Intervention Description
“Is Lung Cancer Screening for You?”—developed and pilot tested by McDonnell et al13—is a brief DA that covers risks factors for lung cancer (principally smoking), a formula for calculating cigarette smoking history (in pack-years), LDCT screening facts, questions to spur patient reflection on screening (plus a question about receiving LDCT screening in the next 30 days), and lung cancer resources (e.g., phone numbers to quit-smoking hotlines). The original DA was a 12-page booklet containing plain-language text and racially/ethnically diverse images.
The “Is Lung Cancer Screening for You?” DA was adapted prior to this study for use on any mobile or other computer-based device via the Redcap survey platform. The Redcap platform is widely available within academic settings and enables low-cost, robust development that will be scalable across the state of South Carolina and eventually anywhere with Internet service. The platform is HIPPA compliant, enabling straightforward IRB review for multiple sites. Visually, the computer-based DA looked identical to the paper-based version, but it also contained interactive elements, such as an ability to increase text size, a read-aloud feature (aimed at low-literacy users), a pack-year calculator, and a patient response area for the reflective statements. The DA was designed to compile patients’ responses in a single-page, on-screen report, which health-care providers can use during the SDM process. For this study, the DA was disseminated on a 12-inch touch-screen tablet computer.
Provider Training
Prior to the study, all providers were given an overview of the study protocol and a short (10-minute) video-based training on how to use the DA. The video included an overview of SDM for LDCT, an SDM exemplar involving a provider/partner and lung cancer survivor, instructions on billing for LDCT screening, and a template for documenting SDM. Providers received this training either in-person during grand rounds or via email (which directed providers to our website: https://lungcancersc.com/resources/for-clinicians/decision-aids).
Recruitment
To be eligible, individuals had to meet the CMS guidelines for being high risk for lung cancer as well as be Medicare- or Medicaid-eligible. Three recruitment approaches were used. In the first, a research team member examined upcoming appointment schedules at two sites (a family practice clinic and a pulmonology clinic), identified eligible patients, and called them to assess participation interest. The second strategy consisted of mailing invitations to patients at the same two clinic sites who met study eligibility criteria (based on information in their electronic medical records) but did not have a scheduled appointment; these invitations were followed up with a call from a research team member. Thirdly, flyers were placed in the clinic waiting room to inform potential participants about the study and let them know how to contact the research coordinator. Eligible participants who made appointments solely for this study were seen via an SDM or wellness appointment, both of which Medicare covers with minimal out-of-pocket fees.
Measures
Feasibility.14 Instrument: Feasibility of Intervention Measure. Items: 4. Measures: The extent to which an intervention can be implemented successfully in a given setting. Scoring: 5 response options, from 1 (Completely Disagree) to 5 (Completely Agree); total score (sum of all items) ranges 1–20 (20 = fully feasible, 1 = not feasible). Cronbach α: 0.89.
Acceptability.14 Instrument: Acceptability of Intervention Measure. Items: 4. Measures: Whether an intervention is agreeable, palatable, or satisfactory. Scoring: 5 response options, from 1 (Completely Disagree) to 5 (Completely Agree); total score (sum of all items) ranges 1–20 (20 = fully acceptable, 1 = unacceptable). Cronbach α: 0.85.
Usability.15 Instrument: System Usability Scale. Items: 10. Measures: Ease of use (user-friendliness) of a technology. Scoring: 5 response options, from 1 (Strongly Disagree) to 5 (Strongly Agree); total score (sum of responses for each statement, with positive items reverse-scored) ranges 1–100 (100 = very easy to use, 1 = very difficult to use). Cronbach α: 0.79–0.97.
Decisional Conflict.16 Instrument: Decisional Conflict Scale. Measures: personal perceptions of: uncertainty in choosing options. Scoring: 3 possible response options (Yes = 0, Not Sure = 2, No = 4); total score (sum of responses, divided by 10, and multiplied by 25) ranges 0–100 (0 = no decisional conflict, 100 = very high decisional conflict). Cronbach α: 0.81.
Screening Intent. Assessed (using an original instrument/item) whether the person intended to be screened within the next 30 days.
Actual Screening. Examined participants’ electronic medical records post-SDM visit to determine if the person followed through with receiving LDCT.
Fidelity. Instrument: Original instrument developed by McDonnell et al.13 Items: 15. Measures: The extent to which providers thoroughly implement study procedures, with a focus on both overall study implementation (e.g., showing the participant the DA, asking the participant about the DA) and SDM implementation (e.g., discussing pros and cons of screening). Scoring: 2 response options (Yes/No).
Data Collection and Analysis
After consenting to participate, each participant completed demographic and computer-proficiency questionnaires. The research coordinator then directed the participant to complete the DA on the tablet. Next, the participant answered questions (via the above-described measures) related to feasibility, acceptability, usability, decisional conflict, and screening intent. Immediately prior to the SDM conversation, the research coordinator gave the provider the tablet containing a summary of the participant’s responses. The research coordinator was present during the entire SDM discussion to observe and record fidelity and appointment time lapse. Lastly, the research coordinator used electronic medical records to determine whether participants received screening post-appointment. Each participant received a $25 incentive for participation.
All data were analyzed using univariate methods, including frequency and calculations of means. The data reported are based on the scoring range for each measurement scale.