BACKGROUND/RATIONALE:
Lung cancer is the leading cause of cancer deaths in the United States. Recent clinical trials provide evidence that lung cancer screening with low dose CT (LDCT) scans decrease mortality among older heavy smokers. Clinical guidelines have been issued with the United States Preventive Services Task Force USPSTF recommending annual screening from age 55 to 80 to those with >30 pack years of smoking who continue to smoke or have quit less than 15 years ago. The Department of Veterans Affairs has conducted 8 demonstration projects to gain insight into the practice and outcomes of lung cancer screening in the Veteran population and anticipates making recommendations regarding lung cancer screening for VA clinical practice in 2016. Evidence clearly delineates both the benefits (mortality reduction) and harms (including false positives, follow-up testing, and over-diagnosis) of lung cancer screening. Preliminary data from an HSR&D pilot study finds that some Veterans are highly reluctant to enter the care pathway associated with lung cancer screening due to its potential harms. Preference assessment methods can help Veterans to weigh benefits and harms, consider the clinical pathway they are entering, anticipate future health states, and communicate these values to health care providers. Explicit methods of preference assessment using discrete choice experiments can better discriminate the relative importance of various outcomes than more commonly used ranking and rating methods. Web based tools provide a feasible way to apply these theoretically grounded methods. Although basic educational tools to inform lung cancer decision making have been developed, there is a lack of validated shared decision making tools that incorporate patient preference assessment and have been integrated into the clinical setting. This team is well positioned to advance decision support for lung cancer screening in the Veteran population.

OBJECTIVE(S):
Specific Aim 1: To elicit stakeholder input to inform the development of a lung cancer screening decision tool (LCSDecTool). In this Aim we use structured interview and focus groups among patients, providers, and clinical leaders, with questions informed by the Promoting Action on Research Implementation in Health Services (PARIHS) framework and the Technology Assessment Model (TAM). The objectives of this aim are to explore:
a.The patient perspective regarding: 1) desired content and format of the LCSDecTool, 2) facilitators and barriers to use of a LCSDecTool in the primary care setting, and 3) acceptability of Web based technology for lung cancer screening decision support
b.The provider perspective regarding: 1) evidence of benefit for lung cancer screening decision support, 2) attitudes towards implementing lung cancer screening decision support in the primary care setting, and 3) acceptability of Web based technology for lung cancer screening decision support
c.The clinical leaders perspective regarding 1) feasibility of integrating the LCSDecTool into clinical practice, 2) training and support needed for use of the LCSDecTool in practice setting
Specific Aim 2: To develop a web based LCSDecTool that incorporates findings from Aim 1. The tool 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.
Specific Aim 3: 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:
H1: Decreased decisional regret and decisional conflict at 1 month following the intervention
H2: Decreased state anxiety and lung cancer worry at 1 month following the intervention
H3: Decreased rates of lung cancer screening at 6 months following the intervention

METHODS:
We will accomplish these Aims through a mixed methods study at the Corporal Michael J. Crescenz VA in Philadelphia (CMCVAMC) and the West Haven VA Medical Center (WHVA). The study utilizes the expertise of a transdisciplinary research team culminating in a randomized trial to evaluate the efficacy of the LCSDecTool as well as feasibility and process outcomes to support future wide spread implementation. In Aim 1 we will conduct 32 structured interviews among Veterans who are eligible for lung cancer screening based on age and smoking history. We will also conduct 6 focus groups of provider stakeholders to address provider perspectives on shared decision making for lung cancer screening that is based in the primary care setting. In Aim 2 we will work with our Web Site Development Team to adapt VA LCS shared decision making materials to a web based program and incorporate preference assessment and smoking cessation content. In Specific Aim 3 we will evaluate the LCSDecTool in a RCT. We will enroll 200 Veterans who are eligible for lung cancer screening and randomize to receive the LCSDecTool or control intervention. Outcomes will include LCS decisions, knowledge, decisional conflict, and adherence to the screening protocol. Implementation outcomes will also be assessed including perceived usefulness and importance of the intervention and the time required to deliver the intervention in the primary care setting.

FINDINGS/RESULTS:
We conducted focus groups (FGs) and structured interviews (SIs) among Providers (MD, RN, or NP) and Veterans in Patient Aligned Care Teams (PACT) at the West Haven and Philadelphia VAs. Veterans who were current smokers or have quit within the past 15 years, were 55 to 80 years of age, and had at least 30 pack years of smoking were eligible. The FG and SI guides were informed by the PARiHS (Promoting Action on Research Implementation in Health Services) framework and Technology Acceptance Model. Transcripts were coded and content analysis conducted using a parallel coding scheme for provider and patient data. We report perceived barriers and facilitators to LCS.


Fifty-three providers and 32 Veterans participated in a FGs (n=9) and SIs, respectively. Veterans' perceived barriers to LCS included 1) anxiety and worry about tests among Veterans and their families, 2) lack of knowledge about LCS availability and procedures, and 3) cost. Providers also perceived patient anxiety to be a barrier, particularly those with post-traumatic stress disorder. Additional barriers noted by providers were 1) competition between resources spent on LCS and smoking cessation, 2) time constraints in the clinic visit, 3) health risks of radiation, 4) travel barriers for Veterans treated at community based clinics, 5) over-screening and over-diagnosis, and 6) lack of infrastructure to ensure adequate follow-up. Some providers questioned whether evidence for the efficacy of LCS would generalize to veteran populations. Factors Veterans perceived as facilitators for LCS were 1) reassurance of good health for Veterans and their families, 2) addressing the high risk of lung cancer among Veterans, and 3) familiarity of Veterans with cancer screening and medical procedures in general. Providers noted the following additional facilitators: 1) ease of ordering the LCS test and, 2) the LCS level B guideline recommendations.

Differences and commonalities in perceived barriers and facilitators to LCS highlight lack of awareness of Veterans regarding LCS benefits, harms, and procedures, and provider concerns regarding patient burden of LCS and opportunity costs of LCS implementation. Findings will inform the content, format, and implementation of LCS decision support in these settings.

IMPACT:
This study will build upon the previous program pilot studies conducted in VA Medical Centers and expand previous work to include data from 2 diverse VA Medical Centers and a focus on preference assessment and the use of web based decision support tools.

The PI is also working with the PALS initiative of Lung Cancer Screening Implementation.

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External Links for this Project

NIH Reporter

Grant Number: I01HX001898-01A2
Link: https://reporter.nih.gov/project-details/9191144

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PUBLICATIONS:

Journal Articles

1. Kim RY, Rendle KA, Mitra N, Saia CA, Neslund-Dudas C, Greenlee RT, Burnett-Hartman AN, Honda SA, Simoff MJ, Schapira MM, Croswell JM, Meza R, Ritzwoller DP, Vachani A. Racial Disparities in Adherence to Annual Lung Cancer Screening and Recommended Follow-Up Care: A Multicenter Cohort Study. Annals of the American Thoracic Society. 2022 Sep 1; 19(9):1561-1569. [view]
2. Schapira MM, Rendle KA. Rising to the De-escalation Challenge: Multilevel Change Needed to Align Clinical Practice with Cancer Screening Guidelines. Medical decision making : an international journal of the Society for Medical Decision Making. 2022 Nov 1; 42(8):1045-1047. [view]
3. Schapira MM. The Conundrum and Challenge of Lung Cancer Screening Shared Decision-making Implementation. Journal of general internal medicine. 2018 Jul 1; 33(7):989-990. [view]
4. Schapira MM, Rodriguez KL, Chhatre S, Fraenkel L, Bastian LA, Kravetz JD, Asan O, Akers S, Vachani A, Prigge JM, Meline J, Ibarra JV, Corn B, Kaminstein D. When Is a Harm a Harm? Discordance between Patient and Medical Experts' Evaluation of Lung Cancer Screening Attributes. Medical decision making : an international journal of the Society for Medical Decision Making. 2021 Apr 1; 41(3):317-328. [view]

DRA: Health Systems, Cancer
DRE: Technology Development and Assessment, Treatment - Efficacy/Effectiveness Clinical Trial, Treatment - Implementation
Keywords: Cancer, Decision Support, Decision-Making, Patient Preferences, Technology Development
MeSH Terms: none