1. What were the results from the original PCORI study?
The goal of our original PCORI‐funded study was to prepare smokers who were seeking tobacco cessation counseling to make informed decisions about lung cancer screening (LCS). We conducted a randomized controlled trial of a patient decision aid (PDA) about LCS. The PDA reflects the updated LCS recommendation from the US Preventive Services Task Force (USPSTF) and screening eligibility criteria from The Centers for Medicare & Medicaid Services, each emphasizing the importance of patients making informed screening decisions. We recruited 516 patients from 13 state tobacco quitlines (telephone‐based cessation services funded by state agencies and operated by call centers) across the US, and randomized them to receive the video‐based PDA “Lung Cancer Screening: Is it right for me?” or standard educational materials. The PDA was a DVD distributed by mail. Follow‐up rates exceeded 85%. At the one‐week follow‐up, patients who received the PDA compared to the standard education materials scored higher in the Preparation for Decision Making Scale—they were better prepared to make a screening decision—felt more informed about the screening options, and were clearer about their values related to the harms and benefits of screening. These findings were statistically significant and the magnitude of these differences exceeded what is observed in randomized trials of decision aids. Patients who viewed the PDA were more knowledgeable than patients assigned to the standard education materials at each follow‐up assessment (P < .0001). Nearly 65% of patients in both study groups scheduled a visit with a healthcare provider to discuss LCS and 32% had been screened by the six‐month follow‐up. Of concern, the patients in the standard education group were making LCS decisions based on a poorer understanding of the tradeoffs, were not as well prepared to talk with their doctor about LCS, felt less well informed, and were less clear about the importance of the harms and benefits of screening, than patients who received the decision aid.
2. Why is this research finding important?
Lung cancer screening rates are low nationally, and increasing screening rates while providing high quality decision support and tobacco counseling is a priority for many groups including the American Cancer Society and American Lung Association. Decisions about screening should be based on an understanding of both the benefits and harms of screening, and not driven by fear and misinformation. Patients have a poor understanding of LCS, some are being screened with inappropriate tests, and discussions between healthcare providers and patients eligible for LCS are infrequent, suggesting few smokers who might be eligible for LCS are being offered screening. Decision aids in general have been shown to increase patients’ knowledge of their options, improve perceptions of their individual risk, reduce decisional conflict, and improve the quality of decision making by better aligning patients’ values with their choices. By focusing on smokers who are seeking cessation services, we are addressing the primary risk factor for lung cancer (tobacco use) while providing support to smokers in making decisions about LCS.
3. What is the goal of this implementation project?
Our primary objective is to increase the number of smokers eligible for LCS who receive high‐quality decision support materials about LCS through tobacco quitlines and go on to make informed decisions about screening. By increasing awareness, we will likely increase the number of quitline callers who are screened for lung cancer. In meeting this objective, we will undertake the following aims (steps):
- Test and refine our LCS patient decision support program implemented through tobacco quitlines
- Evaluate the reach, adoption, and fidelity of the decision support program, and its effectiveness in improving smokers’ decisions about LCS and completion of screening
- Document the resources required to launch and maintain the LCS decision support program by tobacco quitlines.
4. What is the project team doing?
We will use the Consolidated Framework for Implementation Research (CFIR) to anchor and inform the design, outcomes, and evaluation plan. Eight state quitlines operated by six service providers will serve as implementation sites for this project. Phase 1 involves first testing and refining the implementation strategies in 4 quitlines. Phase 2 expands implementation to 4 additional quitlines to maximize coverage of quitline service providers nationally. NAQC will serve as the external facilitator for the project, and local champions have be identified for each site. Site visits will occur prior to launching implementation, and will include training of quitline staff identify callers eligible for LCS. A centralized website, lungscreen.health, will include LCS resources for smokers including our PDA, eligibility criteria, a discussion guide for use with primary care providers, and information about finding LCS programs. During the implementation project, about 10,000 callers will learn about LCS and patient decision support, and may have their lives saved by it.
5. How is the team evaluating this project?
Reach will be determined by the number of callers assessed for initial eligibility for LCS and directed to the PDA over the number of potentially eligible callers based on age. Call center staff will keep a log of all potentially eligible callers based upon age and pack‐year history. Adoption will be determined by the number of quitlines that agree to incorporate the LCS program into their workflow. Fidelity will be assessed through surveys about smokers’ experience with the quitline. The items will focus on whether they were asked about their age, current smoking status, number of cigarettes smoked on average, and number of years smoked. Effectiveness of the LCS program on will be assessed by surveying patients recruited at the time they contact a quitline for smoking cessation services and when they access the LCS resource website. Immediate outcomes will include knowledge of LCS harms and benefits, preparation for decision making, and use of the PDA. Longer‐term outcomes up to 6 months after contacting a quitline will include scheduling an appointment with a health care provider to discuss LCS and completion of LCS.
6. How is the team involving patients and others in making sure the findings reach people who can use them?
The North American Quitline Consortium (NAQC) is our primary quitline stakeholder for this project. NAQC is the leading national and international organization for quitline service providers, funders of quitlines, researchers and other strategic partners. We will continue our successful collaborations with the Center for Community‐ Engaged Translational Research (CCETR) at The University of Texas MD Anderson Cancer Center and NAQC’s network of quitline call centers because together they represent key stakeholders including patients, quitline service providers, call center staff, representatives of state health departments, and researchers. Our Patient Advisory Group (PAG) members have strongly endorsed the need for this project and to make the intervention materials available on a national scale. Finally, the Tobacco Control Advisory Group brings representation of tobacco control experts, experts in health disparities and tobacco use, and primary care to the project. We have engaged the American Cancer Society National Lung Cancer Roundtable (NLCRT) Provider Engagement group to serve as a stakeholder in this project and provide input on the role of PCPs in LCS and how they want to work with quitlines.
7. How will this project help ensure future uptake and use of PCORI results?
An Implementation Guide will be produced and disseminated as part of NAQC’s best practices guides/series to provide state health agencies (which fund quitlines) and quitline service providers with guidance about the role of quitlines in LCS and resources required to implement LCS programs through quitlines that can be adopted on a national scale. Presentations will also be made at the NAQC Conference, posting on the NAQC website, and through communications with the NAQC membership.
Related PCORI-funded Research Project
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.