Lung Cancer Screening Decision Aid Designed for a Primary Care Setting

Key Points Question Can a lung cancer screening (LCS) decision tool designed for use in a primary care clinical setting improve informed LCS decision-making? Findings In this randomized clinical trial of 140 participants, no statistically significant difference in decisional conflict was found at 1 month after intervention (25.7 vs 29.9, on a scale of 0 [none] to 100 [high]). Analysis of secondary outcomes suggests that the LCS decision tool intervention improved LCS knowledge without increasing general anxiety or lung cancer worry. Meaning This patient decision aid designed for use in a primary care setting can inform future research to advance LCS shared decision-making interventions.

preventative organizations, issued guidelines in favor of annual lung cancer screenings for older people with a history of smoking [4][5][6].However, there are concerns that with more screenings an increase in false positives and over diagnosis will occur.The effectiveness of lung cancer screening may also vary by gender, and initial data suggests some Veterans are reluctant to enter an intensive screening process [7].

As the Department of Veteran Affairs expands the paradigm of lung cancer control to include lung cancer screening, it is critical to develop and test decision support tools that 1) educate Veterans regarding expected outcomes, 2) incorporate Veteran preferences and values into the decision-making process, and 3) encourage shared decision-making between Veterans and providers
The VA method of lung cancer screening is unique in that it is designed to increase assessment rates and support among Veterans.Lung cancer screening criteria includes age and the modifiable behavior of smoking.As stated before, the high rate of false positives negatively impacts screening participation, so the assessment of patient preferences will inform participants of strategies to encourage adherence to the program [8].Comorbidity must also be taken into account, as the target screening population is older [9], and at a higher risk for vascular diseases than younger people.A successful paradigm will include these concerns.The unique aspects of the lung cancer screening paradigm increase the importance of preference assessment as part of an informed decision-making process.
A recent Cochrane meta-analysis found that decision aids such as conjoint analysis and best-worse scaling (commonly called discrete choice experiments) can improve receptiveness to lung cancer screening methods [10].However, these tools have not been widely used in clinical practice, and these assessment methods would have to be geared towards Veteran population and require systems to integrate decision support with clinical practice.This proposal will address these gaps by evaluating the usability and acceptability of an explicit preference assessment method as part of a lung cancer screening decision support tool (LCSDecTool) designed for Veterans.

Significance
Veterans are at higher risk of lung cancer due to their increased smoking rate when compared to the general population, both when active and following service time [1].Eight VA Medical Centers have recently completed studies that demonstrate the need for effective screening tactics.The PI of this proposal (Schapira) has completed pilot work with HSR&D Research in this area.and the demonstration projects across 8 sites in the VA health care system found that 56% of the Veterans offered screening agreed to the tests.Before expanding further, it is imperative that decision-support tools are present to encourage participation in lung cancer screening programs.By developing these strategies now, patient preferences can be accounted for in the study guidelines.(Figure 1).

This research is based on the theoretical frameworks of shared decision-making (SDM), implementation science, and technology adoption. SDM incorporates normative and dual process reasoning theories.
Dual process theory recognizes the role of systematic reasoning, which is thought to lead to decisions that people are more likely to follow through with [11].Implementing a decision support tool that APPROVED by CMCVAMC IRB on 03/28/2021 provides evidence-based information clearly reduces the barriers to dual process reasoning leading to higher decision quality and more accurate risk perception [12][13][14][15].This study simultaneously collects data to gauge effectiveness of intervention and implementation.Data collection pertaining to process evaluation will be guided by the Promoting Action on Research Implementation in Health Services (PARIHS) implementation framework [16][17][18] and the Technology Acceptance Model (TAM) [19].This team is qualified to conduct this work, as the core and coinvestigators have a number of relevant experiences to draw from regarding this study.
Pilot data to support this program was conducted at Penn in two parts: 1) an HSR&D pilot (PI Schapira) of preference assessment and risk communication among Veterans considering lung cancer screening, and 2) a Center for the Evaluation of Patient Aligned Care Teams (CE-PACT) pilot grant to develop a web-based health numeracy tutorial for patients enrolled in a Patient Aligned Care Team (PACT) at the CMCVAMC.Qualitative interviews with Veterans were conducted in the HSR&D pilot to define the most critical attributes of lung cancer screening.In the pilot, it was seen that Veterans found pictographs to be useful for conveying expected outcomes, along with gradations indicating risk estimates, and a "margin of error" interval analogy.Veteran concerns included the financial and emotional strain of follow-up tests resulting from false positives.Fifty-one percent (51%) of study participants were African American, 86% were current smokers, and 47% had at least 30 pack years of smoking (this means 1 pack per day for 30 years or 2 packs a day for 15 years).Participants were asked to choose the attributes most and least important to them regarding lung cancer screening from groups of three.Linear regression was used to determine the association between race and other factors via importance weights [20,21].(Figure 3).Eligible patients will be identified through VA Corporate Data Warehouse (CDW), flyers in primary care/pulmonary clinics and the use of a study team consult that will allow providers to refer eligible patients to the study team.When a potential participant is identified, the study team will send the patient an invitation letter to join the study.Use of the CDW database will support this approach, as the dates of scheduled visits are included in the CDW database and updated daily.Efforts will be made to recruit at least 40% African American, 5% Hispanic, and 10% female patients.Eligibility will be determined by in-person or telephone interviews.
APPROVED by CMCVAMC IRB on 03/28/2021 Since MyHealtheVet will be used after consent, the research team will ask patients if they are registered on MyHealtheVet with a premium account that allows them to access Secure Messaging.If they are not registered, the study team will offer that they go to the MyHealtheVet office to sign up.The study team may use MyHealtheVet Secure Messaging to confirm and schedule research appointments and follow-ups.The use of MyHealtheVet is optional.Patients will be enrolled prior to upcoming appointments in primary care/pulmonary clinics to ensure an opportunity for shared decision-making following the intervention All primary care providers in the PACT at the respective VA centers will be sent a description of the overall study through email and/or office mail.Providers will be able to opt out of the study, in which case their patients will not be approached regarding study enrollment.For providers who agree to participate, their patients will be approached regarding study enrollment if they meet inclusion and exclusion criteria.A provider information page will be sent to all participating providers which will include information about the LCSDecTool and example of the LCSDecTool summary sheet.This may include the same providers that participated in Phase 1 and Phase 2.
The LCSDecTool will be programmed to randomly assign the participant to 1 of 2 viewing experiences (Experimental vs. Control).The study visit will occur either in-person or by telephone.The in-person study visit will be in a quiet, private room.Telephone visits will be arranged so that coordinators and participants will both be in a quiet, private setting.After completing informed consent and HIPAA Authorization (for baseline in-person visit), the patient will sign on to the study site, complete baseline assessments, and be randomly assigned to the Experimental or Control intervention.Randomization will occur at the patient level.A research assistant will be available to answer questions for participants during the study visit.The visit may be observed by a member of the web development team to better understand how the tool functions.
Experimental Intervention: Participants randomized to the experimental intervention will receive a message on the screen that they are now going to view the LCSDecTool.At the end of the tool experience, they will be given the option to print out a summary sheet.Participants will complete the immediate post-intervention assessments (T1) on a computer interface.
Control Intervention: Participants will view screen content that that provides general information on health promotion and disease prevention unrelated to lung cancer screening.No printout is given to subjects in this arm.The control intervention will have the same number of screens to review as the LCSDecTool.Participants will complete the immediate post-intervention assessment (T1) using a computer interface.The Control group will complete all of the surveys, with modified versions of Practical Utility of LCSDecTool, Pt Engagement, and End User Satisfaction that cover general cancer screening rather than Lung Cancer specifically.

The baseline visit (T0) research visit will last ~2 hours The immediate post-intervention visit (T1) done in person or by phone will last ~1 hour.
The summary sheet that is presented at the end of the LCSDecTool will have the option to be downloaded, emailed, or printed and a copy given to the subject to have available to refer to during an in-person clinic visit or telehealth visit and serve as a prompt for shared decisionmaking.The subject or study team will also send the summary sheet to the provider through MyHealtheVet Secure Messaging.Studies suggest that printed action plans can be effective in supporting shared decision-making for collaborative goal setting in primary care.[83] Note, that if the subject chooses use email, the subject will type in their own email address.The study will not be storing that email information in the application back end.Outcome assessment will be blinded to group assignment (Table 4).Primary outcomes include decisional conflict, decisional conflict, general anxiety, lung cancer worry, and lung cancer screening uptake at T1 (1 month post-intervention).Health related quality of life and feasibility measures will also be assessed (Table 4

Provider participation in this study
Healthcare providers participating in this study will undergo oral consent prior to recruiting patients.
For those patient-provider dyads in which the patient was randomized into the intervention, their patient may bring the LCSDecTool to the appointment so that they can review it with the provider.Their patient may also bring their summary page to be reviewed with the provider.The subject or study team will also send the summary sheet to the provider through MyHealtheVet Secure Messaging, for those randomized to the experimental arm.They will have the opportunity to engage in shared decision-making regarding Lung Cancer Screening.For those patientprovider dyads in which the patient was randomized into the control, they will have the opportunity to engage in shared decision making regarding general cancer screening and prevention.For either randomized group, the provider will complete a one page "Post-Visit Provider Survey" after each appointment with participating patients.Each participating provider will have between 0 and 20 patients enrolled in the study.At the conclusion of the study, every provider will complete a 3-page survey, which includes System Usability Survey, Technology Acceptance Model, and End User Computing Satisfaction.Total involvement in the study will take approximately 1 hour.

Power and Sample Size -We will enroll 200 Veterans in addition to up to 240 Providers in this
pilot RCT, a sample size that is feasible to enroll and that will provide adequate power to permit testing of key study outcomes.We conducted our power analysis comparing the LCSDecTool to usual care with respect to the two primary outcomes, Decisional Regret and Decisional Conflict, assessed at T2 (1 month post-intervention).We will conclude that the intervention was superior if we reject the null hypothesis of no difference for either or both of these outcomes.Tests will be two-sided and will be conducted using α=0.025 to control the family-wise type I error rate at 0.05.Assuming 10% loss to follow-up at one month post-intervention, 180 patients will be available for analysis.For Decisional Regret at T2, we will have 96% power to detect a medium effect size of 0.60 corresponding to a 10 point difference between intervention and control groups.Assuming SD = 16.6 [95].For the Decisional Conflict outcome, we will have 96% power to detect a medium-sized standardized effect size of 0.5, corresponding to a difference of 2.0 points between groups assuming SD = 3.9.In exploratory analyses of Africa.We will conclude that the intervention was superior if we reject the null hypothesis of no difference for either or both of these outcomes.Tests will be two-sided and will be conducted using α=0.025 to control the family-wise type I error rate at 0.05.Assuming 10% loss to follow-up at one month postintervention, 180 patients will be available for analysis.For Decisional Regret at T2, we will have 96% power to detect a medium effect size of 0.60 corresponding to a 10 point difference between intervention and control groups, an American participants, we will have 80% power to detect a standardized effect size of 0.74 or larger in either outcome.

Amendment March 2019
The purpose of this amendment is to make minor changes to the post-visit provider survey, future screening intentions and replace the former table 4 with the above.

Amendment April 2020addition of the Milwaukee VA site
Veteran recruitment at the West Haven site was low and recruitment at that site will.We are adding the Milwaukee site to try to reach our original goals for patient recruitment.However, each site involves essentially all the primary care providers at the site -hence there will be APPROVED by CMCVAMC IRB on 03/28/2021 another 80 providers recruited from Milwaukee Amendment September 2020 Due to COVID-19 and the increasing amounts of primary care telehealth appointments we are modifying our protocol to include telephone baseline visits to meet our recruitment goals.In addition, we are modifying our protocol to increase compensation for follow-up telephone visits for participants at the Philadelphia site.The reasons for increased compensation are to increase follow-up participation and to properly compensate Veterans for their time spent answering survey questions for the study as follow-up calls are taking up to sixty minutes to complete.Currently, we provide Veterans with a $25 stipend after completion of both 1-and 3-month follow-ups.In this modification, we will provide Veterans with $25 stipends for each of the telephone visits.With the modification, the total amount participants receive will increase from $75 to $100.

5.1.2.
What research methods will be used in the project?Check all that apply.Provide description of the study population (delineate all categories of subjectsmale, female, inpatients, outpatients, providers, family members, employees, etc.).Include anticipated initial enrollment numbers (and number of subjects anticipated to complete all aspects of the protocol).This project involves the recruitment of 200 Veterans and up to 240 Providers.Patient recruitment efforts at the three sites (CMCVAMC, WHVAMC, and Milwaukee VAMC) will target male and female patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer screening.Our recruitment goals for patients are 40% African American, 5% Hispanic patients, and 10% women.State how many subjects will be needed.This project involves the recruitment of up to 100 Veterans and 80 providers from the CMCVAMC/CBOCS.This project involves the recruitment of up to 200 Veterans between CMCVAMC/CBOCS, WHVAMC, and Milwaukee VAMC.This project also involves the recruitment of up to 240 Providers (80 from each site).

5.2.2.
Who will be responsible for recruiting potential subjects?Provide titles of individuals.
Principal Investigator, Sr. Coordinator, and the Research Assistant

5.2.3.
How will initial contact with potential subjects be made?(e.g., local clinics, physician referrals, letters to prospective subjects) NOTE: VA policy prohibits "cold calls" to potential VA research subjects.Provide an introductory letter and telephone script.
Eligible Veterans will be mailed a recruitment letter with study information and an invitation to participate.A study staff member will make a follow-up phone call to the Veteran if there is no reply after one week.During screening phone call, inclusion/exclusion criteria will be confirmed.A second recruitment strategy will be to post study flyers and brochures in the primary care and pulmonary clinic setting and have a recruitment table in the waiting room to provide study information.Study visits will be scheduled the same day as clinic appointments when possible.If necessary, due to the timing, participants can be scheduled up to 2 weeks prior to their appointment time .Summarize any financial compensation that will be offered to subjects.
Veterans will be compensated $100 total incentive ($50 for completing the baseline and immediate post-intervention surveys; and $25 each for completing the 1 and 3-month telephone follow-ups).

5.3.2.
Provide the schedule for compensation.

5.4.5.
Inclusion/Exclusion Criteria: Describe the criteria that determine who will be included in or excluded from the study.

Inclusion Criteria
All Veterans must be enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer screening.Veterans will be age 55 to 80 years, smoking history of 30 or more pack years, and current smoker or smoker who quit within 15 years whose providers have agreed to also participate in the study Inclusion criteria for providers will include practicing or providing leadership in a PACT or involvement in the lung cancer screening through the clinical services of Radiology, Oncology, or Pulmonary Medicine, services that are most involved with the lung cancer screening.

Exclusion Criteria
Exclusion criteria for Veterans will be cognitive impairment as determined by clinical history, previous diagnosis of cancer with the exception of nonmelanoma skin cancer and localized prostate cancer that is 1-year postdiagnosis or more and with no indication of progression, active surveillance of Lung Nodule, Enrolled in CMCVAMC Lung Cancer Screening Program, life expectancy of less than 2 years as indicated by chart review and confirmation with PCP, and inability to speak English during the phone screen.

Describe how a subject can withdraw from the study.
Veteran subjects who want to withdrawal from the study should do so using the HIPAA Revocation form.Providers who want to withdrawal from the study may do so verbally.No consequences for withdrawal.Once we are notified of a participant's decision to withdraw, we can continue to use information about them that has been collected up to that point.No information will be collected after a participant formally withdraws Include a description of how anticipated risk will be minimized and include an analysis of risk vs. potential benefit.Veterans with anxiety or concerns will be referred to their primary care physician.Each Veteran will be assigned an ID number that is not related to any PHI.The providers/leaders will be assigned an ID number so that their baseline assessment can be linked to an ID number.The key containing the link between the study identification number and participant will be maintained on the CMCVAMC's secure server (\\vhaphifpccherp.v04.med.va.gov\shares2\Schapira_Marilyn ) on a separate fold from the collected data.Only Dr. Schapira  A data and safety monitoring committee will be formed and include Dr. Chhatre (Co-I) and Dr. Hubbard (biostatistics).The committee will report to the investigative team on a monthly basis.The committee will review the accuracy and integrity of the data and monitor adequate subject recruitment and enrollment.Dr. Hubbard (biostatistics) is experienced in data management methods.This committee will review all reports of adverse events within 24 hours of their occurrence and on a monthly basis and determine if a change in protocol is indicated due to the occurrence of adverse events 5.7.1.2.If no, describe the data and safety monitoring plan to be followed.

5.8.
Reporting No medical history will be collected from clinical providers.We will collect information such as name, gender, job title, years in current job, email, phone number for clinical leaders/providers.

5.9.2.
Check the PHI to be collected on all subjects for this research protocol.All paper/hard copy data -signed consent and HIPAA authorization forms, subject logs, surveys will be maintained in study binders.The study binders in CMCVAMC will be kept in CHERP, 4100 Chester Ave, Ste 202 in a locked file cabinet.Any electronic data-the subject logs and the key linking participants to their study ID at CMCVAMC will be kept on the secured CMCVAMC server vhaphicherpnas.(\\vhaphifpccherp.v04.med.va.gov\shares2\Schapira_Marilyn ) The log and the key will be kept in separate folders on the server and will not be printed out.

Name
Study personnel with access to study data who are no longer involved with the study data will have access revoked and will be removed from the research staff form 5.10.3.Indicate how and where data/information will be stored and specify pertinent security systems.
All paper/hard copy data-consent forms, subject logs, HIPAA authorization, surveys will be maintained in study binders.The study binders in CMCVAMC will be kept in CHERP, 4100 Chester Ave, Ste 202 in a locked file cabinet.Study staff will walk the hard copy documents to CHERP from the CMCVAMC after interviews sessions.Any electronic data--the subject logs and the key linking participants to their study ID-at CMCVAMC will be kept on the secured VA server vhaphicherpnas.The log and the key will be kept in separate folders.
Electronic Survey data will be entered into the VA REDCap database.No Identifiable information will be included with this data.The VA REDCap database is kept on a VA secured server that is only accessible through an application process 5.10.4.3.List the data/information that will be transmitted or transported, and specify how data will be transported or transmitted from one location to another and how it will be protected during transmission or transportation outside of CMCVAMC.APPROVED by CMCVAMC IRB on 03/28/2021 5.12.Communication Plan 5.12.1.Include plan for ensuring that the study is conducted according to the IRBapproved protocol.
Monthly team meetings will be held with the PI and study staff to discuss the study progress.The PI will ensure that all study activities are being conducted according to the IRB approved protocol 5.12.2.If a multi-site study, include information on • ensuring that all required local site approvals are obtained and notifying the Director of any facility where the research is being conducted but the facility is not engaged, and • keeping all engaged sites informed of changes to the protocol, informed consent, and HIPAA authorization, and • informing local sites of any Serious Adverse Events, Unanticipated Problems, or interim results that may impact conduct of the study, and • notifying all local facility directors and local site investigators (LSI) when a multi-site study reaches the point that it no longer requires engagement of the local facility (e.g., all subsequent follow-up of subjects will be performed by the PI from another facility).Dr. Schapira (PI) will have overall responsibility for the coordination of the study sites, study team members, and the achievement of scientific goals and objectives.
Dr. Bastian, site PI for WHVAMC, will have direct oversight for activities at the WHVAMC.Dr. Schapira   5.13.9.Describe where drug preparation will be done.
5.13.10.All drugs for CMCVAMC subjects must be dispensed through the VA investigational pharmacy.5.13.11.Describe where the study treatment will be administered.
5.13.12.Describe plan for tracking a non-compliant treatment study subject.
5.13.13.Describe the process for the storage, security, dispensing and return of an investigational drug.

month after the intervention) • H2: [Decreased overall anxiety and lung cancer worry at T2 (1 month after the intervention)] • H3: Lower rates of lung cancer screening at T3 (3 months after the intervention)
Descriptive Analysis -Descriptive statistics will include frequencies and percentages for categorical variables, and either mean and standard deviation or median and interquartile range for continuous variables, as appropriate based on distributional characteristics.We will compare baseline characteristics between groups to assess the adequacy of randomization, using t-tests to compare continuous variables and chi-square tests for categorical variables.Characteristics found to differ significantly between intervention groups (defined as p<0.15) will be included as covariates in adjusted analyses.We will examine the distributions of decisional regret, decisional conflict, STAI, and lung cancer worry at T2 (1-month post-intervention) graphically and will calculate summary statistics to assess symmetry and substantial departures from normality.
Define plans for data and statistical analysis, including key elements of the statistical plan, stopping rules and endpoints.Statistical Analysis for H1 -Our primary analysis for H1 outcomes will be intention to treat, including all patients as randomized in the analysis, using linear regression to test whether decisional regret and decisional conflict scores differ by intervention group at T2 after adjustment for baseline characteristics and study site.If the outcome distribution exhibits substantial skew or deviates in other ways from approximate normality, generalized linear mixed models or alternative methods will be used.The dependent variable will be either Decisional Regret or Decisional Conflict, and the primary independent variable will be intervention group.We will include in all models fixed effects for study site to account for potential variation in outcomes associated with care environment.Adjusted analyses will include variables not balanced by randomization.Standard regression diagnostics will be performed and robustness of results to analysis assumptions will be assessed in sensitivity analyses.Tests will be conducted at the twosided α=0.025 level so that the overall type 1 error rate is controlled at the 0.05 level (Bonferroni adjustment).
Statistical Analysis for H2 -Our analysis for H2 outcomes will be intention to treat, including all patients as randomized in the analysis, using linear regression to test whether STAI and lung cancer worry differ between interventions at T2 after adjustment for baseline characteristics and study site.The approach de-scribed above for H1 will be used, with outcomes defined as STAI and lung cancer worry at T2.Standard regression diagnostics will be performed and robustness of results to analysis assumptions will be assessed in sensitivity analyses.Tests will be conducted at the two-sided α=0.025 level so that the overall type 1 error rate is controlled at the 0.05 level (Bonferroni adjustment).
Statistical Analysis for H3 -For H3, we hypothesize that the LCSDecTool intervention, compared to usual care, will result in lower rates of lung cancer screening assessed at 3 months.In this aim, the effect of the LCSDecTool intervention compared to usual care on completion of lung cancer screening will be assessed.Our analysis for H3 will be intention to treat, including all patients as randomized in the analysis using logistic regression adjusted for study site.The dependent variable will be receipt of lung cancer screening within 3 months of the index visit; the primary independent variable will be intervention group, and study site will also be included as a covariate in all analyses.Analyses will also be adjusted for characteristics not balanced by randomization as described above.Because H3 tests only one outcome, tests will be conducted at the two-sided α=0.05 level 9.3.Provide sample size determination and analysis (include anticipated rate of screen failures, study discontinuations, lost to follow-up, etc.) The sample size includes up to 200 Veterans across the 3 sites.In addition, up to 240 providers across the 3 sites with80 Providersat the CMCVAMC site,80 Providers at the West Haven CT Site, and 80 providers at the Milwaukee WI Site.

9.4.
Describe how, where and by whom the data will be analyzed.Power and Sample Size -We will enroll 200 persons in this pilot RCT, a sample size that is feasible to enroll and that will provide adequate power to permit testing of key study outcomes.
• H1: We conducted our power analysis comparing the LCSDecTool to usual care with respect to the two primary outcomes, Decisional Regret and Decisional Conflict, assessed at T2 (1-month post-intervention).Assuming SD = 16.6 [95].For the Decisional Conflict outcome, we will have 96% power to detect a medium-sized standardized effect size of 0.5, corresponding to a difference of 2.0 points between groups assuming SD = 3.9.In exploratory analyses of Africa.We will conclude that the intervention was superior if we reject the null hypothesis of no difference for either or both of these outcomes.Tests will be two-sided and will be conducted using α=0.025 to control the family-wise type I error rate at 0.05.Assuming 10% loss to follow-up at one-month APPROVED by CMCVAMC IRB on 03/28/2021 post-intervention, 180 patients will be available for analysis.For Decisional Regret at T2, we will have 96% power to detect a medium effect size of 0.60 corresponding to a 10-point difference between intervention and control groups, an American participant, we will have 80% power to detect a standardized effect size of 0.74 or larger in either outcome.• H2: Using the same approach as H1, tests will be two-sided comparisons between the intervention and control group at T2 conducted at the α=0.025 level to control the family-wise type I error rate at 0.05.With180 patients available for analysis at T2, we will have 80% power to detect a medium standardized effect size of 0.46 SD.This corresponds to absolute differences between intervention and control arms of approximately 5.5 in STAI assuming SD = 12.0 and 1.6 in lung cancer worry assuming SD = 3.5.In the African American subgroup, we will have 80% power to detect a standardized effect size of 0.74 (medium). APPROVED Dr. Schapira also worked with web developers to improve patient understanding of numeric information used in medical diagnosis.Forty-two participants diagnosed with heart failure had the option to learn in a classroom setting, or in a web-based program.The pilot study found that 95% of participants preferred a computer-based tutorial, with the most viewed modules being Understanding Risk and Taking Medications.Knowledge quizzes embedded in the program noted participant knowledge increased after module completion.The pilot studies demonstrate the research team's experience in the field of risk communication, preference assessment, and the development of web-based interventions.The proposed study is a natural extension of this pilot work.

5. 2 . 4 .5. 3 .
Will you be using any of the following methods to recruit subjects?(Check all that apply.)N/A Local database for which subjects have NOT given prior permission to be contacted for Research.Philadelphia (642); Research & Development (151) APPROVED by CMCVAMC IRB on 03/28/2021 NOTE: If this option is checked, please submit a Waiver of Individual Authorization for Disclosure of Protected Health Information.Personal contact with patients over whom you have direct/indirect oversight Provider (Clinician) Referrals of potential subjects 5.2.5.Indicate the types of recruitment/advertisement materials that will be used: Check all that apply.Submit copies of recruitment materials, for IRB review., e.g.employee newsletters) Study Brochure, Emails to Providers 5.2.6.Non-Veteran Subjects will be given a copy of the Notice of Privacy Practices.YES NOTE: ➢ Every non-Veteran should sign VA form 10-0483, Acknowledgement of the Notice of Privacy Practices (ANOP) ➢ Once the ANOP is signed, the research study staff must send the non-Veteran's name to the CMCVAMC Privacy Officer via encrypted e-mail.The signed ANOP must be kept in the research study binder.➢ If an oral informed consent is used, the NOP should be sent to the non-Veteran via postal mail.In addition, the research study staff must write a Note-to-File that the NOP was sent to the non-Veteran.Compensation for Participation -YES.If yes, complete the following.5.3.1.

5. 5 . 2 .
Describe any anticipated circumstances under which subjects will be withdrawn from the research without their consent.NA 5.5.3.Describe the consequences of a subject's decision to withdraw from the research and the procedures for orderly termination of participation by the subject (e.g., the subject contacting the investigator for an end-of-study visit).APPROVED by CMCVAMC IRB on 03/28/2021

All geographic subdivisions smaller 10 .
than a State, including street address, city, county, precinct, ZIP code, and their equivalent geographical codes, except for the initial three digits of a ZIP code if, according to the current publicly available data from the Bureau of the Census: a.The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people; and b.The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000.All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older.Information Security (Contact the Information Security Officer for additional assistance regarding confidentiality (storage/security) of research data.)5.10.1.List the data/information that will be stored (including signed, original informed consent and HIPAA authorization forms, if applicable, case report forms, etc.) Subject log, signed Consent documents, signed HIPAA authorizations, paper surveys and electronic database of survey data APPROVED by CMCVAMC IRB on 03/28/2021 5.10.2.Describe the steps that will be taken to secure the data (e.g., training, authorization of access, password protection, encryption, physical controls, Certificates of Confidentiality and separation of identifiers and data).

5. 10 . 4 .
Will PHI be transmitted or transported outside of CMCVAMC?NOT APPLICABLE If yes, complete sections 5.10.4.1 through 5.10.4.3, and an Off-site Storage/Transfer of Research Data form.If no, go directly to section 5.11.5.10.4.1.Does the informed consent document and Authorization for Use & Release of Individually Identifiable Health Information for Veterans Health Administration (VHA) Research form disclose entities/individuals to which/whom PHI will be transported or transmitted?Choose an item.5.10.4.2.Specify entities/individuals outside CMCVAMC to which/whom data will be disclosed, the justification for such disclosure and the authority, and how they will access it.

5. 13 . 5 . 5 . 13 . 6 . 5 . 13 . 7 . 5 . 13 . 8 .
Describe blinding and un-blinding procedures.Include the dosage, route of administration, previous use, and the safety and efficacy information on any drug used for research purposes.Describe rationale for the dosage in this study.Justify why the risks are reasonable in relation to anticipated benefits and/or knowledge.

by CMCVAMC IRB on 03/28/2021 CMCVAMC SPECIFIC PROTOCOL SUMMARY Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center (CMCVAMC) Institutional Review Board (IRB)
Instructions: Click in box and start typing or click 'choose an item' and choose the applicable entry.NOTE Philadelphia (642); Research & Development (151) APPROVED

: If you are using a MAC, you may have difficulty with checkboxes and "choose an item" boxes.
PI's Academic Degree(s): MD, MPH Is the study funded?YES If "yes", specify funding agency: VA Health Services Research & Development Service (HSR&D) Is a

grant application requesting funds for the study currently being reviewed? NO CMCVAMC is the only institution involved: NO CMCVAMC is the coordinating center in which the PI is the lead investigator: YES If this answer is yes, complete the next two sections
: ➢ List the name(s) of the other site(s) involved.West Haven VA Medical Center (WHVAMC) Milwaukee VA Medical Center ➢ Provide

the FederalWide Assurance (FWA) numbers for each site
. WHVAMC 00001286, Milwaukee VAMC 00000289 State name of coordinating center if this is not CMCVAMC.n/a Describe

PI's qualifications to conduct this project and attach a copy of PI's VA or NIH biosketch. Be specific in regard to PI's research experience
Director of the Cancer Control Research Program the Abramson Cancer Center at the University of Pennsylvania (Penn).Her research has focused on risk communication and medical decision-making.Her work has advanced methods of shared decision-making including the measurement of health numeracy, communication of risk and uncertainty, and preference assessment.The clinical context of her research has been oncology, encompassing both screening and treatment decisions.Her work has been trans-disciplinary, reflecting the discipline of decision science.She collaborates with experts in clinical medicine, cognitive and social psychology, economics, education, and biostatistics.In work supported by the NCI and the American Cancer Society, she has developed a theoretically based and cross-culturally equivalent measure of health numeracy called the Numeracy Understanding in Medicine . NOTE: If PI does not have any prior research experience, indicate what provisions are being made to provide oversight or mentoring.Dr. Schapira is a Professor at the University of Pennsylvania and the Center for Health Equity Research Program (CHERP) at the Corporal Michael J. Crescenz VA Medical Center (CMVAMC) and co-Instrument (NUMi).The NUMi is being translated into Spanish and a Computer Adaptive Version (CAT) version has been developed.She is now conducting a cohort study to evaluate the NUMi as a screening test for health numeracy that can be used in the clinical setting and communication strategies in the cancer treatment consultation.Her work has also focused on evaluating cancer screening paradigms from a population perspective.Her focus in the decision sciences is reflected in my professional leadership positions including past President of the Society for Medical Decision-making (SMDM) and APPROVED by CMCVAMC IRB on 03/28/2021

State the hypotheses to be tested.
To test the efficacy of the LCSDecTool compared to usual care on improving decision process, clinical, and behavioral outcomes.Primary outcomes include decisional regret, decisional conflict, state trait anxiety, lung cancer worry, and lung cancer screening uptake.We hypothesize that Veterans randomized to the LCSDecTool compared to the control intervention will demonstrate the following: The methods proposed are put forth to help design a Lung Cancer Screening Decision Tool (LCSDecTool) for Veterans.LCSDecTool is intended to improve outcomes and number of high-quality decisions for Veterans eligible for lung cancer screening.High quality decisions are broadly defined as Philadelphia (642);Research & Development (151)APPROVED by CMCVAMC IRB on 03/28/2021 informed decisions in which the patient's choice is aligned with their values and preferences.The linkages to outcomes are described in the table below (Table2).The decision regret scale was adapted to lung cancer screening Data Collection Instrument).Anxiety, as measured by the STAI, and cancer worry have been used as patient-centered outcomes among lung cancer screening recipients [12, 85, 86].A systematic review reports short-term psychological discomfort among many lung cancer screening recipients and short-term increases in distress among those with false-positive results [87].The lung cancer worry scale is adapted from a measure of breast cancer worry after mammography screening [88].A post-visit provider survey will assess whether lung cancer screening was discussed at the visit, if a recommendation was made, and if a test ordered.The following objectives were completed in Phase1 and 2. Phase 1: To elicit stakeholder input to inform the development of a lung cancer screening decision tool (LCSDecTool).In this Phase we use structured interview and focus groups among patients, providers, and clinical leaders.Findings from Phase 1 were used to develop the LCSDecTool in Phase 2. Phase 2: To develop a web based LCSDecTool that will expand existing materials available for Veterans through a Web application that can be used on a desktop, laptop, tablet, or mobile phone.Outcomes will include measures of feasibility, perceived utility, patient engagement, and satisfaction.Philadelphia (642); Research & Development (151) APPROVED by CMCVAMC IRB on 03/28/2021 Section 4: Objectives Section 4.1.Describe the study's purpose, specific aims, or objectives.Phase 3:

/Questionnaires Interviews Audio Taping Behavioral Observations Chart Reviews Video Taping Focus Groups Randomization Double-Blind Control Group Placebo Withhold/Delay Treatment Specimen Collection Deception Telephone Survey Other
(Describe) 5.1.3.

If yes, check all that apply. Race Ethnicity American Indian or Alaska Native Hispanic or Latino Asian Not Hispanic or Latino Black or African American Native Hawaiian or other Pacific Islander APPROVED by CMCVAMC IRB on 03/28/2021 White Other
5.1.5.Does this project target a specific race or ethnic group as subjects?Yes.5.1.6.Will this study bank/store specimens for future research?NO NOTE: Banking is for future specified research.Storage is for the life of this protocol.5.1.6.1.If yes, include information on specimens to be banked/stored.5.1.6.2.If specimens will be banked/stored, specify location.

you anticipate using the banked specimens for other studies beyond the defined study period and defined study parameters
? Choose an item.5.1.6.4.1.If yes, will you need to re-contact subjects?How will this be done?5.1.7.Will this study create a data repository for future studies?NO 5.1.7.1.If yes, describe and/or provide the following: 5.1.7.1.1.The type of data (identified or de-identified) including what protected health elements are to be collected.5.1.7.1.2.The source from which data will be collected (e.g., subjects, non-research data repositories, research data repositories, publicly available, VA source, non-VA source.5.1.7.1.3.

with others including other researchers (VA and non-VA). If the data were collected through a research project, discussion of whether or not the original informed consent allowed for such reuse of the data and if the reuse is consistent with the HIPAA authorization that was obtained.
APPROVED by CMCVAMC IRB on 03/28/2021 5.1.7.1.8.Justification for the use of any identifiers.5.1.7.1.9.

Justification that the data requested represent the minimum necessary to conduct the research.
5.1.7.1.10.A

discussion of plans for obtaining informed consent and HIPAA Authorization, or for requesting the IRB to waive these requirements. If the investigator requests that the requirement for a HIPAA Authorization be waived, justification for this request must be included in information submitted to the IRB.
NOTE: Details of recruitment should be included in the 'procedures' section.Only 'short' responses should be included in the below sections.5.2.1.

consent will be obtained and/or if you are requesting a waiver of informed consent or waiver of documentation of informed consent
be contacted to see if they are interested in participating in research.HIPAA waiver is not needed for Provider subject because study team is NOT collecting patient PHI from the provider.
.Consent to be obtained at baseline; written consent for Veteran with in-person baseline visits; oral consent for Veteran telephone visits.Oral consent for providers.5.4.2.If the research involves multiple phases, specify for which phases of the research the waiver(s) is/are being requested.HIPAA waiver will be obtained to screen computer databases for potential VeteranAPPROVED by CMCVAMC IRB on 03/28/2021 subjects who will

indicate how study personnel will be trained regarding human subjects protections requirements and how to obtain and document informed consent.
All study personnel will be trained/overseen by PI.They will have completed relevant training regarding human subjects protection and how to obtain informed consent.All personnel are required to have CITI (Good Clinical Practices and Ethical Principles), VA Privacy and Information Security Awareness and Rules of Behavior, and Privacy and HIPAA trainings.In addition, all study personnel obtaining informed consent will have taken the VA Research Compliance Officer training.
Subjects have the right to be protected against injury or illegal invasions of their privacy and to preservation of their personal dignity.The more sensitive the research material, the greater the care that must be exercised in obtaining, handling, and storing data.In order to minimize the risk for loss of confidentiality, investigators should only collect personal information that is absolutely essential to the research activity.If personal data must be collected, it should be coded as early in the activity as possible and securely stored so that only the investigator and authorized esteem and altered behavior.Sensory deprivation, sleep deprivation, use of hypnosis, deception or mental stress are examples of psychological risks.)TheVeteransubjectsmay risk distress from considering the topic of lung cancer.Veterans in the study will be at increased risk for lung cancer due to the smoking exposure eligibility requirements.Therefore, it is possible that a discussion of lung cancer screening may lead to anxiety or distress.Subjects with anxiety or concerns will be referred to their primary care physician as all subjects are enrolled in a primary care clinic as it is an inclusion criterion for the study.The primary care physician will be able to evaluate Veteran's level of anxiety/distress and refer them to mental counseling if needed.Provider and clinical leader participants may risk anxiety regarding the potential implementation of a new clinical procedure (Lung cancer screening shared decision-making) in a busyclinical practice.5.6.1.4.Social/Economic (Social/Economic risks include alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling a subject in a way that will have negative consequences, or in some way diminishing those opportunities and powers a person has by virtue of relationships with others.activities for which the subject or others may be criminally or civilly liable.)NA 5.6.1.6.Loss of Confidentiality (In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the APPROVED by CMCVAMC IRB on 03/28/2021 subject to do otherwise.5.6.1.7.Other, e.g.radiation, placebo, washout of medications NA 5.6.1.8.Assess the likelihood and seriousness of such risks.The risk of Veterans feeling distress about discussing cancer screening is not likely to be serious since this targeted group would have most likely discussed lung cancer screening with their providers.The risk of clinicians/leaders' facing negative social opinions is highly unlikely since participants will be working together and inputting ideas.Theft, loss and unauthorized access will be reported immediately to the Privacy Officer, Information Security Officer and IRB 5.6.2.

Indicate potential benefits to be gained by the individual subjects, as well as benefit(s) that may accrue to society in general as a result of the planned work. If the subject will not receive any direct benefit, this fact must be stated here and in the consent form
(PI), Research Coordinator, and Research Assistant will have access to this key.
. The study may not benefit participants.It could benefit future Veterans if a patient centered approach to decision-making regarding lung cancer screening works.This may benefit Veterans and others who are considering Philadelphia (642); Research & Development (151) APPROVED by CMCVAMC IRB on 03/28/2021

Describe alternatives available to the subject outside the research context. If there are no such alternatives, state that the alternative is not to participate in the research study.
This is not a treatment study.The alternative is not to participate.

of Protocol Deviations, Adverse Events (AEs), Serious Adverse Events (SAEs), Breaches of Confidentiality, Unanticipated Adverse Device Effects (UADEs), and Unanticipated/Unexpected Problems
5.8.1.Include procedures for reporting these events to the CMCVAMC IRB and sponsor.NOTE: Except for AEs, all other events must be reported to the CMCVAMC IRB within 5 business days of discovery.Use the CMCVAMC Serious-Adverse Event form for reporting SAEs, UADEs, and unanticipated/unexpected problems.Use the CMCVAMC Protocol Deviation form for reporting protocol deviations.On-site AEs should be reported at the time of continuing review.)For Veterans, we will need to obtain name, date of birth, complete mailing address, social security numbers, race, gender, and medical history such as smoking history, lung cancer history, and life expectancy APPROVED by CMCVAMC IRB on 03/28/2021

Is this Study Investigating the Use of a Drug or Biological Agent? NO If yes, complete the rest of this section. If no, go directly to section 6, unless 5.13 applies.
NOTE: If this study involves an investigational drug, investigator must contact the Pharmacy and Therapeutics (P&T) Committee and provide its approval to IRB. 5.13.1.
and Dr. Bastian will have bi-weekly conference calls to coordinate study protocol and recruitment efforts.Dr.Whittle, site PI for Milwaukee VAMC, will have direct oversight for activities at the Milwaukee VAMC.Dr.Schapira and Dr. Whittle will have bi-weekly conference calls to coordinate study protocol and recruitment effortsDr.Schapira will also have bi-weekly meetings with the analysis team, led by Dr.Hubbard (biostatistics)and including Christopher Roberts (Data Analyst) and Dr. Chhatre to review data collection and recruitment procedures.

Has this protocol has been submitted to the Medical Center's Pharmacy and Therapeutics Committee?
Choose an item.

Explain if the investigational device will be delivered and/or stored by the Principal Investigator or Pharmacy Service. Philadelphia
(642); Research & Development (151) APPROVED by CMCVAMC IRB on 03/28/2021 5.14.7.

This person will not have access to PHI. ➢
Biostatistician will be involved in quantitative data analysis.

This person will not have access to PHI ➢ Dissemination Manager will be involved in communication of study findings. This person will not have access to PHI ➢
Dataset Administrator will be involved in data pulls from CDW for recruitment lists.This person will have access to PHI but not involved in recruiting subjects, obtaining informed consent and administering survey/interview procedures.➢ The Qualitative Researcher will be involved with assisting in qualitative analysis and development of value clarification tool.

Will samples be made anonymous to maintain confidentiality?
Choose an item.(If there is a link, it is not anonymous.Coding is not anonymous.)7.4.

Will specimens be destroyed after the project-specific use is completed?
Choose an item.7.5.

Will specimens be sold in the future?
Choose an item.7.6.

Will subjects be paid for their specimens now or in the future?
Choose an item.7.7.

Will subjects be informed of the results of the specimen testing?
Choose an item.7.8.

Will subjects be informed of results obtained from their DNA?
Choose an item.7.10.

Explain if the study is looking for an association between a genetic marker and a specific disease or condition, but at this point it is not clear if the genetic marker has predictive value.
7.11.Describe

if the study is based on the premise that a link between a genetic marker and a specific disease or condition is such that the marker is clinically useful in predicting the development of that specific disease or condition.
7.12.Will the subject be notified of the results and the provision for genetic counseling?Choose an item.

Include statistical power calculations and the assumptions made in making these calculations. Specific Aim 3 To
test the efficacy of the LCSDecTool compared to usual care on decision process, psychosocial, and behavioral outcomes.We hypothesize that Veterans randomized to the LCSDecTool compared to the control intervention will demonstrate the following:• H1: Decreased decisional regret and decisional conflict at T2 (1