A Systematic Approach to Designing an Implementation Strategy to Increase Lung Cancer Screening and Smoking Cessation Treatment Among Federally Qualified Community Health Center Patients Who Smoke
Phase: NA
Conditions: Smoking Cessation
Sponsor: University of Colorado, Denver

Version 2021.06.10 
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Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
 
Principal Investigator: 
Overall Gina Kruse, site PI Daniel Gundersen 
 
Project Title: 
  A Systematic Approach to designing an Implementation strategy to 
increase Lung cancer screening and Smoking cessation treatment among Federally Qualified community 
Health Center patients who smoke (SAILS-FQHC)  
 
Version Date: 
April 27, 2023 
 
 
 
1. 
 Background and Significance 
 
Tobacco use is the leading preventable cause of death in the US and a major driver of health 
disparities. Smoking prevalence is disproportionately high among people with low levels of 
income and educational achievement, those receiving Medicaid, experiencing homelessness, 
living with HIV, and people in the LGBT+ community. There are also disparities in tobacco use 
by race and ethnicity. American Indians and Alaska Natives have high smoking rates, as do 
other racial and ethnic subgroups such as Puerto Ricans, Cuban-, Vietnamese, and Korean-
Americans.(2, 3) African-Americans also suffer disproportionately from tobacco. Although 
African-Americans have lower smoking prevalence than white Americans, they face higher rates 
of lung cancer mortality.  Tobacco use in groups at risk for health disparities is costly, with an 
estimated 15% of Medicaid expenditures attributable to tobacco.(4) Plus, this expenditure is 
poised to grow based on data in California showing the proportion of current smokers who 
receive Medicaid is growing.(5)  
To address this costly driver of health disparities, we have evidence-based treatment options. 
Both behavioral and pharmacologic treatments are cost-effective and widely available, yet less 
than 30% of US smokers use an evidence-based treatment when they try to quit. Federally-
qualified community health centers (FQHCs) are major providers or care for populations 
disproportionately affected by tobacco. They also have access to resources that place them in a 
position to impact tobacco-related illness. In terms of resources, 45% of FQHC patients are 
MassHealth recipients who are eligible for cessation benefits that include minimal-cost access 
to FDA-approved pharmacotherapies. Many FQHCs have an available but underused tool to 
proactively refer smokers to the Quitline using an eReferral feature, currently in Epic OCHIN, 
and available for mapping in other EHRs.  
Also among our tools for reducing the harms of tobacco is lung cancer screening (LCS). In 
2015, the US Preventative Services Task Force recommended, and Medicare currently covers, 
annual lung cancer screening (LCS) among adults aged 55 to 80 years who have a 30 pack-
year smoking history and currently smoke or have quit within the past 15 years. In March 2021, 
the USPSTF expanded their recommendations to individuals 50-80 years with a 20 pack-year 
smoking history;(6) Medicare coverage for these younger individuals with a shorter pack-year 
history is expected to start in 2023. The expanded screening criteria is inclusive of more women 
and African-Americans. Prior to this expanded eligibility, only 2-5% of eligible Americans had 

 
 
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undergone screening. Previously reported barriers to LCS in FQHCs include ability to assess 
eligibility, costs, lack of support from leadership, and specialty care access. These barriers need 
to be re-examined in the setting of expanded eligibility criteria. 
Optimizing the use of these resources and increasing the delivery of evidence-based 
interventions in community health centers will produce large public health impacts by reducing 
lung cancer mortality and other tobacco-related illness and promoting health equity. 
Implementation science offers important tools to do this. 
 
2. 
Specific Aims and Objectives  
 
We will combine a review of existing qualitative and quantitative data on barriers to lung cancer 
screening and smoking cessation in underserved populations, a quantitative analysis of 
predictors of lung cancer screening and smoking cessation treatment use among 
Massachusetts FQHCs, and a stakeholder advisory board to synthesize these data and select 
an implementation strategies that reflects the critical determinants and the strengths and 
resource constraints of the FQHC context. We have the following aims:  
Aim 1) To design an implementation strategy that targets critical components in the delivery of 
SCT or LCS services for patients who smoke. Deidentified Massachusetts FQHC EHR data will 
be analyzed to identify risk factors for underuse of SCT and LCS among patients who smoke. 
This will be integrated with the growing body of literature on barriers and facilitators to LCS or 
SCT among populations served by FQHCs using a stakeholder engaged approach to identify 
the critical components of implementation in the FQHC context. Using a collaborative design 
process, FQHC stakeholders and investigators will select implementation strategies that target 
the critical barriers to the delivery of LCS and SCT implementation for adults who smoke, 
matching the strategy to local resources such as IT solutions including Quitline eReferrals, 
smoking registries, registries of LCS eligible patients, and task shifting approaches to engage 
navigators or CHWs in SCT and LCS.  
Aim 2) To assess the acceptability, appropriateness and feasibility of the implementation 
strategy. In a pilot test of the strategy with two FQHCs, we will measure implementation process 
outcomes of acceptability, feasibility, and appropriateness of the strategy will be assessed 
through surveys, workflow tracking data, and qualitative interviews with FQHC staff and other 
healthcare providers from two FQHCs. We will also measure reach and effectiveness by 
measuring rates of LCS orders, LCS completion, smoking cessation treatment prescriptions and 
quitline e-referrals in our two pilot FQHCs, compared to two matched non-intervention FQHCs.  
 
3. 
General Description of Study Design 
 
Aim 1) To design an implementation strategy that targets critical components in the delivery of 
SCT or LCS services for patients who smoke. To identify the critical components of LCS and 
SCT implementation, we will combine quantitative data measuring risk factors for underuse of 
these interventions in Massachusetts CHCs and existing literature on barriers to implementation 
of these interventions in a collaborative, stakeholder-engaged approach. We will leverage the 
Azara DRVS system (a data reporting and visualization system that maps onto EHR structured 
data and is used by most Massachusetts FQHCs for quality improvement and data reporting 
purposes) to measure LCS and SCT use patterns including lung cancer screening orders, LCS 
completion, prescription of smoking cessation pharmacotherapies, and quitline e-referral 
utilization. We will examine predictors of underuse of these interventions among LCS eligible 

 
 
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adults patients who smoke. Predictors will include measurement of critical factors that could 
drive inequities such as language assistance needs or geographic accessibility of specialty 
services. This data is stored in the Implementation Science Center for Cancer Control Equity 
Data Ecosystem housed at DF/HCC (HSPH IRB Repository Protocol #IRB20-0988). The Data 
Ecosystem includes deidentified patient level data, community health center organizational data, 
and area-level public health data.  
Review literature on barriers to SCT and LCS: Combined with this analysis of EHR data, our 
team will also review existing literature on the multi-level barriers to implementation of LCS and 
SCT among underserved populations. We will work with the Treadwell library to develop search 
criteria for each intervention. Articles retrieved using these searches will be reviewed to compile 
a list of barriers and facilitators to implementation of LCS and SCT. To optimize the delivery of 
SCT for patients referred for LCS, we will compare barriers and facilitators for implementing 
LCS and barriers and facilitators to implementing SCT in order to identify overlapping critical 
factors that represent efficient, high-impact targets in an implementation strategy. 
Stakeholder advisory group: We will convene a stakeholder advisory group to review the risk 
factors for underuse of these interventions, the list of barriers and facilitators to implementation 
from the existing literature, and a menu of implementation strategies that leverage local 
resources. The members of the stakeholder advisory group will help inform what implementation 
strategies best fit the CHC setting and they will include CHC providers, quality improvement 
specialists, community engagement staff, and specialty providers. This group will be invited to 
advise on interpretation of risk factors identified with analysis of CHC EHR data, the relevance 
of barriers and facilitators identified in the literature in their contexts, and the potential feasibility 
of implementation strategies on the menu of discrete strategies. This menu will include provider 
audit and feedback, technical assistance with the DRVS tool to generate registries/identify 
eligible patients, redefining clinician roles/task-shifting, identification of a clinical champion, 
academic detailing, advisory/stakeholder workgroups through our stakeholder advisory board, 
and leveraging the DRVS population health tool to support and monitor quality improvement in 
delivery of LCS and SCT.(7) The product of this collaborative process will be a menu of these 
discrete strategies that are matched with the critical factors in implementation for each 
intervention in the local FQHC context, paired with an overall external facilitation strategy.  
The group will be asked to participate in four meetings prior to launching the pilot study to inform 
the pilot approach and one meeting after the pilot study to advise on the development of a 
toolkit for community practitioners to support 
use of this implementation approach with 
external facilitation plus the menu of specific 
implementation strategy options. 
Aim 2) To assess the acceptability, 
appropriateness and feasibility of the 
implementation strategy To ensure that we can 
evaluate the acceptability, appropriateness, 
and feasibility of the implementation strategy at 
FQHCs serving groups at risk for inequity, we 
will select two pilot FQHCs that serve these 
populations. In this aim we will measure 
implementation process outcomes of feasibility, 
acceptability, and appropriateness of the 
implementation strategy. We will also use the 
data ecosystem to measure service outcomes 
Figure 1. Brief measures using 5-point scale(1) 
(Completely agree – completely disagree) 
Acceptability of Intervention Measure (AIM)  
1) [Implementation strategy] meets my approval.  
2) [Implementation Strategy] is appealing to me.  
3) I like [Implementation Strategy].  
4) I welcome [Implementation Strategy]. 
Intervention Appropriateness Measure (IAM)  
1) [Implementation Strategy] seems fitting.  
2) [Implementation Strategy] seems suitable.  
3) [Implementation Strategy] seems applicable.  
4) [Implementation Strategy] seems like a good match. 
Feasibility of Intervention Measure (FIM)  
1) [Implementation Strategy] seems implementable.  
2) [Implementation Strategy] seems possible.  
3) [Implementation Strategy] seems doable.  
4) [Implementation Strategy] seems easy to use. 

 
 
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of lung cancer screening CT orders, LCS completion, quitline referrals, and prescription of 
smoking cessation medications.  
Process outcomes: We will use a mixed methods approach to assessment of feasibility, 
acceptability and appropriateness of the strategy (overall strategy plus specific strategies 
selected from the menu of options) will be measured using Weiner’s brief instruments by email 
survey among implementing staff.(1) The email survey will be sent prior to conducting a group 
interview (virtual or in-person, depending on infection control policies) to explore these 
measures.  
 
4. 
Subject Selection 
 
Aim 1) To design an implementation strategy that targets critical components in the delivery of 
SCT or LCS services for patients who smoke. For the aim 1 analysis of predictors of LCS and 
SCT in FQHCs, we will examine LCS eligible adults aged 50-80 who are listed as current 
smokers in the EHR of partner FQHCs and who have had a primary care visit in the past 2 
years. These patients will be selected from the ISCCCE data ecosystem using deidentified data. 
 
Aim 2) To assess the acceptability, appropriateness and feasibility of the implementation 
strategy. 
For the Aim 2 activities, two pilot FQHCs will be intervention sites in which we identify 
implementation barriers and work with the FQHCs to select a menu of implementation 
strategies. Two sites will be control sites, matched by size and patient population 
characteristics. De-identified patient data in the ISCCCE data ecosystem will be used to 
evaluate the impact of the implementation strategy in terms of lung cancer screening and 
smoking cessation treatment rates in the intervention sites compared to two matched control 
sites. 
 
The second subject sample in aim 2 are the FQHC implementation team staff in the intervention 
FQHCs. 
 
5. 
Subject Enrollment 
 
We are seeking a waiver of consent for enrollment of the de-identified patient sample in the data 
ecosystem. The data ecosystem methods and processes have been reviewed by the Harvard 
IRB as a data coordinating center. Data use agreements are in place between partner FQHCs 
and the data coordinating center to share data that is stored in a de-identified database in 
REDCap. 
 
FQHC staff on the implementation teams will be emailed a link to a brief redcap survey that 
includes language about implied consent prior to initiating the survey. Group interview 
participants will be read study information at the start of the group discussion that explains that 
their participation is voluntary, that the discussion will be recorded and transcribed and that their 
data will be kept confidential. Participants will be invited to ask questions prior to starting the 
discussion and recording. 
 
6. 
Study Procedures 
 
Aim 1 

 
 
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In Aim 1 we will convene a stakeholder advisory group (CHC providers, quality improvement 
specialists, community engagement staff, and specialty providers) to review the results of the 
literature review and quantitative analysis of deidentified data in order to select a set of 
implementation strategies from a menu of strategies to implement in Aim 2.  
Quantitative analysis will include: patient level: age, sex, primary payer, race, ethnicity, 
language, zip code (first 3 digits), housing status, educational level, employment status, food 
insecurity, transportation needs, smoking status, receipt of smoking cessation counseling, 
Charlson comorbidity score (CVD, CKD, stroke, cancer, dementia, cirrhosis, diabetes, CHF, 
hypertension, or PVD), obesity, number of visits, history of chest CT, covid history, smoking 
cessation medications; organizational level: implementation climate, leadership, institutional 
resources; and community level: poverty, area deprivation, distance from the health center to 
primary low dose CT facility, and area smoking prevalence. 
The implementation strategies are developed in Aim 1. These include provider training led by 
internal staff on screening for tobacco use and documentation of pack years, establishing 
communications between CHCs and radiology providers, systematic referral of patients eligible 
for lung screening to health center’s patient navigation services, and implementation of Azara 
DRVS alerts notifying the care team when a patient has a care gap in tobacco use status or 
lung screening. 
Aim 2 
The two intervention FQHCs will be asked to identify an implementation team consisting of CHC 
staff members to meet with the study investigators to implement the strategies selected in Aim 
1.  
The qualitative group interviews will be conducted by the PI and the CRC. Participants will be 
the implementing teams at pilot FQHCs, which we expect to include a total of 15 participants 
overall. The discussion guide will be developed using the Consolidated Framework for 
Implementation Research Interview Guide Tool. This framework is selected to align with 
ISCCCE’s overall conceptual model. In these discussions, in addition to exploring the 
acceptability, appropriateness and feasibility of the strategies, the discussion will cover other 
barriers to implementation that were encountered in the inner setting or outer setting, barriers or 
facilitators inherent to the intervention, the impact of the implementing team make-up, and 
barriers and facilitators to the implementation process. We will further explore solutions for 
overcoming those barriers that the group tried or is planning, any inequities in delivery of 
services that the group identified, and any recommended modifications to improve the 
feasibility, acceptability, appropriateness of the implementation strategy or the equity of LCS 
and SCT services delivered. The qualitative group interviews and the survey will take 
approximately 60-90 minutes with the potential of it being shorter depending on how much 
participants share. 
Discussion will be audio-recorded and transcribed for analysis. Analysis will use Nvivo 12 and a 
framework approach that incorporates elements of the Consolidated Framework for 
Implementation Research. Transcripts will be double-coded by a team of two research staff and 
investigators. The coding framework will cover intervention characteristics, inner setting, outer 
setting, impact of individual team members, and the implementation process as well as 
emergent themes, emphasizing equity in implementation.  
Study info will be sent to participants prior to the email survey or the scheduled group interview. 
Qualitative results will be combined with the brief email survey data plus ISCCCE data 
ecosystem resources including organizational characteristics of the participating CHCs and 
outer context, area-level measures of the communities served by the pilot CHCs that is stored in 

 
 
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the ISCCCE Data Ecosystem. Qualitative themes will be presented in a joint display with 
quantitative measures of acceptability, feasibility and appropriateness to gain further insight into 
how the implementation strategies were or were not feasible in the pilot CHC context. 
Service outcomes: We will measure reach and effectiveness of the strategy by measuring 
closure of tobacco use status care gaps, closure of lung screening care gaps, lung screening 
no-shows, and smoking cessation prescriptions in the two pilot sites and two matched non-
intervention FQHCs who participate in the data ecosystem. These outcomes will be measured 
in the pilot sites in the six months before implementation and the six months during the 
implementation.  
 
7. 
Risks and Discomforts 
 
Risks of this project include risks of breach of confidentiality and psychological distress. 
Individuals may find it stressful to answer questions about their work in the resource limited 
setting of the FQHCs. The risks associated with these discussions are minimal, especially when 
compared to the potential to benefit quality of care for FQHC patients. 
 
The information collected about barriers and facilitators to lung cancer screening and smoking 
cessation treatment delivery and information about the feasibility, acceptability and 
appropriateness of the implementation strategy are not expected to place the participant at risk 
of liability, financial standing, employability, insurability or reputation. 
 
To minimize the risk of breach of confidentiality all data will be kept in password protected, 
institutional shared file areas. Data sharing between institutions will include only deidentified 
data. Individuals may find it stressful to answer questions about their work in the resource 
limited setting of the FQHCs. The risks associated with these discussions are minimal, 
especially when compared to the potential to benefit quality of care for FQHC patients. These 
risks will be described by the research staff moderating group discussions and will be clearly 
outlined in the study information script prior to starting the group discussion. 
 
8. 
Benefits 
 
Participants may derive satisfaction from knowing study results may contribute toward improving 
lung cancer screening services or smoking cessation treatment delivery for individuals in their 
community. 
 
9. 
Statistical Analysis 
 
Aim 1 
We will measure the prevalence of lung cancer screening among age-eligible patients 
documented as current smokers in EHRs. Similarly, we will measure the prevalence of smoking 
cessation medication prescriptions (varenicline, nicotine replacement therapy, and bupropion), 
quitline referrals, or other cessation counseling. We will measure the predictors of 
underscreening and undertreatment including: 1) socio-demographics of sex, gender identity, 
race, ethnicity, language, and insurance status, 2) social determinants of health including 
housing instability and transportation needs, 3) comorbid mental and behavioral health 
diagnoses, and 4) area-level measures including area-level deprivation, smoking prevalence 
and distance to low-dose CT facility. Predictors of LCS and predictors of SCT will be assessed 

 
 
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using multilevel logistical models to understand the variation in screening attributable to the 
patient-, clinic-, and area-level. Understanding the contribution of these levels of influence will 
be important for determining critical implementation factors at each level.  
Aim 2 
This pilot study will be underpowered to measure a statistically significant difference pre- and 
post-implementation. It aims to provide data on the estimated effect size and to identify 
predictors of equitable reach and effectiveness. The change in LCS and SCT reach and 
effectiveness will be stratified by key risk factors identified in aim 1 and will include race, 
ethnicity, language, insurance status, social determinants of housing and transportation needs, 
and community-level socioeconomic measures and distance to low-dose CT facilities. This 
exploratory difference in differences analysis will be hypothesis generating to inform a larger 
scale trial of this systematic approach to selecting implementation strategies.  
 
10.   Monitoring and Quality Assurance 
 
Data quality and enrollment will be discussed in weekly steering committee meetings. The PI 
will work with a clinical research coordinator and the Data Ecosystem team to monitor data 
protocol adherence. We do not anticipate adverse events from this research, however, any 
unanticipated problems or adverse events will be reported to the IRB within 5 working days of 
when the unanticipated problem is discovered.  
 
11.   Privacy and Confidentiality 
 
☒ Study procedures will be conducted in a private setting 
☒ Only data and/or specimens necessary for the conduct of the study will be collected 
☒ Data collected (paper and/or electronic) will be maintained in a secure location with appropriate 
protections such as password protection, encryption, physical security measures (locked 
files/areas) 
☒ Specimens collected will be maintained in a secure location with appropriate protections (e.g. 
locked storage spaces, laboratory areas) 
☒ Data and specimens will only be shared with individuals who are members of the IRB-approved 
research team or approved for sharing as described in this IRB protocol 
☒  Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password protection, 
using chain-of-custody procedures, etc.) 
☒   All electronic communication with participants will comply with Mass General Brigham secure 
communication policies 
☒ Identifiers will be coded or removed as soon as feasible and access to files linking identifiers 
with coded data or specimens will be limited to the minimal necessary members of the research 
team required to conduct the research 
☒ All staff are trained on and will follow the Mass General Brigham policies and procedures for 
maintaining appropriate confidentiality of research data and specimens 
☒ The PI will ensure that all staff implement and follow any Research Information Service Office 
(RISO) requirements for this research 
☐ Additional privacy and/or confidentiality protections 
 
 

 
 
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12.   References 
 
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3. 
Nguyen AB. Disaggregating Asian American and Native Hawaiian and Other Pacific Islander 
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Health (PATH) Study, 2013-2014. J Racial Ethn Health Disparities. 2019;6(2):356-63. 
4. 
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Zhu SH, Anderson CM, Wong S, Kohatsu ND. The Growing Proportion of Smokers in Medicaid 
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US Preventive Services Task Force, Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, 
et al. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 
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7. 
Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, et al. A refined 
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