A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)
Phase: NA
Conditions: Lung Cancer
Sponsor: Wake Forest University Health Sciences

A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung 
Cancer Screening: mPATH-Lung (mobile Patient Technology for Health-Lung) 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # IRB00060382 
Clinicatrials.gov:  NCT04083859
Principal Investigator: 
David P. Miller, Jr., MD, MS 
Department of Internal Medicine 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157 
 
 
Co-Investigator(s): 
Christina Bellinger, MD 
Department of Internal Medicine 
Wake Forest School of Medicine 
 
 
Ajay Dharod, MD 
Department of Internal Medicine 
Wake Forest School of Medicine 
 
 
Biostatistician: 
Anna Snavely, PhD 
Department of Biostatistical Sciences 
Wake Forest University School of Medicine 
Medical Center Blvd. 
Winston-Salem, NC 27157 
 
 
Study Coordinator: 
Elena Wright, MS 
 
 
Regulatory Contact: 
Elena Wright, MS 
 
 
Participating Institution(s): 
Wake Forest Baptist Health 
University of North Carolina at Chapel Hill 

A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung 
Cancer Screening: mPATH-Lung (mobile Patient Technology for Health-Lung) 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
 
 
 
Version Date: 
 
 
September 12, 2019 
 
 
Amended: 
 
 
 
June 17, 2025 
 
 
 
 

 
 
  
Table of Contents 
ABSTRACT AND SCHEMA .......................................................................................................... 4 
1.0 
Introduction and Background ............................................................................................ 5 
2.0 
Objectives ......................................................................................................................... 6 
2.1  
Primary Objective .............................................................................................................. 6 
2.2 
Secondary Objectives ....................................................................................................... 6 
3.0 
Study Population ............................................................................................................... 7 
3.1 
Inclusion Criteria ............................................................................................................... 7 
3.2 
Exclusion Criteria .............................................................................................................. 7 
3.3 
Inclusion of Women and minorities ................................................................................... 7 
4.0 
Methods ............................................................................................................................ 7 
4.2 
Registration Procedures .................................................................................................... 8 
4.3  
Participant Recruitment ..................................................................................................... 8 
4.4 
mPATH-Lung Intervention ................................................................................................. 9 
4.5 
Control (usual care) ......................................................................................................... 11 
5.0 
Outcome Measures ......................................................................................................... 11 
5.1 
Primary Outcome ............................................................................................................ 11 
5.2 
Secondary Outcomes ...................................................................................................... 11 
6.0 
Analytic Plan ................................................................................................................... 14 
6.1  
Primary Analysis ............................................................................................................. 14 
6.2  
Secondary Analyses ....................................................................................................... 15 
6.3  
Qualitative Analyses ........................................................................................................ 15 
6.4  
Sample Size and Power .................................................................................................. 16 
6.5  
Accrual Rate .................................................................................................................... 16 
7.0  
Data Management and Security ...................................................................................... 17 
8.0 
Confidentiality and Privacy .............................................................................................. 17 
9.0 
Data Safety and Monitoring ............................................................................................. 18 
10.0 
Reporting of Unanticipated Problems, Adverse Events or Deviations ............................ 18 
11.0  
References ...................................................................................................................... 19 
 
 
 

 
 
ABSTRACT AND SCHEMA 
 
mPATH-Lung (mobile Patient Technology for Health – Lung) is a digital outreach strategy for lung 
cancer screening (LCS). mPATH-Lung (a) queries the electronic health record (EHR) to identify 
potential screening candidates, (b) sends those individuals electronic invitations to visit a web-
based LCS decision aid that confirms eligibility and provides personalized information, and (c) lets 
patients electronically request an LCS clinic appointment.  
 
Our study design is depicted below in Figure 1. We will examine the effect of mPATH-Lung on 
receipt of Lung Cancer Screening (LCS) (Aim 1) in a patient-level pragmatic-design randomized 
controlled trial of 1320 primary care patients conducted in two large health networks with a 
catchment area extending to five states. We will send potentially eligible patients electronic 
invitations to visit our study website, which will determine eligibility and randomly assign patients to 
interact with either mPATH-Lung or an educational program about exercise for lung health. Patient 
knowledge, screening intent, and screening outcomes will be assessed by surveys and review of the 
Electronic Health Record EHR. Additionally, we will use mixed methods to elucidate the drivers of 
patients’ LCS decisions (Aim 2), and assess implementation outcomes that will inform scalability 
and dissemination (Aim 3). 
 
 
 
 

 
 
1.0 
Introduction and Background 
 
Lung cancer is the leading cause of cancer death in the United States.1 In 2019, over 140,000 
Americans will die of lung cancer, a number that is greater than those that will die from breast, 
prostate, and colorectal cancer combined.1,2 Over 80% of lung cancers are diagnosed at advanced 
stages when cure is not possible and 5-year survival is only 5-30%. However, if diagnosed early at 
a localized stage, 5-year survival is 56%.2  
In 2011, the ground-breaking National Lung Screening Trial (NLST) demonstrated that annual 
screening with low-dose computed tomography (CT) decreases lung cancer mortality by 16-20%.3,4 
Currently, several organizations (e.g., the US Preventive Services Task Force, the American 
Cancer Society, and the American Thoracic Society) endorse LCS for high-risk current and former 
smokers,5–7 and Medicare has approved LCS reimbursement for high-risk patients aged 55 to 77 
years.8 Commercial insurers also cover LCS. Nonetheless, in 2015, fewer than 4% of eligible 
patients were screened.9  
While LCS lowers lung cancer mortality, it also carries some risk. Thirty-nine percent of screened 
individuals in the NLST had at least one false positive after three screening rounds, leading to 
costly and sometimes invasive follow-up procedures that did not find cancer.3,10 Screening may also 
detect indolent cancer that never would have affected the patient during his or her lifetime – leading 
to overtreatment and possible physical, psychological, and financial harms.11–13 Thus, current 
guidelines recommend and Medicare requires that providers engage in shared decision making 
with their patients before initiating screening.5–8  
Helping patients make an informed LCS decision is a complex task because the harms and 
benefits vary according to individuals’ risk factors. As an example, in the NLST, the number needed 
to screen to save one life ranged from 161 to 5276 depending on a patient’s risk of developing lung 
cancer.14 Similarly, the number of false positives per life saved ranged from 65 to 1648.14 This wide 
variation highlights the critical importance of providing patients with personalized information so 
they can make an informed decision.  
Shared decision making also requires helping patients consider their own unique values. Patients 
consider multiple factors when making decisions about cancer screening15–17 and weigh them 
differently (often unconsciously). Helping patients clarify which factors are most important to them, 
a process known as values clarification, is a critical aspect of a high-quality shared decision making 
process.18–20 However, we have limited understanding of what factors drive patients’ LCS decisions. 
Qualitative studies found that patients consider several factors in such decisions, including the 
mortality benefit, chance of false positives, emotional (anxiety) factors, and practical barriers (costs, 
transportation); but a weakness of current research is that how they weigh these factors to reach a 
decision is unclear.21–27 Furthermore, to our knowledge, no studies have examined interventions to 
help patients clarify their values and preferences for LCS in routine care.   
Multilevel barriers contribute to the low screening rates observed. Unfortunately, our current 
medical care system relies on time-pressured primary care providers to hold these complex 
discussions with patients, and primary care providers report lack of time as a leading barrier to 
providing guideline-recommended preventive care.28–34 In addition, many providers are unfamiliar 
with LCS guidelines.28,29,35–37 Miller (PI) and Bellinger (Co-I) were the first to document that only half 
of primary care providers could correctly identify 3 of 6 basic eligibility criteria for LCS.38 Given 
these obstacles, providers rarely discuss or order LCS.34,36,39,40 Members of our team searched 
transcripts from over 5000 primary care visits and found that LCS was discussed with only 14 
patients and explanation of potential harms of screening was virtually nonexistent.41 Similarly, many 
patients are unaware of the availability of LCS or its value.21,35  
Decision aids are a partial solution. Currently available decision aids can increase patients’ 
knowledge of LCS,16,42–44 deliver some personalized information,16,45 and help patients make a 
screening decision.16,43 They can also mitigate providers’ knowledge deficits by offering an 

 
 
evidence-based, standardized format for providing patients with information about LCS. However, 
none provide patients with personalized information about the likelihood of the harms of screening, 
nor do they explicitly incorporate values into the decision making process.45 Additionally, while 
physicians have endorsed LCS decision aids as helpful,28 their use still requires time and they fail to 
address system barriers such as coordinating screening visits and insurance pre-approval. In two 
pilot studies conducted by members of our team, less than half of patients who wanted screening 
after watching an LCS decision aid received it.16,46 
To address these multilevel barriers to LCS and the need for personalized, shared decision making, 
our team has developed mPATH-Lung (mobile Patient Technology for Health – Lung), a user-
friendly web-based application that can be systematically deployed to prepare patients and 
providers for meaningful shared decision making visits and help coordinate screening. mPATH-
Lung addresses patient barriers by informing patients of LCS, providing them with personalized 
risk-benefit information, and helping them make decisions consistent with their values. mPATH-
Lung addresses provider knowledge and time barriers by determining patient eligibility for LCS, 
assisting with routine counseling, and streamlining shared decision making visits. mPATH-Lung 
addresses system barriers by leveraging technology to reach patients where they are, facilitating 
LCS visit scheduling and insurance preapprovals, and automatically routing program usage 
information to primary care providers.  
We designed mPATH-Lung with a screen adaptable design, allowing it to be used on smartphones 
or any other device. Over 75% of Americans own a smartphone.47 While a digital divide exists for 
home broadband use, there is no racial/ethnic digital divide for smartphone ownership.47 
Smartphone ownership exceeds 67% even for those with annual household incomes less than 
$30,000 or only a high school education,47 and ownership continues to rise.  
This study will examine mPATH-Lung’s effectiveness, elucidate the factors that drive patients’ 
screening decisions, and explore the potential for future dissemination and implementation using 
widely-accepted implementation frameworks.  
2.0 
Objectives  
2.1  
Primary Objective 
 
• 
Determine the effectiveness of mPATH-Lung on receipt of LCS in a randomized pragmatic 
clinical trial of 1320 patients recruited from two large health networks, Wake Forest Baptist 
Health and the University of North Carolina at Chapel Hill. 
2.2 
Secondary Objectives 
 
• 
Elucidate the drivers of patients’ decisions to receive or forgo LCS through a values 
clarification exercise embedded within mPATH-Lung and supplemental semi-structured 
interviews of at least 50 patients. 
 
• 
Assess several critical implementation outcomes (reach, acceptability, and appropriateness) 
to inform the sustainability and scalability of mPATH-Lung across diverse primary care 
settings 

 
 
3.0 
Study Population  
3.1 
Inclusion Criteria 
 
Eligible patients will: 
• 
Meet the Medicare criteria for LCS, as updated in February 2022: 
o Age 50 – 77 years 
o Smoked at least 20 pack years 
o Current smoker or quit smoking within the past 15 years 
• 
Be scheduled to see a primary care provider within the health network in the next 3-4 weeks 
• 
Have a patient portal account or cellphone number listed in the EHR 
3.2 
Exclusion Criteria   
 
The following patients will be excluded: 
• 
Patients flagged as needing a language interpreter in the EHR (electronic messages and 
intervention is delivered in English only) 
• 
Those for whom LCS would be inappropriate:  
o Prior history of lung cancer 
o Chest CT within the last 12 months 
o Those with medical conditions predicting shorter life expectancy 
• 
Patients whose home address is not within the state of North Carolina. (Due to telehealth 
guidelines) 
3.3 
Inclusion of Women and minorities 
 
Women and men of all races and ethnicity who meet the above-described eligibility criteria are 
eligible for this trial.  
4.0 
Methods 
 
4.1 
Study Sites 
 
The study will be conducted in two large academic-affiliated health networks (Wake Forest Baptist 
Health and UNC) that have over 200 community-based primary care clinics with approximately 900 
PCPs and a catchment area covering all of North Carolina and extending to four neighboring states, 
including portions of rural Appalachia. In 2018 both networks saw 165,601 “ever smokers” who were 
potentially eligible for LCS based on age. Both health networks have the same EHR (EpicTM, Verona, WI) 
that is shared by all of their clinics.  
 
LCS programs and usual care. Both networks have well-established LCS programs. Patients, who may 
self-refer to the LCS program, meet with a provider who confirms screening eligibility, conducts a shared 
decision making visit in accordance with CMS guidelines,8 and orders the screening CT. Afterwards, the 
LCS clinic communicates results to the patient and arranges any needed follow-up testing. Primary care 
providers may also order screening CTs directly, in which case they must conduct the shared decision 
making visit, communicate results, and order any needed follow-up testing. Both networks broadly 
advertise their LCS programs to patients via web campaigns, posters, and mailings. Despite these efforts, 
only 2% of those potentially eligible in 2018 (3,215 of 165,601) were screened. 

 
 
 
4.2 
Registration Procedures 
 
Patients will be participating in a pragmatic trial in which patient data collection will occur by 
retrospective electronic chart review. All patients will receive current guideline-recommended care, 
and we will request a waiver of patient Informed Consent. Therefore, it is impractical to register 
patients with the Cancer Center, and any such registration would jeopardize patient confidentiality. 
 
Following primary data collection, a subset of patients and clinic providers will participate in 
interviews and/or surveys related to the study’s secondary objectives. No sensitive information will 
be collected from these participants. Therefore, we are requesting a waiver of signed consent. We 
will give these participants a study information sheet explaining the purpose of the study, the nature 
of the data to be collected, and the voluntary nature of their participation. 
4.3  Participant Recruitment 
 
We will identify eligible participants for this pragmatic trial in two phases. 
 
Phase One (Sending electronic invitations): Each week we will query the EHR to identify potentially 
eligible participants based on the inclusion and exclusion criteria. We will oversample for non-white 
patients, and we will send identified patients an electronic invitation with an embedded hyperlink to 
our study website. The invitation text can be found in Appendix L. The hyperlink contains an 
anonymous study identifier unique to each patient, allowing us to track who visits the study website, 
an approach we successfully used in our pilot study.46 
 
As shown in Table 1, our preliminary data indicate the EHR 
accurately captures whether patients ever smoked (current or 
former smokers), but not years since quitting or pack-years. 
Therefore, our query will include all ever smokers, and the 
study webpage will gather additional detailed smoking history 
from patients to determine eligibility. Overall, 90% of our 
target sample has a patient portal account, mobile phone, or 
email address on file. Patients with an active portal account 
(defined as ≥1 logins over the past 90 days) will receive a message via MyChart. Those without a 
patient portal account will be sent a text message. Text message recipients will receive up to one 
additional reminder text message 3-7 days after the initial communication. 
 
The study team will ensure each institution’s patient consent forms cover the use of text messaging for 
this pragmatic trail before the invitations are sent. 
 
Phase Two (Confirming eligibility via study website): When patients click on the hyperlink, it will take 
them to the study homepage. The site employs a user-friendly interface we have previously validated in 
low- and high-literacy patients.49 The homepage will inform patients that the website was developed by 
researchers, will ask them a few questions to determine if they meet guideline criteria for lung cancer 
screening, and will then show them a brief video. The homepage will also specify that by proceeding, 
they understand their deidentified data may be used. This study qualifies for exemption under 45 CFR 
46.101. 
 
Potential participants will complete a brief self-survey on the website (Appendix A) to gather additional 
smoking history and determine if they meet eligibility criteria for LCS (as described above in Phase One). If 
patients are eligible for LCS, the study program will randomly assign them, stratified by health system 
network, to either mPATH-Lung or a control program about exercise for lung health using stored random 
Table 1. Accuracy of Smoking History in the 
EHR Compared with Patient Self-Report 
Self-reported 
smoking history 
Accurately 
recorded 
Ever smoker, 
100% (336) 
Years since 
quitting 
44% (149) 
Pack-years 
smoked (+/- 5 
20% (35) 

 
 
permutated blocks. Patients who are ineligible also will be shown the control program, but they will be 
excluded from the study.   
4.4 
mPATH-Lung Intervention 
 
Planned Updates to mPATH-Lung: We have extensively tested the beta version of mPATH-Lung 
(Figure 2) which determines if patients are eligible for LCS via a self-survey, shows eligible patients 
a brief video decision aid, and then invites them to estimate their personal risks and benefits of 
screening by completing 8 survey items needed to calculate their predicted risk of developing lung 
cancer based on the validated Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial 
Model 2012.14,46,50 Patients’ risks of developing lung cancer are used to estimate their anticipated 
benefits (lives saved) and harms (false positives, invasive procedures, and complications) of 
screening, based on a model our team developed.45,46,51 This benefit-harm information is displayed 
to patients as an infographic, the format that maximizes engagement and comprehension, 
particularly for patients with low literacy or numeracy skills.52,53 Patients who decline to estimate 
their personal risks are shown an infographic summarizing the benefits and harms for the average 
risk individual in the NLST cohort. The beta version concludes by asking patients if they want to 
receive screening and then providing them with the phone number for the LCS clinic. 
 
 
 
In preparation for this proposed trial, we will update the beta version with four new features outlined 
below. 
 
Video Decision Aid (Appendix B): The beta version of mPATH-Lung includes a short animated 
proof of concept video that reviews the general risks and benefits of LCS. We will replace this with 
an extensively tested, professionally developed LCS video decision aid that includes a strong 
message about the importance of tobacco cessation.42,44,54 The video will explicitly address the 
risks and benefits outlined in Table 2, including screening-related anxiety and overscreening.  
 
Values Clarification Exercise (Appendix C): Helping patients clarify how they balance the potential 
benefits and harms of screening is a critical element of shared decision making. An explicit values 
clarification exercise can help patients make a screening decision consistent with their values.18 
Patients will complete the exercise immediately after seeing their personalized risk-benefit 
infographic (see Figure 2, fourth panel from left). The exercise will be adapted from previously 
tested values clarification instruments, including some developed by our team members.15,55 First, 

 
 
patients will complete a rating exercise, in which they will rate the importance of the risks and 
benefits, or “attributes,” of the screening decision (e.g., 193 out of 1000 chance of a false positive, 
or 10 lives saved out of 1000) individually on a 5-point Likert scale. Attributes rated will be the same 
as the risks and benefits of screening covered in the video decision aid (Table 2). Afterwards, 
patients will complete a ranking exercise, in which they will indicate their top two attributes in order 
of personal importance. Finally, patients will indicate their screening preference. To maximize 
readability, clarity, and comprehension, we will cognitively test the values clarification exercise 
using “think aloud” exercises with 10-15 patients who are eligible for LCS. In this pre-test, patients 
will complete the values clarification exercise and a cognitive interview to help us evaluate each 
item’s performance (e.g., whether the content is understood in the intended manner, ease of 
completion) and clarity of the instructions. We will use results to iteratively improve materials 
between pre-testing sessions (e.g., revise wording for clarity). Patients who participate in this pre-
testing phase will receive $50 for their time and will be ineligible for the larger study. 
 
Electronic Summaries: On completion of mPATH-Lung, 
participants will be given the option to download a program 
summary including their personalized risk-benefit infographic, 
values clarification results, and screening decision.   
 
Electronic Requests for an LCS Clinic Visit: We will update 
mPATH-Lung so that patients can request an LCS clinic 
appointment directly from the program, mitigating the 
scheduling barrier. mPATH-Lung will present a webform to 
patients who indicate a desire to be screened. A study team 
member will send this information to the lung cancer screening 
clinic staff via the EHR so that they may contact the patient to 
schedule the appointment.  The information in the webform will 
be accompanied by a statement that the patient used mPATH-
Lung, was confirmed eligible for LCS, and is requesting a 
screening clinic appointment. Patients’ answers to each eligibility item will be included to aid in 
insurance precertification so that the shared decision making visit can end with same-day screening 
if indicated. For patients who request a screening clinic appointment, the study team member will 
also upload a copy of the patient’s program summary to the EHR. While patients will still engage in 
the Medicare-mandated shared decision making visit in the LCS clinic or primary care office, the 
easily retrieved mPATH-generated program summary in the EHR will allow the visit to proceed 
efficiently. 
 
Patients who indicate an uncertainty about screening will be encouraged to discuss their concerns 
with their primary care provider at their upcoming appointment. As noted in our study inclusion 
criteria, all invited patients will have a primary care appointment in the next 3-4 weeks.  
 
White Box Testing: We will use white box testing methods56 to ensure the revised version of 
mPATH-Lung functions as planned. White box testing involves entering sequences of data 
purposively designed to test all failsafes and features of the program, including the accuracy of data 
collection.  
 
Usability Testing (Appendix M): Prior to commencing the pragmatic trial, we will conduct usability 
testing to ensure the mPATH-Lung program is appropriately designed for the target population. A study 
team member will meet individually with participants to observe them using the mPATH-Lung program 
following a Concurrent Think Aloud method.  
 
Table 2. Risks/benefits 
(attributes) of screening 
addressed in mPATH-Lung  
Averting death from lung cancer 
Worry/anxiety over an abnormal 
scan 
Experiencing a false alarm 
Undergoing an invasive 
procedure 
Having a serious complication 
from an unnecessary procedure 
Finding a slow growing or 
harmless cancer and needlessly 
treating it 
Radiation exposure 

 
 
Final mPATH-Lung Structure: Patients will proceed through mPATH-Lung as outlined below. 
1. Study website determines LCS eligibility 
2. If eligible, LCS decision aid video displayed 
3. Personalized risks-benefits of screening calculated and displayed as an infographic. 
4. Valued clarification exercise conducted 
5. Patient asked if they would like to receive LCS 
a. If patient answers “yes” or “maybe”: webform presented for patient to request a LCS 
visit of desired 
b. If patient answers “no”: patient encouraged to discuss LCS with primary care 
provider 
6. Patient given option to download an electronic summary   
4.5 
Control (usual care) 
 
Patients randomized to the control arm will be told they meet guideline criteria for lung cancer 
screening, and they will be told to talk to their doctor “to see if screening is right for you.” However, 
control arm patients will not be shown the LCS decision aid, offered the opportunity to estimate 
their predicted benefits and harms of screening, or given the option of requesting a LCS screening 
visit via the program. Instead, control arm patients will see an animated video about exercise for 
lung health based on recommendations from the European Lung Foundation.57 (Appendix D)  
 
All patients will be exposed to each network’s standard LCS outreach efforts, and they will be 
scheduled to see a primary care provider within the next 3-4 weeks as part of the eligibility criteria – 
another opportunity for LCS to be addressed. As noted previously, patients in both health systems 
may self-refer for LCS as part of usual care. 
 
4.6 
Piloting Study Procedures 
 
Prior to beginning enrollment of the study cohort, we will pilot these procedures on a subset of 
patients meeting our inclusion criteria. The purpose of this will be to ensure the automated 
processes function appropriately, and that accrual rates align with what is anticipated. We will 
create a pilot study database to validate our data queries and refine our data collection 
processes. However, data from participants in the pilot phase will not be included in the study 
analyses. 
5.0 
Outcome Measures 
5.1 
Primary Outcome 
 
The primary outcome will be EHR-verified completion of a screening CT within 16 weeks of 
enrollment. While not all patients who are eligible for LCS will choose to receive it, we expect to see 
a significant difference in receipt of screening between arms if mPATH-Lung is effective. This will 
be defined as ANY chest CT within 16 weeks (and we will code to know whether it was a LDCT or 
some other diagnostic chest CT). 
5.2 
Secondary Outcomes 
 

 
 
5.2.1 LCS screening decisions: LCS screening decisions will be captured by the 
mPATH-Lung program in the mPATH-Lung group only. (Time frame = post-
intervention) 
5.2.2 LCS clinic visits scheduled: The proportion of patients in each arm who have 
scheduled a LCS clinic visit will be captured by querying the EHR at each 
site. 
5.2.3 LCS clinic visits completed: The proportion of patients in each arm who have 
completed a LCS clinic visit will be captured by querying the EHR at each 
site. 
5.2.4 LCS scans ordered: The proportion of patients in each arm for whom a LCS 
scan was ordered will be captured by querying the EHR at each site. 
5.2.5 LCS Clinic referral requested through mPATH 
5.2.6 Lung RADS Results: The results of all chest CTs will be captured by querying 
the EHR at each site. 
5.2.7 LCS false positives: A false positive scan will be defined as a Lung-RADS 3 
or 4 result with a negative completed work-up for lung cancer or no diagnosis 
of lung cancer within 12 months of the scan. 
5.2.8 Invasive procedures following LCS scan: We will query the EHR at each site 
to determine the number and proportion of patients in each arm who undergo 
an invasive procedure to investigate an abnormal LCS scan.  
5.2.9 Complications following LCS: We will query the EHR at each site and 
conduct a blinded chart review to determine the number and proportion of 
patients in each arm who experience a complication from an invasive 
procedure done to investigate an abnormal LCS scan.  
5.2.10 Number of diagnosed lung cancers (detected by screening or other) within 16 
months of randomization 
5.2.11 Whether diagnosed lung cancers were detected incedentally or related to 
screening 
5.2.12 Stage of lung cancers diagnosed 
5.2.13 Overscreening: We will determine the proportion of patients with screen 
diagnosed lung cancer in the mPATH-Lung and control groups who are 
deemed too ill for potentially curative surgery by blinded chart review. 
5.2.14 Reach of digital outreach strategy: Reach of the digital outreach strategy is 
defined as the proportion of patients who complete the website study 
eligibility questions. The denominator includes all patients who were sent an 
invitation, regardless of full program completion and whether or not they were 
subsequently determined to be eligible for LCS. 
5.2.15 Completion of mPATH Lung: Completion of mPATH-Lung is defined as the 
proportion of patients who complete mPATH-Lung to the point of indicating 
their screening decision. The denominator includes all patients randomized to 
mPATH-Lung. 
 
5.3 
Exploratory Outcomes 
 
5.3.1 mPATH-Lung Appropriateness: Appropriateness will be measured from the 
provider’s perspective using an emailed survey that includes 8 previously 
validated appropriateness items.58 
5.3.2 mPATH-Lung Acceptability: Acceptability of mPATH-Lung will be measured 
on the post-program survey by the mean of 7 acceptability items drawn from 
the validated System Usability Scale84 and a previously published 

 
 
acceptability survey.85 Patients who fail to complete mPATH-Lung will be 
considered to have found the program unacceptable. 
 
 
Data Sources 
Study Program Database: To determine eligibility for LCS, the study website collects age and 
smoking history from patients (Appendix A). Patients randomized to mPATH Lung also can 
choose to answer 8 demographic, family history, and medical history items (Appendix E) to 
estimate their personal risk for lung cancer based on a validated model.14,46 In our pilot testing, 
76% of mPATH-Lung users completed these items to obtain this information. Patients randomized 
to mPATH-Lung will also complete the values clarification exercise to capture their rankings of 
decision attributes, and will indicate their LCS decision.  
 
Post-program Survey (Appendix F): Immediately after completing the mPATH-Lung program, all 
participants will complete a brief self-survey via the study website. The survey will contain 3 
program acceptability items drawn from the validated System Usability Scale60 and a previously 
published acceptability survey.61  
 
EHR Queries and Chart Reviews (Appendix G): We will query the EHR in each system to 
determine if LCS shared decision making clinic visits were scheduled and completed, if LCS was 
ordered and completed, LCS results (including false positives),and any downstream procedures 
and complications. One potential marker of overscreening, or screening patients who are unlikely to 
benefit, is diagnosing early stage lung cancer in patients too ill for surgery. To estimate the impact 
of mPATH-Lung on overscreening, we will compare the proportion of patients with screen 
diagnosed lung cancer in the mPATH-Lung and control groups who are deemed too ill for 
potentially curative surgery by blinded chart review. Given the paucity of LCS programs within 
North Carolina, it is unlikely that participants would receive screening outside these health 
networks, and any such “outside screening” should occur equally in both arms, minimizing bias.  
 
Semi-structured Patient Interviews:  
We will use qualitative methods to examine situations where initial decisions and subsequent 
behavior are concordant as well as discordant. Our goals here are to deepen our understanding of 
how patients’ decisions may evolve over time, and how those changes may be influenced by 
interactions with providers, family members, or others. We also aim to understand the facilitators 
and barriers to receiving LCS for those who decide they want screening. We will conduct semi-
structured individual interviews with 3 groups of participants reflecting the spectrum of screening 
decisions and screening behavior.(Table 3) All interviews will be conducted after primary data 
collection is complete to avoid biasing outcomes.  
 
Table 3. Groups for semi-structured interviews 
(n≥16 per group) 
Group 
Screening 
Decision 
Screening 
Behavior 
1 
Want 
Screening 
 Half 
Screened / 
Half not 
Screened 
2 
Unsure 
Half 
Screened / 
Half not 
Screened 
3 
Decline 
Screening 
Half 
Screened / 

 
 
Beginning 6 months after the first patient is enrolled, we 
will review our dataset monthly to identify participants 
randomized to the mPATH-Lung arm who have completed Aim 1 study involvement in the prior 4 
weeks. A research assistant will call these patients to ask if they would be willing to participate in a 
45-60-minute interview to discuss their LCS screening decision. Those completing the interview will 
receive a $75 incentive. Interviews will be conducted by phone at the patient’s convenience and 
recorded for later analysis.  
Prior to completing the interview, patients will be asked a series of 7 questions to assess their LCS 
knowledge. (Appendix N) Interviews will be conducting using an interview guide (Appendix H). 
During this interview, we will first ask patients open-ended questions about their screening decision, 
as well as their current thinking about LCS.. We will then discuss how the patient progressed to 
complete screening or why they did not. A total of 12 interviews are generally considered sufficient 
to reach thematic saturation.62,63 Because half of patients in each group will have completed 
screening and half will have not, we anticipate we may need a larger sample to reach saturation. 
Therefore, we will conduct interviews with at least 16 patients in each of the 3 groups shown in 
Table 3 (a minimum of 48 interviews).Each interview group will consist of an equal number of 
patients from each health system. We will analyze the interviews as they are conducted to assess 
whether saturation has been reached (i.e., no new themes emerged), and will continue recruitment 
if saturation is not reached.  
Provider Surveys (Appendix I): Following completion of primary data collection, we will invite all 
primary care providers who had at least one patient randomized to mPATH-Lung to respond to a 
brief emailed survey that includes portions of a previously validated appropriateness instrument.58 
The survey will also collect basic provider sociodemographic and practice setting characteristics to 
let us examine how appropriateness varies by subgroups. We will use the Research Electronic 
Data Capture (REDCap) system, a web-based secure application for building and managing online 
surveys and databases, for this survey. Within the survey, providers will be informed of the program 
(purpose, key messages, procedures for lung screening referral)Providers who complete the survey 
will receive a $10 digital gift card.  
Provider Interviews (Appendix J): The provider survey will reveal whether providers find the 
mPATH-Lung digital outreach strategy appropriate. To gain a deeper understanding of why 
providers’ hold their views about the appropriateness of mPATH-Lung, we will conduct 30-minute 
semi-structured interviews with a subset of at least 24 primary care providers, stratified by clinic 
network and chosen to reflect a diversity of views on appropriateness. Interviews will be conducted 
by video call, recorded for later analysis, and scheduled at a time convenient to the provider. The 
interview guide will explore in greater depth the items assessed on the structured survey (e.g., why 
or why not mPATH-Lung seems like a good match for their practice).  Additionally, we will explore 
whether primary care providers perceive patients’ ability to self-refer to the lung screening clinic for 
a shared decision making visit as helpful or harmful and why. Respondents will receive a $50 digital 
gift card. We estimate that 12 provider interviews in each of the 2 health networks will be sufficient 
to achieve saturation.64,65 We will analyze the interviews as they are conducted, and will continue 
recruitment beyond 12 per health network if saturation is not reached.  
6.0 
Analytic Plan 
 
6.1  
Primary Analysis 
The primary analysis will be carried out based on “intent to treat.” All patients will be included in 
their randomized arm whether or not they actually finish the program. The primary objective of 
effectiveness will be assessed using a logistic regression model with completion of LCS (Y/N) 
within 16 weeks of enrollment as the outcome, treatment arm as the primary independent variable, 
and health system as a covariate per the design.  
Half not 
Screened 

 
 
6.2  
Secondary Analyses 
In secondary analyses of effectiveness, we will assess the effects of age, sex, race and ethnicity, 
insurance status, and rurality on screening rates using logistic regression models. Additionally, we 
will conduct separate subgroup analyses for these covariates to obtain estimates and 95% 
confidence intervals of the intervention effect in these subgroups.  
This same strategy described for analysis of completion of LCS to assess the effectiveness of the 
mPATH-Lung program will be used to assess the impact of the mPATH-Lung program on 
screening intent, scheduled and completed LCS clinic visits, test ordering, and screening-related 
harms (including overscreening). For LCS results, we will provide estimates with confidence 
intervals for the proportion of patients who have Lung-RADS 1 (normal), Lung-RADS 2 
(small/stable nodule), Lung-RADS 3 (nodule with 6-month follow-up recommended), and Lung-
RADS 4 (concerning nodule needing short-term follow-up or biopsy) results. Ordinal logistic or 
linear regression will be used to assess the effect of mPATH-Lung on patient knowledge of LCS, 
depending on the distribution of the outcome. We will also examine knowledge levels in those with 
a strong preference for or against screening. 
We will use descriptive statistics to characterize participants’ screening decisions, ratings on the 
values clarification exercise, most important attributes, and screening behavior. We will use 
multinomial logistic regression to examine the relationships between the most important attribute 
and screening decision, where the outcome is coded on three levels (want screening, unsure, do 
not want screening). We will include the following covariates in the model: age, sex, pack-years of 
smoking, knowledge score, and 5-year life expectancy (to capture comorbidity) using a previously 
validated model.66,67 
We will use descriptive statistics to characterize Reach and Acceptability by patient 
sociodemographic characteristics and invitation modality, and the Appropriateness by provider and 
practice characteristics. Similar to our strategy for analyzing our primary outcome, we will use 
logistic regression to examine the effect of patient characteristics on the Reach measures. 
Patients will answer the acceptability survey at the end of mPATH-Lung. Each of these 7 items is 
scored on a 5-point scale from -2 (worst) to +2 (best), and the mean score will define Acceptability. 
Patients who fail to complete mPATH-Lung will be considered to have found the program 
unacceptable (score of -2). We will use multiple imputation to impute data for participants who 
complete mPATH-Lung but fail to complete the acceptability survey, which should be rare. Linear 
regression will be used to determine which patient covariates are associated with Acceptability. We 
will also examine the proportion of patients who view mPATH-Lung as acceptable (scores >= 0), 
and logistic regression will be used to determine which covariates are associated with Acceptability. 
Each item on the provider Appropriateness survey is scored on a 5-point scale from -2 (worst) to +2 
(best). Linear regression will be used to determine which provider and practice characteristics, 
including number of patients seen in the mPATH-Lung arm, are associated with Appropriateness. 
We will also estimate the proportion of providers who rate mPATH-Lung as appropriate (scores >= 
0), and logistic regression will be used to determine which provider and practice characteristics are 
associated with this outcome. 
6.3  
Qualitative Analyses 
Telephone interviews will be recorded and transcribed verbatim. Transcripts will be reviewed 
against the original audio for quality control before being imported into Atlas.ti software68 for coding 
and data management. Interview transcripts will be paired with individual demographic data and 
post-program survey responses. We will develop the initial codebook using the interview guide and 
survey items as a structure. We will then use an inductive approach to modify the initial codebook 
as new themes emerge. All emergent themes will be discussed amongst the team during the 
coding process. New codes and definitions will be agreed upon by group consensus. All transcripts 

 
 
will be dual coded and differences will be discussed and resolved by consensus. Segments of text 
will be abstracted by code or code combinations and iteratively reviewed/summarized as a team. 
Themes will be determined by the prevalence and salience in the data.69 Qualitative outcomes for 
providers will be compared between the two health networks. 
6.4  
Sample Size and Power 
In 2015 (the year Medicare approved payment for LCS), only 3.9% of eligible Americans were 
screened.9 Given that national screening rates are expected to increase, we will conservatively 
assume the screening rate in the control group will be 10%. A total sample size of 1320 patients 
(approximately 660 in each group) will provide 90% power for detecting a 6% absolute difference in 
screening rates at the 5% two-sided level of significance and approximately 80% power for detecting 
a 5% absolute difference in screening. Because our primary outcome measure is determined by 
electronic health record review and not surveys, there will be no loss to follow-up. 
 
We anticipate sending approximately 26,000 electronic invitations to identify and accrue 1320 
eligible patients. This sample size of 26,000 invitations will allow us to estimate the Reach of the 
electronic invitations to within ±0.6%. Our sample size of 660 patients in the mPATH-Lung arm will 
allow us to estimate the Reach of mPATH-Lung (the proportion of those who complete it) to within 
±3.8%. Our sample size of 660 patients in the mPATH-Lung arm will allow us to estimate the mean 
Acceptability score to within ± 0.076 SD. Due to the highly pragmatic nature of this study, our 
planned sample size will stay 660, but we may over-enroll because it takes time to change the 
mPATH codebase once accrual targets are reached While we are changing the codebase, 
participants who received invitations may continue to visit the mPATH web app and be randomized. 
Therefore, we acknowledge we may over-enroll by a few participants.  
 
Following completion of primary data collection, we will invite all primary care providers who had at 
least one patient randomized to mPATH-Lung to respond to a brief emailed survey. We expect 466 
primary care providers will have at least 1 patient in the mPATH-Lung arm (based on the binomial 
probability assuming 660 patients in the mPATH-Lung arm and an equal probability of seeing one 
of 890 health system providers). Based on our prior studies surveying providers (with response 
rates of 40% - 60%),38,70 we conservatively estimate 30% will respond which will yield 
approximately 140 completed surveys. Our sample size of 140 providers will allow us to estimate 
the mean Appropriateness score to within ± 0.17 SD. 
 
6.5  
Accrual Rate 
In our prior pilot study limited to patients with active portal accounts in a single health system, it required 
10 weeks to identify 1000 potentially eligible patients, of whom 35% (349) completed our study program, 
and 10% (99) were found to be eligible for LCS, yielding 10 patients per week.1 For this pragmatic trial, 
we will accrue patients from two health networks and also include patients with cellphone numbers or 
email addresses, significantly expanding the pool of eligible participants. Patients without portal 
accounts may be less likely to respond, so we conservatively estimate that we will accrue patients at half 
the rate (5%) of our pilot study. Therefore, we will send invitations to 260 patients per week (130 at 
Wake Forest and 130 at UNC) to accrue 13 patients per week, completing accrual over 2 years. We will 
oversample for non- white patients. We will monitor accrual rates and increase the number of invitations 
sent as needed. 
 
6.6  
Study Timeline 
 

 
 
  
 Study Task 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Values clarification exercise 
development and pre-testing 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
mPATH-Lung program revisions and 
testing 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Electronic health record integration and 
testing 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient/provider survey development and 
pre-testing 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pragmatic trial enrollment (Aim 1) 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Lung cancer screening outcomes data 
collection (Aim 1) 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
  
Surveillance tracking of false positives 
and harms (Aim 1) 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Data cleaning 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Patient interviews about values/drivers of 
screening decisions (Aim 2) 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
PCP surveys and interviews about 
mPATH-Lung 
appropriateness/implementation (Aim 3) 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
 
 
 
 
Data analysis  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
Results dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
7.0  Data Management and Security 
 
All mPATH-Lung interaction data including the embedded self-surveys will be stored on a central 
Wake Forest data server using industry standard encryption (e.g., AES-256 bit) to protect personal 
health information. The mPATH-Lung and EHR data will be monitored closely and reviewed at study 
staff meetings every 2 weeks during enrollment. Quality control information (surveys due/completed, 
data entered, missing data, out of range data, inconsistent EHR data, etc.) will also be summarized 
and reviewed, along with accrual rates. 
8.0     Confidentiality and Privacy 
 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner. To help ensure subject privacy 
and confidentiality, only a unique study identifier will appear on data collection forms and in study 
datasets. Any collected patient identifying information corresponding to the unique study identifier 
will be maintained in a linkage file, stored separately from the data. The linkage file will be kept 
secure, with access limited to designated study personnel. An honest broker will mediate the 
electronic health record data queries to limit the exposure of patient identifying information. 
Because some study outcomes will require a manual chart review (for example, determination of 
“overscreening”), the honest broker will create a linkage file containing electronic health record 
numbers that only the study data analyst can access. All personal identifiers (other than dates of 
service and patient zip code) will be removed from the study datasets and only the study ID 
included. One year after publication of the main study findings, the linkage file will be destroyed 
(electronically deleted or shredded in the case of paper forms). Data access will be limited to study 
staff. Data and records will be kept locked and secured, with any computer data password 
protected. No reference to any individual participant will appear in reports, presentations, or 
publications that may arise from the study. 

 
 
9.0    Data Safety and Monitoring 
 
The only anticipated risks specific to this study are loss of data confidentiality. The research team 
will form an internal Data and Safety Monitoring committee, comprised of the PI, Project Manager, 
study statistician (Snavely), and study clinical informaticist (Dharod). This committee will monitor 
the integrity of the study data systems monthly to protect against any security weakness or 
breaches. The study team will immediately apprise the PI of any problems so that appropriate 
action can be taken in a timely manner. The PI will promptly review any participant or other-
reported concerns regarding the study. 
10.0 Reporting of Unanticipated Problems, Adverse Events or 
Deviations 
 
The PI will report any loss of data confidentiality or other adverse event to the Wake Forest IRB and 
the NIH within 5 business days of the discovery the event. 
 
Any unanticipated problems, deviations or protocol changes will be promptly reported by the 
principal investigator or designated member of the research team to the IRB and sponsor or 
appropriate government agency if appropriate.  
 
 

 
 
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