existing primary care doctor or 
psychiatrist or go to the emergency room for evaluation and refer the participant to crisis hotline 
or other community resources that may be beneficial to the participant.  
 
 
 
9. Statistical Considerations  
Aim 1: test the effect of nudges to quit on patient receipt of tobacco treatment.  
The investigators hypothesize patient receipt of tobacco cessation treatment such as medication 
and counseling will be higher after delivery of nudges to quit over usual care.  
Aim 1 analysis: We will compare the patient receipt of tobacco treatment for smoking cessation 
during at 6 months visit across the 2 arms. This pilot trial will be limited in statistical power due 
to its small sample size, but will provide important estimates for R01 proposal power 
calculations. 
 
Aim 2, the investigators will test the effect of nudges to quit on smoking behaviors.  
The investigators hypothesize that smoking behaviors will decrease and quitting behaviors will 
increase in the nudges to quit group compared to usual care. This pilot trial will be limited in 
statistical power due to its small sample size, but will provide important estimates for R01 
proposal power calculations. 
 
Aim 3, the investigators will evaluate the feasibility and preliminary effect of this pilot project 
for a future R01 proposal to systematically evaluate this multilevel intervention adapted for 
CMHCs. These data will inform the design of a future larger well powered trial to evaluate the 
multilevel intervention rigorously. Participant perspectives on acceptability of the intervention, 
collected during follow up visits, will be used to motivate this future work.  
 
This is a pilot trial to evaluate feasibility and preliminary effects. No statistical tests will be 
pursued. 
 
10. REFERENCES  
1. 
CDC. State-Specific Prevalence of Tobacco Product Use Among Adults — United 
States, 2014–2015. MMWR. 2018;67(3):97-102.  
2. 
CDC. Current Cigarette Smoking Among Adults — United States, 2005–2012. MMWR. 
2014;63(2):29-34.  
3. 
Garrett BE, Dube SR, Trosclair A, Caraballo RS, Pechacek TF. Cigarette smoking - 
United States, 1965-2008. MMWR Suppl. Jan 14 2011;60(1):109-13.  
4. 
Results from the 2010 National Survey on Drug Use and Health: Mental Health Findings. 
Rockville, Maryland: SAMHSA (Substance Abuse and Mental Health Services Administration), 
2012.  

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McClave AK, McKnight-Eily LR, Davis SP, Dube SR. Smoking characteristics of adults 
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Parks J, Svendsen D, Singer P, Foti M. Morbidity and Mortality in People with Serious 
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Roberts E, Eden Evins A, McNeill A, Robson D. Efficacy and tolerability of 
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Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of 
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