<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD Journal Publishing DTD v2.0 20040830//EN" "journalpublishing.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" dtd-version="2.0" xml:lang="en" article-type="research-article"><front><journal-meta><journal-id journal-id-type="nlm-ta">JMIR Form Res</journal-id><journal-id journal-id-type="publisher-id">formative</journal-id><journal-id journal-id-type="index">27</journal-id><journal-title>JMIR Formative Research</journal-title><abbrev-journal-title>JMIR Form Res</abbrev-journal-title><issn pub-type="epub">2561-326X</issn><publisher><publisher-name>JMIR Publications</publisher-name><publisher-loc>Toronto, Canada</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">v9i1e69044</article-id><article-id pub-id-type="doi">10.2196/69044</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Paper</subject></subj-group></article-categories><title-group><article-title>Previsit Preparation for Shared Decision-Making in Lung Cancer Screening in Primary Care Using a Paper Decision Aid and an Automated Text Messaging Program: Quasi-Experimental Pilot Study</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name name-style="western"><surname>Ito Fukunaga</surname><given-names>Mayuko</given-names></name><degrees>MSc, MD</degrees><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Wiener</surname><given-names>Renda Soylemez</given-names></name><degrees>MPH, MD</degrees><xref ref-type="aff" rid="aff2">2</xref><xref ref-type="aff" rid="aff3">3</xref><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Toomey</surname><given-names>Shaun</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Wagner</surname><given-names>Joann</given-names></name><degrees>MSW</degrees><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Shi</surname><given-names>Qiming</given-names></name><degrees>MS</degrees><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Balakrishnan</surname><given-names>Kavitha</given-names></name><degrees>BS</degrees><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Nguyen</surname><given-names>Alexandra</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="aff7">7</xref><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Nguyen</surname><given-names>Dan</given-names></name><degrees>BS</degrees><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>McKee</surname><given-names>M Diane</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Bankier</surname><given-names>Alexander A</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Sadasivam</surname><given-names>Rajani S</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Crawford</surname><given-names>Sybil L</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Han</surname><given-names>Paul KJ</given-names></name><degrees>MPH, MD</degrees><xref ref-type="aff" rid="aff12">12</xref><xref ref-type="aff" rid="aff13">13</xref><xref ref-type="aff" rid="aff14">14</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Houston</surname><given-names>Thomas K</given-names></name><degrees>MPH, MD</degrees><xref ref-type="aff" rid="aff15">15</xref></contrib><contrib contrib-type="author"><name name-style="western"><surname>Mazor</surname><given-names>Kathleen M</given-names></name><degrees>EdD</degrees><xref ref-type="aff" rid="aff1">1</xref></contrib></contrib-group><aff id="aff1"><institution>Department of Medicine, University of Massachusetts Chan Medical School</institution><addr-line>Worcester</addr-line><addr-line>MA</addr-line><country>United States</country></aff><aff id="aff2"><institution>Center for Health Optimization and Implementation Research, VA Boston Healthcare System</institution><addr-line>Boston</addr-line><addr-line>MA</addr-line><country>United States</country></aff><aff id="aff3"><institution>National Center for Lung Cancer Screening, Veterans Health Administration</institution><addr-line>Washington</addr-line><addr-line>DC</addr-line><country>United States</country></aff><aff id="aff4"><institution>Pulmonary Center, Boston University Chobanian &#x0026; Avedisian School of Medicine</institution><addr-line>Boston</addr-line><addr-line>MA</addr-line><country>United States</country></aff><aff id="aff5"><institution>Center for Clinical and Translational Science, University of Massachusetts Chan Medical School</institution><addr-line>Worcester</addr-line><addr-line>MA</addr-line><country>United States</country></aff><aff id="aff6"><institution>Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School</institution><addr-line>Worcester</addr-line><addr-line>MA</addr-line><country>United States</country></aff><aff id="aff7"><institution>Department of Obstetrics and Gynecology, University of Arizona</institution><addr-line>Tucson</addr-line><addr-line>AZ</addr-line><country>United States</country></aff><aff id="aff8"><institution>University of Massachusetts Chan Medical School</institution><addr-line>Worcester</addr-line><addr-line>MA</addr-line><country>United States</country></aff><aff id="aff9"><institution>Department of Family Medicine and Community Health, University of Massachusetts Chan Medical School</institution><addr-line>Worcester</addr-line><addr-line>MA</addr-line><country>United States</country></aff><aff id="aff10"><institution>Department of Radiology, University of Massachusetts Chan Medical School</institution><addr-line>Worcester</addr-line><addr-line>MA</addr-line><country>United States</country></aff><aff id="aff11"><institution>Tan Chingfen Graduate School of Nursing, University of Massachusetts Chan Medical School</institution><addr-line>Worcester</addr-line><addr-line>MA</addr-line><country>United States</country></aff><aff id="aff12"><institution>Center for Outcomes Research and Evaluation, Maine Medical Center</institution><addr-line>Portland</addr-line><addr-line>ME</addr-line><country>United States</country></aff><aff id="aff13"><institution>Tufts University School of Medicine</institution><addr-line>Boston</addr-line><addr-line>MA</addr-line><country>United States</country></aff><aff id="aff14"><institution>Division of Cancer Control and Population Sciences, National Cancer Institute</institution><addr-line>Bethesda</addr-line><addr-line>MD</addr-line><country>United States</country></aff><aff id="aff15"><institution>Department of Internal Medicine, Wake Forest University School of Medicine</institution><addr-line>Winston-Salem</addr-line><addr-line>NC</addr-line><country>United States</country></aff><contrib-group><contrib contrib-type="editor"><name name-style="western"><surname>Mavragani</surname><given-names>Amaryllis</given-names></name></contrib></contrib-group><contrib-group><contrib contrib-type="reviewer"><name name-style="western"><surname>Yeh</surname><given-names>Fangyu</given-names></name></contrib><contrib contrib-type="reviewer"><name name-style="western"><surname>Gasmi</surname><given-names>Maha</given-names></name></contrib></contrib-group><author-notes><corresp>Correspondence to Mayuko Ito Fukunaga, MSc, MD, Department of Medicine, University of Massachusetts Chan Medical School, 55 Lake Avenue North, Worcester, MA, 01655, United States, 1 5088561975; <email>mayuko.itofukunaga@umassmed.edu</email></corresp></author-notes><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>17</day><month>9</month><year>2025</year></pub-date><volume>9</volume><elocation-id>e69044</elocation-id><history><date date-type="received"><day>14</day><month>05</month><year>2025</year></date><date date-type="rev-recd"><day>03</day><month>07</month><year>2025</year></date><date date-type="accepted"><day>05</day><month>07</month><year>2025</year></date></history><copyright-statement>&#x00A9; Mayuko Ito Fukunaga, Renda Soylemez Wiener, Shaun Toomey, Joann Wagner, Qiming Shi, Kavitha Balakrishnan, Alexandra Nguyen, Dan Nguyen, M Diane McKee, Alexander A Bankier, Rajani S Sadasivam, Sybil L Crawford, Paul KJ Han, Thomas K Houston, Kathleen M Mazor. Originally published in JMIR Formative Research (<ext-link ext-link-type="uri" xlink:href="https://formative.jmir.org">https://formative.jmir.org</ext-link>), 17.9.2025. </copyright-statement><copyright-year>2025</copyright-year><license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by/4.0/"><p>This is an open-access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">https://creativecommons.org/licenses/by/4.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The complete bibliographic information, a link to the original publication on <ext-link ext-link-type="uri" xlink:href="https://formative.jmir.org">https://formative.jmir.org</ext-link>, as well as this copyright and license information must be included.</p></license><self-uri xlink:type="simple" xlink:href="https://formative.jmir.org/2025/1/e69044"/><abstract><sec><title>Background</title><p>Patient-provider discussions and shared decision-making (SDM) are essential for tailoring lung cancer screening (LCS) decisions to individual patients. However, the implementation of SDM in primary care settings is challenging. Innovative approaches are needed to reach and prepare patients eligible for LCS for SDM in primary care settings and increase LCS uptake.</p></sec><sec><title>Objective</title><p>We piloted previsit preparation comparing 2 strategies: a paper decision aid (DA; DA group) and an enhanced comparator strategy consisting of the paper DA plus an automated text message program (DA+TM group) designed to promote patient-provider LCS discussions. We explored feasibility and gathered preliminary data on its potential effects on LCS discussions, decision-making, and LCS uptake in primary care settings.</p></sec><sec sec-type="methods"><title>Methods</title><p>In a sequential quasi-experimental pilot study, we recruited patients who were eligible for LCS in a single academic health care system. Prior to an upcoming visit, participants in both groups received a paper-based DA by mail. In the DA+TM group, participants also received a series of automated text messages to help them prepare for their LCS discussions. We monitored participant recruitment and retention, as well as patient engagement in DA and text messages. In exploratory analyses, we assessed patient-provider discussion of LCS, SDM, patient knowledge, decision conflict at baseline and in follow-up telephone surveys, and LCS completion measured by electronic health records.</p></sec><sec sec-type="results"><title>Results</title><p>We enrolled and included 48 participants (DA group=19 and DA+TM group=29) in the final analysis. Participants were predominantly White, with a median age of 61.0 (IQR, 57.0&#x2010;65.0), and 58% (28/48) of them were female. Engagement was high in both groups. LCS knowledge significantly improved in the DA+TM group (4.5 baseline vs 6.0 follow-up; <italic>P</italic>=.003), while there was no change in the DA group (5.0 baseline vs 5.0 follow-up, <italic>P</italic>=.23). Median LCS knowledge change from baseline to follow-up was 0.5 (IQR &#x2013;1.0 to 2.5) in the DA group and 1.5 (IQR 0&#x2010;3.0) in the DA+TM group (<italic>P</italic>=.24). Decision conflict in both groups significantly decreased (DA group: 37.5 baseline vs 0 follow-up, <italic>P</italic>&#x003C;.001; DA+TM group: 50.0 baseline vs 20.0 follow-up, <italic>P</italic>=.003). The median SDM process score (a measure of SDM) was 3.0 (IQR 1.5-4.0) in the DA group and 2.0 (IQR 1.0-3.0) in the DA+TM group (<italic>P</italic>=.11). The LCS completion rates were 5% (1/19) in the DA group and 31% (9/29) in the DA+TM group at 3 months (<italic>P</italic>=.07), and 26% (5/19) in the DA group and 34% (10/29) in the DA+TM group at 6 months (<italic>P=</italic>.75).</p></sec><sec sec-type="conclusions"><title>Conclusions</title><p>Previsit preparation was feasible in primary care settings. An enhanced, text message&#x2013;based strategy has the potential to reach and engage broader LCS-eligible populations and prepare patients for LCS discussions with their primary care providers, which may ultimately improve informed decision-making and LCS uptake.</p></sec></abstract><kwd-group><kwd>text messaging</kwd><kwd>decision-making, shared</kwd><kwd>lung cancer</kwd><kwd>cancer screening</kwd><kwd>telemedicine</kwd><kwd>health</kwd></kwd-group></article-meta></front><body><sec id="s1" sec-type="intro"><title>Introduction</title><p>Shared decision-making (SDM) is an essential component of lung cancer screening (LCS) with annual low-dose computed tomography (LDCT). Many medical professional societies, such as the US Preventive Services Task Force, recommend and the Centers for Medicare and Medicaid Services (CMS) has mandated SDM between patients and providers using a decision aid (DA) before enrolling in LCS. SDM is a process in which the patient and health care provider collaboratively review the best available evidence, consider the patient&#x2019;s values and preferences, and then identify the most suitable option for the patient [<xref ref-type="bibr" rid="ref1">1</xref>,<xref ref-type="bibr" rid="ref2">2</xref>]. While LCS reduces lung cancer mortality, it also carries potential harms (eg, false positives, downstream invasive procedures and complications, radiation exposure, and anxiety). Furthermore, the balance of benefits and harms varies depending on an individual&#x2019;s risks for lung cancer and comorbidities; thus, SDM is essential.</p><p>However, high-quality SDM for LCS rarely happens during clinical visits [<xref ref-type="bibr" rid="ref3">3</xref>-<xref ref-type="bibr" rid="ref8">8</xref>]. LCS is still relatively new compared to other cancer screenings. Many patients are not aware of LCS, including the screening process and its potential harms. Providers often discuss the potential benefits but not the potential harms of LCS, and few providers use DAs [<xref ref-type="bibr" rid="ref3">3</xref>-<xref ref-type="bibr" rid="ref8">8</xref>]. Due to multiple competing priorities, providers and patients often lack sufficient time to review LCS in depth and fully engage in SDM during primary care visits. [<xref ref-type="bibr" rid="ref3">3</xref>,<xref ref-type="bibr" rid="ref7">7</xref>]. Despite good intentions, the requirement for SDM for LCS is considered to be a barrier to LCS. Thus, an intervention to support and streamline SDM discussions is urgently needed.</p><p>One strategy to overcome some of the posed challenges is previsit preparation to introduce patients to key LCS facts and allow time for patients to prepare for SDM. By preparing patients, this strategy may also reduce the provider&#x2019;s work to go over the information during the visit. Various DAs for LCS were developed, which improved patient knowledge and decreased decisional conflict in study settings [<xref ref-type="bibr" rid="ref9">9</xref>,<xref ref-type="bibr" rid="ref10">10</xref>]. Text messaging has been shown to increase patient knowledge and uptake of screenings for breast, cervical, and colon cancer and holds significant potential for effectively reaching and engaging the broader populations eligible for LCS. [<xref ref-type="bibr" rid="ref11">11</xref>-<xref ref-type="bibr" rid="ref13">13</xref>]</p><p>Thus, we developed two previsit preparation strategies of different intensities: (1) a mailed paper-based DA and (2) a mailed paper-based DA paired with a previsit automated text messaging program to support SDM for LCS. We then conducted a pilot study to test the feasibility of the 2 strategies and explore their potential effects on LCS discussions, decision-making, and LCS uptake at 3 and 6 months.</p></sec><sec id="s2" sec-type="methods"><title>Methods</title><sec id="s2-1"><title>Study Design</title><p>We conducted a sequential quasi-experimental pilot study of previsit preparation using a paper-based DA (DA group) or the combination of paper-based DA and an automated text messaging program (DA+TM group). This study was conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines (<xref ref-type="supplementary-material" rid="app2">Checklist 1</xref>).</p></sec><sec id="s2-2"><title>Study Setting and Participants</title><p>This study was conducted at 6 primary care clinics within a large academic health care system in the Northeastern United States from November 2020 to December 2022, during the COVID-19 pandemic. This health care system has an alert in the EPIC (Epic Systems Corporation) electronic health record (EHR) health maintenance section to inform providers of their patient&#x2019;s potential eligibility for LCS based on age and smoking history. Primary care providers (PCPs) are encouraged to review the health maintenance section during visits.</p><p>Participants in this study were individuals eligible for LCS who never had an LCS before and who had an upcoming primary care visit. The inclusion criteria were (1) age 55-77 years, (2) cigarette smoking within the past 15 years with a minimum of 30 pack-years (ie, the 2015 CMS eligibility criteria for LCS) [<xref ref-type="bibr" rid="ref14">14</xref>,<xref ref-type="bibr" rid="ref15">15</xref>], (3) English-speaking, (4) owning a cell phone with text messaging capability, and (5) having an upcoming scheduled primary care visit. The exclusion criteria were (1) PCP&#x2019;s exclusion of the patient based on their medical conditions (eg, under hospice care and severe mental illness), (2) active cancer, (3) history of lung cancer, (4) previous LCS, and (5) chest CT within the past 12 months.</p></sec><sec id="s2-3"><title>Recruitment Procedures</title><p>We identified patients potentially eligible for LCS who had an upcoming primary care appointment based on their age, histories of tobacco use, and previous chest imaging studies via EHR data. We recruited patients who had a primary care visit within 1&#x2010;4 weeks for the DA group and within 2&#x2010;5 weeks for the DA+TM group to ensure that the participants had enough time to receive the interventions prior to their visits and minimize the difference in the duration between the last day of the interventions (the day when the participants received DA in the DA group and the day when the participants received the last text message in the DA+TM group) and their scheduled visit days between the 2 groups.</p><p>We mailed invitation letters to all potentially eligible patients. One week after the mailing, a research staff member made a telephone call to those who did not opt out and confirmed study eligibility.</p></sec><sec id="s2-4"><title>Interventions</title><p>We delivered the paper-based DA developed by the Agency for Healthcare Research and Quality, which was publicly available during the study period. We developed an LCS text message program based on existing DAs in collaboration with patients eligible for LCS [<xref ref-type="bibr" rid="ref16">16</xref>]. The text message program consisted of 14 messages providing key information about LCS (eg, eligibility, benefits, and harms) and a link to the DA for more detailed information. This program emphasized the importance of understanding both the benefits and harms of LCS, SDM, and smoking cessation and encouraged patients to discuss LCS with their provider at their next visit (<xref ref-type="table" rid="table1">Table 1</xref>). We delivered 1 text message per day for 14 days, always in the same order.</p><table-wrap id="t1" position="float"><label>Table 1.</label><caption><p>Example of lung cancer screening text messages and learning objectives.</p></caption><table id="table1" frame="hsides" rules="groups"><thead><tr><td align="left" valign="bottom">Learning objective of each text message</td><td align="left" valign="bottom">Text message</td></tr></thead><tbody><tr><td align="left" valign="top">Introduction</td><td align="left" valign="top">Hi [FIRST NAME], this is the Lung Cancer Screening Message Center at xxxx. Your appointment with your primary care doctor is coming up soon. Based on your smoking history, we would like to send you text messages about lung cancer screening for the next 14 days. We would like you to learn about lung cancer screening before your next visit.</td></tr><tr><td align="left" valign="top">Pros and cons of lung cancer screening</td><td align="left" valign="top">Lung cancer screening has both pros and cons. It is important to learn about the pros and cons before you decide whether to have lung cancer screening.</td></tr><tr><td align="left" valign="top">What are cons of lung cancer screening?</td><td align="left" valign="top">What are the cons of lung cancer screening? One con is that you could get a false alarm. Lung cancer screening may find spots in the lungs that are NOT due to cancer. If this happens, you could need more testing to find out if the spots are due to cancer or NOT due to cancer.</td></tr><tr><td align="left" valign="top">Your value and preference</td><td align="left" valign="top">Should you be screened? Talk with your doctor to decide whether lung cancer screening is right for you. It will depend on your overall health and what is most important to you. Refer to the pamphlet that we sent to you if you would like to learn more. [a link to a decision aid].</td></tr><tr><td align="left" valign="top">Smoking cessation</td><td align="left" valign="top">Lung cancer screening does not replace the need for quitting smoking. As you know, quitting smoking could reduce your chance of getting lung cancer.</td></tr><tr><td align="left" valign="top">Closing message</td><td align="left" valign="top">We hope that you feel ready to talk about lung cancer screening with your doctor at your next visit. Think about some questions that you would like to ask. You can go to the website: [a link to a decision aid] for more information. We hope you found these messages helpful!</td></tr></tbody></table></table-wrap></sec><sec id="s2-5"><title>Study Protocol</title><p>After obtaining informed consent, the study staff administered a baseline survey over the phone. Then, the study staff mailed the paper-based DA to all participants and started a text messaging intervention for the participants in the DA+TM group. The study staff confirmed the completion of the PCP visit in the EHR and aimed to conduct a follow-up telephone survey within 2 business days of the index primary care visit. The EHR was reviewed 3 and 6 months after the index visit for the completion of LDCT for LCS and regular chest computed tomography (CT).</p><p>We chose a sequential quasi-experimental design so that we could incrementally learn the process of the primary care flow, monitor the timing of recruitment, interventions, and PCP visits, and revise our study protocol if necessary. We originally planned to enroll the first 30 participants in the DA group and the next 30 participants in the DA+TM group. Due to the COVID-19 pandemic, recruitment was slower than expected. Thus, after we enrolled the first 16 participants in the DA group, we switched our enrollment efforts from the DA group to the DA+TM group. After enrolling 30 participants in the DA+TM group, we switched back to the DA group and enrolled 3 additional participants. After enrolling a total of 49 participants, we ended recruitment since we ran out of the recruitment pool from the 6 primary care clinics.</p></sec><sec id="s2-6"><title>Measures</title><sec id="s2-6-1"><title>Recruitment and Retention</title><p>We monitored the rates of recruitment and retention from study enrollment to the completion of follow-up surveys. We also monitored whether participants kept the original PCP appointments or rescheduled their appointments using the EHR.</p></sec><sec id="s2-6-2"><title>Participant Characteristics</title><p>During recruitment calls, we collected data on participants&#x2019; ages and detailed smoking history to confirm study eligibility. During the baseline survey call, we collected data on the remaining demographics, family history of lung cancer, previous technology use, and perceived lung cancer risk [<xref ref-type="bibr" rid="ref17">17</xref>]. We measured reading health literacy with the Single-Item Literacy Screener and listening health literacy with the item developed by the Health Literacy Cancer Prevention research team (Table S1 in <xref ref-type="supplementary-material" rid="app1">Multimedia Appendix 1</xref>) [<xref ref-type="bibr" rid="ref18">18</xref>,<xref ref-type="bibr" rid="ref19">19</xref>].</p></sec><sec id="s2-6-3"><title>Patient Engagement in DA and Text Messages</title><p>To evaluate intervention feasibility, we measured patient engagement with the mailed DA and text messages by self-report. We asked how much of these materials participants read and whether they clicked the link to a DA in the text messages in a follow-up survey (Table S1 in <xref ref-type="supplementary-material" rid="app1">Multimedia Appendix 1</xref>).</p></sec><sec id="s2-6-4"><title>LCS Discussion and SDM</title><p>Patient self-reported LCS discussion and SDM were measured at follow-up after the PCP visit. We asked participants whether they talked about LCS with their providers. If they had an LCS discussion, we asked participants who initiated the LCS discussion, whether their providers made LCS recommendations, and what recommendations they made (Table S1 in <xref ref-type="supplementary-material" rid="app1">Multimedia Appendix 1</xref>).</p><p>The degree of SDM was measured with the shared decision-making process survey that consists of 4 items [<xref ref-type="bibr" rid="ref20">20</xref>]. Participants were asked how much they discussed with their providers about the reason to have or not to have LCS (recorded as A lot or Some=1, A little or Not at all=0), whether their provider explained the options (to have or not to have LCS or to take more time to decide), and whether their providers asked the participant&#x2019;s desire to proceed with LCS (recorded as Yes=1, or No=0). The total SDM process score ranges from 0 to 4, and a higher score indicates more SDM.</p></sec><sec id="s2-6-5"><title>LCS Knowledge</title><p>Participants&#x2019; LCS knowledge, such as benefits and harms of LCS, was measured at baseline and follow-up using 9 questions adapted from a previous study (Table S2 in <xref ref-type="supplementary-material" rid="app1">Multimedia Appendix 1</xref>) [<xref ref-type="bibr" rid="ref10">10</xref>]. We created the LCS knowledge score, with the number of correct responses ranging from 0 to 9.</p></sec><sec id="s2-6-6"><title>Decisional Conflict</title><p>Decisional conflict was measured with the 10-item Decisional Conflict Scale (DCS) in baseline and follow-up surveys [<xref ref-type="bibr" rid="ref21">21</xref>,<xref ref-type="bibr" rid="ref22">22</xref>]. The DCS score ranges from 0 (no conflict) to 100 (high conflict), and a score lower than 25 is associated with implementing a decision.</p></sec><sec id="s2-6-7"><title>Stage of Decision-Making</title><p>The stage of decision-making was assessed with the &#x201C;Stage of Decision Making&#x201D; tool at baseline and in follow-up surveys [<xref ref-type="bibr" rid="ref23">23</xref>]. The stage of decision-making is the individual&#x2019;s readiness to engage in decision-making, progress in making a choice, and willingness to consider or reconsider options. We measured the stage of decision-making because the individual may respond differently to decision support or need different decision support depending on their stage of decision-making.</p></sec><sec id="s2-6-8"><title>LCS Uptake</title><p>LDCT order, appointment, and completion data were collected from the EHR at 3 and 6 months after the PCP visit. We also measured regular chest CT completion at 6 months after the PCP visit.</p></sec></sec><sec id="s2-7"><title>Statistical Analysis</title><p>Since this is a pragmatic trial in a real-world primary care setting, we included all participants regardless of whether they received text messages, rescheduled their appointments, or had an LCS discussion with their providers during their visits, and conducted an intention-to-treat analysis. Descriptive statistics were computed for participants&#x2019; demographics, responses to surveys, and LDCT outcomes. Continuous variables were summarized as median and IQR. Categorical variables were summarized as frequencies and proportions. The proportions of smoking status, health literacy, and the baseline stage of decision-making were compared by Fisher exact test. We first compared the LCS knowledge and DCS scores between baseline and follow-up surveys in each group using the Wilcoxon rank-sum test. Then, we compared the changes in LCS knowledge and DCS scores from baseline to follow-up surveys and SDM process scores between the groups by the Wilcoxon rank-sum test, and LCS discussion and LCS uptake between the arms by Fisher exact test. In addition, we conducted sensitivity analyses of SDM, LCS knowledge, and DCS scores among participants who reported LCS discussions with their providers. All statistical analyses were conducted using Stata 18 (StataCorp LLC).</p></sec><sec id="s2-8"><title>Ethical Considerations</title><p>This study was approved by the University of Massachusetts Chan Medical School institutional review board. Consent forms were mailed to all interested potential participants. A waiver of documentation of consent was obtained from the Institutional Review Board; all participants provided verbal informed consent before participation. Participants were offered a US $25 gift card for completion of each study survey (baseline and follow-up). Study data were handled in pseudonymized form using a coded key, accessible only to the research team. All personal data were stored securely on encrypted University of Massachusetts Chan Medical School servers. No identifiable images or personal information are included in the paper or any supplemental materials.</p></sec></sec><sec id="s3" sec-type="results"><title>Results</title><sec id="s3-1"><title>Recruitment and Retention</title><p>The recruitment pool of 324 patients yielded 49 participants (19 in the DA group and 30 in the DA+TM group) with a recruitment rate of 15.4% (<xref ref-type="fig" rid="figure1">Figure 1</xref>). One participant in the DA+TM group could not receive text messages due to discontinuation of their text messaging plan. All participants had PCP visits. Notably, 4 (21%) participants in the DA group and 8 (27%) participants in the DA+TM group rescheduled their appointments. A total of 2 (11%) participants in the DA group had their appointment more than 4 weeks after the baseline survey. In the DA+TM group, 3 (10%) participants had their appointment within 2 weeks of the baseline survey, and 4 (13% ) participants had their appointment more than 5 weeks after the baseline survey. Overall, 16/19 (84%) participants in the DA group and 28/30 (93%) participants in the DA+TM group completed the follow-up survey. Due to appointment changes and participants&#x2019; availability, 2/16 participants in the DA group and 4/28 participants in the DA+TM group completed a follow-up survey more than 7 days after the PCP visit. For LCS uptake, that is, LDCT order and completion, we excluded 1 participant in the DA + TM group who passed away within 3 months after the PCP visit and included 19 participants in the DA group and 29 participants in the DA + TM group.</p><fig position="float" id="figure1"><label>Figure 1.</label><caption><p>CONSORT (Consolidated Standards of Reporting Trials) flowchart. DA: decision aid; EHR: electronic health record; PCP: primary care provider; TM: text message.</p></caption><graphic alt-version="no" mimetype="image" position="float" xlink:type="simple" xlink:href="formative_v9i1e69044_fig01.png"/></fig></sec><sec id="s3-2"><title>Study Population</title><p><xref ref-type="table" rid="table2">Table 2</xref> describes participant characteristics. Participants were predominantly White, with 58% (28/48) female and a median age of 61 (IQR 57&#x2010;65) years. In terms of smoking status, 47% (9/19) of the participants in the DA group and 69% (20/29) of the participants in the DA+TM group reported currently smoking (<italic>P</italic>=.23). Regarding health literacy, 16% (3/19) of the participants in the DA group and 31% (9/29) of the participants in the DA+TM group reported limited reading health literacy (<italic>P</italic>=.32), and 53% (10/19) of the participants in the DA group and 76% (22/29) of the participants in the DA+TM group reported limited listening literacy (<italic>P</italic>=.12).</p><table-wrap id="t2" position="float"><label>Table 2.</label><caption><p>Participant characteristics.</p></caption><table id="table2" frame="hsides" rules="groups"><thead><tr><td align="left" valign="bottom">Characteristics</td><td align="left" valign="bottom">DA<sup><xref ref-type="table-fn" rid="table2fn1">a</xref></sup> group (n=19)</td><td align="left" valign="bottom">DA+TM<sup><xref ref-type="table-fn" rid="table2fn2">b</xref></sup> group (n=29)</td></tr></thead><tbody><tr><td align="left" valign="top">Age in years, median (IQR)</td><td align="left" valign="top">60 (57-64)</td><td align="left" valign="top">62 (56-68)</td></tr><tr><td align="left" valign="top" colspan="3">Sex, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Female</td><td align="left" valign="top">13 (68)</td><td align="left" valign="top">15 (52)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Male</td><td align="left" valign="top">6 (32)</td><td align="left" valign="top">14 (48)</td></tr><tr><td align="left" valign="top" colspan="3">Race, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>White</td><td align="left" valign="top">18 (95)</td><td align="left" valign="top">27 (93)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Black</td><td align="left" valign="top">0 (0)</td><td align="left" valign="top">0 (0)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Native American or Alaska Native</td><td align="left" valign="top">0 (0)</td><td align="left" valign="top">1 (3)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Other</td><td align="left" valign="top">1 (5)</td><td align="left" valign="top">1 (3)</td></tr><tr><td align="left" valign="top" colspan="3">Ethnicity, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Hispanic or Latino</td><td align="left" valign="top">1 (5)</td><td align="left" valign="top">2 (7)</td></tr><tr><td align="left" valign="top" colspan="3">Annual income (US $), n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>&#x003C;30,000</td><td align="left" valign="top">8 (42)</td><td align="left" valign="top">12 (41)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>30,000-59,999</td><td align="left" valign="top">6 (32)</td><td align="left" valign="top">9 (31)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>60,000-99,999</td><td align="left" valign="top">3 (16)</td><td align="left" valign="top">2 (7)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>&#x003E;100,000</td><td align="left" valign="top">0 (0)</td><td align="left" valign="top">0 (0)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Prefer not to answer</td><td align="left" valign="top">2 (11)</td><td align="left" valign="top">6 (21)</td></tr><tr><td align="left" valign="top" colspan="3">Education level, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>High school graduate or less</td><td align="left" valign="top">6 (32)</td><td align="left" valign="top">13 (45)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Some college</td><td align="left" valign="top">8 (42)</td><td align="left" valign="top">8 (28)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Associate degree</td><td align="left" valign="top">3 (16)</td><td align="left" valign="top">1 (3)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Bachelor&#x2019;s degree</td><td align="left" valign="top">2 (11)</td><td align="left" valign="top">6 (21)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Advanced college degree</td><td align="left" valign="top">0 (0)</td><td align="left" valign="top">1 (3)</td></tr><tr><td align="left" valign="top">Limited reading health literacy, n (%)</td><td align="left" valign="top">3 (16)</td><td align="left" valign="top">9 (31)</td></tr><tr><td align="left" valign="top">Limited listening health literacy, n (%)</td><td align="left" valign="top">10 (53)</td><td align="left" valign="top">22 (76)</td></tr><tr><td align="left" valign="top" colspan="3">Technology use, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Smartphone ownership</td><td align="left" valign="top">18 (95)</td><td align="left" valign="top">23 (79)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Regular email usage</td><td align="left" valign="top">14 (74)</td><td align="left" valign="top">19 (66)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Text message usage</td><td align="left" valign="top">18 (95)</td><td align="left" valign="top">27 (93)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Previous patient portal usage</td><td align="left" valign="top">14 (74)</td><td align="left" valign="top">21 (72)</td></tr><tr><td align="left" valign="top" colspan="3">Smoking status, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Current</td><td align="left" valign="top">9 (47)</td><td align="left" valign="top">20 (69)</td></tr><tr><td align="left" valign="top">Smoking duration by pack-year, median (IQR)</td><td align="left" valign="top">44 (33-52.5)</td><td align="left" valign="top">52 (33.5-52)</td></tr><tr><td align="left" valign="top" colspan="3">General health, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Excellent</td><td align="left" valign="top">3 (16)</td><td align="left" valign="top">1 (3)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Very good</td><td align="left" valign="top">1 (5)</td><td align="left" valign="top">4 (14)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Good</td><td align="left" valign="top">7 (37)</td><td align="left" valign="top">9 (31)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Fair</td><td align="left" valign="top">6 (32)</td><td align="left" valign="top">12 (41)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Poor</td><td align="left" valign="top">2 (11)</td><td align="left" valign="top">3 (10)</td></tr><tr><td align="left" valign="top" colspan="3">Mental health, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Excellent</td><td align="left" valign="top">3 (16)</td><td align="left" valign="top">5 (17)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Very good</td><td align="left" valign="top">4 (21)</td><td align="left" valign="top">5 (17)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Good</td><td align="left" valign="top">8 (42)</td><td align="left" valign="top">9 (31)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Fair</td><td align="left" valign="top">3 (16)</td><td align="left" valign="top">6 (21)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Poor</td><td align="left" valign="top">1 (5)</td><td align="left" valign="top">4 (14)</td></tr><tr><td align="left" valign="top">Family history of lung cancer, n (%)</td><td align="left" valign="top">10 (53)</td><td align="left" valign="top">13 (45)</td></tr><tr><td align="left" valign="top" colspan="3">Perceived lung cancer risk<sup><xref ref-type="table-fn" rid="table2fn3">c</xref></sup>, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Very low</td><td align="left" valign="top">3 (16)</td><td align="left" valign="top">5 (18)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Somewhat low</td><td align="left" valign="top">5 (26)</td><td align="left" valign="top">2 (7)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Moderate</td><td align="left" valign="top">5 (26)</td><td align="left" valign="top">10 (36)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Somewhat high</td><td align="left" valign="top">4 (21)</td><td align="left" valign="top">9 (32)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Very high</td><td align="left" valign="top">2 (11)</td><td align="left" valign="top">2 (7)</td></tr></tbody></table><table-wrap-foot><fn id="table2fn1"><p><sup>a</sup>DA: decision aid.</p></fn><fn id="table2fn2"><p><sup>b</sup>TM: text message.</p></fn><fn id="table2fn3"><p><sup>c</sup>n=1 missing data in the DA+TM group.</p></fn></table-wrap-foot></table-wrap></sec><sec id="s3-3"><title>DA and Text Message Engagement</title><p>In the DA group, 63% (10/16) of the participants reported reading all or most of the DA while in the DA+TM group, 57% (16/28) of the participants reported reading all or most of the DA, and 21% (6/28) of the participants reported reading none of it (<xref ref-type="table" rid="table3">Table 3</xref>). In the DA+TM group, 75% (21/28) of the participants reported reading all or most of the text messages, and only 39% (11/28) of the participants reported using the link to access the DA. Among the 6 participants who did not read a mailed DA at all in the DA+TM group, none accessed DA from the links provided in the text messages. However, 5 participants read all or most of the text messages, while 1 participant read only a few of the text messages. In summary, 63% (10/16) of the participants in the DA group reported reading all or most of the mailed DA and 82% (23/28) of the participants in the DA+TX group reported reading all or most of the mailed DA or the text messages (<italic>P</italic>=.17).</p><table-wrap id="t3" position="float"><label>Table 3.</label><caption><p>Patient self-report engagement in the intervention.</p></caption><table id="table3" frame="hsides" rules="groups"><thead><tr><td align="left" valign="bottom">DA<sup><xref ref-type="table-fn" rid="table3fn1">a</xref></sup> and TM<sup><xref ref-type="table-fn" rid="table3fn2">b</xref></sup> engagement</td><td align="left" valign="bottom">DA group (n=16)</td><td align="left" valign="bottom">DA+TM group (n=28)</td></tr></thead><tbody><tr><td align="left" valign="top" colspan="3">Decision-aid reading, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>All or most</td><td align="left" valign="top">10 (63)</td><td align="left" valign="top">16 (57)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Some or a little</td><td align="left" valign="top">6 (38)</td><td align="left" valign="top">4 (14)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>None</td><td align="left" valign="top">0 (0)</td><td align="left" valign="top">6 (21)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Did not receive, do not remember</td><td align="left" valign="top">0 (0)</td><td align="left" valign="top">2 (7)</td></tr><tr><td align="left" valign="top" colspan="3">Text message reading, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>All or most</td><td align="left" valign="top">&#x2014;<sup><xref ref-type="table-fn" rid="table3fn3">c</xref></sup></td><td align="left" valign="top">21 (75)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Some or a few</td><td align="left" valign="top">&#x2014;</td><td align="left" valign="top">6 (21)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>None</td><td align="left" valign="top">&#x2014;</td><td align="left" valign="top">0 (0)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Could not receive text messages</td><td align="left" valign="top">&#x2014;</td><td align="left" valign="top">1 (4)</td></tr></tbody></table><table-wrap-foot><fn id="table3fn1"><p><sup>a</sup>DA: decision aid.</p></fn><fn id="table3fn2"><p><sup>b</sup>TM: text message.</p></fn><fn id="table3fn3"><p><sup>c</sup>Not applicable.</p></fn></table-wrap-foot></table-wrap></sec><sec id="s3-4"><title>LCS Discussion and SDM</title><p>Most participants (94%, 15/16 in the DA group and 82%, 23/28 in the DA+TM group) reported having an LCS conversation with their PCPs during the visit (<italic>P</italic>=.39). Furthermore, 56% (9/16) of the participants in the DA group and 57% (16/28) of the participants in the DA+TM group stated they initiated the LCS conversation (<italic>P</italic>=1.00). In terms of the provider&#x2019;s LCS recommendation, 63% (10/16) of the participants in the DA group and 61% (17/28) of the participants in the DA+TM group reported receiving recommendations from their providers (<italic>P</italic>=1.00). With the exception of 1 participant in the DA+TM group who was advised not to undergo LCS, 26/27 participants in the 2 groups were recommended for LCS.</p><p>The median of the SDM process score measuring degree of SDM (with 0 being low and 4 being high) was 3.0 (IQR 1.5&#x2010;4.0) in the DA group (n=16) and 2.0 (IQR 1.0&#x2010;3.0) in the DA+TM group (n=26 due to 2 missing data; <italic>P</italic>=.11).</p></sec><sec id="s3-5"><title>LCS Knowledge</title><p>The median patient LCS knowledge score in the DA group was 5 of 9 (IQR 4&#x2010;6) at baseline and 5 of 9 (IQR, 4.5&#x2010;7) at follow-up, without significant change (<italic>P</italic>=.23). On the other hand, the median patient LCS knowledge in the DA+TM group significantly improved from 4.5 (IQR 3&#x2010;6) at baseline to 6 (IQR 5&#x2010;6) at follow-up (<italic>P</italic>=.003; <xref ref-type="fig" rid="figure2">Figure 2</xref>). However, there was no statistically significant difference in the change of LCS knowledge score from baseline to follow-up between the 2 groups (DA: 0.5, IQR &#x2013;1 to 2.5) and DA+TM: 1.5, IQR 0&#x2010;3; <italic>P</italic>=.24). Details about performance by group on specific LCS knowledge questions are provided in Table S2 in <xref ref-type="supplementary-material" rid="app1">Multimedia Appendix 1</xref>.</p><fig position="float" id="figure2"><label>Figure 2.</label><caption><p>Lung cancer screening knowledge at the baseline and follow-up surveys. Boxes indicate 25th to 75th percentile. Dots indicate an outlier. DA: decision aid; LCS: lung cancer screening; TM: text messages. Lines indicate a median.</p></caption><graphic alt-version="no" mimetype="image" position="float" xlink:type="simple" xlink:href="formative_v9i1e69044_fig02.png"/></fig></sec><sec id="s3-6"><title>Decisional Conflict</title><p>The total median DCS decreased significantly from 40 (IQR 20.0&#x2010;70.0) at baseline to 0 (IQR 0&#x2010;15.0) at follow-up in the DA group (n=15 with 1 missing data; <italic>P</italic>&#x003C;.001) and from 50.0 (IQR 32.5&#x2010;65.0) to 20 (IQR 0&#x2010;42.5) in the DA+TM group (<italic>P</italic>&#x003C;.001; <xref ref-type="fig" rid="figure3">Figure 3</xref>). The median change of the total DCS was 25.0 (IQR 15.0&#x2010;50.0) in the DA group and 20.0 (IQR 10.0&#x2010;47.5) in the DA+TM group (<italic>P</italic>=.50). A DCS of less than 25 means the participants were ready to make a decision. At baseline, 31.3% (5/16) of the participants in the DA group and 14.3% (4/18) of the participants in the DA+TM group had a total DCS less than 25 (<italic>P</italic>=.25). At follow-up, 80% (12/15, n=1 missing data) of the participants in the DA group and 50% (14/28) of the participants in the DA+TM group had the total DCS less than 25 (<italic>P</italic>=.10). Figures S1 and Table S3 in <xref ref-type="supplementary-material" rid="app1">Multimedia Appendix 1</xref> describe the Informed, Value, Support, and Uncertainty subscales.</p><fig position="float" id="figure3"><label>Figure 3.</label><caption><p>Decisional conflict scale at the baseline and follow-up surveys. Lines indicate a median. Boxes indicate 25th to 75th percentile. Dots indicate an outlier. DA: decision aid, DCS: decisional conflict scale; TM: text messages.</p></caption><graphic alt-version="no" mimetype="image" position="float" xlink:type="simple" xlink:href="formative_v9i1e69044_fig03.png"/></fig></sec><sec id="s3-7"><title>Stage of Decision-Making</title><p>At baseline, the participants were at diverse stages of decision-making about LCS. Among the participants in the DA group, 19% (3/16) of the participants had not begun to think about the choices, 50% (8/16) of the participants were considering the options, and 25% (4/16) of the participants had already made a decision and were unlikely to change their minds (<xref ref-type="fig" rid="figure4">Figure 4</xref>). Among the participants in the DA+TM group, 43% (12/28) of the participants had not begun to think about the choices, 25% (7/28) of the participants were considering the options, and 11% (3/28) of the participants had already made a decision and were unlikely to change their minds. There was no statistically significant difference in the baseline stages of decision-making between the 2 groups (<italic>P</italic>=.07). The stage of decision-making shifted toward decision-making at follow-up in both groups, and 79% (11/14, 2 missing data) of the participants in the DM group and 64% (18/28) of the participants in the DA+TM group stated that they had already made a decision and were unlikely to change their mind.</p><fig position="float" id="figure4"><label>Figure 4.</label><caption><p>Stage of decision making at the baseline and follow-up surveys. DA: decision aid, TM: text messages.</p></caption><graphic alt-version="no" mimetype="image" position="float" xlink:type="simple" xlink:href="formative_v9i1e69044_fig04.png"/></fig></sec><sec id="s3-8"><title>LCS Uptake</title><p><xref ref-type="table" rid="table4">Table 4</xref> describes LDCT ordering, scheduling, and completion rates at 3 and 6 months after the index PCP visit. Within 3 months after the index PCP visit, 26% (5/19) of the participants in the DA group and 48% (14/29) of the participants in the DA+TM group had LDCT orders (<italic>P</italic>=.15), and 5% (1/19) of the participants in the DA group and 31% (9/29) of the participants in the DA+TM group completed LDCT for LCS (<italic>P</italic>=.07). Within 6 months after the index PCP visit, 26% (5/19) of the participants in the DA group and 34% (10/29) of the participants in the DA+TM group completed LDCT for LCS (<italic>P</italic>=.75). Also, 2 participants in each group had chest CT for other indications during the study period.</p><table-wrap id="t4" position="float"><label>Table 4.</label><caption><p>Lung cancer screening uptake.</p></caption><table id="table4" frame="hsides" rules="groups"><thead><tr><td align="left" valign="bottom">LDCT<sup><xref ref-type="table-fn" rid="table4fn1">a</xref></sup> for LCS<sup><xref ref-type="table-fn" rid="table4fn2">b</xref></sup></td><td align="left" valign="bottom">DA<sup><xref ref-type="table-fn" rid="table4fn3">c</xref></sup> group (n=19)</td><td align="left" valign="bottom">DA+TM<sup><xref ref-type="table-fn" rid="table4fn4">d</xref></sup> group (n=29)</td><td align="left" valign="bottom"><italic>P</italic> value</td></tr></thead><tbody><tr><td align="left" valign="top" colspan="4">3 months after PCP<sup><xref ref-type="table-fn" rid="table4fn5">e</xref></sup> visit, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Order</td><td align="left" valign="top">5 (26)</td><td align="left" valign="top">14 (48)</td><td align="left" valign="top">.15</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Appointment</td><td align="left" valign="top">3 (16)</td><td align="left" valign="top">12 (41)</td><td align="left" valign="top">.11</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Completion</td><td align="left" valign="top">1 (5)</td><td align="left" valign="top">9 (31)</td><td align="left" valign="top">.07</td></tr><tr><td align="left" valign="top" colspan="4">6 months after PCP visit, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Order</td><td align="left" valign="top">7 (37)</td><td align="left" valign="top">14 (48)</td><td align="left" valign="top">.56</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Appointment</td><td align="left" valign="top">7 (37)</td><td align="left" valign="top">13 (45)</td><td align="left" valign="top">.77</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>Completion</td><td align="left" valign="top">5 (26)</td><td align="left" valign="top">10 (34)</td><td align="left" valign="top">.75</td></tr><tr><td align="left" valign="top" colspan="4">Chest CT<sup><xref ref-type="table-fn" rid="table4fn6">f</xref></sup>, n (%)</td></tr><tr><td align="left" valign="top"><named-content content-type="indent">&#x00A0;&#x00A0;&#x00A0;&#x00A0;</named-content>6 months from PCP visit</td><td align="left" valign="top">2 (11)</td><td align="left" valign="top">2 (7)</td><td align="left" valign="top">1.00</td></tr></tbody></table><table-wrap-foot><fn id="table4fn1"><p><sup>a</sup>LDCT: low-dose computed tomography.</p></fn><fn id="table4fn2"><p><sup>b</sup>LCS: lung cancer screening.</p></fn><fn id="table4fn3"><p><sup>c</sup>DA: decision aid.</p></fn><fn id="table4fn4"><p><sup>d</sup>TM: text message.</p></fn><fn id="table4fn5"><p><sup>e</sup>PCP: primary care provider.</p></fn><fn id="table4fn6"><p><sup>f</sup>CT: computed tomography.</p></fn></table-wrap-foot></table-wrap></sec><sec id="s3-9"><title>Sensitivity Analysis of the Participants Who Reported LCS Discussion</title><p>Tables S4-S6 and Figures S2 and S3 in <xref ref-type="supplementary-material" rid="app1">Multimedia Appendix 1</xref> describe the results of the sensitivity analysis of SDM, LCS knowledge, decision conflict, and LCS uptake among participants who reported LCS discussion during their PCP visit. Our findings of SDM, LCS knowledge, decisional conflict, and LCS uptake were similar between our sensitivity and primary analyses among all participants.</p></sec></sec><sec id="s4" sec-type="discussion"><title>Discussion</title><sec id="s4-1"><title>Principal Findings</title><p>We successfully conducted a sequential quasi-experimental pilot study to evaluate the feasibility and to explore potential outcomes of the previsit preparation strategies for SDM in LCS in primary care settings. Our study protocol appeared to be feasible, given that our recruitment rate was similar to that of other studies evaluating the effectiveness of a DA for LCS in primary care settings [<xref ref-type="bibr" rid="ref24">24</xref>,<xref ref-type="bibr" rid="ref25">25</xref>] and the retention rate was high. We found that previsit preparation using a mailed DA with or without automated text messaging was feasible. Most participants in both groups reported discussing LCS with their provider. Patient decision conflict was significantly reduced in both groups from baseline to follow-up. We observed significant improvement in LCS knowledge among the participants in the DA+TM group, but not among those in the DA group. These findings provide promising preliminary signals on the potential of the enhanced previsit preparation using text messaging to broadly reach patients eligible for LCS and to improve informed decision-making and uptake of LCS. However, the degree of SDM remained limited in both groups.</p><p>LCS discussion rates in our study exceeded 80% in both groups, surpassing the 60% rates reported in a previous study about SDM in LCS [<xref ref-type="bibr" rid="ref25">25</xref>]. Furthermore, approximately 60% of the participants in our study reported initiating the LCS conversation. Although the exact reason for the high LCS discussion rates is unclear, receiving the information in advance rather than immediately before their PCP visit might have provided more time for patients to think about and prepare for LCS discussions with their providers.</p><p>In our pilot study, the 6 participants who did not read DAs reported reading text messages. This finding supports the high acceptability of text messages observed during the development of the LCS text messages and aligns with prior studies showing similar acceptability for text messages to support SDM for colon cancer screening among individuals diverse in income, race, and health literacy [<xref ref-type="bibr" rid="ref26">26</xref>]. Individuals with low income and limited health literacy often need assistance to review DAs [<xref ref-type="bibr" rid="ref10">10</xref>]. Thus, text messages have the potential to improve the reach and engagement of broader LCS-eligible populations in SDM.</p><p>In the DA+TM group, patient LCS knowledge significantly improved at follow-up, despite 31% reporting limited health literacy. Presenting new information in small doses in a sequential manner may have decreased cognitive load for learners, especially for those with limited health literacy [<xref ref-type="bibr" rid="ref27">27</xref>,<xref ref-type="bibr" rid="ref28">28</xref>]. However, the participants in both groups still had a deficit of detailed knowledge on the potential harms of LCS and the limited degree of SDM, which may reflect more on providers&#x2019; practice than patients&#x2019; factors. Improving patient understanding and SDM may require a provider-level intervention in addition to this patient-facing previsit intervention.</p></sec><sec id="s4-2"><title>Comparison With Prior Work</title><p>Despite the CMS mandate, how best to reach and support patients eligible for LCS in SDM in primary care settings is unknown. Various DAs for LCS have been shown to improve patient knowledge and decrease decisional conflict in study settings [<xref ref-type="bibr" rid="ref9">9</xref>]. Web-based DAs increased the uptake of LCS in primary care settings but did not improve the quality of SDM in previous randomized controlled trials (RCTs) [<xref ref-type="bibr" rid="ref24">24</xref>,<xref ref-type="bibr" rid="ref25">25</xref>]. Still, adoption of DAs in real-world clinical settings remains challenging [<xref ref-type="bibr" rid="ref29">29</xref>].</p><p>Our pilot study differed from previous studies in 2 main ways [<xref ref-type="bibr" rid="ref24">24</xref>,<xref ref-type="bibr" rid="ref25">25</xref>]. First, we used an automated text messaging system as a channel to reach and deliver information to patients. Second, we delivered a DA and text messaging program to the participants outside of clinical and study visits, whereas previous RCTs delivered DAs during the study visit right before the primary care visit [<xref ref-type="bibr" rid="ref24">24</xref>,<xref ref-type="bibr" rid="ref25">25</xref>]. This approach is potentially more feasible in real-world clinical settings with limited resources.</p></sec><sec id="s4-3"><title>Limitations</title><p>This study has some limitations. First, our participants were predominantly White and from a single health care system, limiting generalizability. However, our participants were diverse in socioeconomic status. Second, the sample size of this pilot study was small and there was an imbalance between the 2 groups. Third, there may have been differences in participants&#x2019; characteristics and stages of decision-making between the 2 groups that could have affected the outcomes. In addition, the temporal effect of the COVID-19 pandemic and unmeasured providers&#x2019; characteristics and SDM practices may have affected the outcomes due to the sequential design of the study. Thus, comparability and statistical power for between-group analyses of participants&#x2019; characteristics and outcomes are limited. A RCT with a larger sample size powered to detect clinically meaningful differences between groups is needed for further evaluation. Still, our pilot study demonstrated interesting preliminary findings to explore how to help patients prepare for LCS discussions prior to their primary care visits.</p></sec><sec id="s4-4"><title>Conclusions</title><p>An enhanced previsit preparation strategy using an automated text messaging program is feasible in primary care settings and potentially effective in reaching and engaging the broader LCS-eligible population in SDM for LCS. Our pilot study suggests that a previsit automated text messaging program combined with a mailed DA may improve basic LCS knowledge without exacerbating disparities related to the digital divide or health literacy level. Previsit preparation enhanced by a text messaging program may facilitate SDM discussions about LCS and ultimately increase LCS uptake.</p></sec></sec></body><back><ack><p>This study was supported by the National Heart, Lung, and Blood Institute (grant 1K12HL138049-01) and the National Center for Advancing Translational Science (grant UL1TR001453). The authors thank Dr Kristina Crother for sharing the knowledge questions. Grammarly was used to correct grammatical errors. MIF&#x2019;s effort is supported by the National Heart, Lung, and Blood Institute (grant 1K12HL138049-01) and the National Cancer Institute of the National Institutes of Health (award K08CA283304). RSW is supported in part by resources from the VA Boston Healthcare System.</p><p>The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the US government. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.</p></ack><notes><sec><title>Data Availability</title><p>The datasets for this manuscript are available from the corresponding author upon reasonable request and institutional review board approval.</p></sec></notes><fn-group><fn fn-type="conflict"><p>AAB is a consultant to Daiichi Pharmaceuticals, AstraZeneca, and AbbVie.</p></fn></fn-group><glossary><title>Abbreviations</title><def-list><def-item><term id="abb1">CMS</term><def><p>Centers for Medicare &#x0026; Medicaid Services</p></def></def-item><def-item><term id="abb2">CONSORT</term><def><p>Consolidated Standards of Reporting Trials</p></def></def-item><def-item><term id="abb3">CT</term><def><p>computed tomography</p></def></def-item><def-item><term id="abb4">DA</term><def><p>decision aid</p></def></def-item><def-item><term id="abb5">DCS</term><def><p>Decisional Conflict Scale</p></def></def-item><def-item><term id="abb6">EHR</term><def><p>electronic health record</p></def></def-item><def-item><term id="abb7">LCS</term><def><p>lung cancer screening</p></def></def-item><def-item><term id="abb8">LDCT</term><def><p>low&#x2010;dose computed tomography</p></def></def-item><def-item><term id="abb9">PCP</term><def><p>primary care provider</p></def></def-item><def-item><term id="abb10">RCT</term><def><p>randomized controlled trial</p></def></def-item><def-item><term id="abb11">SDM</term><def><p>shared decision-making</p></def></def-item></def-list></glossary><ref-list><title>References</title><ref id="ref1"><label>1</label><nlm-citation citation-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>L&#x00E9;gar&#x00E9;</surname><given-names>F</given-names> </name><name name-style="western"><surname>Witteman</surname><given-names>HO</given-names> </name></person-group><article-title>Shared decision making: examining key 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